Trial | Phase | Enrollment | Study Type | Start Date | Status |
A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Clinical Activity of Durvalumab in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) or With Lenalidomide Plus R-CHOP (R2-CHOP) in Subjects With [NCT03003520] | Phase 2 | 46 participants (Actual) | Interventional | 2017-02-28 | Completed |
An Open-label, Prospective, Randomized, Controlled Clinical Trial of the Use of Reduced Duration Versus Standard Duration Steroid Replacement Therapy for Acute Adrenal Insufficiency in Patients With Septic Shock [NCT00842933] | Phase 4 | 32 participants (Anticipated) | Interventional | 2007-05-31 | Terminated(stopped due to Unable to meet enrollment goal prior to PI transfer) |
Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial [NCT02367118] | Phase 3 | 90 participants (Anticipated) | Interventional | 2015-06-30 | Recruiting |
Effect of Prednisone and Aspirin on Pregnancy Outcomes After Embryo Transfer Among Patients With Thyroid Autoimmunity: a Randomized Clinical Trial [NCT05578456] | Phase 4 | 540 participants (Anticipated) | Interventional | 2022-11-01 | Not yet recruiting |
A Randomized Phase II Study of OGX-427 (a Second-Generation Antisense Oligonucleotide to Heat Shock Protein-27) in Patients With Castration Resistant Prostate Cancer Who Have Not Previously Received Chemotherapy for Metastatic Disease [NCT01120470] | Phase 2 | 74 participants (Actual) | Interventional | 2010-09-30 | Completed |
A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer [NCT00411528] | Phase 2 | 185 participants (Actual) | Interventional | 2006-09-30 | Completed |
The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach [NCT01933724] | Phase 3 | 12 participants (Actual) | Interventional | 2014-02-17 | Active, not recruiting |
Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency [NCT02565680] | Phase 2/Phase 3 | 100 participants (Actual) | Interventional | 2012-02-29 | Completed |
Comparing Two Dosing Regimens of the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus [NCT06124703] | | 162 participants (Anticipated) | Interventional | 2023-11-10 | Not yet recruiting |
Multi-center Randomized Study to Compare Efficacy and Safety of Decitabine Plus CHOP (D-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT03553537] | Phase 3 | 100 participants (Anticipated) | Interventional | 2018-06-30 | Not yet recruiting |
A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus [NCT00539838] | Phase 3 | 33 participants (Actual) | Interventional | 2007-12-19 | Terminated(stopped due to The study was terminated prematurely when the decision was made that ocrelizumab was not likely to benefit this patient population.) |
S1312, A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination With CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients With Relapsed/Refractory CD22-Positive Acute Leukemia (Including B-ALL, Mixed Phenotypic Leukemia, and Burkitt's [NCT01925131] | Phase 1 | 50 participants (Actual) | Interventional | 2014-06-13 | Completed |
Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial [NCT00088530] | Phase 3 | 140 participants (Actual) | Interventional | 2004-07-31 | Completed |
A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies [NCT01054313] | Phase 1 | 103 participants (Actual) | Interventional | 2010-01-31 | Completed |
A Multicenter, Open-label, Phase Ii Study of Dasatinib in Combination With Melphalan and Prednisone (D-MP) in Advanced, Relapsed / Refractory Multiple Myeloma Patients [NCT01116128] | Phase 2 | 8 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to difficulty in enrolling patients) |
ALinC 17, Classification ©), B-precursor Induction Treatment (I) [NCT01225874] | | 3,762 participants (Actual) | Interventional | 1999-12-31 | Completed |
Medical Therapy in Idiopathic Retroperitoneal Fibrosis: a Multicenter, Randomized, Controlled Trial of Prednisone vs Low-dose Prednisone Plus Methotrexate [NCT01240850] | Phase 3 | 200 participants (Anticipated) | Interventional | 2007-05-31 | Recruiting |
EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial [NCT02858804] | Phase 4 | 55 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
A Phase 2, Randomized, Non-Comparative, Two-Arm Open Label, Multiple-Center Study Of CP-751,871 In Combination With Docetaxel/Prednisone In Chemotherapy- Naive (Arm A) And Docetaxel/Prednisone Refractory (Arm B) Patients With Hormone Insensitive Prostate [NCT00313781] | Phase 2 | 204 participants (Actual) | Interventional | 2006-05-31 | Completed |
Allogeneic HSCT Without Preparative Chemotherapy or With Low-Intensity Preparative Chemotherapy Using Sirolimus and Sirolimus-Generated Donor Th2 Cells for Therapy of Refractory Leukemia, Lymphoma, Myeloma, or Myelodysplastic Syndrome [NCT00074490] | Phase 2 | 442 participants (Actual) | Interventional | 2004-01-01 | Terminated(stopped due to Premature closure due to inability to accrue to ARM IVD, cohorts 1 and 2) |
A Phase II Study of R-CHOP and Ibritumomab Tiuxetan (Zevalin) for Elderly Patients With Previously Untreated Diffuse Large B-Cell Lymphoma [NCT00058422] | Phase 2 | 65 participants (Actual) | Interventional | 2003-02-10 | Completed |
An Open Label Study Evaluating The Effect Of Single Doses Of PF-04171327 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects [NCT01199900] | Phase 1 | 18 participants (Actual) | Interventional | 2010-08-31 | Completed |
A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease [NCT00302003] | Phase 3 | 287 participants (Actual) | Interventional | 2006-02-28 | Completed |
Open-label Multi-center Randomized Non-inferiority Study to Compare Efficacy and Safety of Pegylated Liposomal Doxorubicin Versus Doxorubicin for Newly Diagnosed Peripheral T-cell Lymphoma [NCT03952572] | Phase 3 | 244 participants (Anticipated) | Interventional | 2019-05-10 | Recruiting |
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis [NCT00282347] | Phase 3 | 144 participants (Actual) | Interventional | 2006-01-31 | Completed |
Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids [NCT03974867] | | 72 participants (Anticipated) | Interventional | 2019-07-31 | Not yet recruiting |
A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia [NCT01345708] | Phase 2 | 23 participants (Actual) | Interventional | 2009-01-31 | Completed |
A Phase 1 and Phase 2 Study of Lenalidomide (Revlimid) in Combination With Cyclophosphamide (Endoxan) and Prednison (REP) in Relapsed/Refractory Multiple Myeloma [NCT01352338] | Phase 1/Phase 2 | 82 participants (Actual) | Interventional | 2011-08-31 | Completed |
"A Phase III Trial Comparing ARA-C/High-Dose Mitoxantrone (ALL-2') to A Standard Vincristine/Prednisone Based Regimen ('L-20') as Induction Therapy For Adult Patients With Acute Lymphoblastic Leukemia (ALL): The ALL-4 Protocol" [NCT00002766] | Phase 3 | 170 participants (Actual) | Interventional | 1996-03-31 | Completed |
Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study [NCT00026208] | Phase 2 | 76 participants (Actual) | Interventional | 2001-06-30 | Completed |
A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Prev [NCT06047080] | Phase 3 | 1,130 participants (Anticipated) | Interventional | 2023-09-18 | Recruiting |
A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular D [NCT05811351] | Phase 2 | 300 participants (Anticipated) | Interventional | 2023-03-06 | Recruiting |
An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer [NCT04577833] | Phase 1 | 136 participants (Actual) | Interventional | 2020-11-13 | Active, not recruiting |
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Re [NCT04497844] | Phase 3 | 696 participants (Actual) | Interventional | 2020-09-23 | Active, not recruiting |
A Phase 3, Multicenter, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High [NCT03217812] | Phase 3 | 220 participants (Actual) | Interventional | 2017-11-23 | Active, not recruiting |
Registry of IgA Nephropathy in Chinese Children [NCT03015974] | | 1,200 participants (Anticipated) | Observational [Patient Registry] | 2016-01-31 | Recruiting |
Gulf War Illness Inflammation Reduction Trial [NCT02506192] | Phase 2 | 83 participants (Actual) | Interventional | 2015-07-31 | Completed |
Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II [NCT00070018] | Phase 2 | 46 participants (Actual) | Interventional | 2004-02-29 | Completed |
A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia [NCT00227591] | Phase 2 | 48 participants (Actual) | Interventional | 2005-12-31 | Completed |
A Randomized, Open-label,Controlled Phase II b Study to Demonstrate Efficacy and Safety of Sirolimus Chronic Rejection After Lung Transplant [NCT04415476] | Phase 2 | 0 participants (Actual) | Interventional | 2020-06-30 | Withdrawn(stopped due to Study did not proceed to IRB approval.) |
A Phase 1b Clinical Trial of Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial) [NCT04477512] | Phase 1 | 18 participants (Actual) | Interventional | 2021-02-19 | Active, not recruiting |
Rituximab From the First Episode of Minimal Change Nephrotic Syndrome for Preventing Relapse Risk in Adult Patients: a Multicenter Randomized Controlled Trial [NCT03970577] | Phase 2 | 148 participants (Anticipated) | Interventional | 2020-07-29 | Recruiting |
A Bidimensional Early Intervention Strategy of Standard of Care Combined With Host Immunomodulation in Elderly Patients With Mild or Moderate COVID-19: A Multicentre, Randomized, Controlled, Adaptive Platform Study [NCT05855395] | | 5,815 participants (Anticipated) | Interventional | 2023-05-26 | Recruiting |
Prospective, Multi-center Phase I/II Trial of Lenalidomide and Dose-Adjusted EPOCH-R in MYC-Associated B-Cell Lymphomas [NCT02213913] | Phase 1/Phase 2 | 46 participants (Anticipated) | Interventional | 2014-07-29 | Active, not recruiting |
A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU) [NCT03847272] | Phase 2 | 29 participants (Anticipated) | Interventional | 2019-08-01 | Recruiting |
An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Pemphigus [NCT04598477] | Phase 3 | 213 participants (Anticipated) | Interventional | 2021-07-15 | Recruiting |
The Effect of Some Drugs Used in Treatment of Vasculitis on the Complement System in Children Attending Assiut University Hospital. [NCT03692416] | Phase 3 | 70 participants (Anticipated) | Interventional | 2018-11-11 | Active, not recruiting |
A Randomised, Double-Blind, Multicentre Phase Ⅲ Study to Evaluate Abiraterone Acetate Versus Placebo Combined With Prednisone in Subjects With Asymptomatic or Mild Symptoms Without Chemotherapy, Metastatic Castration Resistant Prostate Cancer. [NCT04056754] | Phase 3 | 268 participants (Actual) | Interventional | 2014-07-16 | Completed |
H-9926-LCH III: Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis [NCT00488605] | Phase 3 | 0 participants (Actual) | Interventional | 2023-08-01 | Withdrawn(stopped due to This is a duplicate record and the sponsor has registered the study.) |
CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial [NCT01210677] | Phase 4 | 0 participants (Actual) | Interventional | 2014-04-30 | Withdrawn(stopped due to No funding obtained.) |
An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy [NCT01217697] | | 0 participants | Expanded Access | | Approved for marketing |
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis [NCT03600805] | Phase 3 | 83 participants (Actual) | Interventional | 2018-11-20 | Terminated(stopped due to Protracted recruitment timeline exacerbated by COVID-19 pandemic) |
A Trial to Evaluate the Long Term Prognosis in Rosai-Dorfman Disease [NCT05284942] | Phase 4 | 20 participants (Anticipated) | Interventional | 2011-10-01 | Recruiting |
"Randomized Phase II Study Evaluating the Feasibility of a Chemotherapy With Docetaxel-Prednisone in a Weekly Schedule or Every 3 Weeks, for Castration-resistant Metastatic Prostate Cancer Elderly Patients (>=75), Vulnerable or Frail , as Defined by the C [NCT01254513] | Phase 2 | 66 participants (Actual) | Interventional | 2010-12-09 | Completed |
GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease [NCT03584516] | Phase 2/Phase 3 | 155 participants (Actual) | Interventional | 2019-01-17 | Active, not recruiting |
Research Institute of Nephrology, Jinling Hospital [NCT01161459] | | 100 participants (Anticipated) | Interventional | 2010-06-30 | Completed |
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. [NCT01269021] | | 176 participants (Actual) | Interventional | 2010-11-30 | Completed |
A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer [NCT00288080] | Phase 3 | 612 participants (Actual) | Interventional | 2005-12-31 | Completed |
A Phase III, Multicenter, Open-Label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL [NCT01287741] | Phase 3 | 1,418 participants (Actual) | Interventional | 2011-07-26 | Terminated(stopped due to The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.) |
Pilot Study of Idiotype Vaccine and EPOCH-Rituximab Chemotherapy in Untreated Mantle Cell Lymphoma [NCT00005780] | Phase 2 | 26 participants (Actual) | Interventional | 2000-06-01 | Completed |
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study [NCT05959720] | | 180 participants (Anticipated) | Observational [Patient Registry] | 2023-09-05 | Recruiting |
A Dose Escalation and Expansion Study of the Safety and Pharmacokinetics of XL102 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors [NCT04726332] | Phase 1 | 373 participants (Anticipated) | Interventional | 2021-02-10 | Recruiting |
A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects [NCT03750383] | Phase 1 | 48 participants (Actual) | Interventional | 2018-11-02 | Completed |
IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA [NCT02451748] | Phase 4 | 32 participants (Actual) | Interventional | 2015-08-31 | Completed |
A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma [NCT04484506] | Phase 2 | 150 participants (Anticipated) | Interventional | 2011-10-20 | Recruiting |
Efficacy of Consolidative Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Limited-stage Follicular Lymphoma: Wuhan University Cancer Center -NHL01 Trial [NCT02449252] | Phase 3 | 120 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
Leflunomide Treatment for IgG4-RD [NCT03715699] | | 70 participants (Anticipated) | Interventional | 2018-07-01 | Recruiting |
A Phase I/II Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib in Patients With Metastatic Castration-resistant Prostate Cancer Following Standard of Care Treatment [NCT04060394] | Phase 1/Phase 2 | 74 participants (Anticipated) | Interventional | 2019-09-13 | Active, not recruiting |
Prospective Study of Rituximab Combined With Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia [NCT01358253] | Phase 4 | 100 participants (Actual) | Interventional | 2010-12-31 | Completed |
A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study With Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys With Duchenne Muscular Dystrophy (DMD) [NCT03439670] | Phase 2 | 121 participants (Actual) | Interventional | 2018-06-29 | Completed |
Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial [NCT05188911] | | 30 participants (Anticipated) | Observational | 2020-07-15 | Recruiting |
A Three-arm, Multicenter, Open-label Randomized Controlled Trial of Hydroxychloroquine and Low-dose Prednisone on Recurrent Spontaneous Abortion With Undifferentiated Connective Tissue Diseases: Protocol for the Immunosuppressant Regimens for Living FEtus [NCT03671174] | | 420 participants (Anticipated) | Interventional | 2019-08-02 | Recruiting |
A Randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma With Acalabrutinib [NCT04546620] | Phase 2 | 453 participants (Anticipated) | Interventional | 2021-10-19 | Recruiting |
[NCT01569204] | Phase 2 | 100 participants (Anticipated) | Interventional | 2012-10-31 | Completed |
A Single-arm, Multi-center, Phase Ib/II Study of Selinexor in Combination With R-CHOP Followed by Selinexor Maintenance for Untreated EBV-positive DLBCL Patients (Xplore Trial) [NCT05577364] | Phase 1/Phase 2 | 54 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting |
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or M [NCT03072238] | Phase 3 | 1,101 participants (Actual) | Interventional | 2017-06-30 | Active, not recruiting |
Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial [NCT02370550] | Phase 4 | 240 participants (Anticipated) | Interventional | 2015-03-31 | Recruiting |
Comparison of Gemcitabine, Oxaliplatin and Pegaspargase and Etoposide, Vincristine, Doxorubicin, Cyclophosphamide and Prednisone as First-line Chemotherapy in Patients With NK/T-cell Lymphoma:a Prospective Randomized Phase III Study [NCT02359162] | Phase 3 | 50 participants (Actual) | Interventional | 2015-05-31 | Terminated(stopped due to The study is out of date) |
Phase 2 Trial of Alemtuzumab and Dose-Adjusted Epoch in Chemotherapy Naive Aggressive T and NK-Cell Lymphomas [NCT00069238] | Phase 2 | 31 participants (Actual) | Interventional | 2003-09-19 | Completed |
A Randomized, Multicenter, Parallel-group, Open-label Study to Evaluate the Therapeutic Benefit of an Initially Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Dosing Regimen, in Combination With Cyclosporine and Corticosteroids in de [NCT00419926] | Phase 4 | 313 participants (Actual) | Interventional | 2006-12-31 | Completed |
Randomized, Multicentric, Open Label, Parallel Group Trial to Compare the Efficacy of 6-months Versus 3-months Therapy With Prednisolone for the First Episode of Idiopathic Nephrotic Syndrome in Children Younger Than 4 Years [NCT03141970] | Phase 3 | 170 participants (Actual) | Interventional | 2015-07-01 | Active, not recruiting |
Phase II Trial of Radiation With Androgen Deprivation: Abiraterone Acetate, Prednisone and Luteinizing Hormone Releasing Hormone Agonist Prior to Radiation Therapy [NCT01023061] | Phase 2 | 24 participants (Actual) | Interventional | 2010-03-31 | Completed |
A Randomized, Controlled, Single Center Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Androgen Deprivation Therapy Combined With Docetaxel for High Risk and Very High Risk Prostate Cancer [NCT04869371] | Phase 2 | 75 participants (Anticipated) | Interventional | 2018-12-12 | Active, not recruiting |
Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy [NCT01829958] | | 201 participants (Actual) | Interventional | 2013-04-30 | Active, not recruiting |
A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) as Front-Line Therapy for Adults With Acute Lymphoblastic Leukemia/Lymphoma [NCT03023046] | Phase 2 | 54 participants (Actual) | Interventional | 2017-02-23 | Completed |
Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial [NCT03617432] | Phase 2 | 114 participants (Anticipated) | Interventional | 2018-08-28 | Recruiting |
An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of Ixazomib (MLN9708), a Next-Generation Proteasome Inhibitor, Administered in Combination With a Standard Care Regimen of Melphalan and Prednisone in Patients With Newly Diagnosed Multiple [NCT01335685] | Phase 1/Phase 2 | 61 participants (Actual) | Interventional | 2011-06-27 | Completed |
Multimodal Analysis and Electroretinogram in VKH From Acute Onset - a Prospective Study [NCT03811366] | | 12 participants (Actual) | Interventional | 2011-06-01 | Completed |
A Multicenter Randomized Trial of First Line Treatment for Newly Diagnosed Immune Thrombocytopenia: Standard Steroid Treatment Versus Combined Steroid and Cyclosporin [NCT05459649] | Phase 2 | 253 participants (Anticipated) | Interventional | 2022-07-20 | Not yet recruiting |
Everolimus in Association With Very Low-dose Tacrolimus Versus Enteric-coated Mycophenolate Sodium With Low-dose Tacrolimus in de Novo Renal Transplant Recipients - A Prospective Single Center Study [NCT02084446] | Phase 4 | 120 participants (Actual) | Interventional | 2012-12-31 | Completed |
Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA) [NCT00443430] | Phase 4 | 85 participants (Actual) | Interventional | 2007-05-31 | Completed |
A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T Versus Hormone Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT05204927] | Phase 3 | 400 participants (Anticipated) | Interventional | 2022-02-14 | Recruiting |
Immune Checkpoint Blockade for Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers [NCT03816332] | Phase 1 | 12 participants (Actual) | Interventional | 2019-11-08 | Active, not recruiting |
Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs. RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma [NCT01856192] | Phase 2 | 349 participants (Actual) | Interventional | 2013-08-27 | Active, not recruiting |
Prednisone in Uric Acid Lowering in Symptomatic Heart Failure PATients With Hyperuricemia (PUSH-PATH Study 2) [NCT02129764] | Phase 2/Phase 3 | 205 participants (Actual) | Interventional | 2013-12-31 | Completed |
Total XV - Total Therapy Study XV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00137111] | Phase 3 | 501 participants (Actual) | Interventional | 2000-07-08 | Completed |
Randomized Phase II Study About the Application of Pegfilgrastim (Neulasta) at Day 2 or Day 4 Within the Treatment in Patients With Aggressive Non-Hodgkin's Lymphoma Aged 61 to 80 Years With 6 or 8 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxor [NCT00726700] | Phase 2 | 109 participants (Actual) | Interventional | 2004-05-31 | Completed |
Phase II Study of Intensified CVP, Rituximab, and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like Lymphoma [NCT00133991] | Phase 2 | 23 participants (Actual) | Interventional | 2005-07-31 | Completed |
Study 200622: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Adolescent and Adult Subjects With Severe Hypereosinophilic Syndrome [NCT02836496] | Phase 3 | 108 participants (Actual) | Interventional | 2017-03-07 | Completed |
Abiraterone Acetate Maintenance in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer. Randomized Phase II Study. [NCT02036060] | Phase 2 | 119 participants (Actual) | Interventional | 2014-02-07 | Completed |
A Randomized, Controlled, Single-blind Study of Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult [NCT02056418] | Phase 4 | 30 participants (Anticipated) | Interventional | 2014-01-31 | Active, not recruiting |
Phase I/II Study of Ruxolitinib Plus L-asparaginase, Vincristine, and Prednisone in Adult Patients With Relapsed or Refractory Early T Precursor Acute Lymphocytic Leukemia [NCT03613428] | Phase 1/Phase 2 | 12 participants (Anticipated) | Interventional | 2018-12-01 | Not yet recruiting |
Impact and Interplay of Corticosteroid Regimen and Exercise Training on DMD Muscle Function [NCT04322357] | Phase 2 | 89 participants (Anticipated) | Interventional | 2020-07-30 | Recruiting |
High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial [NCT01356511] | Phase 4 | 261 participants (Actual) | Interventional | 2010-09-30 | Completed |
Randomized Phase-II Trial of Abiraterone Acetate Plus LHRH-therapy Versus Abiraterone Acetate Sparing LHRH-therapy in Patients With Progressive Chemotherapy-naïve Castration-resistant Prostate Cancer (SPARE) [NCT02077634] | Phase 2 | 68 participants (Actual) | Interventional | 2014-05-31 | Completed |
A Phase I/II Study of Carfilzomib in Combination With R-CHOP (CR-CHOP) for Patients With Diffuse Large B-cell Lymphoma [NCT02073097] | Phase 1/Phase 2 | 48 participants (Actual) | Interventional | 2015-01-28 | Active, not recruiting |
Double-blind, Placebo-controlled, Randomized Study of the Safety and Tolerability of Isoxsuprine HCL Combined With High Dose Steroid Treatment of Multiple Sclerosis (MS) Relapse [NCT03752307] | Phase 1/Phase 2 | 2 participants (Actual) | Interventional | 2019-02-15 | Completed |
A Phase 1 Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT113176 in Healthy Subjects, With an Optional Pharmacological Effects [NCT04249323] | Phase 1 | 110 participants (Actual) | Interventional | 2020-01-27 | Completed |
[NCT01376401] | Phase 2 | 60 participants (Anticipated) | Interventional | 2011-07-31 | Completed |
Effects of Rifaximin Treatment in Patients With Acute Alcoholic Hepatitis: A Comparative Pilot Study [NCT02116556] | Phase 2 | 29 participants (Actual) | Interventional | 2013-04-30 | Enrolling by invitation |
A Phase Ib/II Trial of Combined SGN-35 (BrentuximabVedotin) Therapy With Cyclophosphamide, Procarbazine, Prednisone, Etoposide and Mitoxantrone (BrEPEM) for Older Patients With Untreated Hodgkin Lymphoma (HL) [NCT03576378] | Phase 1/Phase 2 | 41 participants (Actual) | Interventional | 2018-08-08 | Active, not recruiting |
A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone [NCT00033293] | Phase 3 | 53 participants (Actual) | Interventional | 2004-03-15 | Completed |
A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients [NCT02921789] | Phase 2 | 67 participants (Actual) | Interventional | 2017-05-22 | Completed |
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial [NCT03593759] | Phase 3 | 194 participants (Anticipated) | Interventional | 2019-01-15 | Recruiting |
Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial With Emphasis on Geriatric Assessment and Quality of Life [NCT00911183] | Phase 2 | 67 participants (Actual) | Interventional | 2008-12-02 | Completed |
A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER [NCT01995513] | Phase 4 | 509 participants (Actual) | Interventional | 2013-10-22 | Completed |
A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy [NCT02159690] | Phase 2 | 0 participants (Actual) | Interventional | 2014-09-30 | Withdrawn(stopped due to loss of funding) |
Ib Dose Finding Study of LDE225 Plus Docetaxel/Prednisone in Patients With Advanced or Metastatic Castration Resistant Prostate Cancer Who Experience Disease Progression After Receiving Docetaxel [NCT02182622] | Phase 1 | 0 participants (Actual) | Interventional | 2014-07-31 | Withdrawn |
Long-term Prednisone Use in Patients With Advanced Heart Failure (ACCF/AHA Stage D) and Hyperuricemia [NCT02282683] | Phase 2/Phase 3 | 90 participants (Anticipated) | Interventional | 2013-12-31 | Recruiting |
A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen [NCT00069745] | Phase 3 | 0 participants | Interventional | 2003-09-30 | Completed |
A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL) [NCT01148446] | Phase 3 | 226 participants (Actual) | Interventional | 2003-01-31 | Completed |
A Phase II Study Of Pegylated Liposomal Doxorubicin (Doxil) In Combination With Rituxan, Cyclophosphamide, Vincristine and Prednisone (DR-COP) In Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas [NCT00184002] | Phase 2 | 68 participants (Actual) | Interventional | 2003-01-10 | Completed |
Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical Trial [NCT03864250] | | 124 participants (Anticipated) | Interventional | 2018-11-26 | Recruiting |
DELTA Study Dutch Evaluation in Liver Transplantation To Assess the Efficacy of Cyclosporine A Microemulsion With C-2h Monitoring Versus Tacrolimus With Trough Monitoring in de Novo Liver Transplant Recipients [NCT00149994] | Phase 4 | 171 participants (Actual) | Interventional | 2002-12-31 | Completed |
A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients [NCT00650468] | Phase 4 | 397 participants (Actual) | Interventional | 1999-11-30 | Completed |
A New Timed-Release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-Centre, Double-Blind, Active Controlled Study With Open Extension on the New Drug Only [NCT00146640] | Phase 3 | 288 participants (Actual) | Interventional | 2004-08-31 | Completed |
Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome [NCT01197040] | Phase 3 | 117 participants (Actual) | Interventional | 2009-10-31 | Completed |
A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Doctaxel and Prednisone With and Without Bevacizumab (IND #7921, NSC #704865) in Men With Hormone Refractory Prostate Cancer [NCT00110214] | Phase 3 | 1,050 participants (Actual) | Interventional | 2005-04-30 | Completed |
Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia [NCT01326494] | Phase 4 | 92 participants (Actual) | Interventional | 2011-04-30 | Completed |
A Phase II Study of Punctual, Cyclic, and Intensive Chemotherapy With Liposomal Cytarabine (Depocyt®) CNS Prophylaxis for Adults With Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma [NCT02043587] | Phase 2 | 31 participants (Actual) | Interventional | 2014-01-31 | Terminated(stopped due to Original investigator for the trial has left) |
A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC) [NCT00137436] | Phase 1/Phase 2 | 93 participants (Actual) | Interventional | 2005-10-31 | Completed |
A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the P [NCT00119678] | Phase 2 | 183 participants (Actual) | Interventional | 2005-09-30 | Completed |
"First Line Treatment in HIV-related Large Cell Non Hodgkin Lymphoma at High Risk, Including Early Consolidation With High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation" [NCT01045889] | Phase 2 | 27 participants (Actual) | Interventional | 2007-01-31 | Completed |
A Randomized Phase-II Pilot Trial of Docetaxel and Prednisone Versus Radiation Therapy Plus Docetaxel and Prednisone in Patients With Nonmetastatic and Oligometastatic Castrate Resistant Prostate Cancer [NCT01087580] | Phase 2 | 0 participants (Actual) | Interventional | 2011-03-31 | Withdrawn |
A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma [NCT05934097] | Phase 1 | 0 participants (Actual) | Interventional | 2022-12-31 | Withdrawn(stopped due to This study was withdrawn (Sponsor decision).) |
The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis . A Randomized Clinical Trial [NCT05931744] | Phase 2/Phase 3 | 120 participants (Actual) | Interventional | 2021-05-01 | Completed |
A Phase I Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Escalating Doses of Inotuzumab Ozogamicin (DA-EPOCH-InO) in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia [NCT03991884] | Phase 1 | 24 participants (Actual) | Interventional | 2019-09-24 | Completed |
A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer [NCT03009981] | Phase 3 | 504 participants (Anticipated) | Interventional | 2017-03-06 | Active, not recruiting |
LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis [NCT02205762] | Phase 2/Phase 3 | 1,400 participants (Anticipated) | Interventional | 2016-11-02 | Recruiting |
A Single-Cohort, Phase 2 Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) [NCT02953678] | Phase 2 | 71 participants (Actual) | Interventional | 2016-12-30 | Completed |
A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma [NCT00376961] | Phase 2 | 68 participants (Actual) | Interventional | 2006-08-31 | Completed |
A Phase 1, Open-label, Functional Imaging Study to Assess Whether CC-90011 Reverses the Castration Resistance Due to Lineage Switch in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Have Failed Enzalutamide as Last Prior Therapy [NCT04628988] | Phase 1 | 6 participants (Actual) | Interventional | 2021-07-28 | Completed |
A Phase II Study of Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18F-DCFPyL-PET/CT in Newly Diagnosed Prostate Cancer [NCT03860987] | Phase 2 | 11 participants (Actual) | Interventional | 2019-04-30 | Active, not recruiting |
A Phase 2, Randomized Study of Duvelisib Administered in Combination With Rituximab vs R-CHOP in Subjects With Relapsed/Refractory Follicular Lymphoma (FRESCO) [NCT02605694] | Phase 2 | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn(stopped due to Sponsor is focusing on studies which can enable registration of duvelisib) |
Romidepsin in Combination With CHOEP as First Line Treatment Before Hematopoietic Stem Cell Transplantation in Young Patients With Nodal Peripheral T-cell Lymphomas: a Phase I-II Study [NCT02223208] | Phase 1/Phase 2 | 89 participants (Actual) | Interventional | 2014-09-30 | Active, not recruiting |
A Multicenter, Single-arm, Open II Phase Clinical Trial Evaluating the Efficacy of Chidamide Combined With Prednisone, Cyclophosphamide, Etoposide, and Methotrexate (PECM) in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) [NCT03321890] | Phase 2 | 102 participants (Anticipated) | Interventional | 2017-03-07 | Recruiting |
A Phase I Adaptive Dose, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT118335 in Healthy Subjects [NCT03315338] | Phase 1 | 143 participants (Actual) | Interventional | 2017-09-15 | Completed |
Phase II Study of Oral PRednisone 5 mg Bid Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of Vascular Endothelial Growth Factor Receptor-tyrosine Kinase Inhibitors [NCT02479490] | Phase 2 | 8 participants (Actual) | Interventional | 2015-09-22 | Terminated |
A Phase 1/2 Study of Ixazomib as a Replacement for Bortezomib or Carfilzomib for Multiple Myeloma (MM) Patients Recently Relapsed or Refractory to Their Last Combination Regimen Containing Either Bortezomib or Carfilzomib [NCT02206425] | Phase 1/Phase 2 | 45 participants (Actual) | Interventional | 2014-09-30 | Completed |
A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma [NCT05351346] | Phase 3 | 1,100 participants (Anticipated) | Interventional | 2022-06-01 | Recruiting |
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO-CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS [NCT00938587] | Phase 2 | 86 participants (Actual) | Interventional | 2009-10-07 | Completed |
Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study) [NCT00792948] | Phase 2 | 97 participants (Actual) | Interventional | 2009-09-01 | Active, not recruiting |
Safety and Efficacy Study of Mitoxantrone Hydrochloride Liposome Injection Plus Cyclophosphamide,Vincristine and Prednison (CNOP)in Diffuse Large B Cell Lymphoma [NCT02595242] | Phase 1 | 0 participants (Actual) | Interventional | 2015-06-30 | Withdrawn |
A Prospective, Multicentric, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis. [NCT03290456] | | 146 participants (Anticipated) | Interventional | 2019-08-20 | Recruiting |
A Phase 1/2 Open-Label Multicenter Study of Avadomide (CC-122) in Combination With R-CHOP-21 for Previously Untreated Poor Risk (IPI>=3) Diffuse Large B-Cell Lymphoma [NCT03283202] | Phase 1 | 35 participants (Actual) | Interventional | 2017-10-04 | Completed |
A Randomized Trial of Treatment in Patients With IgG4-Related Disease [NCT02458196] | Phase 2 | 60 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD [NCT00562497] | Phase 3 | 192 participants (Actual) | Interventional | 2008-01-31 | Completed |
Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma [NCT00151281] | Phase 2 | 25 participants (Actual) | Interventional | 2004-11-30 | Completed |
Randomized Phase II Study to Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT02445404] | Phase 2 | 134 participants (Anticipated) | Interventional | 2015-09-23 | Recruiting |
Phase II Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R in Untreated De Novo Diffuse Large B-Cell Lymphomas [NCT03188198] | Phase 2 | 60 participants (Anticipated) | Interventional | 2016-06-01 | Recruiting |
A Phase III, Randomized, Active-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Long-Term Safety of Mometasone Furoate/Formoterol Fumarate (MF/F, MK-0887A [SCH418131]), Compared With Mometasone Furoate (MF, MK-0887 [SCH032088]), in Chi [NCT02741271] | Phase 3 | 181 participants (Actual) | Interventional | 2016-05-11 | Completed |
An Open-Label, Multinational, Multicenter, Phase IIIB Study to Assess Safety of Rituximab Following Subcutaneous Administration in Patients With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A [NCT02406092] | Phase 3 | 122 participants (Actual) | Interventional | 2015-10-13 | Completed |
A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, SAD and MAD Study to Measure the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT125134 in Healthy Subjects [NCT03508635] | Phase 1 | 130 participants (Actual) | Interventional | 2014-09-30 | Completed |
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions [NCT02190994] | Phase 4 | 100 participants (Anticipated) | Interventional | 2013-08-31 | Recruiting |
Efficacy and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization Compared With Budesonide Aqueous Nasal Spray and Oral Steroids for the Treatment of Chronic Rhinosinusitis With Polyposis. [NCT03687515] | Phase 3 | 91 participants (Actual) | Interventional | 2015-01-01 | Completed |
Effectiveness Evaluation of Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Early Esophageal Cancer Invading More Than 2/3 Esophageal Perimeter [NCT03165344] | | 66 participants (Actual) | Interventional | 2017-02-10 | Completed |
CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid [NCT03492255] | | 49 participants (Actual) | Interventional | 2018-04-12 | Terminated(stopped due to Significative difference between percentage of renal response (primary outcome) between the two study arms.) |
A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer [NCT00770848] | Phase 1/Phase 2 | 162 participants (Actual) | Interventional | 2008-11-30 | Completed |
A Phase I-II Trial of DA-EPOCH-R Plus Ixazomib as Frontline Therapy for Patients With MYC-aberrant Lymphoid Malignancies: The DACIPHOR Regimen [NCT02481310] | Phase 1/Phase 2 | 38 participants (Actual) | Interventional | 2015-10-28 | Active, not recruiting |
A Phase 1, Open-label, Multicenter Trial of Oral Azacitidine (CC-486) Plus R-CHOP in Subjects With High Risk (IPI 3 or More) Previously Untreated Diffuse Large B-cell Lymphoma or Grade 3B Follicular Lymphoma. [NCT02343536] | Phase 1 | 59 participants (Actual) | Interventional | 2015-04-29 | Completed |
Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma Not Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation (BPV). [NCT02237261] | Phase 2 | 46 participants (Actual) | Interventional | 2014-11-30 | Completed |
An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alon [NCT02855359] | Phase 2 | 24 participants (Actual) | Interventional | 2016-08-31 | Terminated(stopped due to Sponsor decision based on portfolio prioritization) |
Efficacy of Mycophenolate Mofetil Versus Leflunomide as Maintenance Treatment for IgG4-RD Patients With Internal Organ Involvement [NCT05789017] | | 60 participants (Anticipated) | Interventional | 2022-07-01 | Recruiting |
An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose LY3884961 in Infants With Type 2 Gaucher Disease [NCT04411654] | Phase 1/Phase 2 | 15 participants (Anticipated) | Interventional | 2021-06-29 | Recruiting |
A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT04446117] | Phase 3 | 575 participants (Actual) | Interventional | 2020-06-30 | Active, not recruiting |
Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid® CC-5013) With Every Three Week Docetaxel (Taxotere®) In Subjects With Androgen Independent Prostate Cancer [NCT01378091] | Phase 1 | 64 participants (Actual) | Interventional | 2005-08-31 | Completed |
LAL-BR/2001: Study Treatment to Low Risk ALL [NCT00526175] | Phase 4 | 150 participants (Anticipated) | Interventional | 2001-06-30 | Completed |
A Phase II Study of Initial Treatment With Methotrexate in Large Granular Lymphocytic (LGL) Leukemia [NCT00003910] | Phase 2 | 59 participants (Actual) | Interventional | 1999-09-15 | Terminated |
A Comparison of Effects of Standard Dose vs. Low Dose Advagraf® With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response [NCT00933231] | Phase 3 | 281 participants (Actual) | Interventional | 2009-08-17 | Completed |
Safety and Efficacy of Low Dose Colchicine or Prednisone Combining With Standard Drug in Patients With Recurrent In-stent Restenosis: a Prospective, Randomized, Open-label Trial [NCT06090890] | Phase 4 | 252 participants (Anticipated) | Interventional | 2023-10-30 | Not yet recruiting |
Effect of Short-Term Prednisone Therapy on C-Reactive Protein Change in Emergency Department Patients With Acute Heart Failure and Elevated Inflammatory Marker [NCT05668676] | Phase 2/Phase 3 | 120 participants (Anticipated) | Interventional | 2023-02-16 | Recruiting |
CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer [NCT05288166] | Phase 3 | 900 participants (Anticipated) | Interventional | 2022-04-14 | Recruiting |
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial [NCT04875702] | | 650 participants (Anticipated) | Interventional | 2023-11-15 | Not yet recruiting |
An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer [NCT04497584] | Phase 2 | 37 participants (Anticipated) | Interventional | 2021-08-04 | Recruiting |
A Phase 1b Study of Adaptive Androgen Deprivation Therapy for State IV Castration Sensitive Prostate Cancer [NCT03511196] | Early Phase 1 | 17 participants (Actual) | Interventional | 2018-09-17 | Active, not recruiting |
A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis [NCT03207815] | Phase 2 | 74 participants (Actual) | Interventional | 2017-07-26 | Terminated(stopped due to Development program terminated) |
A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) For the Treatment of Acute GVHD in Patients Who Receive Allogeneic Hematopoietic Stem Cell Transplantation [NCT00136903] | Phase 2 | 32 participants (Actual) | Interventional | 2005-04-27 | Completed |
The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus and Improvement of Quality of Life: A Randomized, Double Blind, Controlled Study [NCT02106468] | Phase 2 | 30 participants (Actual) | Interventional | 2013-05-31 | Completed |
A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia [NCT01903486] | Phase 4 | 0 participants (Actual) | Interventional | 2013-03-31 | Withdrawn(stopped due to Unable to recruit participants.) |
A Phase II Study of the Bruton's Tyrosine Kinase Inhibitor, Zanubrutinib, in Combination With Lenalidomide Plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma [NCT05200312] | Phase 2 | 36 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
A Pilot Study to Estimate the Safety and Tolerability of the Combination of Polatuzumab Vedotin With Dose Adjusted Rituximab, Etoposide, Cyclophosphamide, and Doxorubicin (DA-EPCH-PR) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas [NCT04231877] | Phase 1 | 50 participants (Anticipated) | Interventional | 2020-10-27 | Recruiting |
Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease [NCT04987450] | | 40 participants (Anticipated) | Observational | 2018-10-01 | Recruiting |
A Phase II Study to Determine the Response Kinetics, Safety, and Efficacy of Brentuximab Vedotin and Nivolumab Alone and Then Combined With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone for Patients With Untreated Primary Mediastinal Large B-Ce [NCT04745949] | Phase 2 | 40 participants (Anticipated) | Interventional | 2021-05-10 | Recruiting |
Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I/II Dose Finding Trial and Data Registry [NCT04151082] | Phase 1/Phase 2 | 15 participants (Actual) | Interventional | 2019-10-31 | Active, not recruiting |
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer [NCT03748641] | Phase 3 | 765 participants (Actual) | Interventional | 2019-01-25 | Active, not recruiting |
A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer [NCT03431350] | Phase 1/Phase 2 | 136 participants (Actual) | Interventional | 2018-03-02 | Active, not recruiting |
A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens [NCT03412565] | Phase 2 | 265 participants (Actual) | Interventional | 2018-04-26 | Active, not recruiting |
A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy [NCT02195479] | Phase 3 | 706 participants (Actual) | Interventional | 2014-12-09 | Active, not recruiting |
A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT02123758] | Phase 1 | 57 participants (Actual) | Interventional | 2014-07-09 | Active, not recruiting |
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults [NCT02003222] | Phase 3 | 488 participants (Actual) | Interventional | 2014-05-19 | Active, not recruiting |
An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma [NCT01998971] | Phase 1 | 242 participants (Actual) | Interventional | 2014-02-18 | Active, not recruiting |
Phase Ib, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN-509 in Combination With Abiraterone Acetate in Patients With Metastatic Castrate Resistant Prostate Cancer (CRPC [NCT01792687] | Phase 1 | 6 participants (Actual) | Interventional | 2013-02-05 | Active, not recruiting |
A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease [NCT01314118] | Phase 2 | 131 participants (Actual) | Interventional | 2011-05-04 | Active, not recruiting |
A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma [NCT00101010] | Phase 2 | 80 participants (Actual) | Interventional | 2005-09-30 | Completed |
Characterization of the Molecular Mechanisms Involved in Delayed-Type Hypersensitivity Reactions to House Dust Mite, Diphencyprone, Nickel, and Tuberculin Purified Protein Derivative in Healthy Volunteers [NCT03625219] | | 54 participants (Actual) | Interventional | 2018-07-26 | Completed |
A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement [NCT04432714] | Phase 1/Phase 2 | 81 participants (Anticipated) | Interventional | 2020-06-09 | Recruiting |
Prospective Controlled Trial in Clinical Stages I-II Supradiaphragmatic Hodgkin's Disease: Evaluation of Treatment Efficacy, (Long Term) Toxicity and Quality of Life in Two Different Prognostic Subgroups [NCT00005584] | Phase 3 | 1,649 participants (Actual) | Interventional | 1998-10-31 | Active, not recruiting |
Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS). A Multicenter, Prospective, Controlled, Randomized Trial. [NCT02200146] | Phase 3 | 94 participants (Actual) | Interventional | 2009-03-31 | Completed |
A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia [NCT02723994] | Phase 2 | 171 participants (Actual) | Interventional | 2016-09-30 | Active, not recruiting |
Phase II Study of Combination of Hyper-CVAD and Dasatinib in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) [NCT00390793] | Phase 2 | 107 participants (Actual) | Interventional | 2006-09-28 | Active, not recruiting |
An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity Undergoing In Vitro Fertilization [NCT04943146] | | 402 participants (Anticipated) | Observational | 2021-03-01 | Recruiting |
Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH-21, R-BL-M-04 and Autologous Stem Cells Transplantation in Patients With High-Grade B-cell Lymphoma Double-hit and High-Grade B-cell Lymphoma Not Otherwise [NCT03479918] | Phase 3 | 80 participants (Anticipated) | Interventional | 2018-03-15 | Recruiting |
Abiraterone Dose De-Escalation Study: A Prospective Study Evaluating Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose. [NCT05276492] | Phase 1 | 50 participants (Anticipated) | Interventional | 2025-06-01 | Recruiting |
Phase Ib/II Clinical Study of TQB3616 Capsules in Combination With Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT05156450] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-01-01 | Not yet recruiting |
A Phase II Study of Metronomic Chemotherapy in Elderly Non-fit Patients (>65 Years) With Aggressive B-Cell Lymphomas [NCT03161054] | Phase 2 | 21 participants (Actual) | Interventional | 2017-09-12 | Completed |
CINRG0513: A Trial of Chronotherapy of Corticosteroids in Duchenne Muscular Dystrophy [NCT02036463] | Phase 2 | 0 participants (Actual) | Interventional | 2014-11-30 | Withdrawn(stopped due to No funding for project.) |
A Randomized, Phase II, Multicenter, Open Label, Study Evaluating Sirolimus and Prednisone in Patients With Refined Minnesota Standard Risk, Ann Arbor 1/2 Confirmed Acute Graft-Versus-Host Disease (BMT CTN 1501) [NCT02806947] | Phase 2 | 127 participants (Actual) | Interventional | 2016-10-31 | Completed |
OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris [NCT02613910] | Phase 3 | 1 participants (Actual) | Interventional | 2015-12-23 | Terminated(stopped due to Novartis has acquired the rights to ofatumumab and terminated the OPV116910 and OPV117059 studies. This decision is not linked to any safety consideration.) |
Adcetris (Brentuximab Vedotin), Substituting Vincristine in the OEPA/COPDac Regimen [Treatment Group 3 (TG3) of Euro-Net C1] With Involved Node Radiation Therapy for High Risk Pediatric Hodgkin Lymphoma (HL) [NCT01920932] | Phase 2 | 77 participants (Actual) | Interventional | 2013-08-12 | Active, not recruiting |
Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (REFRACT): A Randomised Phase II Trial of Investigator Choice Standard Therapy Versus Sequential Novel Therapy Experimental Arms [NCT05848765] | Phase 2 | 284 participants (Anticipated) | Interventional | 2023-09-04 | Recruiting |
An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long Term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid [NCT05681481] | Phase 3 | 160 participants (Anticipated) | Interventional | 2023-03-22 | Recruiting |
Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study [NCT05428826] | Phase 4 | 41 participants (Anticipated) | Interventional | 2022-11-25 | Recruiting |
Phase 1/2 Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies [NCT05371054] | Phase 1/Phase 2 | 130 participants (Anticipated) | Interventional | 2023-04-05 | Recruiting |
A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid [NCT05267600] | Phase 2/Phase 3 | 160 participants (Anticipated) | Interventional | 2022-06-09 | Recruiting |
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly- [NCT04824092] | Phase 3 | 899 participants (Actual) | Interventional | 2021-05-11 | Active, not recruiting |
International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 [NCT03643276] | Phase 3 | 5,000 participants (Anticipated) | Interventional | 2018-07-15 | Recruiting |
A Phase II Trial of Brief Duration Combination Chemotherapy and Rituximab With Prophylactic Pegfilgrastim, Followed by Maintenance Rituximab, in Elderly/Poor Performance Status Patients With Large B-Cell Non-Hodgkin's Lymphoma [NCT00193479] | Phase 2 | 51 participants (Actual) | Interventional | 2003-04-30 | Completed |
A Phase II Study With a Lead-in Safety Phase of Abiraterone in Combination With PDMX1001/Niclosamide in Castration-Resistant Prostate Cancer (CRPC) [NCT02807805] | Phase 2 | 37 participants (Actual) | Interventional | 2016-10-31 | Active, not recruiting |
Phase II Study of Combination of Hyper-CVAD and Ponatinib in Patients With Philadelphia (PH) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) [NCT01424982] | Phase 2 | 88 participants (Actual) | Interventional | 2011-10-05 | Active, not recruiting |
A 12 Month, Multicenter, Randomized, Parallel, Open-label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-transplant Versus Minimization, in de Novo Kidney Transp [NCT00154284] | Phase 3 | 114 participants (Actual) | Interventional | 2005-07-31 | Completed |
A Pilot Randomized Controlled Trial of De Novo Belatacept-Based Immunosuppression in Lung Transplantation [NCT03388008] | Phase 2 | 27 participants (Actual) | Interventional | 2019-12-17 | Completed |
Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID) [NCT04451174] | Phase 3 | 60 participants (Actual) | Interventional | 2020-06-23 | Terminated(stopped due to Corticosteroid use approval) |
Multicentre, Single Arm, Open Label, Non Controlled Phase IV Clinical Trial to Evaluate Safety of Cabazitaxel (Jevtana) in Combination With Oral Prednisone (or Prednisolone) for the Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer [NCT02074137] | Phase 4 | 10 participants (Actual) | Interventional | 2014-07-31 | Completed |
A Phase II Comparative, Open-Label, Randomized, Multicenter, China-Only Study to Investigate the Pharmacokinetics, Efficacy and Safety of Subcutaneous Rituximab Versus Intravenous Rituximab Both in Combination With CHOP in Previously Untreated Patients Wi [NCT04660799] | Phase 2 | 50 participants (Actual) | Interventional | 2021-02-24 | Completed |
The Role of Exclusive Enteral Nutrition in the Pediatric Inflammatory Bowel Disease Microbiome: a Pilot Study [NCT02521064] | | 31 participants (Actual) | Observational | 2015-07-31 | Completed |
A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer [NCT03934840] | Phase 2 | 61 participants (Anticipated) | Interventional | 2019-10-10 | Recruiting |
STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial [NCT00268476] | Phase 2/Phase 3 | 11,992 participants (Actual) | Interventional | 2005-07-08 | Active, not recruiting |
[NCT00000524] | Phase 2 | 0 participants | Interventional | 1986-07-31 | Completed |
A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated [NCT00417079] | Phase 3 | 755 participants (Actual) | Interventional | 2007-01-31 | Completed |
Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN) [NCT03549663] | | 108 participants (Anticipated) | Interventional | 2018-07-04 | Recruiting |
Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression [NCT02137239] | Phase 2 | 58 participants (Actual) | Interventional | 2015-12-31 | Completed |
Clinical and Laboratory Evaluation of Acute Rejection, Myocyte Growth, Repair, and Oxidative Stress Following de Novo Cardiac Transplant: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens With MPA TDM [NCT00157014] | Phase 3 | 111 participants (Actual) | Interventional | 2004-05-10 | Completed |
CABAzitaxel With or Without Prednisone in Patients With Metastatic CAstration REsistant Prostate Cancer (mCRPC) Progressed During or After a Previous Docetaxel-based Chemotherapy:a Multi-center,Prospective,Two-arm, Open Label, Non Inferiority Phase II Stu [NCT03356912] | Phase 2 | 220 participants (Anticipated) | Interventional | 2017-11-22 | Enrolling by invitation |
Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis [NCT02161653] | Phase 4 | 135 participants (Actual) | Interventional | 2010-04-30 | Completed |
Phase I/II Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas (Primary Effusion Lymphoma and Large Cell Lymphoma Arising in KSHV-Associated Multicentric Castleman Disease) [NCT02228512] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2014-08-15 | Withdrawn |
A Pilot Study of EPOCH-F/R Induction Chemotherapy and Reduced-Intensity, HLA-Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation, With Cyclosporine & Methotrexate GVHD Prophylaxis for Refractory or Relapsed Hematologic Malignancies [NCT00051311] | Phase 2 | 62 participants (Actual) | Interventional | 2003-01-03 | Completed |
A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma [NCT00049673] | Phase 3 | 332 participants (Actual) | Interventional | 2002-10-15 | Completed |
Pilot Study of Allogeneic/Syngeneic Blood Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas [NCT00043979] | Phase 2 | 60 participants (Actual) | Interventional | 2002-09-19 | Completed |
Myfortic (Enteric-coated Mycophenolate Sodium) for the Treatment of Non-infectious Intermediate Uveitis - a Prospective, Controlled, Randomized Multicenter Trial [NCT01092533] | Phase 3 | 44 participants (Actual) | Interventional | 2010-03-31 | Completed |
A Phase II Study of Rituximab, Lenalidomide, and Ibrutinib Combined With Chemotherapy for Patients With High Risk Diffuse Large B-Cell Lymphoma [NCT02636322] | Phase 2 | 60 participants (Actual) | Interventional | 2016-03-29 | Completed |
Randomized Controlled Trial of Prednisone in Cystic Fibrosis Pulmonary Exacerbations [NCT03070522] | Phase 3 | 84 participants (Anticipated) | Interventional | 2017-05-01 | Recruiting |
Assessment of Glucocorticoid Responsiveness and Mechanisms of Resistance in Hypereosinophilic Syndromes [NCT01524536] | Phase 4 | 26 participants (Actual) | Interventional | 2012-02-16 | Completed |
Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy [NCT00004124] | Phase 3 | 983 participants (Actual) | Interventional | 1999-10-15 | Completed |
A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma [NCT05901519] | Phase 2 | 20 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP Versus Placebo Plus R-CHOP in Treatment-naïve Patients With MCD Subtype DLBCL [NCT05234684] | Phase 3 | 150 participants (Anticipated) | Interventional | 2022-11-02 | Recruiting |
"A Novel Pediatric-Inspired Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia" [NCT01920737] | Phase 2 | 39 participants (Actual) | Interventional | 2013-08-31 | Active, not recruiting |
A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852) in Combination With Rituximab-CHOP in Patients With Newly Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma (DLBCL) [NCT00972478] | Phase 1/Phase 2 | 83 participants (Actual) | Interventional | 2010-11-15 | Active, not recruiting |
Investigator Initiated Pilot Study of Microarray Directed Therapy for Diffuse Large B-cell Lymphoma Using Genasense With CHOP-R [NCT00736450] | Early Phase 1 | 37 participants (Actual) | Interventional | 2008-07-23 | Terminated(stopped due to Manufacturer is no longer making the drug.) |
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) [NCT04663347] | Phase 1/Phase 2 | 662 participants (Anticipated) | Interventional | 2020-11-03 | Recruiting |
Multicenter Phase II Single Arm Open-label Study on the Feasibility, Safety and Efficacy of Combination of CHOP-21 Supplemented With Obinutuzumab and Ibrutinib in Untreated Young High Risk Diffuse Large B-cell Lymphoma (DLBCL) Patients. [NCT02670317] | Phase 2 | 1 participants (Actual) | Interventional | 2016-09-30 | Terminated(stopped due to GA101-CHOP not advantage from rituximab-CHOP) |
A Randomized, Double-blind Double Dummy, Parallel Control and Multi-center Clinical Trial to Compare the Efficacy and Safety of Tacrolimus Capsules in Treatment of Lupus Nephritis With Leflunomide Tablets [NCT01342016] | Phase 3 | 84 participants (Actual) | Interventional | 2011-04-30 | Terminated(stopped due to Due to safety concern of active control drug) |
A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Pa [NCT01200758] | Phase 3 | 410 participants (Actual) | Interventional | 2011-02-15 | Completed |
A Phase IB Open-label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Androgen Deprivation Therapy and Other Agents in Subjects With Castrate-resista [NCT03150056] | Phase 1 | 73 participants (Actual) | Interventional | 2017-07-18 | Terminated(stopped due to This study has been terminated due to meeting protocol defined futility.) |
A Sequential Multiple Assignment Randomized Trial (SMART) Developing and Optimizing Patient-Tailored Adaptive Treatment Strategies (ATS) for Acute Severe Ulcerative Colitis [NCT05867329] | Phase 4 | 162 participants (Anticipated) | Interventional | 2023-09-30 | Recruiting |
A Phase II Study of Split-Dose R-CHOP in Older Adults With Diffuse Large B-cell Lymphoma [NCT03943901] | Phase 2 | 26 participants (Anticipated) | Interventional | 2021-02-17 | Recruiting |
Phase I and Dose-Expansion Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas [NCT03220022] | Phase 1 | 54 participants (Anticipated) | Interventional | 2018-03-16 | Recruiting |
Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement [NCT05789030] | | 90 participants (Anticipated) | Interventional | 2022-07-01 | Recruiting |
A Sequential Phase I/Randomized Phase II Trial of Vorinostat and Risk-Adapted Chemotherapy With Rituximab in HIV-Related B-Cell Non-Hodgkin's Lymphoma [NCT01193842] | Phase 1/Phase 2 | 107 participants (Actual) | Interventional | 2010-10-06 | Completed |
An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(TM))(MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose T [NCT00602641] | Phase 3 | 306 participants (Actual) | Interventional | 2008-02-29 | Active, not recruiting |
Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma [NCT00408005] | Phase 3 | 1,895 participants (Actual) | Interventional | 2007-01-22 | Active, not recruiting |
Multicentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow up [NCT01349270] | Phase 3 | 40 participants (Actual) | Interventional | 2004-06-30 | Completed |
HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma [NCT01356680] | Phase 3 | 1,100 participants (Actual) | Interventional | 2012-01-13 | Completed |
GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease [NCT03139604] | Phase 3 | 439 participants (Actual) | Interventional | 2017-07-19 | Completed |
A National, Open-label, Multicenter, Randomized, Comparative Phase IIb Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 65 Years With Sequential Melphalan/Prednisone/Velcade (MPV) Followed by Revlimid/Low Dose Dexamethasone (Rd) [NCT01237249] | Phase 2 | 250 participants (Actual) | Interventional | 2011-02-28 | Completed |
A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-Prostatectomy [NCT02849990] | Phase 2 | 22 participants (Actual) | Interventional | 2017-03-09 | Completed |
Phase II Study of Octreotide Treatment of Advanced, Recurrent Thymoma [NCT00003283] | Phase 2 | 38 participants (Anticipated) | Interventional | 1998-10-13 | Completed |
A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined With Enzalutamide or Abiraterone/Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer [NCT03480646] | Phase 1/Phase 2 | 242 participants (Anticipated) | Interventional | 2017-11-15 | Active, not recruiting |
High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) [NCT00075725] | Phase 3 | 3,154 participants (Actual) | Interventional | 2003-12-29 | Completed |
A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease [NCT00025259] | Phase 3 | 1,734 participants (Actual) | Interventional | 2002-09-30 | Completed |
A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer [NCT00024167] | Phase 3 | 265 participants (Actual) | Interventional | 2002-04-30 | Terminated(stopped due to Terminated due to slow accrual) |
SWOG-9704 A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant) [NCT00004031] | Phase 3 | 397 participants (Actual) | Interventional | 1997-07-31 | Completed |
The Effect of Low Doses of Intermediate Acting Corticosteroids on the Prolongation of Pregnancy in Threatened Preterm Birth [NCT06103227] | Phase 2/Phase 3 | 26 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
Phase I/Ib Study of Parsaclisib (INCB50465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (PaR-CHOP) Immunochemotherapy for Patients With Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma [NCT04323956] | Phase 1 | 50 participants (Actual) | Interventional | 2020-06-15 | Active, not recruiting |
Randomized Phase II Study of Olaparib Maintenance Following Cabazitaxel-Carboplatin Induction Chemotherapy in Men With Aggressive Variant Prostate Cancer (AVPC) [NCT03263650] | Phase 2 | 119 participants (Actual) | Interventional | 2017-10-03 | Active, not recruiting |
An Open Label Study Evaluating The Effect Of Single Doses Of Pf-04308515 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects [NCT01199029] | Phase 1 | 18 participants (Actual) | Interventional | 2010-08-31 | Completed |
A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer [NCT00890617] | Phase 1 | 9 participants (Actual) | Interventional | 2009-03-31 | Completed |
Intensive Treatment For T-CELL Acute Lymphoblastic Leukemia and Advanced Stage Lymphoblastic Non-Hodgkin's Lymphoma: A Pediatric Oncology Group Phase III Study [NCT01230983] | Phase 3 | 573 participants (Actual) | Interventional | 1996-06-30 | Completed |
Multicenter Registry of Pediatric Lupus Nephritis in China [NCT03791827] | | 1,200 participants (Anticipated) | Observational | 2018-12-01 | Recruiting |
A Phase 1 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With CD30-Positive Mature T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic Large Cell Lymphoma [NCT01309789] | Phase 1 | 39 participants (Actual) | Interventional | 2011-02-28 | Completed |
The Role of Oral Steroids in the Management of Chronic Rhinosinusitis Without Nasal Polyps [NCT02927834] | | 24 participants (Actual) | Interventional | 2015-08-31 | Completed |
Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas. Prospective Randomized Multicenter Trial [NCT01380028] | Phase 3 | 162 participants (Actual) | Interventional | 2011-07-22 | Terminated(stopped due to successfull Interim Analysis) |
Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A [NCT01858922] | Phase 2 | 40 participants (Actual) | Interventional | 2012-12-19 | Active, not recruiting |
A Pilot Study to Evaluate the Efficacy and Safety of Budesonide as an Alternative to Prednisone for Liver Transplant Immune Suppression [NCT03304626] | Phase 2 | 40 participants (Actual) | Interventional | 2017-06-27 | Completed |
Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL) [NCT01251107] | Phase 3 | 331 participants (Actual) | Interventional | 2000-03-31 | Completed |
In Vivo Prednisolone/Prednisone Pharmacokinetic Pilot Study in Children With Asthma Exacerbations [NCT01260623] | | 20 participants (Actual) | Observational | 2009-09-09 | Completed |
A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer [NCT01155791] | Phase 1 | 2 participants (Actual) | Interventional | 2010-04-30 | Terminated |
A Randomized, Partially Blinded, Pilot Study of the Effects of Pioglitazone on HCV RNA in Overweight Subjects With Chronic HCV Genotypes 1 or 4 Infection. [NCT01157975] | Phase 2 | 0 participants (Actual) | Interventional | 2008-10-31 | Withdrawn(stopped due to Study was completed in another site) |
Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment [NCT01156883] | | 76 participants (Actual) | Interventional | 2010-04-30 | Completed |
Short Term Study on the Effect of a Fixed Dose of 12.5 mg of Prednisone as Starting Dose in Polymyalgia Rheumatica [NCT01169597] | Phase 4 | 60 participants (Actual) | Interventional | 2009-01-31 | Completed |
A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma [NCT03782532] | Phase 3 | 486 participants (Actual) | Interventional | 2019-01-25 | Completed |
An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens for de Novo Renal Transplant Recipients: A Comparison of a Sirolimus / EC-MPS (Myfortic) / Tacrolimus Regimen, an Everolimus / EC-MPS / Tacr [NCT01183247] | Phase 4 | 63 participants (Actual) | Interventional | 2008-07-31 | Completed |
A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-b [NCT06136624] | Phase 3 | 1,200 participants (Anticipated) | Interventional | 2023-12-22 | Not yet recruiting |
The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia [NCT03121690] | Phase 4 | 500 participants (Anticipated) | Interventional | 2017-12-01 | Active, not recruiting |
A Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAD and MAD of CORT125281 in Healthy Subjects [NCT03335956] | Phase 1 | 48 participants (Actual) | Interventional | 2017-09-21 | Completed |
A Single Arm, Multi-center, Phase II Clinical Trial of Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma and CD79A/CD79B Genetic Abnormality [NCT04668365] | Phase 2 | 59 participants (Anticipated) | Interventional | 2020-12-25 | Recruiting |
A Single Arm, Multi-center, Phase II Clinical Trial of VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma [NCT04433156] | Phase 2 | 60 participants (Anticipated) | Interventional | 2020-04-22 | Recruiting |
A Phase I and Feasibility Study of Everolimus (RAD001) Plus R-CHOP for New Untreated Diffuse Large B-Cell Lymphoma (DLBCL) [NCT01334502] | Phase 1 | 26 participants (Actual) | Interventional | 2012-03-31 | Completed |
Budesonide in Liver Transplantation [NCT03315052] | Phase 4 | 0 participants (Actual) | Interventional | 2019-01-31 | Withdrawn(stopped due to Delay in IRB approval) |
A Randomized Phase III Study to Compare Bortezomib, Melphalan, Prednisone (VMP) With High Dose Melphalan Followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma [NCT01208766] | Phase 3 | 1,503 participants (Actual) | Interventional | 2011-01-31 | Active, not recruiting |
Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pr [NCT01308567] | Phase 3 | 1,168 participants (Actual) | Interventional | 2011-05-05 | Completed |
A Phase I, Single Center, Placebo-Controlled, Blinded Pilot Study of Ipratropium Bromide in Children Admitted to the Intensive Care Unit With Status Asthmaticus [NCT02872597] | Phase 1 | 30 participants (Actual) | Interventional | 2016-09-05 | Completed |
A Phase II Study Evaluating Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Double and Triple Hit Lymphoma, Double Expressor Lymphoma and High-Gr [NCT04479267] | Phase 2 | 49 participants (Anticipated) | Interventional | 2020-08-21 | Recruiting |
Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas [NCT01030900] | Phase 2 | 50 participants (Actual) | Interventional | 2009-10-22 | Completed |
A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma [NCT01026220] | Phase 3 | 166 participants (Actual) | Interventional | 2009-12-07 | Completed |
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY) [NCT04221477] | Phase 3 | 252 participants (Anticipated) | Interventional | 2020-08-10 | Active, not recruiting |
Glucocorticoid Effects in Patients With DM Type 2 [NCT03661684] | Early Phase 1 | 10 participants (Actual) | Interventional | 2016-06-03 | Completed |
Randomized Three-Arm Trial to Evaluate the Effect of Neoadjuvant Apalutamide Alone or in Combination With Abiraterone Acetate and GnRH Agonist on Enhancing Surgical Outcome of Nerve-Sparing Radical Prostatectomy in Men With High-Risk Prostate Cancer [NCT02949284] | Phase 2 | 90 participants (Anticipated) | Interventional | 2017-06-20 | Recruiting |
A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas [NCT00006721] | Phase 3 | 571 participants (Actual) | Interventional | 2001-03-31 | Active, not recruiting |
Initial Treatment of Patients With Immune Thrombocytopenic Purpura: The ITP^2 Study [NCT00991939] | Phase 3 | 8 participants (Actual) | Interventional | 2010-01-31 | Terminated(stopped due to The study was closed due to accrual futility there were only a total of 8 subjects enrolled.) |
Alloantibodies in Pediatric Heart Transplantation [NCT01005316] | | 290 participants (Actual) | Observational | 2010-01-31 | Terminated(stopped due to Inability to meet accrual goals within the funding period.) |
A Phase II Study of Iodine-131-Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma [NCT00770224] | Phase 2 | 87 participants (Actual) | Interventional | 2009-04-30 | Completed |
A Phase 1 Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Abiraterone in Patients With Castrate Resistant Prostate Cancer Progressing on Abiraterone [NCT04296578] | Phase 1 | 0 participants (Actual) | Interventional | 2020-10-31 | Withdrawn(stopped due to Study did not start) |
Cinobufacini Tablets Combined With R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone)/CHOP in Treatment of Diffuse Large B Cell Lymphoma: A Phase II Randomized, Controlled and Multi-center Study [NCT02871869] | Phase 2/Phase 3 | 316 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or Without Lenalidomide in Subjects With Castrate-Resistant Prostate Cancer (CRPC) [NCT00988208] | Phase 3 | 1,059 participants (Actual) | Interventional | 2009-11-11 | Completed |
Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation [NCT00717379] | Phase 4 | 50 participants (Actual) | Interventional | 2007-05-31 | Completed |
Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma [NCT00577993] | Phase 3 | 210 participants (Actual) | Interventional | 1998-03-16 | Completed |
A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma [NCT00686335] | Phase 2 | 12 participants (Actual) | Interventional | 2008-06-30 | Completed |
A Phase I/II Study of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer [NCT00459186] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2005-11-30 | Completed |
Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis [NCT03479502] | Phase 4 | 1 participants (Actual) | Interventional | 2018-01-05 | Terminated(stopped due to Lack of personnel to help with recruiting) |
A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate [NCT00634933] | Phase 2 | 222 participants (Actual) | Interventional | 2008-03-31 | Terminated(stopped due to The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.) |
A Six-week Evaluator-Blind, Randomized, Active-Controlled Evaluation of the Effects of Three Doses of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI), Montelukast, and Beclomethasone Dipropionate (BDP HFA) on the HPA Axis in Asthm [NCT01615874] | Phase 2 | 0 participants (Actual) | Interventional | 2013-01-31 | Withdrawn |
The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Rand [NCT05018520] | Phase 3 | 800 participants (Anticipated) | Interventional | 2021-09-17 | Recruiting |
An Open-Label, Randomized, Pharmacokinetic Study of vinCRIStine Sulfate LIPOSOME Injection Ready-to-Use (VSLI-RTU) Formulation (1-Vial) and Marqibo® Formulation (3-Vials) in Patients With Hematological Malignancies [NCT04243434] | Phase 1 | 56 participants (Anticipated) | Interventional | 2020-08-15 | Not yet recruiting |
Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma [NCT00841945] | Phase 3 | 334 participants (Actual) | Interventional | 2005-04-30 | Terminated(stopped due to other drugs other studies) |
Th2 Effects on Eicosanoid Pathways: Implications for Altered Innate Responses in Asthma [NCT00853411] | | 0 participants (Actual) | Interventional | 2008-12-31 | Withdrawn(stopped due to Terminated by Investigator due to lack of eligible subjects.) |
A Phase II Trial of Bortezomib (Velcade) Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease [NCT00815919] | Phase 2 | 22 participants (Actual) | Interventional | 2008-12-31 | Completed |
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Chidamide Combined With CHOP(Cyclophosphamide, Doxorubicin, Vincristine, Prednisone ) in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma [NCT03853044] | Phase 2 | 23 participants (Anticipated) | Interventional | 2018-12-29 | Active, not recruiting |
Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma. A Randomized, Open Label, Phase III Study by Fondazione Italiana Linfomi. [NCT05058404] | Phase 3 | 602 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
Phase 1 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma [NCT04739813] | Phase 1 | 55 participants (Anticipated) | Interventional | 2021-07-09 | Recruiting |
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL [NCT04529772] | Phase 3 | 600 participants (Anticipated) | Interventional | 2020-10-08 | Recruiting |
A Phase 1 Study of Lenalidomide in Combination With EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL) [NCT04301076] | Phase 1 | 30 participants (Anticipated) | Interventional | 2021-08-31 | Recruiting |
Safety and Feasibility of Stem Cell Gene Transfer Following R-EPOCH for Non-Hodgkin Lymphoma in AIDS Patients Using Peripheral Blood Stem/Progenitor Cells Treated With a Lentivirus Vector-Encoding Multiple Anti-HIV RNAs [NCT02337985] | Phase 1 | 10 participants (Anticipated) | Interventional | 2015-11-20 | Active, not recruiting |
A Phase II Study to Evaluate Low-Dose Alemtuzumab as a Glucocorticoid-Sparing Agent for Initial Systemic Treatment of Acute Graft-Versus-Host Disease [NCT00410657] | Phase 2 | 53 participants (Anticipated) | Interventional | 2006-07-31 | Completed |
A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer [NCT01619813] | Phase 2 | 85 participants (Actual) | Interventional | 2012-12-14 | Completed |
A Multi-Centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone, and Rituximab (BCVP-R) for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First- [NCT00428142] | Phase 2 | 95 participants (Actual) | Interventional | 2007-05-01 | Completed |
A Randomized Phase II Study of OGX-011 in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Hormone Refractory Prostate Cancer [NCT00258388] | Phase 2 | 82 participants (Actual) | Interventional | 2005-09-28 | Completed |
Exploratory Study of Molecular Phenotype Changes and Personalized Treatment for Patients With Castration Resistant Prostate Cancer [NCT02208583] | | 150 participants (Anticipated) | Interventional | 2014-06-30 | Recruiting |
Early Steroid Use in Infants With Clinical Pneumocystis Jiroveci Pneumonia (PCP) in the Queen Elizabeth Central Hospital, Blantyre, Malawi [NCT02149433] | | 78 participants (Actual) | Interventional | 2012-05-31 | Completed |
A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage [NCT04440267] | Phase 2 | 50 participants (Anticipated) | Interventional | 2020-06-20 | Not yet recruiting |
Selinexor Combined With Prednisone, Etoposide, and Lenalidomide as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for Refractory Diffuse Large B-cell Lymphoma With p53 and/or c-Myc Expression [NCT05498636] | Phase 1/Phase 2 | 67 participants (Anticipated) | Interventional | 2022-10-01 | Not yet recruiting |
A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY) [NCT01578655] | Phase 3 | 630 participants (Actual) | Interventional | 2012-08-31 | Completed |
Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis [NCT05479448] | | 30 participants (Anticipated) | Observational | 2022-06-03 | Recruiting |
A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Wee [NCT01393639] | Phase 2 | 323 participants (Actual) | Interventional | 2011-09-30 | Completed |
A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer [NCT01188187] | Phase 3 | 1,022 participants (Actual) | Interventional | 2010-11-30 | Completed |
A Multicenter, Phase 2 Study Evaluating the Value of Radiotherapy in Advanced Diffuse Large B-cell Lymphoma Patients With Extranodal Involvement and Large Tumors Who Had Complete Remission as Assessed by PET-CT After Immune-chemotherapy [NCT05874778] | Phase 2 | 108 participants (Anticipated) | Interventional | 2023-05-15 | Not yet recruiting |
Moscow-Berlin 2008 Multicenter Randomised Study for Treatment of Acute Lymphoblastic Leukemia in Children and Adolescents [NCT01953770] | | 3,000 participants (Anticipated) | Interventional | 2008-02-29 | Active, not recruiting |
A Multicenter, Randomized, Open-label, Controlled Study of Nevirapine (VIRAMUNE®) and a Short Course of Prednisone to Determine the Safety and Effectiveness of This Strategy in Preventing Nevirapine (VIRAMUNE®) Associated Rash. [NCT02184299] | Phase 4 | 138 participants (Actual) | Interventional | 1999-04-30 | Completed |
Dexamethasone Versus Prednisone for Asthma Treatment in the Pediatric Inpatient Population; a Feasibility Study [NCT03133897] | Phase 3 | 20 participants (Actual) | Interventional | 2018-03-05 | Terminated(stopped due to it was felt by the sponsoring institution that the current standard of oversight expected by the Health Canada regulations, would not be possible to achieve) |
A Phase I/II Multicenter, Open-Label Study of YM155 Plus Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors [NCT00514267] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2007-05-31 | Completed |
The Combination of Prednisone and Recombinant Human Thrombopoietin vs Prednisone Monotherapy for Treatment in Immune Thrombocytopenia in Pregnancy [NCT05333744] | Phase 2 | 90 participants (Anticipated) | Interventional | 2021-06-01 | Recruiting |
Phase II Study of Multimodality Therapy in Mantle Cell Lymphoma [NCT00004231] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
The Effect of Prednisone and Solu-Medrol on Physical Exercise in COPD Patients and the Inflammaroty Response During and After Exercis. [NCT01978665] | Phase 4 | 14 participants (Actual) | Interventional | 2013-04-30 | Completed |
A Phase 1b Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone or Apalutamide in mCRPC (ARES: Androgen Receptor Eradication Study) [NCT05295927] | Phase 1 | 3 participants (Actual) | Interventional | 2022-03-23 | Terminated(stopped due to Administrative Decision) |
A Phase II Study of Durvalumab Treatment Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies [NCT03847649] | Phase 2 | 60 participants (Anticipated) | Interventional | 2020-03-09 | Recruiting |
Advanced ChemoHormonal Therapy for Treatment Naïve Metastatic Prostate Cancer: Apalutamide and Abiraterone Acetate With Prednisone and Androgen Deprivation Therapy After Treatment With Docetaxel and Androgen Deprivation Therapy [NCT04267887] | Phase 2 | 7 participants (Actual) | Interventional | 2020-05-11 | Active, not recruiting |
Phase II Pilot Study of Brentuximab Vedotin, Rituximab and Dose Attenuated CHP in Elderly Patients With DLBCL [NCT02734771] | Phase 2 | 24 participants (Anticipated) | Interventional | 2016-06-30 | Active, not recruiting |
A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cance [NCT02257736] | Phase 3 | 982 participants (Actual) | Interventional | 2014-11-30 | Active, not recruiting |
A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate [NCT01972217] | Phase 2 | 158 participants (Actual) | Interventional | 2014-04-01 | Completed |
A Randomized Study of Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone in Patients With Prostate Cancer Who Have PSA Progression After Prostatectomy and/or Radiotherapy [NCT01786265] | Phase 2 | 310 participants (Anticipated) | Interventional | 2013-02-05 | Active, not recruiting |
A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China [NCT03099122] | Phase 4 | 115 participants (Actual) | Interventional | 2017-08-16 | Completed |
Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) [NCT02119273] | Phase 4 | 0 participants (Actual) | Interventional | 2014-09-30 | Withdrawn(stopped due to Lack of enrollment) |
Belatacept for the Management of Moderately Sensitized Patients at Risk for Delayed Graft Function (DGF) [NCT02130817] | Phase 4 | 0 participants (Actual) | Interventional | 2014-09-24 | Withdrawn(stopped due to Organ transplant criteria made recruitment difficult. Closed with IRB 10/09/2015.) |
A Prospective, Randomized, Controlled Pilot Study of Early-Use Long Acting Tacrolimus (Envarsus XR) in Lung Transplant Recipients [NCT04469842] | Early Phase 1 | 48 participants (Anticipated) | Interventional | 2023-08-31 | Not yet recruiting |
Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study [NCT04175431] | Phase 2 | 100 participants (Anticipated) | Interventional | 2020-09-30 | Recruiting |
A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy [NCT00109837] | Phase 2 | 79 participants (Actual) | Interventional | 2005-04-30 | Completed |
Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPP/ABV Hybrid Chemotherapy in Patients With Stage III/IV Hodgkin's Disease [NCT00002462] | Phase 3 | 615 participants (Actual) | Interventional | 1989-09-30 | Active, not recruiting |
Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute [NCT02036489] | Phase 4 | 107 participants (Actual) | Interventional | 2008-01-31 | Completed |
Comparisons Of Inflammatory Biomarkers And Cardiovascular Risk Scores Before And After Conversion To Full Dose Myfortic® Using Two Hour Neoral® Monitoring. [NCT02058875] | Phase 4 | 0 participants (Actual) | Interventional | 2014-02-28 | Withdrawn(stopped due to The study funder retracted their grant funding offer before contract signed.) |
Off-label Use of Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis: Effectiveness and Safety [NCT03222687] | Phase 4 | 25 participants (Actual) | Interventional | 2015-09-01 | Completed |
A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, H [NCT06099990] | Phase 1 | 660 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11) [NCT05008224] | Phase 2 | 146 participants (Actual) | Interventional | 2021-10-07 | Active, not recruiting |
Randomized, Parallel-group, Double-blind, Comparative Bioequivalence Trial of MabionCD20 Compared to MabThera (Rituximab by Hoffman-La Roche) in Patients With Diffuse Large B-cell Lymphoma [NCT02617485] | Phase 3 | 143 participants (Actual) | Interventional | 2015-12-31 | Completed |
An Open-label Phase 2 Multi-center Study of Enzalutamide and Abiraterone and Biomarkers of Androgen Response and Resistance During Rising PSA: BARRIER-P Trial [NCT02429193] | Phase 2 | 16 participants (Anticipated) | Interventional | 2016-03-31 | Completed |
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Crescents : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. [NCT04833374] | Phase 3 | 200 participants (Anticipated) | Interventional | 2021-05-24 | Recruiting |
Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm:a Randomized Controlled Trial [NCT03039608] | | 72 participants (Actual) | Interventional | 2017-02-10 | Completed |
Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study [NCT00544219] | | 156 participants (Actual) | Interventional | 2007-09-30 | Completed |
A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide [NCT06173362] | Phase 2 | 75 participants (Anticipated) | Interventional | 2023-11-09 | Recruiting |
Efficacy and Safety of Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica (ITTG PMR): An Open-label 52-week Randomized Controlled Trial [NCT06172361] | Phase 3 | 98 participants (Anticipated) | Interventional | 2024-01-15 | Not yet recruiting |
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1) [NCT06091254] | Phase 3 | 478 participants (Anticipated) | Interventional | 2023-12-12 | Recruiting |
A Phase 1/2 Study of Nivolumab and Ipilimumab in Combination With Sirolimus and Prednisone in Kidney Transplant Recipients With Selected Unresectable or Metastatic Cutaneous Cancers [NCT05896839] | Phase 1/Phase 2 | 16 participants (Anticipated) | Interventional | 2024-08-11 | Recruiting |
Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial [NCT05674994] | Phase 3 | 110 participants (Anticipated) | Interventional | 2023-10-26 | Recruiting |
A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects With Peripheral T-cell Lymphoma (PTCL) With Less Than 10% CD30 Expression [NCT04569032] | Phase 2 | 80 participants (Anticipated) | Interventional | 2020-11-12 | Recruiting |
Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies [NCT01254864] | Phase 2 | 190 participants (Actual) | Interventional | 2011-03-16 | Completed |
Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment? [NCT03550781] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2018-06-01 | Not yet recruiting |
A Phase 1 Study to Evaluate Safety, Toxicity, and Potential Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma [NCT05035862] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-03-16 | Recruiting |
A Phase II Study of Nivolumab in Combination With DA-REPOCH Followed by Short Course Nivolumab Consolidation in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma [NCT03749018] | Phase 2 | 30 participants (Anticipated) | Interventional | 2019-01-02 | Active, not recruiting |
Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease: a Prospective, Multicenter, Randomized, Open-label, Clinical Trial [NCT03323476] | Phase 3 | 136 participants (Anticipated) | Interventional | 2018-02-02 | Recruiting |
Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients [NCT02573012] | Phase 4 | 314 participants (Actual) | Interventional | 2016-03-29 | Completed |
PROUD Study - Preventing Opioid Use Disorders [NCT04766996] | Phase 4 | 57 participants (Actual) | Interventional | 2021-05-17 | Terminated(stopped due to Loss of surgery team member deemed the study procedures impossible to achieve, and no replacement could be found in a timely manner to complete trial as initially planned.) |
A Phase 1 Study Combining Venetoclax With a Pediatric-Inspired Regimen for Newly Diagnosed Adults With B Cell Ph-Like Acute Lymphoblastic Leukemia [NCT05157971] | Phase 1 | 6 participants (Anticipated) | Interventional | 2022-03-17 | Recruiting |
Utility of Prednisone in the Treatment of Cellulitis [NCT00893048] | Phase 2 | 0 participants (Actual) | Interventional | 2010-01-15 | Withdrawn(stopped due to Study never enrolled any subjects before auto-terminated by the internal IRB.) |
Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering [NCT06072768] | Phase 2 | 200 participants (Anticipated) | Interventional | 2023-03-09 | Recruiting |
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Prog [NCT04907227] | Phase 3 | 81 participants (Actual) | Interventional | 2020-09-23 | Terminated(stopped due to The data did not support study endpoints) |
A Phase II Study of Blinatumomab and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients ≥ 65 Years of Age With Newly Diagnosed Philadelphia-Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL) and of Dasatinib, Prednisone [NCT02143414] | Phase 2 | 53 participants (Actual) | Interventional | 2015-06-30 | Active, not recruiting |
An Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous Pemphigoid [NCT00472030] | Phase 4 | 2 participants (Actual) | Interventional | 2007-08-31 | Completed |
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine [NCT02994927] | Phase 3 | 331 participants (Actual) | Interventional | 2017-03-15 | Completed |
A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of Aggressive B Cell Lymphoma [NCT00004197] | Phase 2 | 0 participants | Interventional | 1999-06-25 | Completed |
CSP #553 - Adjuvant Therapy in Prostate Carcinoma Treatment [NCT00132301] | Phase 3 | 298 participants (Actual) | Interventional | 2006-06-30 | Completed |
A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer [NCT00519285] | Phase 3 | 1,224 participants (Actual) | Interventional | 2007-08-31 | Completed |
A Pilot Study of Adefovir Dipivoxil Alone and After Prednisone Priming for the Treatment of Asian Patients With HBeAg-positive Chronic Hepatitis B [NCT00715715] | | 0 participants (Actual) | Interventional | 2008-04-30 | Withdrawn(stopped due to Withdrawn studies.) |
A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Asparaginase (DA-EPOCH-A) for Adults With Acute Lymphoblastic Leukemia/Lymphoma [NCT02538926] | Phase 2 | 0 participants (Actual) | Interventional | 2018-07-01 | Withdrawn(stopped due to Drugs unavailable) |
Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma [NCT06045247] | Phase 2 | 40 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma [NCT06043323] | Phase 2 | 20 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
Efficacy and Safety of Tofacitinib (TF) Combined With Iguratimod(IGU) in the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA) [NCT04928066] | Phase 4 | 100 participants (Actual) | Interventional | 2020-03-01 | Completed |
The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study [NCT04918524] | | 126 participants (Anticipated) | Observational | 2018-09-11 | Recruiting |
Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China [NCT03855007] | Phase 4 | 400 participants (Actual) | Interventional | 2016-01-01 | Completed |
Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia [NCT02877303] | Phase 2 | 80 participants (Anticipated) | Interventional | 2016-11-01 | Recruiting |
A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants [NCT06097364] | Phase 3 | 733 participants (Anticipated) | Interventional | 2023-11-14 | Recruiting |
Randomized Open-label Study of the Impact of Prolonged Systemic Corticosteroid Therapy on the Course and Relapse Risk of Checkpoint Inhibitor Interstitial Lung Disease (Pneumonitis) Related to the Treatment of Solid Tumors With Anti-programmed-death Type [NCT04036721] | Phase 4 | 85 participants (Anticipated) | Interventional | 2019-10-01 | Suspended(stopped due to SARS-CoV-2 cases stopped the recruitment in Organisation since July 2020) |
A Multicentric, Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion (SDI) in Patients With Previously Untreated Advanced Follicular Lymphoma [NCT03817853] | Phase 4 | 114 participants (Actual) | Interventional | 2019-02-26 | Completed |
Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00549848] | Phase 3 | 600 participants (Actual) | Interventional | 2007-10-29 | Completed |
Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI) [NCT00104299] | Phase 2/Phase 3 | 197 participants (Actual) | Interventional | 2005-01-31 | Completed |
A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Ex-Vivo Cultured Allogenic Mesenchymal Stem Cells For the Treatment of Extensive Chronic Graft Versus Host Disease [NCT00972660] | Phase 2 | 52 participants (Anticipated) | Interventional | 2009-09-30 | Enrolling by invitation |
Dexamethasone-suppression-test Predicts Later Development of Adrenal Insufficiency After a 14 Days' Course of Prednisone in Healthy Volunteers [NCT00975078] | Phase 4 | 39 participants (Actual) | Interventional | 2009-05-31 | Completed |
A Phase 1b, Open-Label, Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With R-CHOP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8) [NCT04974996] | Phase 1 | 0 participants (Actual) | Interventional | 2022-02-01 | Withdrawn(stopped due to Decision to not proceed with study.) |
An Observational Study of Continuous Oral Dosing of an Irreversible CYP17 Inhibitor, Abiraterone Acetate (CB7630), in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma [NCT00544440] | Phase 2 | 57 participants (Actual) | Interventional | 2007-10-31 | Completed |
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC) [NCT00571675] | Phase 2 | 220 participants (Actual) | Interventional | 2007-10-31 | Completed |
A Multicenter Randomized Open Label Study to Assess Efficacy and Safety of a Steroid Avoidance Regimen in Comparison to a Treatment With Steroids, in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS) 2.16 g/d for 6 Weeks and Cyclosporine Micro [NCT00413920] | Phase 3 | 222 participants (Actual) | Interventional | 2007-04-30 | Completed |
A Feasibility Pilot and Phase II Study Of Chemoimmunotherapy With Epratuzumab (IND #12034) for Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia (ALL) [NCT00098839] | Phase 1/Phase 2 | 134 participants (Actual) | Interventional | 2005-02-28 | Completed |
(REASON) Double-blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-l-carnitine in the Prevention of Sagopilone-induced Peripheral Neuropathy. [NCT00751205] | Phase 2 | 150 participants (Actual) | Interventional | 2008-08-31 | Completed |
Corticosteroid Treatment for Community-Acquired Pneumonia A Randomized, Double-blind Study- The STEP Trial [NCT00973154] | Phase 3 | 800 participants (Actual) | Interventional | 2009-12-31 | Completed |
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma [NCT00540644] | Phase 2 | 70 participants (Actual) | Interventional | 2007-10-31 | Completed |
Comparison of Two Tapering Strategies of Prednisone in Patients With Generalised Myasthenia Gravis Treated With Prednisone and Azathioprine: a Single-blind Randomised Controlled Multicenter Study [NCT00987116] | Phase 4 | 118 participants (Actual) | Interventional | 2009-06-30 | Completed |
A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 [NCT01332968] | Phase 3 | 1,401 participants (Actual) | Interventional | 2011-07-06 | Completed |
A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB T [NCT00057811] | Phase 2 | 97 participants (Actual) | Interventional | 2004-06-30 | Completed |
Phase II Study of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With B-lymphocyte Antigen CD20 (CD20) Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT) [NCT00066469] | Phase 2 | 55 participants (Actual) | Interventional | 2004-04-30 | Completed |
First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG. [NCT00801281] | Phase 3 | 250 participants (Actual) | Interventional | 2007-02-28 | Completed |
Evaluation of Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Patients With Non-Hodgkin's Lymphoma [NCT00651755] | | 23 participants (Actual) | Interventional | 2008-03-31 | Completed |
A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer [NCT00811031] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn |
Open, Single Center, Randomised, Parallel Group Pilot Study to Investigate a Calcineurin Free Immunosuppressive Treatment for de Novo Renal Transplant Recipients: A Comparison of a Rapamycin/MMF/Steroids Regime to a Cyclosporine A Neoral/MMF/Steroids Regi [NCT00812123] | Phase 4 | 127 participants (Actual) | Interventional | 2001-01-31 | Completed |
A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) With Standard APO (Doxorubicin, Prednisone, Vincristine) Versus Consolidation With a Regimen Including Vinblastine [NCT00059839] | Phase 3 | 129 participants (Actual) | Interventional | 2003-11-30 | Completed |
An Abiraterone Acetate Plus Prednisone Drug-Drug Interaction Study With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01017939] | Phase 1 | 34 participants (Actual) | Interventional | 2010-01-31 | Completed |
A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement [NCT00424749] | Phase 2 | 4 participants (Actual) | Interventional | 2007-06-30 | Terminated(stopped due to Company providing study drug terminated study due to lack of funds) |
Phase II Study of Pembrolizumab In Combination With R-CHOP for Patients With Untreated, High-Risk, Non-Germinal Center-Derived DLBCL [NCT03995147] | Phase 2 | 51 participants (Anticipated) | Interventional | 2019-08-29 | Recruiting |
Active Immunization of Sibling Stem Cell Transplant Donors Against Purified Myeloma Protein of the Stem Cell Recipient With Multiple Myeloma in the Setting of Non-Myeloablative, HLA-Matched Allogeneic Peripheral Blood Stem Cell Transplantation [NCT00006184] | Phase 2 | 20 participants (Actual) | Interventional | 2001-02-08 | Completed |
Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma [NCT00004228] | Phase 3 | 393 participants (Actual) | Interventional | 2000-06-30 | Completed |
A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD) [NCT02959944] | Phase 3 | 193 participants (Actual) | Interventional | 2017-05-11 | Completed |
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP HFA Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis When Administered in Adolescent and Adult Subjects (12 t [NCT01133626] | Phase 3 | 107 participants (Actual) | Interventional | 2010-06-30 | Completed |
Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma [NCT02767674] | Phase 3 | 258 participants (Anticipated) | Interventional | 2016-05-31 | Recruiting |
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer [NCT00887198] | Phase 3 | 1,088 participants (Actual) | Interventional | 2009-04-28 | Completed |
Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL) [NCT00900445] | | 0 participants (Actual) | Observational | 2008-03-24 | Withdrawn |
Safety and Efficacy of Cemiplimab (PD-1 Blockade) in Selected Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma (CONTRAC) [NCT04339062] | Phase 1 | 12 participants (Anticipated) | Interventional | 2020-07-15 | Active, not recruiting |
Targeting Inflammation and Alloimmunity in Heart Transplant Recipients With Tocilizumab (RTB-004) [NCT03644667] | Phase 2 | 200 participants (Anticipated) | Interventional | 2018-12-20 | Recruiting |
Phase I Study of Inotuzumab Ozogamicin With 3 and 4 Drug Augmented Berlin-Frankfurt-Münster (BFM) Re-Induction for Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) [NCT03962465] | Phase 1 | 36 participants (Anticipated) | Interventional | 2022-07-22 | Active, not recruiting |
A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Mantle Cell Lymphoma [NCT00101101] | Phase 2 | 43 participants (Actual) | Interventional | 2004-07-31 | Completed |
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Adult Subjects With a History of Grass Pollen Induced Rhinoconjunctivitis Wit [NCT00562159] | Phase 3 | 439 participants (Actual) | Interventional | 2007-11-30 | Completed |
Phase 1 Study to Evaluate the Safety of REducing the Prophylactic Dose of DEXamethasone Around Docetaxel Infusion in Patients With Early or Advanced Breast Cancer and Prostate Cancer [NCT02776436] | Phase 1 | 46 participants (Actual) | Interventional | 2016-01-31 | Active, not recruiting |
Clinical, Multicenter, Single-arm, Treatment With a Scheme With Low Doses of Bortezomib / Melphalan / Prednisone (MPV) in Patients With Multiple Myeloma (MM) Newly Diagnosed Symptomatic ≥75 Years [NCT02773550] | Phase 4 | 24 participants (Actual) | Interventional | 2014-01-31 | Terminated(stopped due to Low recruiment.) |
A Randomized, Open-label, Dose-ranging Study of Oral Delayed Release Prednisone in Patients With Untreated Polymyalgia Rheumatic (PMR) [NCT02702778] | Phase 2 | 8 participants (Actual) | Interventional | 2016-02-29 | Terminated(stopped due to lack of study recruitment) |
Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC-RP Trial): A Randomized, Open-label, Multi-centre Phase-2 Study Evaluating the Pathological Complete Response (pCR) Rate Following Neoadjuvant Therapy in Participants With [NCT02543255] | Phase 2 | 76 participants (Actual) | Interventional | 2016-09-30 | Completed |
Randomized Phase II Study of Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide Progression [NCT03764540] | Phase 2 | 214 participants (Anticipated) | Interventional | 2019-04-01 | Recruiting |
A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease [NCT02703194] | Phase 4 | 68 participants (Actual) | Interventional | 2016-03-31 | Completed |
Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation for Fibrolamellar or Non-fibrolamellar Hepatocellular Carcinoma (HCC) Including Fibrolamellar HCC [NCT02702960] | Phase 2 | 0 participants (Actual) | Interventional | 2016-03-31 | Withdrawn(stopped due to This study was withdrawn due to lack of necessary resources from the liver transplant surgical group.) |
Multicenter, Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH-21, R-mNHL-BFM-90 and (Auto-SCT)in Patients With DLBCL [NCT02842931] | Phase 3 | 300 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis [NCT03827018] | Phase 2 | 70 participants (Actual) | Interventional | 2018-09-20 | Completed |
European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents [NCT02684708] | Phase 3 | 2,200 participants (Anticipated) | Interventional | 2015-10-01 | Active, not recruiting |
Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients [NCT02809079] | Phase 4 | 100 participants (Anticipated) | Interventional | 2016-01-31 | Enrolling by invitation |
Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis [NCT00956059] | | 40 participants (Anticipated) | Interventional | 2009-09-30 | Not yet recruiting |
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group, 6-Week Study to Evaluate the Effect of Multiple Doses of FlutiForm™ 250/10 Microgram HFA pMDI Twice Daily, FlutiForm™ 100/10 Microgram HFA pMDI Twice Daily, Prednisone and Placebo [NCT00657774] | Phase 1 | 160 participants (Anticipated) | Interventional | 2008-04-30 | Completed |
Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma [NCT00644306] | Phase 3 | 232 participants (Actual) | Interventional | 2002-04-30 | Terminated(stopped due to survival advantage demonstrated) |
A Phase II Pilot Trial of Bortezomib (PS-341, Velcade) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) [NCT00873093] | Phase 2 | 148 participants (Actual) | Interventional | 2009-03-31 | Completed |
An Open, Multicentre, Randomised, Parallel Group Pilot-Study to Compare Safety and Efficacy of Discontinuation of Mycophenolate Mofetil From a Tacrolimus/MMF/Steroid Triple Regimen Following Kidney Transplantation [NCT00693381] | Phase 3 | 152 participants (Actual) | Interventional | 2003-02-28 | Completed |
A Prospective Phase II Trial of Modified MRC UKALL Ⅻ/ECOG E2993 Regimen in the Treatment of Low Risk Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia for Young Adults [NCT02660762] | Phase 2 | 100 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
A QT/QTc and Multi-dose PK Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration- Resistant Prostate Cancer [NCT00910754] | Phase 1 | 33 participants (Actual) | Interventional | 2009-05-31 | Completed |
A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipi [NCT02763761] | Phase 2 | 0 participants (Actual) | Interventional | 2016-08-16 | Withdrawn(stopped due to Insufficient enrollment) |
An Open-Label, Multi-Centre, Randomised, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma [NCT00825149] | Phase 1 | 137 participants (Actual) | Interventional | 2009-02-28 | Completed |
DFCI ALL Adult Consortium Protocol: Adult ALL Trial [NCT01005758] | Phase 2 | 180 participants (Anticipated) | Interventional | 2009-01-31 | Not yet recruiting |
Phase I/II Randomized, Double-blind, Placebo-controlled Cross-over Study of Prednisone on Airway Inflammatory Response to Inhaled Wood Smoke. [NCT03861390] | Phase 1/Phase 2 | 14 participants (Anticipated) | Interventional | 2019-03-22 | Recruiting |
Randomization of Cytarabine Monotherapy Versus Standard-of-Care Vinblastine/Prednisone for Frontline Treatment of Langerhans Cell Histiocytosis (TXCH LCH0115) [NCT02670707] | Phase 3 | 124 participants (Anticipated) | Interventional | 2016-03-07 | Recruiting |
Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) [NCT04918147] | Phase 2 | 75 participants (Anticipated) | Interventional | 2021-10-13 | Recruiting |
Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts [NCT04542824] | Phase 1/Phase 2 | 102 participants (Anticipated) | Interventional | 2020-08-20 | Active, not recruiting |
A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomeru [NCT00430677] | Phase 2/Phase 3 | 423 participants (Actual) | Interventional | 2007-06-30 | Terminated(stopped due to Terminated due to failure to meet the primary efficacy endpoint in the Short-term Period) |
A Randomized, Open-label, Multi-center Phase III Trial Comparing Tisagenlecleucel to Standard of Care in Adult Participants With Relapsed or Refractory Follicular Lymphoma (FL) [NCT05888493] | Phase 3 | 108 participants (Anticipated) | Interventional | 2023-10-02 | Recruiting |
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma [NCT05675410] | Phase 3 | 1,875 participants (Anticipated) | Interventional | 2023-05-11 | Recruiting |
An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura [NCT05468320] | Phase 3 | 61 participants (Anticipated) | Interventional | 2022-11-21 | Recruiting |
Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma [NCT05283720] | Phase 2 | 394 participants (Anticipated) | Interventional | 2022-06-14 | Recruiting |
A Phase II/III Randomized Study of R-MiniCHOP With or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell L [NCT04799275] | Phase 2/Phase 3 | 422 participants (Anticipated) | Interventional | 2021-05-20 | Recruiting |
A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphom [NCT03914625] | Phase 3 | 6,720 participants (Anticipated) | Interventional | 2019-07-03 | Recruiting |
Phase I/II Study of Lenalidomide (Revlimid), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R2CHOP) Chemoimmunotherapy in Patients With Newly Diagnosed Diffuse Large Cell and Follicular Grade IIIA/B B Cell Lymphoma [NCT00670358] | Phase 1/Phase 2 | 138 participants (Actual) | Interventional | 2008-08-25 | Active, not recruiting |
A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) [NCT04598451] | Phase 3 | 222 participants (Actual) | Interventional | 2020-12-01 | Completed |
A Phase 1 PK and Dose Escalation and Expansion Study of DST-2970 in Patients With Prostate Cancer With Rising PSA on Treatment With Abiraterone Acetate [NCT04291664] | Phase 1 | 54 participants (Anticipated) | Interventional | 2020-01-31 | Active, not recruiting |
A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase I/II Trial to Study Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With ANCA-associated Vasculitis [NCT05197842] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2022-02-22 | Recruiting |
A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma [NCT04626791] | Phase 2 | 45 participants (Anticipated) | Interventional | 2021-08-03 | Recruiting |
A Phase II Study of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) Alternating With Pralatrexate (P) as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin Lymphoma [NCT01336933] | Phase 2 | 34 participants (Actual) | Interventional | 2011-07-06 | Completed |
Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma [NCT00352027] | Phase 2 | 81 participants (Actual) | Interventional | 2006-07-20 | Completed |
A Phase 1 Study of R-CHOP Plus SYK Inhibitor TAK-659 for the Front-Line Treatment of High-Risk Diffuse Large B Cell Lymphoma (DLBCL) [NCT03742258] | Phase 1 | 12 participants (Actual) | Interventional | 2019-03-13 | Active, not recruiting |
A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation. [NCT00345046] | Phase 4 | 60 participants (Actual) | Interventional | 2002-09-30 | Completed |
An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Antitumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With RCHOP Chemotherapy and Rituximab (MabThera®) Maintenance in Patients With First-line Advanced Follicular [NCT00896519] | Phase 2 | 30 participants (Anticipated) | Interventional | 2009-03-31 | Not yet recruiting |
The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis With Mild Proteinuria in Children [NCT02532790] | Phase 2 | 100 participants (Anticipated) | Interventional | 2015-08-31 | Recruiting |
A Prospective, Phase II/III Randomized, Mult-institutional Controlled, Open-label, Phase II Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Patients With Acquired Hemophilia A [NCT00306670] | Phase 2/Phase 3 | 2 participants (Actual) | Interventional | 2006-04-30 | Terminated(stopped due to Sponsor no longer funding study.) |
Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients [NCT01009970] | Phase 2 | 50 participants (Anticipated) | Interventional | 2010-05-31 | Recruiting |
A Phase I/II Study of Azacitidine (Vidaza), Docetaxel and Prednisone for Patients With Hormone Refractory Metastatic Prostate Cancer Previously Treated With a Taxotere Containing Regimen. [NCT00503984] | Phase 1/Phase 2 | 22 participants (Actual) | Interventional | 2007-05-31 | Terminated(stopped due to Withdrawal of Funding) |
A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study With and Without Enzastaurin in Combination With Docetaxel and Prednisone, Followed By Enzastaurin Maintenance as First-Line Treatment in Hormone Refractory Metastatic Prostate Cancer Patient [NCT00466440] | Phase 2 | 108 participants (Actual) | Interventional | 2007-06-30 | Completed |
A Phase 2, Multicenter, Open-Label Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC) [NCT00385827] | Phase 2 | 106 participants (Actual) | Interventional | 2006-11-30 | Terminated(stopped due to Prematurely stopped after Independent Data Monitoring Committee (IDMC) evaluation for lack of efficacy.) |
An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma (FL). [NCT00494780] | Phase 2 | 59 participants (Actual) | Interventional | 2007-06-30 | Completed |
Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE, Thalidomide, and Dexamethasone Ver [NCT00507416] | Phase 3 | 502 participants (Actual) | Interventional | 2007-06-30 | Completed |
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure [NCT00953303] | Phase 2/Phase 3 | 102 participants (Actual) | Interventional | 2009-01-31 | Completed |
Treatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo-controlled Multicentre Clinical Trial [NCT02712697] | | 140 participants (Anticipated) | Interventional | 2016-06-30 | Not yet recruiting |
A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone [NCT00294658] | Phase 3 | 126 participants (Actual) | Interventional | 2006-06-30 | Completed |
Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL [NCT00121199] | Phase 2 | 73 participants (Actual) | Interventional | 2005-06-30 | Completed |
Phase II Study of the Dose Adjusted EPOCH Regimen in Combination With Ofatumumab/Rituximab as Therapy for Patients With Newly Diagnosed or Relapsed/Refractory Burkitt Leukemia or Relapsed/Refractory Acute Lymphoblastic Leukemia [NCT02199184] | Phase 2 | 6 participants (Actual) | Interventional | 2015-01-14 | Completed |
SIMPLE Study: A Prospective and Randomized Trial of a Simplified Immunosuppressive Protocol Utilizing Low Dose EnvarsusXR [NCT04773392] | Phase 4 | 80 participants (Anticipated) | Interventional | 2021-11-23 | Recruiting |
SAABR: Single Arm Phase II Study of AR Targeted Therapy + Atezolizumab + GnRH Analog and Stereotactic Body Radiotherapy (SBRT) to the Prostate in Men With Newly Diagnosed Hormone-sensitive Metastatic Prostate Cancer [NCT04262154] | Phase 2 | 28 participants (Actual) | Interventional | 2020-03-03 | Active, not recruiting |
Phase 2 Clinical Trial for Comprehensive Treatment Program for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Tagraxofusp (SL-401) in Combination With HCVAD/Mini-CVD and VENETOCLAX [NCT04216524] | Phase 2 | 40 participants (Anticipated) | Interventional | 2020-05-29 | Recruiting |
A Phase 1 Study of ABL001 in Combination With Dasatinib, Prednisone, and Blinatumomab in Patients With BCR-ABL Positive (BCR-ABL+) B-cell Acute Lymphoblastic Leukemia (B-ALL) and Chronic Myeloid Leukemia (CML) [NCT03595917] | Phase 1 | 40 participants (Anticipated) | Interventional | 2018-07-24 | Recruiting |
Efficacy of Alternating Immunochemotherapy Consisting of R-CHOP + R-HAD vs R-CHOP Alone, Followed by Maintenance Therapy Consisting of Additional Lenalidomide + Rituximab vs Rituximab Alone for Older Patients With Mantle Cell Lymphoma [NCT01865110] | Phase 3 | 623 participants (Actual) | Interventional | 2013-11-30 | Active, not recruiting |
International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy [NCT00690560] | Phase 2 | 30 participants (Actual) | Interventional | 2007-05-31 | Completed |
A Randomized, Double-Blind, Controlled, Phase II Multicenter Trial of CTLA4Ig (Abatacept) Plus Cyclophosphamide vs Cyclophosphamide Alone in the Treatment of Lupus Nephritis [NCT00774852] | Phase 2 | 137 participants (Actual) | Interventional | 2008-11-30 | Completed |
An Open, Randomized, Multicentre Clinical Study to Compare the Safety and Efficacy of a Combination of Sequential Therapy of Tacrolimus (FK506) With Monoclonal Anti-IL2R Antibodies and Mycophenolate Mofetil Versus Tacrolimus (FK506) With Steroids in Liver [NCT00693524] | Phase 2 | 94 participants (Actual) | Interventional | 2002-11-30 | Completed |
Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) [NCT00772668] | | 3 participants (Actual) | Interventional | 2009-09-25 | Terminated(stopped due to Funding) |
Adjusted Steroid Therapy in Children With Idiopathic Nephrotic Syndrome [NCT02649413] | Phase 4 | 75 participants (Anticipated) | Interventional | 2016-03-31 | Not yet recruiting |
Renal Allograft Tolerance Through Mixed Chimerism [NCT00801632] | Phase 2 | 5 participants (Actual) | Interventional | 2008-12-31 | Completed |
Phase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis [NCT02496585] | Phase 2 | 33 participants (Anticipated) | Interventional | 2015-07-31 | Active, not recruiting |
Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage [NCT00705822] | Phase 3 | 54 participants (Actual) | Interventional | 2006-08-31 | Terminated(stopped due to low recruitment rate) |
A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging [NCT00822120] | Phase 2 | 371 participants (Actual) | Interventional | 2009-07-31 | Completed |
Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis [NCT04551781] | | 450 participants (Actual) | Interventional | 2020-04-01 | Completed |
Prospective Multicenter Randomized Open-label Controlled Trial Assessing Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia [NCT02627417] | Phase 3 | 216 participants (Anticipated) | Interventional | 2015-12-31 | Recruiting |
"Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD - a Randomized, Double-blind, Non-inferiority Study (The RECUT-Trial)" [NCT02386735] | | 470 participants (Anticipated) | Interventional | 2015-03-31 | Recruiting |
The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol [NCT00706680] | Phase 4 | 30 participants (Anticipated) | Interventional | 2008-02-29 | Recruiting |
Prospective Observational Trial to Evaluate Clinical Prognosis and the Risk Factors for Progression for Myasthenia Gravis Patients [NCT04101578] | | 2,000 participants (Anticipated) | Observational | 2017-02-08 | Recruiting |
Circadian Variation in Cytokines and the Effect of Timed Release Tablet Prednisone in Polymyalgia Rheumatica [NCT00836810] | Phase 2/Phase 3 | 12 participants (Actual) | Interventional | 2009-10-31 | Completed |
A Phase III Multicenter, Open-label Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma [NCT00719472] | Phase 3 | 451 participants (Actual) | Interventional | 2008-07-31 | Completed |
Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP [NCT00450385] | Phase 2 | 57 participants (Actual) | Interventional | 2007-04-24 | Terminated(stopped due to Investigator Decision due to insufficient accrual.) |
Randomized Study Comparing 4 and 6 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 21-day Intervals, Both With 6 Cycles of Immunotherapy With the Monoclonal Anti-CD20-Positive B-Cell Lymphoma Aged 18-60 Year [NCT00278421] | Phase 3 | 592 participants (Actual) | Interventional | 2005-11-30 | Completed |
A Phase I/II of Vorinostat Plus CHOP in Untreated T-cell Non-Hodgkin's Lymphoma [NCT00787527] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2008-11-30 | Completed |
Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial. [NCT00755859] | Phase 4 | 206 participants (Actual) | Interventional | 1998-05-31 | Completed |
A Prospective, Single Arm, Open-label, Phase II Study of Chidamide in Combination With R-CHOP in the Treatment of de Novo, Elderly, High-risk Diffuse Large B-cell Lymphoma [NCT02753647] | Phase 2 | 49 participants (Anticipated) | Interventional | 2016-04-30 | Recruiting |
A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma. [NCT00715208] | Phase 2 | 55 participants (Actual) | Interventional | 2008-09-30 | Completed |
A Phase 2, Multicenter, Randomized Study of IMC-A12 or IMC-1121B Plus Mitoxantrone and Prednisone in Metastatic Androgen-Independent Prostate Cancer (AIPC) Following Disease Progression on Docetaxel-Based Chemotherapy [NCT00683475] | Phase 2 | 138 participants (Actual) | Interventional | 2008-08-31 | Completed |
Colchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety [NCT03128905] | Phase 3 | 111 participants (Actual) | Interventional | 2018-02-05 | Completed |
Comparison of the Efficacy and Safety of Leflunomide Versus Placebo Combine With the Basic Prednisone Therapy in Patients With Active Phase of Takayasu's Arteritis: a Randomized Controlled Double-blinded Trial [NCT02981979] | | 116 participants (Anticipated) | Interventional | 2016-12-31 | Recruiting |
Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus [NCT02558517] | Phase 3 | 136 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
A Randomized Trial of the I-BFM-SG for the Management of Childhood Non-B Acute Lymphoblastic Leukemia [NCT00764907] | Phase 3 | 4,000 participants (Anticipated) | Interventional | 2002-11-30 | Recruiting |
Optimum Immunosuppression in Renal Transplant Recipients at High Risk of Developing New Onset Diabetes After Transplantation: A Multicenter, Prospective, Controlled and Randomized Trial. [NCT01002339] | Phase 4 | 134 participants (Actual) | Interventional | 2010-02-28 | Terminated(stopped due to Terminated: higher rate of acute rejection in the Cyclosporin A group) |
An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients [NCT00931918] | Phase 2 | 206 participants (Actual) | Interventional | 2009-10-31 | Completed |
Randomized Phase II Trial of Docetaxel With or Without PSA-TRICOM Vaccine in Patients With Castrate-Resistant Metastatic Prostate Cancer [NCT01145508] | Phase 2 | 10 participants (Actual) | Interventional | 2010-08-31 | Terminated(stopped due to Poor accrual) |
Phase III Randomized Trial of Autologous and Allogeneic Stem Cell Transplantation Versus Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia in First Remission [NCT00002514] | Phase 3 | 1,929 participants (Actual) | Interventional | 1993-05-07 | Completed |
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Inactive Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis - Including a Sub-study in Japanese Patients [NCT01124838] | Phase 3 | 261 participants (Actual) | Interventional | 2010-08-31 | Completed |
A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study) [NCT00717470] | Phase 4 | 1,252 participants (Actual) | Interventional | 2008-05-14 | Completed |
A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chro [NCT06143891] | Phase 3 | 240 participants (Anticipated) | Interventional | 2023-11-30 | Recruiting |
Smart Stop: A Phase II Trial of Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Prior to and With Standard Chemotherapy for Patients With Newly Diagnosed DLBCL [NCT04978584] | Phase 2 | 60 participants (Anticipated) | Interventional | 2022-03-03 | Recruiting |
A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 Gangliosidosis [NCT03952637] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2019-08-19 | Active, not recruiting |
Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial [NCT03153527] | Phase 4 | 573 participants (Anticipated) | Interventional | 2017-05-31 | Recruiting |
Targeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease Activity [NCT00092222] | Phase 2 | 75 participants (Actual) | Interventional | 2004-10-28 | Active, not recruiting |
P-CO-Li (Pulmonary Covid-19 Longterm Intervention Study) [NCT04782700] | | 0 participants (Actual) | Interventional | 2021-04-01 | Withdrawn(stopped due to Due to recruitment we decided to withdraw the study.) |
Pilot Study for Therapy Optimising for Hodgkin's Lymphoma in Childhood and Adolescence; Optimising Therapy for Boys With Hodgkin's Lymphoma in Intermediate and Advanced Stages. Safety and Efficacy Study for Drug Combination VECOPA [NCT00398554] | Phase 2 | 16 participants (Actual) | Interventional | 2005-06-30 | Completed |
Randomized, Prospective Single-center Study Comparing a Rapid Discontinuation of Corticosteroids (Steroid Withdrawal) With Corticosteroid Therapy in Kidney Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy [NCT00596947] | Phase 4 | 18 participants (Actual) | Interventional | 2005-10-31 | Terminated(stopped due to due to low study enrollment) |
The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil [NCT00885820] | Phase 4 | 240 participants (Actual) | Interventional | 2001-09-30 | Completed |
A Prospective Study of Bortezomib Combined With CHEP Regimen in the Treatment of Primary Peripheral T Cell Lymphoma [NCT04061772] | Phase 2 | 54 participants (Anticipated) | Interventional | 2019-08-12 | Recruiting |
A Phase II Study of Satraplatin and Prednisone in Metastatic Androgen Independent Prostate Cancer (AIPC) [NCT00634647] | Phase 2 | 24 participants (Actual) | Interventional | 2008-02-19 | Completed |
Vaginal Prednisone Administration for Prevention of Adrenal Crisis - a Bioequivalence Study [NCT02689960] | Phase 2 | 12 participants (Actual) | Interventional | 2017-01-31 | Completed |
A Phase I Study Evaluating the Safety, Tolerability and Biological Activity of EZN-3042, a Survivin mRNA Antagonist, Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL) [NCT01186328] | Phase 1 | 6 participants (Actual) | Interventional | 2010-08-24 | Terminated(stopped due to Enzon Pharmaceuticals decided to end its development of EZN-3042.) |
Budesonide Inhalation Suspension for Acute Asthma in Children [NCT00393367] | Phase 4 | 179 participants (Actual) | Interventional | 2006-12-31 | Completed |
An Open Label, Multicenter, Phase I/II Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease [NCT04220632] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2020-06-18 | Terminated(stopped due to Adverse events of the first patient) |
Effects of p38 Inhibitor AZD7624 in Corticosteroid Resistant Asthma [NCT02753764] | Phase 2 | 2 participants (Actual) | Interventional | 2017-01-31 | Completed |
Single Center, Open-label Randomized Prospective Trial: Effect of Sirolimus on Polycystic Liver Disease [NCT00934791] | | 2 participants (Actual) | Interventional | 2009-02-28 | Terminated(stopped due to Terminated due to inadequate enrollment) |
A Phase 1 Study Of Palbociclib (IND#141416), A CDK 4/6 Inhibitor, In Combination With Chemotherapy In Children With Relapsed Acute Lymphoblastic Leukemia (ALL) Or Lymphoblastic Lymphoma (LL) [NCT03792256] | Phase 1 | 15 participants (Anticipated) | Interventional | 2019-04-11 | Active, not recruiting |
AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA [NCT01055496] | Phase 1 | 103 participants (Actual) | Interventional | 2010-03-31 | Completed |
Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery [NCT02703376] | Phase 1 | 8 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
Phase II Study of Treatment of Relapsed Agressive Lymphomas [NCT00842595] | Phase 2 | 50 participants (Actual) | Interventional | 2003-12-31 | Completed |
A Phase I/Ib Study of Alisertib Plus R-EPOCH for Treatment of Myc-Positive Aggressive B-Cell Lymphomas [NCT02700022] | Phase 1 | 1 participants (Actual) | Interventional | 2016-10-31 | Terminated(stopped due to Lack of funding) |
Serum Free Fatty Acids Desaturase Activity Indices in Sera of Patients on Long-term High-dose Corticosteroid Treatment [NCT02872584] | | 20 participants (Anticipated) | Observational | 2016-09-30 | Not yet recruiting |
Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer. [NCT03348670] | Phase 2/Phase 3 | 600 participants (Anticipated) | Interventional | 2023-08-18 | Active, not recruiting |
A Phase 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients [NCT01780844] | Phase 2 | 149 participants (Actual) | Interventional | 2013-03-05 | Completed |
A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma [NCT01992653] | Phase 1/Phase 2 | 85 participants (Actual) | Interventional | 2013-11-29 | Completed |
A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone [NCT01685268] | Phase 1/Phase 2 | 49 participants (Actual) | Interventional | 2012-09-30 | Completed |
Phase I Study of Docetaxel, Prednisone and Pazopanib in Men With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) and Poor-Risk Factors [NCT01385228] | Phase 1 | 36 participants (Actual) | Interventional | 2011-06-30 | Completed |
A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen [NCT00676650] | Phase 3 | 873 participants (Actual) | Interventional | 2008-07-31 | Terminated(stopped due to Study A6181120 was prematurely discontinued due to futility on 27 September 2010. No new or unexpected safety issues were identified.) |
A Multicenter Phase IB Dose Escalation Study to Evaluate the Safety, Feasibility and Efficacy of the Torisel-Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (T-R-CHOP), Torisel-Rituximab-Fludarabine-Cyclophosphamide (T-R-FC) and Torisel-Ritu [NCT01389427] | Phase 1/Phase 2 | 41 participants (Actual) | Interventional | 2011-11-30 | Completed |
Steroids and Azathioprine in Early and Advanced IgA Nephropathy: Amendments to a Prospective Randomised Multicenter Trial [NCT01392833] | Phase 3 | 46 participants (Actual) | Interventional | 1999-12-31 | Completed |
Phase 1b/2, Open-Label Trial to Evaluate Safety and Preliminary Efficacy of Epcoritamab As Monotherapy or Combined With Standard-of-Care Therapies in Chinese Subjects With B-Cell Non-Hodgkin Lymphoma [NCT05201248] | Phase 1 | 49 participants (Actual) | Interventional | 2022-03-10 | Active, not recruiting |
A Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated Vasculitis [NCT03967925] | Phase 2 | 31 participants (Actual) | Interventional | 2019-02-01 | Active, not recruiting |
Diagnosis and Treatment of Male Infertility Related to Inflammatory Syndrome: Therapeutic Trial [NCT01407484] | | 200 participants (Actual) | Interventional | 2011-03-02 | Completed |
Inflammatory, Functional and Image Composite Measure to Define Asthma Control [NCT00597064] | Phase 4 | 70 participants (Anticipated) | Interventional | 2006-07-31 | Recruiting |
Phase IV Study of Oral Prednisone Taper vs. Placebo Following Intravenous Steroids for the Treatment of Acute Relapses in Multiple Sclerosis Within the Ticino Cohort [NCT01411514] | Phase 4 | 27 participants (Actual) | Interventional | 2011-08-31 | Terminated(stopped due to Difficulties to recruit patients) |
A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free De-novo Immunosuppression After Liver Transplantation [NCT00890253] | Phase 2 | 29 participants (Anticipated) | Interventional | 2010-01-31 | Recruiting |
A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease [NCT00350545] | | 37 participants (Actual) | Interventional | 2006-08-31 | Completed |
A Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA) [NCT00203047] | Phase 4 | 414 participants (Actual) | Interventional | 2005-01-31 | Terminated(stopped due to Slow enrollment decreased sample size; No unexpected safety issues.) |
Randomized, Multi-Center Comparative Trial of Tacrolimus w/Steroids and Standard Daclizumab Induction vs a Novel Steroid-Free Tacrolimus Based Immunosuppression Protocol w/ Extended Daclizumab Induction in Pediatric Renal Transplantation [NCT00141037] | Phase 1/Phase 2 | 130 participants (Actual) | Interventional | 2004-03-31 | Completed |
A Phase II, Open-Label, Multi-Center, Prospective, Randomized Study of LCP-Tacro Tablets vs. Azathioprine, in Combination With Corticosteroids, for the Treatment of Autoimmune Hepatitis [NCT00608894] | Phase 2 | 13 participants (Actual) | Interventional | 2007-12-31 | Terminated(stopped due to Study was discontinued due to slow enrollment) |
A Randomized Phase II Study of Dose-Adjusted EPOCH-R and R-VACOP-B in Primary Mediastinal (Thymic) Large B-Cell Lymphoma [NCT00983944] | Phase 2 | 0 participants (Actual) | Interventional | 2009-09-30 | Withdrawn(stopped due to Inadequate Accrual) |
A Randomized, Phase III, Placebo-Controlled Multicenter Study to Demonstrate the Effectiveness and Safety of the Combination Enzyme Tablet (Wobe-Mugos E) as Adjuvant Therapy to Standard of Care Treatment in Patients With Stages II or III Multiple Myeloma [NCT00014339] | Phase 3 | 0 participants | Interventional | 2000-03-31 | Active, not recruiting |
A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, an [NCT00689936] | Phase 3 | 1,623 participants (Actual) | Interventional | 2008-08-21 | Completed |
A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-asparaginase) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (ALL) [NCT00671034] | Phase 3 | 166 participants (Actual) | Interventional | 2008-07-21 | Completed |
A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone [NCT00626678] | Phase 2 | 48 participants (Anticipated) | Interventional | 2008-01-31 | Completed |
A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease [NCT02614612] | Phase 1 | 31 participants (Actual) | Interventional | 2015-12-31 | Completed |
A Phase 1 Study of Combining Ibrutinib, Dasatinib and Prednisone in Patients 60 Years or Older With Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia [NCT02815059] | Phase 1 | 0 participants (Actual) | Interventional | 2016-09-28 | Withdrawn(stopped due to Termination of Investigator Initiated Studies using Ibrutinib) |
ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer [NCT03827473] | Phase 2 | 1 participants (Actual) | Interventional | 2019-02-08 | Terminated(stopped due to The trial was closed because the changing standard of care landscape, making this trial not impactful anymore.) |
Prospective Study of Apalutamide and Abiraterone Acetate iN ChemoTHerapy-Naïve mEn With mCRPC Stratified by Race [NCT03098836] | Phase 2 | 93 participants (Actual) | Interventional | 2017-07-10 | Active, not recruiting |
The Combination of Lower Dosage of Chemotherapy With Tyrosine Kinase Inhibitor to Treat Newly Diagnosed ph+ Acute Lymphoblastic Leukemia Patients [NCT02690922] | Phase 4 | 40 participants (Anticipated) | Interventional | 2016-03-31 | Not yet recruiting |
An Open-label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (Cmc-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, Cd22- Positive, Follicular B-cell Non Hodgk [NCT00562965] | Phase 3 | 29 participants (Actual) | Interventional | 2007-11-30 | Terminated(stopped due to See termination reason in detailed description.) |
A Randomised Multicentric Phase III Study for the Treatment of Young Patients With High Risk (IPI 2-3) Diffuse Large B-Cell Lymphoma. Dose Dense Chemotherapy + Rituximab +/- Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous St [NCT00499018] | Phase 3 | 399 participants (Anticipated) | Interventional | 2006-01-31 | Active, not recruiting |
A Randomized, Single-blind, Placebo-controlled, Crossover Studyto Assess The Dose Response Of Prednisone On Biochemical Andclinical Markers Of Efficacy And Safety In Adult Healthyvolunteers [NCT02767089] | Phase 1 | 37 participants (Actual) | Interventional | 2005-10-31 | Completed |
Phase 1/2, Open Label, Sequential Cohort Study of a Single Intracranial Dose of AVASPA Gene Therapy for Treatment of Children With Typical Canavan Disease [NCT04833907] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 2021-04-01 | Active, not recruiting |
Multicenter Randomized Double-blind Study Comparing the Efficacy and Safety of Rituximab in Combination With Corticosteroids to Corticosteroids Plus Placebo in the Treatment of Non-infectious Active Mixed Cryoglobulinemia Vasculitis [NCT02556866] | Phase 2 | 14 participants (Actual) | Interventional | 2015-07-17 | Terminated(stopped due to lack of recruitment) |
PITT0503: Clinical Trial of Coenzyme Q10 and Prednisone in Duchenne Muscular Dystrophy [NCT00308113] | Phase 3 | 3 participants (Actual) | Interventional | 2007-04-30 | Terminated(stopped due to New enrollment has been suspended, currently following previously enrolled participants) |
An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic L [NCT03384654] | Phase 2 | 47 participants (Actual) | Interventional | 2018-05-14 | Completed |
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365) [NCT02861573] | Phase 1/Phase 2 | 1,200 participants (Anticipated) | Interventional | 2016-11-17 | Recruiting |
A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults [NCT02166463] | Phase 3 | 600 participants (Actual) | Interventional | 2015-03-19 | Active, not recruiting |
A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer [NCT00642018] | Phase 2 | 154 participants (Actual) | Interventional | 2008-03-31 | Completed |
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01591122] | Phase 3 | 313 participants (Actual) | Interventional | 2012-03-27 | Completed |
Phase I/II, Open-Label Study to Determine Safety and Efficacy of Sotatercept (ACE-011) in Adults With Red Blood Cell Transfusion- Dependent Diamond Blackfan Anemia [NCT01464164] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2012-01-31 | Terminated(stopped due to Supporter terminated the study due to no active patients (secondary to travel restrictions due to COVID).) |
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) [NCT00720109] | Phase 2/Phase 3 | 63 participants (Actual) | Interventional | 2008-07-14 | Completed |
A Randomized, Open-Label, Multicenter Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone (VcR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly [NCT00722137] | Phase 3 | 487 participants (Actual) | Interventional | 2008-05-01 | Completed |
Compare the Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule Versus Combined With Levamisole for Primary Nephrotic Syndrome in Children: A Prospective, Multi-center, Randomized, Double-blind, Non-inferiority Study [NCT05772871] | Phase 4 | 402 participants (Anticipated) | Interventional | 2023-04-26 | Recruiting |
A Phase 1b, Open Label, Global, Multicenter, Dose Determination, Randomized Dose Expansion Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of Iberdomide (CC-220) in Combination W [NCT04884035] | Phase 1 | 174 participants (Anticipated) | Interventional | 2021-09-15 | Recruiting |
A Randomized Study of Daily vs. High-dose Weekly Prednisone Therapy in Duchenne Muscular Dystrophy [NCT00110669] | Phase 3 | 64 participants (Actual) | Interventional | 2004-01-31 | Completed |
Multicenter Randomized Phase II Study of Treatment With R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI. [NCT01848132] | Phase 2 | 121 participants (Actual) | Interventional | 2013-10-03 | Completed |
Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath [NCT01879514] | | 200 participants (Anticipated) | Interventional | 2010-01-31 | Recruiting |
A Prospective, Randomized, Open-Label, Pilot Study To Compare The Effect On Carotid Atherosclerosis Of A Tacrolimus-Based Regimen With Conversion From A Tacrolimus- To A Sirolimus-Based Regimen At 3-4 Months Post-Transplant In De Novo Renal Transplant Rec [NCT00311311] | Phase 3 | 72 participants (Actual) | Interventional | 2006-04-30 | Terminated(stopped due to See termination reason in detailed description.) |
A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases [NCT00623766] | Phase 2 | 99 participants (Actual) | Interventional | 2008-07-31 | Completed |
An Open-label,Multicenter Randomised Study of CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for the New Diagnosed Young Patients With T Cell Non-hodgkin Lymphoma [NCT01746992] | Phase 4 | 200 participants (Anticipated) | Interventional | 2012-09-30 | Active, not recruiting |
Treatment of High Risk Adult Acute Lymphoblastic Leukemia [NCT00853008] | Phase 4 | 100 participants (Anticipated) | Interventional | 2003-01-31 | Completed |
Randomized Phase II Study of Dose-Adjusted EPOCH vs. NHL-15 Chemotherapy for Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma (NHL) [NCT00005964] | Phase 2 | 59 participants (Actual) | Interventional | 2000-05-31 | Completed |
[NCT00006054] | | 0 participants | Interventional | 2000-03-31 | Terminated |
A Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer [NCT00087165] | Phase 2 | 22 participants (Actual) | Interventional | 2005-01-31 | Completed |
[NCT00006055] | | 10 participants | Interventional | 2000-03-31 | Active, not recruiting |
The Efficacy of Oral Prednisone in Treating Langerhans Cell Histiocytosis of Bone in Childhood and Adolescence: A Multi-center, Open-label, Randomized-controlled, Phase II Study [NCT06078969] | Phase 2 | 118 participants (Anticipated) | Interventional | 2023-11-01 | Recruiting |
Serologically Active, Clinically Stable Systemic Lupus Erythematosus (SLE) [NCT00000421] | Phase 2 | 154 participants (Actual) | Interventional | 1997-09-30 | Completed |
A Multicenter, Randomized, Double Blinded, Placebo-controlled Clinical Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis by the AlcHepNet Consortium [NCT04072822] | Phase 2 | 147 participants (Actual) | Interventional | 2020-07-10 | Completed |
"Nutritional Ergogenic Aids: The Effects of Carbohydrate-Protein Supplementation During Endurance Exercise" [NCT00972387] | | 12 participants (Actual) | Interventional | 2009-08-31 | Completed |
A National, Multi-Center, Open-Label Study of Velcade in Combination With Melphalan and Prednisone (V-MP) in Older Untreated Multiple Myeloma Patients. [NCT00388635] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2004-04-30 | Completed |
Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y) [NCT00863460] | Phase 2 | 140 participants (Actual) | Interventional | 2008-10-03 | Active, not recruiting |
[NCT00000147] | | 0 participants | Interventional | 1988-07-31 | Active, not recruiting |
Lenalidomide, Melphalan, Prednisone, and Thalidomide (RMPT) for Relapsed/Refractory Multiple Myeloma [NCT00961467] | Phase 2 | 44 participants (Actual) | Interventional | 2007-02-28 | Completed |
Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy [NCT00001212] | Phase 2 | 45 participants | Interventional | 1986-11-30 | Completed |
[NCT00014755] | Phase 1 | 35 participants | Interventional | 1997-12-31 | Completed |
A Phase III Trial To Evaluate The Safety And Efficacy Of Specific Immunotherapy, Recombinant Idiotype Conjugated To KLH With GM-CSF, Compared To Non-Specific Immunotherapy, KLH With GM-CSF, In Patients With Follicular Non-Hodgkin's Lymphoma [NCT00017290] | Phase 3 | 0 participants | Interventional | 2000-11-30 | Active, not recruiting |
Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma [NCT02951728] | Phase 1/Phase 2 | 58 participants (Anticipated) | Interventional | 2016-10-31 | Active, not recruiting |
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults [NCT00797810] | Phase 4 | 25 participants (Anticipated) | Interventional | 2006-12-31 | Recruiting |
Feasibility Study of CO-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of Acquired Immunodeficiency Syndrome (AIDS)-Related Lymphoma [NCT00799136] | Phase 2 | 6 participants (Actual) | Interventional | 2008-02-29 | Completed |
PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma [NCT00147875] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2004-03-31 | Completed |
Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With 3 Cycles Pulses of High-dose Dexamethasone (HD-DXM) [NCT02914054] | Phase 2/Phase 3 | 36 participants (Actual) | Interventional | 2016-10-01 | Completed |
A Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Proliferative and Involuting Cutaneous Infantile Hemangioma [NCT01072045] | Phase 2 | 50 participants (Actual) | Interventional | 2010-01-31 | Completed |
Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet [NCT01075711] | | 2,728 participants (Actual) | Observational | 2009-04-30 | Completed |
Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome [NCT00362531] | Phase 2/Phase 3 | 0 participants | Interventional | 2004-11-30 | Completed |
Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone [NCT00907452] | | 143 participants (Actual) | Interventional | 2009-07-29 | Completed |
A Phase II Study of AZD2171 in Metastatic Androgen Independent Prostate Cancer [NCT00436956] | Phase 2 | 59 participants (Actual) | Interventional | 2006-10-16 | Completed |
Eosinophil-guided Prednisone Administration in COPD Exacerbation Requiring Ventilatory Support [NCT03981081] | Phase 4 | 192 participants (Anticipated) | Interventional | 2019-04-02 | Recruiting |
An Open-label, Randomized, Phase 2 Study of R-CHOP Plus Enzastaurin Versus R-CHOP in the First-Line Treatment of Patients With Intermediate and High-Risk Diffuse Large B-Cell Lymphoma [NCT00451178] | Phase 2 | 101 participants (Actual) | Interventional | 2007-05-31 | Completed |
A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study To Determine The Efficacy And Safety Of Lenalidomde (Revlimid®) In Combination With Melphalan And Prednisone Versus Placebo Plus Melphalan And Prednisone In [NCT00405756] | Phase 3 | 459 participants (Actual) | Interventional | 2007-01-31 | Completed |
The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children [NCT02532777] | Phase 2 | 100 participants (Anticipated) | Interventional | 2015-08-31 | Recruiting |
A Phase II Trial of Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease [NCT00388362] | Phase 2 | 36 participants (Actual) | Interventional | 2005-11-30 | Completed |
A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma [NCT00301821] | Phase 2 | 107 participants (Actual) | Interventional | 2006-01-31 | Completed |
A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare [NCT00423098] | Phase 2 | 81 participants (Actual) | Interventional | 2007-02-28 | Completed |
A Prospective, Open-label, Controlled Multicenter Trial to Assess the Efficacy and Safety of an Induction Regimen of Cyclosporine Micro Emulsion, Enteric-coated Mycophenolate Sodium (EC-MPS) and Corticosteroids, Followed by Administration of Everolimus an [NCT00371826] | Phase 4 | 126 participants (Actual) | Interventional | 2006-03-31 | Completed |
A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy [NCT00348816] | Phase 2 | 21 participants (Actual) | Interventional | 2006-05-31 | Terminated(stopped due to Loss of funding) |
A Collaborative Trial for the Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia [NCT00136084] | Phase 3 | 238 participants (Actual) | Interventional | 2002-08-31 | Completed |
A Phase II Trial to Assess the Safety of Immunosuppression Withdrawal in Liver Transplant Recipients [NCT00135694] | Phase 2 | 275 participants (Actual) | Interventional | 2005-10-31 | Completed |
Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer [NCT00134056] | Phase 3 | 1,038 participants (Actual) | Interventional | 2006-08-31 | Completed |
Phase 1 Study of Copanlisib With Dose-adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas [NCT04933617] | Phase 1 | 8 participants (Actual) | Interventional | 2022-03-24 | Completed |
A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study [NCT04745832] | Phase 3 | 82 participants (Actual) | Interventional | 2021-08-13 | Terminated(stopped due to Discontinuation of zandelisib program) |
COrticosteroids in acUte uRticAria in emerGency dEpartment [NCT03545464] | Phase 3 | 240 participants (Anticipated) | Interventional | 2019-09-21 | Recruiting |
A Phase I/II Trial of CHOEP Chemotherapy Plus Lenalidomide as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin's Lymphoma [NCT02561273] | Phase 1/Phase 2 | 54 participants (Actual) | Interventional | 2015-09-28 | Completed |
Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II [NCT01309672] | Phase 2 | 41 participants (Actual) | Interventional | 2011-08-09 | Active, not recruiting |
Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies [NCT00381680] | Phase 3 | 275 participants (Actual) | Interventional | 2007-03-31 | Completed |
A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy [NCT00485303] | Phase 2 | 58 participants (Actual) | Interventional | 2007-06-30 | Completed |
Phase I/II Trial of Epothilone Analog BMS-247550 (Ixabepilone), Mitoxantrone, and Prednisone in Hormone Refractory Prostate Cancer (HRPC) Patients Previously Treated With Chemotherapy [NCT00331344] | Phase 1/Phase 2 | 100 participants (Actual) | Interventional | 2006-04-30 | Completed |
Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management: COPD Prednisone Sub-Study [NCT02534402] | Phase 4 | 40 participants (Actual) | Interventional | 2015-08-31 | Active, not recruiting |
A Phase II Study of the Novel Proteasome Inhibitor Bortezomib in Combination With Rituximab, Cyclophosphamide and Prednisone in Patients With Relapsed/Refractory Indolent B-Cell Lymphoproliferative Disorders and Mantle Cell Lymphoma (MCL) [NCT00295932] | Phase 1/Phase 2 | 79 participants (Actual) | Interventional | 2005-12-13 | Completed |
A Multicenter, National, Open-label, Prospective, Randomized Study to Evaluate Efficacy and Tolerability of Enteric-coated Mycophenolate Sodium 1440 mg/Day With Tacrolimus Reduced Dose Versus Enteric-coated Mycophenolate Sodium 720 mg/Day With Tacrolimus [NCT00284934] | Phase 3 | 94 participants (Actual) | Interventional | 2005-12-31 | Completed |
Steroid Free Immunosuppression in Liver Transplantation [NCT00296244] | Phase 4 | 40 participants (Actual) | Interventional | 2006-02-28 | Completed |
A Phase 2, Prospective, Randomized, Multicenter, Double-blind, Active-control, Parallel-group Study to Determine the Safety of and to Select a Treatment Regimen of CC-4047 (Pomalidomide) Either as Single-agent or in Combination With Prednisone to Study Fu [NCT00463385] | Phase 2 | 88 participants (Actual) | Interventional | 2007-04-01 | Completed |
A Phase II Randomized Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old o [NCT00290498] | Phase 2 | 67 participants (Actual) | Interventional | 2005-08-01 | Completed |
A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis [NCT00288626] | Phase 2 | 25 participants (Actual) | Interventional | 2006-07-31 | Completed |
A Single-arm, Multi-center, Phase II Clinical Trial of R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Medium to High Risk/High Risk Diffuse Large B Cell Lymphoma [NCT04214626] | Phase 2 | 60 participants (Actual) | Interventional | 2020-01-02 | Active, not recruiting |
RANDOMIZED, MULTICENTRIC STUDY COMPARING THE EFFECT OF TWO REGIMENS OF COMBINED IMMUNOSUPPRESSIVE THERAPY IN THE TREATMENT OF INFLAMMATORY CARDIOMYOPATHY CZECH-ICIT (CZECH INFLAMMATORY CARDIOMYOPATHY IMMUNOSUPPRESSION TRIAL) [NCT01877746] | Phase 3 | 234 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
Phase I/II Open Label Dose Escalation Study of the 17α-Hydroxylase/ C17,20-Lyase Inhibitor, Abiraterone Acetate in Hormone Refractory Prostate Cancer [NCT00473746] | Phase 1/Phase 2 | 66 participants (Actual) | Interventional | 2006-06-30 | Completed |
An Open-Label, Phase 1 Study to Examine the Pharmacokinetic Interactions Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects [NCT01886209] | Phase 1 | 28 participants (Anticipated) | Interventional | 2013-06-30 | Completed |
[NCT01895049] | Phase 4 | 171 participants (Actual) | Interventional | 2013-08-31 | Completed |
Regulatory T Cell Modulation in Kidney Transplantation With Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24) [NCT04066114] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2019-12-11 | Completed |
A Phase 1b/2 Study of Docetaxel and Prednisone, With or Without ISIS 183750 (an eIF4E Inhibitor), in Patients With Castrate-Resistant Prostate Cancer [NCT01234025] | Phase 1/Phase 2 | 113 participants (Actual) | Interventional | 2010-11-30 | Completed |
A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD) [NCT00204737] | Phase 4 | 12 participants (Actual) | Interventional | 2004-12-31 | Completed |
An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel Versus Standard of Care Therapy as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-23) [NCT05605899] | Phase 3 | 300 participants (Anticipated) | Interventional | 2023-02-10 | Recruiting |
International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newl [NCT00205751] | Phase 2/Phase 3 | 350 participants (Anticipated) | Interventional | 2001-08-31 | Completed |
Efficacy of 6x R-CHOP Followed by Myeloablative Radiochemotherapy and Autologous Stem Cell Transplantation vs. 3 x (R-CHOP/R-DHAP) Followed by a High Dose ARA-C Containing Myeloablative Regimen and Autologous Stem Cell Transplantation [NCT00209222] | Phase 3 | 360 participants (Anticipated) | Interventional | 2004-07-31 | Recruiting |
Autologous Blood or Marrow Transplantation for Aggressive Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning [NCT00238368] | Phase 2 | 59 participants (Actual) | Interventional | 2004-02-29 | Completed |
A Prospective Phase II Study of Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma [NCT04899570] | Phase 2 | 20 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
A Randomized, Prospective Double Blind Placebo Control Clinical Trial of Prednisone as Adjunctive Therapy for the Treatment of Hospitalized Patients With Pulmonary TB and HIV Co-infection [NCT00414414] | Phase 3 | 0 participants (Actual) | Interventional | 2007-02-28 | Withdrawn(stopped due to Funding not awarded) |
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica [NCT03600818] | Phase 3 | 118 participants (Actual) | Interventional | 2018-10-09 | Terminated(stopped due to Protracted recruitment timeline exacerbated by COVID-19 pandemic) |
A Randomized, Controlled Mutiple-center Clinical Research on the Treatment With Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma [NCT01949818] | Phase 4 | 120 participants (Anticipated) | Interventional | 2012-09-30 | Recruiting |
A Prospective, Open, Randomized Controlled Stage II Trial Investigating the Efficacy and Safety of Thymosin Alpha-1 in Treating Moderate to Severe Immune-related Adverse Events [NCT06178146] | Phase 4 | 40 participants (Anticipated) | Interventional | 2023-09-01 | Recruiting |
Phase II Study of Mogamulizumab With DA-EPOCH in Patients With Aggressive T Cell Lymphoma [NCT05996185] | Phase 2 | 36 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
Investigator-Initiated, Pilot Translational Study of Circulating Tumor Cells to Identify Predictive Factors of Response to Abiraterone Acetate in Men With Castration-Resistant Prostate Cancer [NCT01961843] | | 40 participants (Actual) | Interventional | 2013-10-31 | Active, not recruiting |
A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer [NCT05848011] | Phase 2 | 150 participants (Anticipated) | Interventional | 2023-09-28 | Recruiting |
A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy [NCT01969019] | Phase 4 | 70 participants (Anticipated) | Interventional | 2010-01-31 | Recruiting |
A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults [NCT04530565] | Phase 3 | 348 participants (Anticipated) | Interventional | 2021-01-25 | Recruiting |
An Open-Label, Phase I/II Study of ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma [NCT04517435] | Phase 1/Phase 2 | 13 participants (Actual) | Interventional | 2021-04-28 | Active, not recruiting |
Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease [NCT01981889] | Phase 4 | 53 participants (Actual) | Interventional | 2013-10-31 | Completed |
DRESS - Setting of Corticosteroid Treatment. [NCT01987076] | | 112 participants (Anticipated) | Interventional | 2013-10-31 | Recruiting |
A Randomized Phase 2 Study of Cabozantinib (XL184) in Combination With Abiraterone in Chemotherapy Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer [NCT01995058] | Phase 2 | 54 participants (Actual) | Interventional | 2013-12-31 | Terminated(stopped due to Study stopped after results of cabozantinib Phase 3 CRPC study XL184-307.) |
A Phase II Randomized Prospective Trial of Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (CRPC) Patients Progressing on Enzalutamide [NCT02685267] | Phase 2 | 9 participants (Actual) | Interventional | 2016-02-29 | Terminated |
Glucocorticoids Promote Osteoclast Survival [NCT00572299] | | 3 participants (Actual) | Observational | 2004-01-31 | Terminated(stopped due to Terminated due to recruitment problems) |
A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study [NCT00225173] | Phase 2 | 45 participants (Anticipated) | Interventional | 2001-10-31 | Terminated |
Frontline Selinexor(ATG-010) Plus R-CHOP Therapy for High-risk GCB-subtype Diffuse Large B-Cell Lymphoma [NCT05422066] | Phase 2 | 50 participants (Anticipated) | Interventional | 2022-07-26 | Recruiting |
Phase II Study of Talazoparib With Androgen Deprivation Therapy and Abiraterone in Castration Sensitive Prostate Cancer [NCT04734730] | Phase 2 | 70 participants (Anticipated) | Interventional | 2021-05-04 | Recruiting |
A Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) [NCT02913196] | Phase 1 | 16 participants (Actual) | Interventional | 2016-12-30 | Active, not recruiting |
An Open, Single-arm, Multicenter Study of R-CMOP Protocol for Primary Treatment of Diffuse Large B-cell Lymphoma Based on Cardiac Function Screening [NCT05777369] | | 30 participants (Anticipated) | Interventional | 2023-03-31 | Not yet recruiting |
An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation [NCT01332097] | Phase 2 | 183 participants (Actual) | Interventional | 2011-03-31 | Completed |
Phase II, Randomised, Multicentre Study With Two Treatment Arms (R-COMP Versus R-CHOP) in Newly Diagnosed Elderly Patients (≥60 Years) With Non-localised Diffuse Large B-cell Lymphoma (DLBCL)/Follicular Lymphoma Grade IIIb. [NCT02012088] | Phase 2 | 91 participants (Actual) | Interventional | 2013-10-11 | Active, not recruiting |
A Phase 1/2 Dose Escalation Study of Subretinally Injected SAR439483 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D [NCT03920007] | Phase 1/Phase 2 | 15 participants (Actual) | Interventional | 2019-09-12 | Active, not recruiting |
Treatment of Older Adults With Acute Lymphoblastic Leukemia [NCT00973752] | Phase 2 | 30 participants (Actual) | Interventional | 2009-08-31 | Completed |
Phase II Trial of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated Intermediate or High Grade Non-Hodgkin's Lymphoma [NCT00005959] | Phase 2 | 0 participants | Interventional | 1999-12-31 | Active, not recruiting |
Phase II Trial of EPOCH and Rituxan Combined Therapy in Patients With Refractory or Relapsed CD20 Positive Intermediate Grade B-cell Non-Hodgkin's Lymphoma [NCT00006669] | Phase 2 | 0 participants (Actual) | Interventional | 1999-09-30 | Withdrawn |
A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hor [NCT06136650] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 2023-12-18 | Recruiting |
Optimizing Immunosuppression for Steroid-Refractory Anti-PD-1/PD-L1 Pneumonitis [NCT04438382] | Phase 2 | 1 participants (Actual) | Interventional | 2021-01-07 | Active, not recruiting |
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma [NCT03269669] | Phase 2 | 95 participants (Anticipated) | Interventional | 2018-01-23 | Recruiting |
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis - I [NCT01138657] | Phase 3 | 239 participants (Actual) | Interventional | 2010-08-31 | Completed |
A Phase II Clinical Trial of Lenalidomide and Prednisone in Low and Intermediate-1 IPSS Risk, Non-del (5q) MDS Patients [NCT01133275] | Phase 2 | 28 participants (Actual) | Interventional | 2010-04-28 | Completed |
Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma [NCT01132807] | Phase 2 | 164 participants (Actual) | Interventional | 2010-05-31 | Completed |
A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone [NCT01088529] | Phase 2 | 66 participants (Actual) | Interventional | 2009-12-31 | Completed |
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroid [NCT01085097] | Phase 2 | 46 participants (Actual) | Interventional | 2010-09-01 | Completed |
A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Pain Palliation Benefit of Adding Custirsen to a Taxane for Second-Line Chemotherapy in Men With Castrate Resistance Prostate Cancer [NCT01083615] | Phase 3 | 14 participants (Actual) | Interventional | 2010-03-31 | Terminated(stopped due to Unable to enroll due to criteria for stable baseline pain) |
A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia [NCT00194987] | Phase 2/Phase 3 | 102 participants (Actual) | Interventional | 2001-04-30 | Completed |
An Open-label Phase 1/2 Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer [NCT01084655] | Phase 1/Phase 2 | 38 participants (Actual) | Interventional | 2010-07-31 | Completed |
Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive [NCT00556127] | Phase 2 | 94 participants (Actual) | Interventional | 2002-06-30 | Completed |
Phase I/II Trial of Melphalan, Prednisone Plus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Stem Cell Transplant [NCT00477750] | Phase 1/Phase 2 | 33 participants (Actual) | Interventional | 2005-06-30 | Completed |
Low Dose Prednisone Therapy in Women With Recurrent Pregnancy Loss [NCT04558268] | Phase 2/Phase 3 | 242 participants (Anticipated) | Interventional | 2020-12-31 | Not yet recruiting |
A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody IMC-3G3 Plus Mitoxantrone Plus Prednisone or Mitoxantrone Plus Prednisone in Metastatic Castration-Refractory Prostate Cancer Following Disease Progression or Intolerance on Docetaxel-bas [NCT01204710] | Phase 2 | 123 participants (Actual) | Interventional | 2010-10-31 | Completed |
Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients [NCT01683552] | Phase 2 | 45 participants (Actual) | Interventional | 2010-09-30 | Completed |
Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency [NCT04536662] | Phase 4 | 120 participants (Anticipated) | Interventional | 2020-10-01 | Not yet recruiting |
Randomized, Open, Parallel, Single-center, Non-inferiority Clinical Trial, With an Active Control Group, Comparing Two Oral Prednisone Regimens With the Aim of Optimizing the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 Infecti [NCT04534478] | Phase 4 | 120 participants (Anticipated) | Interventional | 2020-09-07 | Not yet recruiting |
Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose [NCT02216747] | Phase 4 | 100 participants (Anticipated) | Interventional | 2014-09-30 | Not yet recruiting |
Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas [NCT05389423] | Phase 1 | 20 participants (Anticipated) | Interventional | 2023-06-27 | Recruiting |
Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation: a Double-blind, Randomized, Controlled Trial [NCT04234360] | Phase 3 | 600 participants (Anticipated) | Interventional | 2021-10-12 | Recruiting |
Open Label Safety and Efficacy of Once Weekly Steroid in Patients With LGMD and Becker Muscular Dystrophy [NCT04054375] | Phase 2 | 20 participants (Actual) | Interventional | 2019-07-01 | Completed |
Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity, PSA Decline and Genetic Variation in Proteins Involved in Androgen Metabolism in Metastatic Hormone Naive Prostate Cancer [NCT03833921] | Phase 2 | 130 participants (Anticipated) | Interventional | 2019-05-23 | Recruiting |
A Dynamic Allocation Modular Sequential Trial of Approved and Promising Therapies in Men With Metastatic Castrate Resistant Prostate Cancer [NCT02703623] | Phase 2 | 196 participants (Actual) | Interventional | 2016-05-18 | Active, not recruiting |
A Feasibility Trial of Everolimus (RAD001),an mTOR Inhibitor, Given in Combination With Multiagent Re-Induction Chemotherapy in Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia (ALL) [NCT01523977] | Phase 1 | 22 participants (Actual) | Interventional | 2011-11-30 | Completed |
A Randomized Phase II Trial of Dasatinib Plus Abiraterone Compared to Abiraterone Alone for Metastatic, Castration-Resistant Prostate Cancer Prior to Chemotherapy [NCT01685125] | Phase 2 | 96 participants (Anticipated) | Interventional | 2012-09-30 | Active, not recruiting |
Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD) [NCT00107198] | Phase 2 | 188 participants (Actual) | Interventional | 2006-01-02 | Active, not recruiting |
Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly [NCT01648556] | | 200 participants (Anticipated) | Interventional | 2012-09-30 | Recruiting |
A New Clinical Therapy for Bell's Palsy [NCT01686464] | | 882 participants (Actual) | Interventional | 1998-06-30 | Completed |
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Ther [NCT01193257] | Phase 3 | 1,099 participants (Actual) | Interventional | 2010-11-15 | Completed |
A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN) [NCT00657059] | Phase 3 | 151 participants (Actual) | Interventional | 2007-09-30 | Completed |
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants [NCT00307671] | Phase 4 | 108 participants (Actual) | Interventional | 2005-07-31 | Completed |
Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma [NCT01321008] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2011-05-31 | Terminated(stopped due to Slow Accrual) |
An International Single-Arm Study to Provide Further Safety and Efficacy Data on the Bortezomib(Velcade)/Melphalan/Prednisone Regimen in Previously Untreated Transplant Ineligible Multiple Myeloma Patients [NCT00799539] | | 0 participants | Expanded Access | | No longer available |
Lenalidomide and Low Dose Dexamethasone Induction Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy for Newly Diagnosed High-risk Multiple Myeloma [NCT00691704] | Phase 2 | 18 participants (Actual) | Interventional | 2008-08-31 | Completed |
A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study [NCT02960022] | Phase 2 | 900 participants (Anticipated) | Interventional | 2016-12-22 | Recruiting |
A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer [NCT00744497] | Phase 3 | 1,930 participants (Actual) | Interventional | 2008-10-31 | Completed |
Open Label Randomized Study of Thymoglobulin Versus Daclizumab Induction Therapies for the Reduction of Acute Rejection in Live Donor Kidney Transplant Recipients With a Positive Crossmatch [NCT00275509] | Phase 3 | 56 participants (Actual) | Interventional | 2007-01-31 | Completed |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy [NCT00638690] | Phase 3 | 1,195 participants (Actual) | Interventional | 2008-05-31 | Completed |
Efficacy and Safety of Budesonide Capsules (3x3mg/d)Versus Prednisone in Patients With a Diagnose of Active Autoimmune Hepatitis. A Double-blind, Randomized, Active-controlled, Multicentre Study [NCT00838214] | Phase 2/Phase 3 | 208 participants (Actual) | Interventional | 2001-03-31 | Completed |
A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human av Integrins (CNTO 95) in Combination With Docetaxel for the First-Line Treatment of Subjects With Metastatic Hormone Refractory Prostate Cancer [NCT00537381] | Phase 2 | 131 participants (Actual) | Interventional | 2007-05-31 | Completed |
Glucocorticosteroid Action in Inflammatory Disease [NCT00841802] | Phase 4 | 0 participants (Actual) | Interventional | 2008-07-31 | Withdrawn(stopped due to Realized there was a design flaw.) |
Association of Rituximab to Immunochemotherapy With CVP + Interferon in Newly Diagnosed Follicular Lymphoma Patients With Intermediate-high FLIPI Score. Phase II Study. [NCT00842114] | Phase 2 | 50 participants (Actual) | Interventional | 2006-02-28 | Completed |
Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study [NCT00866307] | Phase 1 | 104 participants (Actual) | Interventional | 2009-02-23 | Completed |
Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma After Autologous Stem Cell Transplantation or Conventional Chemotherapy OSHO #077 [NCT01002703] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2009-09-30 | Recruiting |
Randomized Study of the Treatment of Primary Immune Thrombocytopenic Purpura (ITP) in Newly Diagnosed Untreated Adult Patients. Comparison of Standard Dose Prednisone Versus High-dose Dexamethasone. [NCT00657410] | Phase 3 | 150 participants (Actual) | Interventional | 2008-04-30 | Completed |
AIEOP LLA 2000 Multicenter Study for the Diagnosis and Treatment of Childhood Acute Lymphoblastic Leukemia [NCT00613457] | Phase 3 | 2,039 participants (Actual) | Interventional | 2000-09-30 | Completed |
Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation. [NCT00636935] | Phase 4 | 0 participants (Actual) | Interventional | 2008-02-29 | Withdrawn(stopped due to No patient completed protocol) |
Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission. [NCT02997605] | Phase 4 | 102 participants (Actual) | Interventional | 2017-01-31 | Completed |
A Phase 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia [NCT05761171] | Phase 2 | 78 participants (Anticipated) | Interventional | 2023-11-20 | Recruiting |
A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell [NCT04980222] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-03-22 | Recruiting |
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer [NCT01193244] | Phase 3 | 1,560 participants (Actual) | Interventional | 2010-10-01 | Completed |
Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial [NCT02683291] | Phase 4 | 48 participants (Actual) | Interventional | 2014-01-31 | Completed |
Ozurdex as Monotherapy for Treatment of Non-infectious Intermediate, Posterior, or Panuveitis [NCT05101928] | Phase 4 | 84 participants (Anticipated) | Interventional | 2021-11-30 | Recruiting |
Modified BFM-95 Regimen for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults:a Prospective Phase II Study [NCT02396043] | Phase 2 | 50 participants (Anticipated) | Interventional | 2015-03-31 | Recruiting |
A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. [NCT01172639] | Phase 4 | 400 participants (Actual) | Interventional | 2009-02-28 | Completed |
Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis [NCT03711448] | Phase 2 | 38 participants (Anticipated) | Interventional | 2019-01-07 | Recruiting |
Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective Cohort [NCT04745728] | Phase 3 | 200 participants (Anticipated) | Interventional | 2021-04-14 | Recruiting |
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26) [NCT00689845] | | 120 participants (Anticipated) | Interventional | 2007-06-30 | Recruiting |
Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer [NCT00627354] | Phase 2 | 90 participants (Anticipated) | Interventional | 2006-09-30 | Completed |
Phase II Study Of Dose-Adjusted Epoch-Rituximab (EPOCH-R) Chemotherapy For Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's Lymphoma (NHL) [NCT00032019] | Phase 2 | 78 participants (Actual) | Interventional | 2002-02-28 | Completed |
Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life [NCT00039351] | Phase 2 | 32 participants (Actual) | Interventional | 2002-03-31 | Completed |
Phase II Randomized Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels [NCT02867020] | Phase 2 | 128 participants (Actual) | Interventional | 2017-10-11 | Completed |
"Screening Protein Predictive of Response to Tumor Necrosis Factor-α Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway" [NCT02878161] | Phase 4 | 240 participants (Anticipated) | Interventional | 2016-01-31 | Enrolling by invitation |
Prospective Study of Prednisone Versus Sirolimus in the Treatment of Idiopathic Retroperitoneal Fibrosis [NCT04047576] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2018-07-01 | Recruiting |
A Randomized Controlled Trial to Compare Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in Chronic Pulmonary and Allergic Bronchopulmonary Aspergillosis Overlap Syndrome [NCT05444946] | | 104 participants (Anticipated) | Interventional | 2022-06-15 | Recruiting |
A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT125236 in Healthy Subjects, With an Optional Pharmacological Effects [NCT05003713] | Phase 1 | 82 participants (Actual) | Interventional | 2021-08-03 | Completed |
Selective CD28 Blockade With Lulizumab Compared to CNI Inhibition With Tacrolimus in Renal Transplant Recipients [NCT04903054] | Phase 2 | 0 participants (Actual) | Interventional | 2022-01-10 | Withdrawn(stopped due to Limited period of availability of a supply of the study drug and difficulties in enrollment) |
A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma [NCT00911859] | Phase 2 | 118 participants (Actual) | Interventional | 2009-06-30 | Completed |
Treatment Intensification With R-ICE and High-Dose Cyclophosphamide for Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning [NCT00809341] | Phase 2 | 27 participants (Actual) | Interventional | 2009-01-31 | Terminated(stopped due to Low accrual) |
An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHO [NCT00877006] | Phase 3 | 447 participants (Actual) | Interventional | 2009-04-30 | Completed |
Multicenter Prospective Observational Study Assessing Outcomes, Adverse Events, Treatment Patterns and Related Costs in Patients Diagnosed With Bullous Pemphigoid [NCT02837965] | | 150 participants (Anticipated) | Observational | 2013-04-30 | Recruiting |
ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer [NCT03903835] | Phase 3 | 750 participants (Anticipated) | Interventional | 2019-02-01 | Recruiting |
Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia [NCT05660473] | Phase 2 | 100 participants (Anticipated) | Interventional | 2022-10-31 | Recruiting |
An Open-label, Multi-center, Phase Ib Clinical Trial of Chidamide Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphoma Patients [NCT02809573] | Phase 1 | 30 participants (Actual) | Interventional | 2016-08-11 | Completed |
Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis. [NCT02921555] | Phase 4 | 75 participants (Actual) | Interventional | 2018-10-11 | Completed |
An International, Multicentre, Randomised Controlled Trial. Treatment for Classical Hodgkin Lymphoma in Children and Adolescents Standard Treatment (Chemotherapy and RT) Compared With Experimental Treatment (Chemotherapy Without RT or Restricted to RT) [NCT02797717] | | 2,200 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
Phase II Prospective Trial of Addition of Rituximab to Reduced Dose CHOP Chemotherapy in DLBC L Patients Aged 65 Years and Over [NCT02792491] | Phase 2 | 57 participants (Actual) | Interventional | 2012-08-31 | Active, not recruiting |
Counteracting Deleterious Metabolic Glucocorticoid Effects With Metformin - A Double-blind, Randomized, Placebo-controlled, Cross-over Study [NCT04659915] | Phase 4 | 19 participants (Actual) | Interventional | 2021-02-25 | Completed |
A Phase II Randomized Study of Enzalutamide+Leuprolide Versus Enzalutamide+Leuprolide+Abiraterone Acetate+Prednisone as Neoadjuvant Therapy for HIgh-Risk Prostate Cancer Undergoing Prostatectomy [NCT02268175] | Phase 2 | 75 participants (Actual) | Interventional | 2014-10-31 | Completed |
Oral Dexamethasone Versus Oral Prednisone in Children Hospitalized With Asthma: A Randomized Control Study [NCT02780479] | Phase 4 | 6 participants (Actual) | Interventional | 2017-03-20 | Terminated(stopped due to insufficient number of participants met the enrollment criteria.) |
Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease [NCT02619552] | | 50 participants (Actual) | Observational | 2011-08-31 | Completed |
Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis [NCT01400464] | Phase 4 | 150 participants (Anticipated) | Interventional | 2009-07-31 | Active, not recruiting |
Phase I/II Study of MLN4924 Alone Followed by Dose-Adjusted EPOCH-Rituximab + MLN4924 With Gene Expression Profiling and Mutational Analysis in Relapsed/Refractory de Novo Diffuse Large B-Cell Lymphoma [NCT01415765] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2011-07-15 | Withdrawn |
Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status [NCT00333008] | Phase 2 | 27 participants | Interventional | 2006-05-31 | Recruiting |
An Multicenter, Randomized Study of Comparison of Docetaxel Plus Prednisone With Mitoxantrone Plus Prednisone in the Patients With Hormone-refractory (Androgen-independent) Metastatic Prostate Cancer [NCT00436839] | Phase 3 | 228 participants (Actual) | Interventional | 2007-01-31 | Completed |
An Adaptive, Two Part, Two Period, Single Sequence, Drug Interaction Study Between Dolutegravir 50 mg and Prednisone in Adult Healthy Volunteers [NCT01425099] | Phase 1 | 12 participants (Actual) | Interventional | 2011-09-30 | Completed |
Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study [NCT01432080] | Phase 2 | 12 participants (Actual) | Interventional | 2011-09-30 | Terminated(stopped due to Not meeting recruitment targets) |
Toward Improved Understanding of Pathogenesis and Treatment of Childhood Onset Dermatomyositis [NCT00035958] | Phase 2/Phase 3 | 75 participants | Interventional | 2002-08-31 | Terminated(stopped due to Incorporating the recommendations of the NIH-formed DSMB in the study procedures would make the project budget over the limit for this funding mechanism.) |
A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination With Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) [NCT04556617] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2020-09-21 | Terminated(stopped due to study terminated due to business realignment) |
"Protocol CCAM 05-02 Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma" [NCT01527422] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2006-01-31 | Completed |
A Phase I Study Of G3139 Antisense Oligonucleotide (Oblimersen) In Combination With CHOP And Rituximab In Untreated Advanced Stage Diffuse Large B Cell Lymphoma [NCT00070083] | Phase 1 | 0 participants | Interventional | 2003-07-31 | Completed |
Phase 1b/2, Multicenter, Open-label Study of Oprozomib, Melphalan, and Prednisone in Transplant Ineligible Patients With Newly Diagnosed Multiple Myeloma [NCT02072863] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2014-01-31 | Completed |
Phase II Study of Dose-Adjusted EPOCH+/-Rituximab in Adults With Untreated Burkitt Lymphoma, c-MYC Positive Diffuse Large B-Cell Lymphoma and Plasmablastic Lymphoma [NCT01092182] | Phase 2 | 194 participants (Actual) | Interventional | 2010-03-25 | Completed |
A Phase I Trial of Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Anti-prostate-specific Membrane Antigen Monoclonal Antibody in Patients With Metastatic, Castrate-resistant Prostate Cancer [NCT00916123] | Phase 1 | 15 participants (Actual) | Interventional | 2009-05-31 | Completed |
Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia [NCT00919243] | Phase 4 | 40 participants (Anticipated) | Interventional | 2009-02-28 | Completed |
A Multicenter Phase 1, Open-Label Trial of Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies [NCT05270057] | Phase 1 | 33 participants (Anticipated) | Interventional | 2023-01-26 | Recruiting |
A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer [NCT00416533] | Phase 2 | 47 participants (Anticipated) | Interventional | 2004-08-31 | Completed |
Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas [NCT00554164] | Phase 3 | 1,073 participants (Actual) | Interventional | 2007-11-30 | Completed |
Treatment Bell´s Palsy: Prednisone vs Prednisone Valacyclovir [NCT00561106] | | 42 participants (Actual) | Interventional | 2002-12-31 | Completed |
Treatment for Newly Diagnosed Patients With Stage III/IV Non-Hodgkin Lymphoma-Study XIII (A Therapeutic Pilot Study) [NCT00187122] | | 42 participants (Actual) | Interventional | 1993-03-31 | Completed |
Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC) [NCT00182741] | Phase 2 | 19 participants (Actual) | Interventional | 2004-09-30 | Completed |
A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma [NCT00512980] | Phase 2 | 0 participants | Interventional | 2008-08-31 | Terminated(stopped due to lower recruitment rates as expected) |
Large Cell Lymphoma, Pilot Study III [NCT00187070] | | 8 participants (Actual) | Interventional | 1997-12-31 | Completed |
Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer [NCT05405439] | Phase 1/Phase 2 | 39 participants (Actual) | Interventional | 2022-08-25 | Terminated(stopped due to The sponsor voluntarily terminated the study) |
A Phase 2 Study of Pomalidomide as a Replacement for Lenalidomide for Multiple Myeloma Patients Relapsed or Refractory to a Lenalidomide-Containing Combination Regimen [NCT02188368] | Phase 2 | 45 participants (Actual) | Interventional | 2014-07-07 | Terminated(stopped due to Lack of enrollment) |
Evaluation of Ruxolitinib and Lenalidomide Combination as a Therapy for Patients With Myelofibrosis [NCT01375140] | Phase 2 | 31 participants (Actual) | Interventional | 2011-09-22 | Completed |
International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic or Biphenotypic Leukemia [NCT00550992] | | 445 participants (Anticipated) | Interventional | 2006-01-31 | Recruiting |
Investigating the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus [NCT05591144] | | 129 participants (Actual) | Interventional | 2022-10-30 | Completed |
Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial [NCT03804723] | | 321 participants (Anticipated) | Interventional | 2019-06-30 | Not yet recruiting |
Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma [NCT01004991] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2010-01-31 | Completed |
Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia [NCT03488225] | Phase 2 | 4 participants (Actual) | Interventional | 2018-03-28 | Terminated(stopped due to the study was closed early due to competing trials) |
A Selective Frontline Cabazitaxel Therapeutic Pathway for Castration-Resistant Prostate Cancer With Integrated Biomarkers [NCT02844582] | Phase 2 | 2 participants (Actual) | Interventional | 2017-12-20 | Terminated(stopped due to Poor accrual of subjects onto study) |
TNF-alpha Antagonists for Acute Exacerbations of COPD: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial [NCT00789997] | Phase 2/Phase 3 | 81 participants (Actual) | Interventional | 2008-11-30 | Completed |
Randomized Phase III Study in Low Grade Lymphoma Comparing Maintenance Anti-CD20 Antibody Versus Observation Following Induction Therapy [NCT00003204] | Phase 3 | 515 participants (Actual) | Interventional | 1998-03-31 | Completed |
[NCT00004482] | Phase 2 | 40 participants | Interventional | 1999-12-31 | Completed |
[NCT00004686] | Phase 2 | 300 participants | Interventional | 1994-02-28 | Completed |
Alemtuzumab and CHOP Chemotherapy for Aggressive Histology Peripheral T Cell Lymphomas: A Multi-Centre Phase I and II Study [NCT00363090] | Phase 1/Phase 2 | 84 participants (Anticipated) | Interventional | 2006-09-30 | Recruiting |
Iberoamerican Phase III International Study, Open, Multicenter, Randomized, Comparative of Thalidomide / Cyclophosphamide / Dexamethasone Versus Thalidomide / Dexamethasone Versus Thalidomide / Melphalan / Prednisone as Induction Therapy Followed by Maint [NCT01532856] | Phase 3 | 64 participants (Actual) | Interventional | 2007-01-31 | Active, not recruiting |
Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer [NCT00350051] | Phase 2 | 53 participants (Actual) | Interventional | 2006-08-01 | Completed |
ALL-BFM 2000 Multi-Center Study for the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia [NCT00430118] | Phase 3 | 4,559 participants (Actual) | Interventional | 2000-07-31 | Completed |
The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy. [NCT00440219] | Phase 3 | 34 participants (Anticipated) | Interventional | 2010-11-30 | Completed |
A Randomised Trial of Prednisone and Tamoxifen in Patients With Idiopathic Retroperitoneal Fibrosis [NCT00440349] | Phase 2 | 38 participants | Interventional | 2000-10-31 | Active, not recruiting |
A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With Melphalan/Prednisone/Velcade Versus Thalidomide / Prednisone / Velcade and Maintenance Treatment With Thalidomide / Velcade Versus Prednisone / Velcad [NCT00443235] | Phase 3 | 260 participants (Anticipated) | Interventional | 2005-03-31 | Completed |
A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942) [NCT00592111] | Phase 2 | 21 participants (Actual) | Interventional | 1996-03-31 | Completed |
Preventing Tuberculosis-associated Immune Reconstitution Inflammatory Syndrome in High-risk Patients: a Randomized Placebo-controlled Trial of Prednisone [NCT01924286] | Phase 3 | 240 participants (Actual) | Interventional | 2013-08-30 | Completed |
The Clinical Efficacy and Safety of Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE ,a Multicentre Observational Study [NCT05644210] | | 80 participants (Anticipated) | Observational | 2022-10-01 | Recruiting |
A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis [NCT01612377] | Phase 2 | 18 participants (Actual) | Interventional | 2012-03-31 | Terminated(stopped due to missed endpoint of meaningful clinical benefit, compared to prednisolone 2.7mg) |
PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia [NCT00494897] | Phase 4 | 374 participants (Actual) | Interventional | 1996-06-30 | Completed |
A Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Efficacy and Safety of corticoSTEROids Added to Standard Therapy in Patients With Acute Heart Failure (STERO-AHF) [NCT05809011] | Phase 2/Phase 3 | 120 participants (Anticipated) | Interventional | 2023-04-24 | Recruiting |
A Phase Ib Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Patients With Untreated BCL-2 Immunohistochemistry (IHC) [NCT04790903] | Phase 1 | 50 participants (Anticipated) | Interventional | 2021-07-02 | Active, not recruiting |
A Randomized Double-Blind Controlled Trial of Single Oral Dose Dexamethasone Versus Five Days of Oral Prednisone in Acute Mild to Moderate Adult Asthma [NCT01241006] | Phase 4 | 376 participants (Actual) | Interventional | 2011-01-31 | Completed |
LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive [NCT00526305] | Phase 4 | 100 participants (Anticipated) | Interventional | 2000-01-31 | Completed |
Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a [NCT00508040] | Phase 2 | 58 participants (Actual) | Interventional | 2007-09-30 | Completed |
A Pilot Study of the Efficacy of the Chop-Montak Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma [NCT00513188] | | 0 participants (Actual) | Interventional | 2007-02-28 | Withdrawn |
A Safety and Pharmacokinetics Study of Niraparib Plus Androgen Receptor-Targeted Therapy (Apalutamide or Abiraterone Acetate Plus Prednisone) in Men With Metastatic Castration-Resistant Prostate Cancer [NCT02924766] | Phase 1 | 34 participants (Actual) | Interventional | 2016-10-03 | Completed |
Effects of Fluticasone/Salmeterol (Advair®) in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation [NCT00531791] | Phase 3 | 14 participants (Actual) | Interventional | 2007-11-30 | Completed |
Evaluation of Lenalidomide (CC-5013) and Prednisone as a Therapy for Patients With Myelofibrosis (MF) [NCT00352794] | Phase 2 | 40 participants (Actual) | Interventional | 2006-07-07 | Completed |
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT) [NCT04787744] | Phase 2/Phase 3 | 464 participants (Anticipated) | Interventional | 2021-07-01 | Recruiting |
Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed MYC/BCL2 Double-Expressor DLBCL [NCT04231448] | Phase 3 | 423 participants (Actual) | Interventional | 2020-05-21 | Active, not recruiting |
Treatment of Primary Minimal Change Nephropathy: A Randomized Open-labeled Non-inferiority Study on Prednisolone and Vitamin D [NCT03210688] | Phase 4 | 64 participants (Anticipated) | Interventional | 2018-05-01 | Recruiting |
Modified BFM (Berlin-Frankfurt-Munster)Backbone Therapy for Chinese Children or Adolescents With Newly Diagnosed Lymphoblastic Lymphoma [NCT02845882] | Phase 3 | 150 participants (Anticipated) | Interventional | 2016-01-31 | Active, not recruiting |
A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807) [NCT00557193] | Phase 3 | 218 participants (Actual) | Interventional | 2008-01-15 | Active, not recruiting |
P-Gemoxd Regimen Followed by Radiotherapy Versus P-CHOP Regimen Followed by Radiotherapy in ENKTL With Early Stage: a Randomized, Multicenter, Open-label, Phase 2 Study [NCT02918747] | Phase 2 | 100 participants (Actual) | Interventional | 2016-09-30 | Active, not recruiting |
Phase II Study to Determine the Effects of Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate in Patients Who Are Scheduled for Radical Prostatectomy With Genomic Correlates of Pathological Response [NCT00598858] | Phase 2 | 0 participants (Actual) | Interventional | 2009-01-31 | Withdrawn(stopped due to Halted due to zero accrual and lack of funding) |
Medical Ethics Committee of Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University [NCT04356430] | Phase 2 | 75 participants (Anticipated) | Interventional | 2019-04-01 | Active, not recruiting |
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT03706365] | Phase 2/Phase 3 | 350 participants (Anticipated) | Interventional | 2018-11-26 | Active, not recruiting |
LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma [NCT04043494] | Phase 3 | 683 participants (Anticipated) | Interventional | 2019-08-23 | Recruiting |
First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents [NCT00433459] | Phase 3 | 2,134 participants (Actual) | Interventional | 2007-01-31 | Completed |
A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma [NCT02529852] | Phase 1/Phase 2 | 59 participants (Actual) | Interventional | 2015-11-04 | Completed |
Prognostic Significance of Early Positron Emission Tomography (PET) With Fluorine-18 Fluorodeoxyglucose ([18F] FDG) in Intermediate and High Grade Non-Hodgkin's Lymphoma [NCT00110006] | | 0 participants (Actual) | Interventional | 2004-12-31 | Withdrawn(stopped due to No accrual) |
Belimumab Treatment for IgG4-related Disease, a Prospective, Open-label Clinical Trial [NCT04660565] | Phase 4 | 60 participants (Anticipated) | Interventional | 2021-01-31 | Recruiting |
Randomized Phase Ii Trial Of Weekly Docetaxel, Estramustine And Prednisone Versus Docetaxel And Prednisone In Patient With Hormone-Resistant Prostate Cancer [NCT00541281] | Phase 2 | 150 participants (Actual) | Interventional | 2003-12-31 | Completed |
A Phase 2 Study to Investigate the Safety, Tolerability and Anti-tumor Activity of Golidocitinib in Combination With CHOP as the Front-line Treatment for Participants With Peripheral T-cell Lymphomas (PTCL) [NCT05963347] | Phase 2 | 45 participants (Anticipated) | Interventional | 2023-08-03 | Recruiting |
A Double-blind, Placebo-controlled Study to Evaluate the Effects of Oral Steroids on Skin of Patients With Moderate to Severe Atopic Dermatitis Patients [NCT02908698] | | 16 participants (Actual) | Interventional | 2017-01-24 | Terminated(stopped due to Primary outcome was met in the 16 patients that completed the study per protocol) |
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in Subjects With Polymyalgia Rheumatica [NCT02899026] | Phase 3 | 0 participants (Actual) | Interventional | 2018-03-15 | Withdrawn(stopped due to GSK decision to return rights to sirukumab to Janssen and discontinue sirukumab development in polymyalgia rheumatica.) |
A Study Comparing Measures of Ventilatory Heterogeneity (VH) in Asthma Patients [NCT01621386] | Phase 1 | 34 participants (Actual) | Interventional | 2013-01-31 | Completed |
An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's Disease [NCT01235689] | Phase 3 | 252 participants (Actual) | Interventional | 2011-02-11 | Completed |
Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas [NCT03984448] | Phase 2/Phase 3 | 363 participants (Anticipated) | Interventional | 2019-10-22 | Active, not recruiting |
An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hy [NCT03532022] | Phase 3 | 0 participants (Actual) | Interventional | 2018-10-04 | Withdrawn(stopped due to Protocol re-design required following EU Phase III results) |
A Multicenter, Phase III, Randomized Study to Evaluate the Efficacy of Response-adapted Strategy to Define Maintenance After Standard Chemoimmunotherapy in Patients With Advanced-stage Follicular Lymphoma. [NCT02063685] | Phase 3 | 807 participants (Actual) | Interventional | 2012-07-31 | Completed |
Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC) [NCT02910245] | Phase 3 | 136 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
A Phase Ib Study Evaluating Glofitamab (RO7082859) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin (POLA) Plus Rituximab (R), Cyclophosphamide, Doxorubici [NCT03467373] | Phase 1 | 172 participants (Anticipated) | Interventional | 2018-03-13 | Active, not recruiting |
Multicenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis. [NCT01536535] | Phase 4 | 431 participants (Actual) | Interventional | 2012-07-10 | Completed |
Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis [NCT04951986] | Phase 3 | 732 participants (Anticipated) | Interventional | 2021-08-11 | Recruiting |
[NCT00854061] | Phase 3 | 172 participants (Actual) | Interventional | 2009-02-28 | Completed |
Multitarget Therapy for Idiopathic Membranous Nephropathy [NCT04424862] | Phase 4 | 82 participants (Actual) | Interventional | 2020-06-09 | Completed |
Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma [NCT00004039] | Phase 2 | 0 participants (Actual) | Interventional | 1998-06-30 | Withdrawn(stopped due to No patient accruals) |
Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT01834209] | | 0 participants | Expanded Access | | No longer available |
Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy, a Multicentric, Randomized, Double-blind, Placebo-controlled Study [NCT05024448] | Phase 4 | 96 participants (Actual) | Interventional | 2013-08-27 | Completed |
A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germi [NCT01040871] | Phase 2 | 164 participants (Actual) | Interventional | 2010-01-31 | Completed |
A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer [NCT01695005] | Phase 1 | 237 participants (Actual) | Interventional | 2012-10-31 | Completed |
A Phase II Open Label Study of Brentuximab Vedotin in Combination With CHEP in Patients With Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL) [NCT05006664] | Phase 2 | 33 participants (Anticipated) | Interventional | 2021-10-31 | Not yet recruiting |
A Phase 2, Study of Apalutamide and Abiraterone Acetate in Castration-Resistant Metastatic Prostate Cancer Patients Evaluating a Predetermined Biomarker Signature [NCT03360721] | Phase 2 | 7 participants (Actual) | Interventional | 2018-03-06 | Active, not recruiting |
An Exploratory Randomized Phase II Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer [NCT02218606] | Phase 2 | 80 participants (Actual) | Interventional | 2014-08-31 | Completed |
The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach [NCT01940094] | Phase 3 | 159 participants (Actual) | Interventional | 2014-02-28 | Active, not recruiting |
Phase Ib Study of BKM120 Combined With Abiraterone Acetate for Docetaxel-pretreated, Castrate-resistant, Metastatic Prostate Cancer [NCT01741753] | Phase 1 | 4 participants (Actual) | Interventional | 2012-11-30 | Terminated(stopped due to Due to slow accrual the supllier of BKM120 asked we cease further enrollment.) |
A Multicenter Phase II Study of Subcutaneous Velcade Plus Oral Melphalan and Prdnisone or Plus Cycloposphamide and Prednisone or Plus Prednisone in Newly Diagnosed Elderly Multiple Myeloma Patients [NCT01190787] | Phase 2 | 150 participants (Anticipated) | Interventional | 2010-07-31 | Active, not recruiting |
The Treatment of Multiple Myeloma Utilizing VBMCP Chemotherapy Alternating With High-Dose Cyclophosphamide and Alpha2b-Interferon Versus VBMCP: A Phase III Study for Previously Untreated Multiple Myeloma [NCT00002556] | Phase 3 | 312 participants (Actual) | Interventional | 1994-07-31 | Completed |
A RANDOMIZED PHASE III TRIAL COMPARING DEXAMETHASONE WITH PREDNISONE IN INDUCTION TREATMENT AND BONE MARROW TRANSPLANTATION WITH INTENSIVE MAINTENANCE TREATMENT IN ADOLESCENT AND ADULT ACUTE LYMPHOBLASTIC LEUKEMIA (ALL-4) [NCT00002700] | Phase 3 | 392 participants (Anticipated) | Interventional | 1995-08-31 | Completed |
Phase III Trial of CHOP Versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients With Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma [NCT00003150] | Phase 3 | 630 participants (Anticipated) | Interventional | 1997-12-31 | Completed |
A Phase II Study to Evaluate Efficacy and Tolerability of Methotrexate in Combination With Glucocorticoids for the Treatment of Newly Diagnosed Acute Graft-Versus-Host Disease After Nonmyeloablative Hematopoietic Cell Transplantation [NCT00357084] | Phase 2 | 53 participants (Anticipated) | Interventional | 2006-05-31 | Completed |
Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study [NCT00005578] | Phase 3 | 219 participants (Actual) | Interventional | 1997-03-31 | Completed |
Investigating Biomarkers of Steroid Resistant Asthma [NCT00361920] | | 40 participants (Actual) | Interventional | 2006-08-31 | Completed |
An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT01424930] | Phase 2 | 25 participants (Actual) | Interventional | 2011-10-31 | Completed |
A Phase II Clinical Trial of Cabazitaxel Plus Prednisone With Octreotide in the Treatment of Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel [NCT01469338] | Phase 2 | 9 participants (Actual) | Interventional | 2012-07-31 | Terminated(stopped due to lack of funding) |
Mitoxantrone, Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer (HRPC) [NCT00452387] | Phase 2 | 22 participants (Actual) | Interventional | 2007-05-31 | Terminated(stopped due to Early stopping rule) |
Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer [NCT01478308] | Phase 2 | 0 participants (Actual) | Interventional | 2011-06-30 | Withdrawn(stopped due to No accrual in initial period, PI decided to close study.) |
Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis [NCT00262405] | Phase 2 | 44 participants (Actual) | Interventional | 2001-01-31 | Completed |
Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy [NCT00268567] | Phase 2/Phase 3 | 0 participants | Interventional | 2002-10-31 | Completed |
Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss [NCT00416143] | Phase 2/Phase 3 | 60 participants | Interventional | 2006-06-30 | Recruiting |
A Single Center, Open Label, Comparative, Controlled Trial to Assess the Risks and Benefits of Steroid Elimination vs. Steroid Therapy After Renal Transplantation [NCT00273559] | | 60 participants (Anticipated) | Observational | 2006-01-31 | Active, not recruiting |
Treatment of Children and Adolescents With Diffuse Intrinsic Pontine Glioma and High Grade Glioma [NCT00278278] | Phase 3 | 150 participants (Anticipated) | Interventional | 2003-09-30 | Active, not recruiting |
REPLACE: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids [NCT00284947] | Phase 4 | 7 participants (Actual) | Interventional | 2006-01-31 | Completed |
Phase II, Randomized, Open-label, Multicenter Study in Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Who Have PRIMary Resistance to Abiraterone Acetate or Enzalutamide Treatment Comparing the Anti-tumor Effect of CABa [NCT02379390] | Phase 2 | 8 participants (Actual) | Interventional | 2015-06-17 | Terminated(stopped due to Unsatisfactory patient accrual) |
A Randomized Double Blinded Placebo-Controlled Phase III Trial Comparing Cyclosporine Plus Steroids With or Without Myfortic as Primary Treatment for Extensive Chronic Graft Versus Host Disease [NCT00298324] | Phase 3 | 34 participants (Actual) | Interventional | 2006-09-30 | Terminated(stopped due to Due to slow accrual) |
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies [NCT00304018] | Phase 1 | 5 participants (Actual) | Interventional | 2002-10-31 | Completed |
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis [NCT00307645] | Phase 3 | 160 participants | Interventional | 2003-05-31 | Terminated |
A Phase I/II Study of Docetaxel/Prednisone and PTK 787/ZK 222584 in Previously Untreated Metastatic Hormone Refractory Prostate Cancer [NCT00293371] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 2005-02-28 | Terminated(stopped due to low accrual) |
A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve [NCT00089856] | Phase 3 | 626 participants (Actual) | Interventional | 2004-07-31 | Terminated(stopped due to Based on futility analysis showing <30% chance of meeting primary endpoint.) |
A Phase I Study of CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas [NCT00323323] | Phase 1 | 24 participants (Actual) | Interventional | 2004-03-31 | Completed |
Serial Response and Biomarker-Guided Steroid Taper for Children With GVHD [NCT05090384] | Phase 2 | 50 participants (Anticipated) | Interventional | 2022-10-20 | Recruiting |
A Dose-Finding Phase Ib Study of the Oral BCL-2 Inhibitor Venetoclax (ABT-199) in Combination With Standard Induction Therapy, Dasatinib, Prednisone, (and Rituximab in CD20+ Patients) in Adult Patients With Newly Diagnosed and Relapsed Philadelphia Chromo [NCT04872790] | Phase 1 | 20 participants (Anticipated) | Interventional | 2022-09-02 | Recruiting |
A Phase 2 Course Determining Study for Men With Hormone-Naïve Metastatic Prostate Cancer (HNMPCa) [NCT03821792] | Phase 2 | 60 participants (Anticipated) | Interventional | 2019-07-22 | Active, not recruiting |
Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia [NCT00039130] | Phase 2 | 105 participants (Actual) | Interventional | 2002-05-31 | Completed |
Phase I Cinical Sudy of Lposomal Mitoxantrone Hydrochloride Combined With Cyclophosphamide, Vincristine, Etoposide and Prednisone (CMOEP) in Previously Untreated Peripheral T-cell Lymphoma [NCT05458180] | Phase 1 | 18 participants (Anticipated) | Interventional | 2022-07-07 | Not yet recruiting |
Three-Arm Randomized Phase II Clinical Study of Irofulven/Prednisone, Irofulven/Capecitabine/Prednisone or Mitoxantrone/Prednisone in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer Patients [NCT00124566] | Phase 2 | 135 participants (Actual) | Interventional | 2004-06-30 | Completed |
Three-dimensional Facial Swelling Evaluation of Pre-operative Single-dose of Prednisone in Third Molar Surgery: a Split-mouth Randomized Controlled Trial [NCT05830747] | Phase 4 | 34 participants (Actual) | Interventional | 2022-02-01 | Completed |
A Multicenter,Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH and R-CEOP90, With or Without Upfront Auto-HSCT,in Newly Diagnosed Young Patients With Intermediate/High-risk DLBCL [NCT03213977] | Phase 3 | 475 participants (Anticipated) | Interventional | 2017-02-01 | Recruiting |
A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain [NCT00133224] | Phase 3 | 408 participants (Actual) | Interventional | 2005-07-31 | Terminated(stopped due to Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.) |
Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed, Standard Risk Multiple Myeloma [NCT01054144] | Phase 2 | 27 participants (Actual) | Interventional | 2010-01-14 | Completed |
A Phase II Open-label, Parallel Group Study of Abiraterone Acetate Plus Prednisone in African American and Caucasian Men With Metastatic Castrate-resistant Prostate Cancer [NCT01940276] | Phase 2 | 100 participants (Actual) | Interventional | 2013-10-31 | Completed |
"Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Oral Cyclophosphamide (TPC) in the Therapy of Myelofibrosis With Myeloid Metaplasia (MMM)" [NCT00445900] | Phase 2 | 22 participants (Anticipated) | Interventional | 2004-10-31 | Completed |
A Pilot Study of Rituximab in Combination With Corticosteroids for the Initial Treatment of Immune Thrombocytopenic Purpura [NCT00486421] | Early Phase 1 | 22 participants (Anticipated) | Interventional | 2007-01-31 | Completed |
Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation [NCT00133172] | Phase 4 | 85 participants (Actual) | Interventional | 2005-07-31 | Terminated(stopped due to Varience of supply chain from that required by protocol) |
A Phase II Study Evaluating the Efficacy and Safety of Bortezomib (Velcade™) Combined With ACVBP Regimen in Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT00136565] | Phase 2 | 60 participants (Actual) | Interventional | 2006-01-08 | Completed |
The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children, Double-Blind, Placebo-Controlled Study [NCT00504946] | Phase 3 | 85 participants (Actual) | Interventional | 2005-09-30 | Completed |
Mechanism and Response of Thymoglobulin in Patients With Myelodysplastic Syndrome (MDS) [NCT00466843] | Phase 2 | 54 participants (Anticipated) | Interventional | 2007-04-30 | Recruiting |
A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) [NCT05578976] | Phase 3 | 900 participants (Anticipated) | Interventional | 2023-02-08 | Recruiting |
A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma [NCT05371093] | Phase 3 | 230 participants (Anticipated) | Interventional | 2022-09-12 | Recruiting |
A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma [NCT04759586] | Phase 3 | 244 participants (Anticipated) | Interventional | 2021-10-05 | Recruiting |
A Phase I/II Study of M9241 With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and M9241 With Docetaxel in Castration Resistant Prostate Cancer [NCT04633252] | Phase 1/Phase 2 | 86 participants (Anticipated) | Interventional | 2021-02-23 | Recruiting |
Randomized Controlled Trial of Preoperative Steroids in Autoimmune Thyroid Disease [NCT04542278] | Phase 4 | 30 participants (Actual) | Interventional | 2020-11-13 | Completed |
Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma [NCT03436654] | Phase 2 | 112 participants (Anticipated) | Interventional | 2018-06-21 | Recruiting |
The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study [NCT02784210] | Phase 2 | 30 participants (Anticipated) | Interventional | 2016-10-05 | Recruiting |
Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL) [NCT01371630] | Phase 1/Phase 2 | 276 participants (Anticipated) | Interventional | 2011-08-26 | Recruiting |
A Phase III Randomized Trial of CHOP Chemotherapy Plus Rituxan (IDEC-C2B8) Versus CHOP Chemotherapy Alone for Newly Diagnosed, Previously Untreated, Aggressive Non-Hodgkin's Lymphoma [NCT00004112] | Phase 3 | 0 participants | Interventional | 1999-09-01 | Completed |
[NCT00378443] | | 0 participants | Interventional | 2006-01-31 | Active, not recruiting |
A Randomized, Phase II Trial of AZD2171, Docetaxel, and Prednisone Compared to Docetaxel and Prednisone in Patients With Metastatic, Hormone Refractory Prostate Cancer [NCT00527124] | Phase 2 | 57 participants (Actual) | Interventional | 2007-11-30 | Terminated(stopped due to Closure was recommended by CTEP due to slow accrual.) |
A Multicenter Double-blind Randomized Controlled Trial of Systemic Corticosteroid Therapy in AECOPD Patients Admitted to Hospital With Higher Blood Eosinophil Levels [NCT05059873] | Phase 4 | 456 participants (Anticipated) | Interventional | 2023-03-05 | Not yet recruiting |
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC) [NCT01715285] | Phase 3 | 1,209 participants (Actual) | Interventional | 2013-02-12 | Completed |
Study on the Effect of Glucocorticoid Intervention on the Improvement of Blood Glucose in Patients With Exogenous Insulin Antibody Syndrome [NCT04357392] | Early Phase 1 | 20 participants (Anticipated) | Interventional | 2020-05-20 | Not yet recruiting |
Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection [NCT04344288] | Phase 2 | 11 participants (Actual) | Interventional | 2020-04-21 | Terminated(stopped due to Competent Authority's decision) |
Role of Short Term Systemic Corticosteroid Therapy in the Management of Chronic Rhinosinusitis Without Nasal Polyps [NCT01676415] | Phase 4 | 9 participants (Actual) | Interventional | 2012-08-31 | Terminated(stopped due to participants are no longer receiving intervention due to clinical logistics) |
A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Patients With Castration-Resistant Prostate Cancer [NCT01666314] | Phase 1/Phase 2 | 137 participants (Actual) | Interventional | 2012-08-20 | Completed |
Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma [NCT02987244] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2016-03-31 | Recruiting |
Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma [NCT00501826] | Phase 2 | 160 participants (Anticipated) | Interventional | 2007-07-11 | Recruiting |
Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer [NCT04812366] | Phase 2 | 315 participants (Anticipated) | Interventional | 2021-09-21 | Recruiting |
The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids [NCT00170196] | Phase 3 | 216 participants (Actual) | Interventional | 2005-08-31 | Completed |
Treatment Of Newly Diagnosed Adult Acute Lymphoblastic Leukemia With Intensified Post Remission Therapy Containing PEG-Asparaginase. [NCT00184041] | Phase 2 | 47 participants (Actual) | Interventional | 2004-07-31 | Completed |
A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL) [NCT01359592] | Phase 2 | 159 participants (Actual) | Interventional | 2011-09-30 | Active, not recruiting |
Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00187005] | Phase 3 | 53 participants (Actual) | Interventional | 1998-07-31 | Terminated(stopped due to Toxicity) |
A Phase I-II Study of the Combination of Ruxolitinib or Dasatinib With Chemotherapy in Patients With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL) [NCT02420717] | Phase 2 | 11 participants (Actual) | Interventional | 2015-07-15 | Terminated(stopped due to Study was closed early due to low accrual and lack of response.) |
HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD [NCT02661503] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 2016-07-31 | Recruiting |
A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With an Open-label Cohort to Assess the Safety, Tolerability, and Efficacy of Namilumab in Subjects With Active Cardiac Sarcoidosis [NCT05351554] | Phase 2 | 1 participants (Actual) | Interventional | 2022-08-23 | Terminated(stopped due to Sponsor business decision not related to safety) |
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer [NCT04100018] | Phase 3 | 984 participants (Anticipated) | Interventional | 2020-02-06 | Active, not recruiting |
A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predom [NCT02043678] | Phase 3 | 806 participants (Actual) | Interventional | 2014-03-30 | Active, not recruiting |
Gene Transfer for Patients With Fanconi Anemia Complementation Group A (FANCA) [NCT01331018] | Phase 1 | 3 participants (Actual) | Interventional | 2012-02-22 | Active, not recruiting |
A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease [NCT00929695] | Phase 3 | 164 participants (Actual) | Interventional | 2009-06-30 | Completed |
A Phase 2 Open-Label, Randomized, Multi-center Study of Neoadjuvant Abiraterone Acetate (CB7630) Plus Leuprolide Acetate and Prednisone Versus Leuprolide Acetate Alone in Men With Localized High Risk Prostate Cancer [NCT00924469] | Phase 2 | 58 participants (Actual) | Interventional | 2009-11-30 | Completed |
A Phase IV Multicenter, Randomized, Double-blind Study. prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab: Induction of REmission and Maintenance [NCT00480272] | Phase 4 | 251 participants (Actual) | Interventional | 2007-05-31 | Completed |
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Re [NCT01308580] | Phase 3 | 1,200 participants (Actual) | Interventional | 2011-04-30 | Completed |
Immune Monitoring to Facilitate Belatacept Monotherapy [NCT04177095] | Phase 4 | 17 participants (Actual) | Interventional | 2020-02-11 | Completed |
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets and Relationship With Relapse [NCT02954939] | | 50 participants (Anticipated) | Interventional | 2017-03-01 | Recruiting |
A Phase II Study of Rituximab Intense Dosing With CHOP-21 (RID-CHOP) in Patients With Previously Untreated High or High-Intermediate Risk IPI (3-5) Diffuse Large B-Cell Lymphoma (DLBCL) [NCT01539174] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to No Funding Source and Competing Trials) |
[NCT01540812] | | 418 participants (Actual) | Observational | 2012-02-29 | Completed |
A Phase III Study of Large Cell Lymphomas in Children and Adolescents: Comparison of APO vs APO + IDMTX/HDARA-C and Continuous vs Bolus Infusion of Doxorubicin [NCT00002618] | Phase 3 | 242 participants (Anticipated) | Interventional | 1994-12-31 | Completed |
Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia [NCT00002744] | Phase 3 | 1,970 participants (Actual) | Interventional | 1996-05-31 | Completed |
Induction Intensification in Infant ALL: A Children's Oncology Group Study [NCT00002756] | Phase 2 | 221 participants (Actual) | Interventional | 1996-06-30 | Completed |
A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma [NCT00006890] | Phase 2 | 67 participants (Actual) | Interventional | 2000-07-12 | Completed |
A Randomized Open-label Phase IIa Study Evaluating Quantified Bone Scan Response Following Treatment With Radium-223 Dichloride Alone or in Combination With Abiraterone Acetate or Enzalutamide in Subjects With Castration-resistant Prostate Cancer Who Have [NCT02034552] | Phase 2 | 68 participants (Actual) | Interventional | 2014-03-07 | Completed |
Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma. [NCT02752815] | Phase 4 | 290 participants (Anticipated) | Interventional | 2016-06-14 | Active, not recruiting |
Phase II Trial of Sequential Modification of Immunosuppression, Interferon Alpha, and Promace-Cytabom For Treatment of Post-Cardiac Transplant Lymphoproliferation. [NCT00002657] | Phase 2 | 20 participants (Actual) | Interventional | 1995-05-31 | Completed |
A Phase 2, Single-Arm, Open-Label, Multicenter Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in the Frontline Treatment of Chinese Patients With CD30-Positive (CD30+) Peripheral T-Ce [NCT05673785] | Phase 2 | 52 participants (Anticipated) | Interventional | 2023-02-10 | Recruiting |
[NCT00000146] | Phase 3 | 0 participants | Interventional | 1988-07-31 | Active, not recruiting |
Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma [NCT00022945] | Phase 2 | 0 participants | Interventional | | Completed |
Randomized Multicenter, Phase III Trial Evaluating the Safety of 2 Schedules of Cabazitaxel (Bi-weekly Versus Tri-weekly) Plus Prednisone in Elderly Men (≥ 65years) With mCRPC Previously Treated With a Docetaxel-containing Regimen [NCT02961257] | Phase 3 | 196 participants (Actual) | Interventional | 2017-05-05 | Completed |
A Phase I Study To Evaluate The Safety Of Cellular Immunotherapy Using Genetically Modified Autologous Cd20-Specific Cd8+ T Cell Clones For Patients With Relapsed Cd20+ Indolent Lymphomas [NCT00012207] | Phase 1 | 12 participants (Anticipated) | Interventional | 2000-09-30 | Completed |
A Randomized Phase III Study Of Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) With 2-Weekly CHOP Chemotherapy In Elderly Patients With Intermediate Or High-Risk Non-Hodgkin's Lymphoma [NCT00028717] | Phase 3 | 400 participants (Anticipated) | Interventional | 2001-02-28 | Active, not recruiting |
[NCT00000596] | Phase 2 | 0 participants | Interventional | 1978-06-30 | Completed |
Allogeneic Stem Cell Transplantation Following Nonmyeloablative Chemotherapy in Patients With Hemoglobinopathies [NCT00034528] | Phase 2 | 2 participants (Actual) | Interventional | 2001-09-30 | Terminated(stopped due to Due to slow recruitment) |
The Use of Modified BFM +/- Compound 506U78 (Nelarabine) (NSC# 686673, IND #52611) in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia [NCT00016302] | | 100 participants (Actual) | Interventional | 2001-04-30 | Completed |
A Phase III, Randomized, Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gr [NCT00043147] | Phase 3 | 0 participants | Interventional | 2002-04-30 | Completed |
Randomised Study Comparing 6 And 8 Cycles Of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine And Prednisone) At 14-Day Intervals (CHOP-14), Both With Or Without The Monoclonal Anti-CD20 Antibody Rituximab In Patients Aged 61 To 80 Year [NCT00052936] | Phase 3 | 1,506 participants (Actual) | Interventional | 2001-01-31 | Completed |
A Randomized Phase II Study Of BMS 247550 Or Mitoxantrone And Prednisone In Patients With Taxane Resistant Hormone Refractory Prostate Cancer [NCT00058084] | Phase 2 | 80 participants (Actual) | Interventional | 2003-03-31 | Completed |
Diffuse Large B Cell And Peripheral T Cell Non-Hodgkin's Lymphomas (NHL) In The Elderly. Influence Of Prolonged Oral Etoposide Added To CHOP Combination Chemotherapy In Patients With Good Physiological Status. An EORTC Randomized Phase II-III Trial Includ [NCT00060385] | Phase 2/Phase 3 | 3 participants (Actual) | Interventional | 2003-03-31 | Terminated(stopped due to low accrual) |
Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma [NCT00070447] | Phase 2 | 0 participants | Interventional | 2003-11-30 | Completed |
2-CDA and Rituximab as Remission Induction and Rituximab as In Vivo Purging Prior to Peripheral Stem Cell Mobilization in Patients With Chronic Lymphocytic Leukemia (CLL) - A Prospective Multicenter Phase II Trial [NCT00072007] | Phase 2 | 43 participants (Actual) | Interventional | 2002-06-30 | Completed |
Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma [NCT00079261] | Phase 2 | 25 participants (Actual) | Interventional | 2004-01-31 | Completed |
Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma [NCT00135499] | Phase 3 | 138 participants (Actual) | Interventional | 2001-10-16 | Terminated(stopped due to Recruitment too low) |
Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study [NCT00135967] | Phase 2/Phase 3 | 30 participants | Interventional | 2002-05-31 | Completed |
Phase II Study of Efficacy and Safety of Tofacitinib in Patients With Polymyalgia Rheumatica [NCT04799262] | Phase 2 | 14 participants (Actual) | Interventional | 2021-01-01 | Completed |
A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients [NCT00275535] | Phase 4 | 165 participants (Actual) | Interventional | 2001-04-30 | Completed |
A Phase I/II Trial of STI-571 and Chemotherapy in Lymphoid Blast Crisis of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoid Leukemia [NCT00015860] | Phase 1/Phase 2 | 0 participants | Interventional | 2001-05-31 | Completed |
PILOT MULTINATIONAL PROTOCOLS IN ACUTE LYMPHOBLASTIC LEUKEMIA AND DIFFUSE NON-HODGKIN'S LYMPHOMA [NCT00018954] | Phase 2 | 0 participants | Interventional | 1992-10-31 | Completed |
A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy For Mantle Cell Lymphoma [NCT00020943] | Phase 2 | 79 participants (Actual) | Interventional | 2001-06-30 | Completed |
A Double-Blind Randomized Trial of Steroid Withdrawal in Sirolimus- and Cyclosporine-Treated Primary Transplant Recipients [NCT00023244] | Phase 2 | 274 participants (Actual) | Interventional | 2001-01-31 | Terminated(stopped due to Effective August 13, 2004: Unanticipated high incidence of post-transplant lymphoproliferative disorder) |
A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma [NCT05051891] | Phase 3 | 356 participants (Anticipated) | Interventional | 2021-12-22 | Recruiting |
Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease [NCT00031824] | Phase 3 | 82 participants (Actual) | Interventional | 2002-04-30 | Completed |
High Dose Oral Steroids in Sudden Sensorineural Hearing Loss [NCT03255473] | Phase 2 | 4 participants (Actual) | Interventional | 2017-08-30 | Completed |
Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF [NCT04702256] | Phase 3 | 196 participants (Anticipated) | Interventional | 2021-12-09 | Recruiting |
A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer [NCT03338790] | Phase 2 | 292 participants (Actual) | Interventional | 2017-12-19 | Active, not recruiting |
A Randomized Study of Two Methods of CNS Prophylaxis in Patients With Acute Lymphoblastic Leukemia [NCT00019409] | Phase 3 | 0 participants (Actual) | Interventional | 1999-10-31 | Withdrawn |
Intensive Induction Therapy for Children With Acute Lymphoblastic Leukemia (ALL) Who Experience a Bone Marrow Relapse [NCT00049569] | | 126 participants (Anticipated) | Interventional | 2003-01-31 | Completed |
Calcineurin Inhibitor Sparing Protocol in Living Donor Pediatric Kidney Transplantation [NCT00023231] | | 35 participants (Actual) | Interventional | 2001-02-28 | Completed |
A Multi-Center Phase I/II Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) [NCT00667615] | Phase 1/Phase 2 | 30 participants (Actual) | Interventional | 2008-04-30 | Completed |
[NCT02115997] | Phase 4 | 30 participants (Actual) | Interventional | 2015-07-06 | Completed |
Pilot Study Using Induction Chemo-immunotherapy Followed by Consolidation With Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adult [NCT03719105] | Early Phase 1 | 40 participants (Anticipated) | Interventional | 2019-03-01 | Recruiting |
A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis. [NCT00580229] | Phase 2/Phase 3 | 50 participants (Actual) | Interventional | 2007-12-31 | Completed |
Phase II, Randomized, Open-Label, Two-Arm, Multicenter Study of MEDI-522, a HuMA Directed Against the Human Alpha V Beta 3 Integrin, in Combination With Docetaxel, Prednisone, and Zoledronic Acid in the Treatment of Patients With Metastatic Androgen-Indep [NCT00072930] | Phase 2 | 150 participants | Interventional | 2003-12-31 | Completed |
Efficacy of Maintenance Therapy With Rituximab After Induction Chemotherapy (R-CHOP vs. R-FC) for Elderly Patients With Mantle Cell Lymphoma Not Suitable for Autologous Stem Cell Transplantation [NCT00209209] | Phase 3 | 570 participants (Anticipated) | Interventional | 2004-01-14 | Active, not recruiting |
A Phase 1 Trial of the Combination of Perifosine and Docetaxel With or Without Prednisone [NCT00399087] | Phase 1 | 39 participants (Actual) | Interventional | 2004-11-30 | Completed |
Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease [NCT00041210] | Phase 3 | 850 participants (Anticipated) | Interventional | 2001-10-31 | Active, not recruiting |
Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma [NCT00041327] | Phase 2 | 19 participants (Actual) | Interventional | 2002-10-31 | Completed |
A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas [NCT00045500] | Phase 1 | 0 participants | Interventional | 2002-06-30 | Completed |
Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) With Advanced Stage Diffuse Large B-Cel [NCT00080847] | Phase 2 | 160 participants (Actual) | Interventional | 2004-03-31 | Terminated |
T-Cell Depleted, Reduced-Intensity Allogeneic Stem Cell Transplantation From Haploidentical Related Donors For Hematologic Malignancies [NCT00080925] | Phase 1 | 20 participants (Anticipated) | Interventional | 2004-02-29 | Completed |
Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis [NCT04882683] | | 50 participants (Anticipated) | Interventional | 2021-06-01 | Recruiting |
A Phase I/II, Multi-Center, Open Label Study of Melphalan, Prednisone, Thalidomide and Defibrotide in Advanced and Refractory Multiple Myeloma Patients [NCT00406978] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2006-02-28 | Completed |
LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma [NCT00161239] | | 64 participants (Anticipated) | Interventional | 2005-02-28 | Terminated(stopped due to toxicity) |
Randomised Trial Comparing Chemotherapy Mit CHOEP (Cyclophosphamid, Doxorubicin, Vincristin, Etoposid Und Prednison) In 21-Day Intervals In Standard And Escalated Doses In Patients Aged 18-60 Years Of Age With Aggresive Non-Hodgkin-Lymphomas Favourable Pr [NCT00053768] | Phase 3 | 392 participants (Actual) | Interventional | 2002-04-30 | Completed |
Treatment of Acute Lymphoblastic Leukemia in Children [NCT00165178] | Phase 3 | 498 participants (Actual) | Interventional | 2000-09-30 | Completed |
Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL). [NCT00169156] | Phase 2 | 27 participants (Actual) | Interventional | 2005-12-31 | Completed |
Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma [NCT00055640] | Phase 2 | 9 participants (Actual) | Interventional | 2002-10-31 | Completed |
Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia [NCT00187057] | | 6 participants (Actual) | Interventional | 2002-09-30 | Completed |
A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study) [NCT00040937] | Phase 2 | 147 participants (Actual) | Interventional | 2002-06-30 | Completed |
A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL). [NCT00195871] | Phase 2 | 155 participants (Actual) | Interventional | 2004-02-29 | Active, not recruiting |
A Phase I, Open-Label, Dose-Finding Study of Afuresertib Administered in Combination With Either Enzalutamide (Xtandi) or Abiraterone (Zytiga) in Male Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) [NCT02380313] | Phase 1 | 0 participants (Actual) | Interventional | 2015-10-31 | Withdrawn(stopped due to Study cancelled: Withdrawn before enrollment of any participants) |
Phase II Trial of Abiraterone Acetate Combined With Dutasteride With Correlative Assessment of Tumor Androgen Levels and Androgen Receptor Sequence and Signaling at Baseline and at Progression [NCT01393730] | Phase 2 | 40 participants (Actual) | Interventional | 2011-09-30 | Completed |
A Pilot Phase II Study to Determine the Safety of the Combination of ONTAK (DAB389IL-2), an Interleukin-2 Fusion Toxin, in Combination With CHOP in Peripheral T-Cell Lymphoma [NCT00337987] | Phase 2 | 49 participants (Actual) | Interventional | 2005-11-30 | Completed |
Combination Therapy of Sirolimus and Glucocorticoids for the Maintenance of Remission in Patients With IgG4-related Disease [NCT05746689] | | 20 participants (Anticipated) | Interventional | 2023-03-01 | Not yet recruiting |
TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study [NCT04182984] | | 200 participants (Anticipated) | Observational [Patient Registry] | 2019-11-04 | Recruiting |
A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol [NCT00374231] | Phase 4 | 40 participants (Actual) | Interventional | 2002-10-31 | Completed |
An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667) [NCT03407144] | Phase 2 | 340 participants (Anticipated) | Interventional | 2018-04-09 | Active, not recruiting |
Phase I/II Study of Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-Associated Large Cell Lymphoma [NCT02911142] | Phase 1/Phase 2 | 12 participants (Actual) | Interventional | 2017-07-03 | Active, not recruiting |
Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy [NCT01381874] | Phase 2 | 297 participants (Actual) | Interventional | 2011-08-24 | Completed |
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia: A Prospective, Single-arm, Single-center Clinical Trial [NCT05594784] | Phase 2 | 60 participants (Anticipated) | Interventional | 2022-10-08 | Recruiting |
Phase 1b/2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma [NCT03223610] | Phase 1/Phase 2 | 145 participants (Anticipated) | Interventional | 2018-02-09 | Recruiting |
Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion [NCT02344017] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2015-02-28 | Completed |
A Randomised, Double-blind, Placebo-controlled Trial Assessing the Efficacy of SLITone in House Dust Mite Allergic Patients [NCT00633919] | Phase 2/Phase 3 | 124 participants (Actual) | Interventional | 2006-07-31 | Completed |
A Phase II Study of Combination Nilotinib and Hyper-CVAD in Patients Newly Diagnosed With Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia or Chronic Myeloid Leukemia Blast-Phase Lymphoid Lineage [NCT01670084] | Phase 2 | 0 participants (Actual) | Interventional | 2012-12-31 | Withdrawn(stopped due to No Accrual) |
A Phase 2 Study of Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients With CD30-Positive Peripheral T-Cell Lymphomas [NCT03113500] | Phase 2 | 48 participants (Actual) | Interventional | 2017-05-25 | Active, not recruiting |
Phase I/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination With R-CHOP in a Cohort of Patients With DLBCL/tFL/ High Grade B-NHL [NCT03704714] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2018-11-20 | Suspended(stopped due to Protocol being amended for stats/accrual changes as per PI) |
Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans [NCT03269747] | Phase 4 | 16 participants (Actual) | Interventional | 2017-12-06 | Completed |
Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis [NCT03793439] | Phase 1 | 5 participants (Actual) | Interventional | 2019-05-15 | Completed |
An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects [NCT03721965] | Phase 1/Phase 2 | 2 participants (Actual) | Interventional | 2019-12-31 | Terminated(stopped due to The study was terminated due to insufficient efficacy in a separate phase III study) |
[NCT00699803] | Phase 2 | 64 participants (Actual) | Interventional | 2008-05-31 | Completed |
Multicenter, Open-Label, Randomized Study on Steroid-Free Immunosuppression, in Comparison With Daily Steroid Therapy, in Pediatric Renal Transplant : Impact on Growth, Bone Metabolism and Acute Rejection [NCT00707759] | Phase 3 | 28 participants (Actual) | Interventional | 2008-06-30 | Completed |
A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients [NCT00828061] | Phase 1 | 19 participants (Actual) | Interventional | 2009-02-04 | Completed |
Reduction in Symptomatic Esophageal Stricture Formation Post-two Stage Complete Barrett's Excision for High Grade Dysplasia or Early Adenocarcinoma With Short-term Steroid Therapy: A Randomized, Double-blinded, Placebo-controlled, Multicenter Trial. [NCT02039115] | Phase 4 | 3 participants (Actual) | Interventional | 2014-03-31 | Terminated(stopped due to Closed for low enrollment and the inability to complete the study.) |
A Phase I Study of PCUR-101 in Combination With Androgen Directed Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer [NCT04677855] | Phase 1 | 48 participants (Anticipated) | Interventional | 2021-03-30 | Recruiting |
Phase 1 Dose Finding Study of Belinostat Plus Cyclophosphamide/Vincristine/Doxorubicin/Prednisone (CHOP) Regimen (BelCHOP) for Treatment of Patients With Peripheral T-cell Lymphoma(PTCL) [NCT01839097] | Phase 1 | 23 participants (Actual) | Interventional | 2013-05-31 | Completed |
The Role of Perioperative Systemic Steroids in Patients With Chronic Rhinosinusitis Without Polyps (CRSsNP) [NCT02748070] | | 81 participants (Actual) | Interventional | 2015-08-31 | Completed |
Randomized, Open Label, Multicenter Study of Belatacept-based Early Steroid Withdrawal Regimen With Alemtuzumab or rATG Induction Compared to Tacrolimus-based Early Steroid Withdrawal Regimen With rATG Induction in Renal Transplantation [NCT01729494] | Phase 4 | 316 participants (Actual) | Interventional | 2012-09-30 | Completed |
Efficacy and Safety of Single-dose Rituximab Biosimilar in the Initial Episode of Paediatric Steroid-sensitive Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial [NCT05850546] | Phase 3 | 138 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma [NCT01818752] | Phase 3 | 955 participants (Actual) | Interventional | 2013-07-08 | Completed |
A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) [NCT01086540] | Phase 2 | 57 participants (Actual) | Interventional | 2011-06-24 | Completed |
Steroid Withdrawal and Novo Donor-specific Anti-HLA Antibodies in Renal Transplant Patients: a Prospective, Randomized and Controlled Study in Parallel Groups [NCT02284464] | Phase 4 | 230 participants (Actual) | Interventional | 2015-02-28 | Completed |
An Open-label, Prospective, Randomized, Pilot Clinical Study to Study the Efficacy of MEDIHONEY® Rinses Compared to Intranasal Corticosteroid Rinses in Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery [NCT02562924] | | 40 participants (Actual) | Interventional | 2015-11-30 | Completed |
One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study [NCT03560466] | Phase 3 | 365 participants (Actual) | Interventional | 2018-06-21 | Active, not recruiting |
Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate Versus Mitoxantrone/Prednisone Alone in Patients With Hormone Refractory Metastatic Prostate Cancer and Pain [NCT00003232] | Phase 3 | 227 participants (Actual) | Interventional | 1997-11-24 | Completed |
A Phase III Study of Efficacy, Safety and Tolerability of Chronocort® Compared With Standard Glucocorticoid Replacement Therapy in the Treatment of Congenital Adrenal Hyperplasia [NCT02716818] | Phase 3 | 122 participants (Actual) | Interventional | 2016-02-22 | Completed |
a 3 Arm Randomized Study on Health-related Quality of Life of Elderly Patients With Advanced Soft Tissue Sarcoma Undergoing Doxorubicin Alone Every Three Weeks or Doxorubicin Weekly or Cyclophosphamide Plus Predniso(lo)ne Treatment [NCT04780464] | Phase 3 | 185 participants (Anticipated) | Interventional | 2022-04-11 | Recruiting |
Phase Ib/II Study of the Combination of Low-Intensity Chemotherapy and Tagraxofusp in Patients With Acute Lymphoblastic Leukemia (ALL) [NCT05032183] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2022-02-17 | Recruiting |
A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial [NCT00255606] | Phase 3 | 360 participants (Anticipated) | Interventional | 2005-08-31 | Completed |
Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children: an Open-label Randomized Trial Comparing Anakinra vs sTEroids [NCT05805930] | Phase 3 | 48 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients [NCT00228020] | Phase 3 | 212 participants (Actual) | Interventional | 2001-05-31 | Completed |
[NCT00268515] | Phase 2 | 0 participants | Interventional | 1998-04-30 | Completed |
Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Cyclophosphamide, Vincristine and Prednisone in the Treatment of Untreated PTCL [NCT04548700] | Phase 1 | 63 participants (Anticipated) | Interventional | 2020-12-24 | Recruiting |
A Randomised Phase II Study of Two Dose Schedules of PI-88 in Combination With Docetaxel in Patients With Androgen-independent Prostate Cancer [NCT00268593] | Phase 2 | 48 participants (Actual) | Interventional | 2005-08-31 | Completed |
Comparative Study of 3 or 6 Months Initial Steroid Treatment in Children Under 6 Years of Age With Steroid Sensitive Nephrotic Syndrome:a Randomized, Double-blind, Placebo-controlled Study [NCT04536181] | Phase 3 | 0 participants (Actual) | Interventional | 2021-01-01 | Withdrawn(stopped due to lack of funding) |
A Phase IV, Multicenter, National, Non-comparative, Open-label Study of Cabazitaxel, Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Second-line Treatment of Patients With Metastatic Castration-resistant Prostate Cancer and Af [NCT01649635] | Phase 4 | 45 participants (Actual) | Interventional | 2012-07-31 | Completed |
Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL. [NCT00244127] | Phase 2 | 75 participants | Interventional | 2002-10-31 | Active, not recruiting |
[NCT00284271] | Phase 2 | 65 participants (Actual) | Interventional | 2004-01-31 | Completed |
Optimising Therapy for Boys With Hodgkin's Lymphoma and Quality Assurance of Therapy for Girls With Hodgkin's Lymphoma Until Start of a New Prospective Trial for Hodgkin's Lymphoma in Childhood and Adolescence [NCT00416832] | Phase 2 | 648 participants (Anticipated) | Interventional | 2002-11-30 | Completed |
Focal Cerebral Arteriopathy Steroid Trial [NCT06040255] | Phase 4 | 80 participants (Anticipated) | Interventional | 2023-10-01 | Not yet recruiting |
Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients ≥ Age 60 With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study [NCT00107380] | Phase 2 | 86 participants (Actual) | Interventional | 2005-11-30 | Completed |
2-Weekly CHOP Chemotherapy With Dose-Dense Rituximab for the Treatment of Patients Aged 61 to 80 Years With Aggressive CD-20 Positive B-Cell Lymphomas: A Phase-II/Pharmacokinetic Study (CHOP-R-ESC) [NCT00290667] | Phase 2 | 586 participants (Actual) | Interventional | 2004-02-29 | Completed |
A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma. [NCT00211185] | Phase 2 | 49 participants (Actual) | Interventional | 2004-03-14 | Completed |
Prednisone Treatment for Vestibular Neuronitis [NCT00271791] | Phase 2 | 17 participants (Actual) | Interventional | 2005-09-30 | Completed |
[NCT00264953] | Phase 3 | 1,395 participants (Actual) | Interventional | 1998-05-31 | Completed |
[NCT00265031] | Phase 3 | 0 participants | Interventional | 1999-01-31 | Completed |
A Single-arm, Prospective Clinical Study on the Antitumor Activity and Safety of Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors [NCT05887726] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-08-01 | Not yet recruiting |
Randomized Study Comparing an Immuno-Chemotherapy With 6 Cycles of the Monoclonal Anti-CD20 Antibody Rituximab in Combination With 6 Cycles of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) at 21-day Intervals or 14-d [NCT00278408] | Phase 3 | 700 participants (Actual) | Interventional | 2005-11-30 | Completed |
A Phase II Trial of Docetaxel/Prednisone in Combination With Sargramostim as Treatment for Hormone-refractory Prostate Cancer [NCT00313482] | Phase 2 | 35 participants (Actual) | Interventional | 2006-04-30 | Terminated(stopped due to Low accrual) |
Phase II Study of Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation [NCT04679012] | Phase 2 | 20 participants (Anticipated) | Interventional | 2021-09-24 | Recruiting |
Phase III, Double-Blind, Randomized, Placebo-Controlled Trial of FavID® (Id/KLH) and GM-CSF Following CHOP/Rituximab as First-Line Therapy in Subjects With High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma [NCT00324831] | Phase 3 | 480 participants (Anticipated) | Interventional | | Suspended |
Five-Year Single-Blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis: Oral Cyclophosphamide Versus High Dose Intravenous Cyclophosphamide Versus Intermediate Dose Intrav [NCT00336414] | Phase 3 | 0 participants (Actual) | Interventional | 2006-06-30 | Withdrawn(stopped due to the study is withdrawn due to low and unexpected enrollment rate) |
CHOP Plus Rituximab (CHOP-R) in Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL) or CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT) [NCT00309881] | Phase 2 | 75 participants (Anticipated) | Interventional | 2003-04-30 | Completed |
Phase Ib - II Study of Entospletinib (ENTO) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) Patients With aaIPI>=1 Treated by Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (R-CHOP) [NCT03225924] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2017-07-26 | Terminated(stopped due to Stop of drug development) |
A Phase III, International, Multicenter, Randomised Open Label Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Patients With Childhood Onset Idiopathic Nephrotic Syndrome [NCT05627557] | Phase 3 | 80 participants (Anticipated) | Interventional | 2023-03-29 | Recruiting |
A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours [NCT05489211] | Phase 2 | 670 participants (Anticipated) | Interventional | 2022-09-06 | Recruiting |
Phase 1 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System [NCT05211336] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-04-19 | Recruiting |
Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis [NCT03804931] | Phase 2/Phase 3 | 120 participants (Anticipated) | Interventional | 2019-01-20 | Recruiting |
Phase IA Study of AAVrh.10hFXN Gene Therapy for the Cardiomyopathy of Friedreich's Ataxia [NCT05302271] | Phase 1 | 10 participants (Anticipated) | Interventional | 2022-02-22 | Recruiting |
Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma [NCT01622439] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2012-06-30 | Completed |
Standard Chemotherapy (CHOP Regimen) Versus Sequential High-Dose Chemotherapy With Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas and Poor Prognostic Factors: A Randomized Phase III Study (MISTRAL) [NCT00003215] | Phase 3 | 400 participants (Anticipated) | Interventional | 1997-04-30 | Completed |
Immunosuppression in Renal Transplantation in The Elderly: Time to Rethink. - nEverOld Study [NCT01631058] | Phase 4 | 90 participants (Anticipated) | Interventional | 2012-07-31 | Recruiting |
CELLO-1: A Phase 1b/2 Open-Label Study Evaluating Tazemetostat in Combination With Enzalutamide or Abiraterone/Prednisone in Chemotherapy Naive Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT04179864] | Phase 1/Phase 2 | 104 participants (Anticipated) | Interventional | 2019-11-18 | Active, not recruiting |
Postoperative Steroids and Recovery After Spine Fusion [NCT04568837] | Phase 4 | 420 participants (Anticipated) | Interventional | 2021-03-01 | Not yet recruiting |
Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognos [NCT01659099] | Phase 3 | 671 participants (Actual) | Interventional | 2012-09-30 | Terminated(stopped due to experimental treatment not Superior to standard - no need to continue the follow-up) |
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome [NCT04623541] | Phase 1/Phase 2 | 184 participants (Anticipated) | Interventional | 2020-11-25 | Recruiting |
Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer [NCT01692483] | | 0 participants (Actual) | Observational | 2013-07-31 | Withdrawn(stopped due to Sponsor determined study is not required according to PFDA Circular 2013-004) |
Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease. [NCT02237820] | Phase 4 | 80 participants (Anticipated) | Interventional | 2014-11-30 | Recruiting |
Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment [NCT03760835] | Phase 4 | 150 participants (Anticipated) | Interventional | 2016-08-11 | Recruiting |
A Phase 1, Open-label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects [NCT01711827] | Phase 1 | 21 participants (Actual) | Interventional | 2012-02-29 | Completed |
A Phase 1, Three-Part, Open-Label, Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination With Abiraterone Acetate Plus a Corticosteroid, Apalutamide, or Docetaxel With or Without Prednisone in Men With Metastatic Castration-Sensitive P [NCT04666129] | Phase 1 | 72 participants (Anticipated) | Interventional | 2021-02-18 | Recruiting |
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lup [NCT01714817] | Phase 3 | 695 participants (Actual) | Interventional | 2013-01-22 | Terminated(stopped due to Inability to meet protocol objectives.) |
Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study [NCT01742338] | Phase 4 | 125 participants (Anticipated) | Interventional | 2012-05-03 | Suspended(stopped due to The study has been suspended to address research staffing and the feasibility of continued recruitment) |
An Intention-to-Treat Study of Salvage Chemotherapy Followed by Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of High-Risk or Relapsed Hodgkin Lymphoma [NCT00574496] | Phase 2 | 25 participants (Actual) | Interventional | 2007-11-13 | Completed |
Study of R-ACVBP and DA-EPOCH-R in Patients With Newly Diagnosed Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma [NCT03018626] | Phase 3 | 402 participants (Anticipated) | Interventional | 2017-07-27 | Recruiting |
A Phase 2 Study of Loncastuximab Tesirine and Rituximab (Lonca-R) Followed by DA-EPOCH-R in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma [NCT05600686] | Phase 2 | 24 participants (Anticipated) | Interventional | 2023-05-24 | Recruiting |
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Di [NCT03274492] | Phase 3 | 1,000 participants (Actual) | Interventional | 2017-11-16 | Active, not recruiting |
Efficacy and Toxicity of Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer With Progression After Treatment With Docetaxel [NCT01750866] | Phase 2 | 0 participants (Actual) | Interventional | 2013-02-28 | Withdrawn(stopped due to No accrual) |
Phase II Trial to Evaluate Benefit of Early Switch From First-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the Opposite Sequence, Exploring Molecular Markers and Mechanisms of Taxane Resistance in Men With Metastatic Castration-Resistant Prosta [NCT01718353] | Phase 2 | 63 participants (Actual) | Interventional | 2013-03-31 | Completed |
A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy [NCT01758120] | Phase 4 | 135 participants (Actual) | Interventional | 2012-12-31 | Active, not recruiting |
A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease [NCT01758393] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2012-12-31 | Recruiting |
Use of Dose Adjusted EPOCH-R in the Treatment of Childhood Mature B Cell Malignancies [NCT01760226] | Early Phase 1 | 4 participants (Actual) | Interventional | 2013-01-31 | Completed |
A Phase III, Randomized, Open, Parallel-controlled, Multi-center Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis [NCT02457221] | Phase 3 | 314 participants (Actual) | Interventional | 2015-03-10 | Completed |
Prednisone Plus Chloroquine Versus Chloroquine for the Treatment of Hyper-reactive Malarial Splenomegaly in Papua New Guinea: a Randomized Open-label Trial [NCT01785979] | Phase 3 | 0 participants (Actual) | Interventional | 2016-01-31 | Withdrawn(stopped due to Lack of funding) |
The Effect of Prednisone Versus Doxycycline in Active, Moderately Severe Graves' Orbitopathy: A Randomized, Multi-center, Double-blind, Parallel-controlled Trial [NCT01809444] | Phase 2/Phase 3 | 146 participants (Anticipated) | Interventional | 2012-11-30 | Recruiting |
Outcome of Muscle Function and Disease Activity in Patients With Recent Onset Polymyositis and Dermatomyositis - a 1-year Follow-up Register Study [NCT01813617] | | 72 participants (Actual) | Observational [Patient Registry] | 2010-09-30 | Completed |
Pre-operative Assessment of the Anti-Proliferative Effects and Genomic Alterations of 2 Weeks of Abiraterone Acetate Compared to 2 Weeks of an Aromatase Inhibitor in Post-menopausal Hormone Receptor Positive Operable Breast Cancer [NCT01814865] | Phase 2 | 0 participants (Actual) | Interventional | 2013-05-31 | Withdrawn(stopped due to Funding was not acquired) |
A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of DA-EPOCH Regimen for Non-Hodgkin's Lymphoma With Hemophagocytic Lymphohistiocytosis [NCT01818908] | Phase 2 | 50 participants (Anticipated) | Interventional | 2012-06-30 | Active, not recruiting |
A Randomised, Multi-centre, Double-blind, Active-controlled, Parallel Group Study to Assess the Efficacy and Safety of Modified Release Prednisone (Lodotra®) Compared to Immediate Release Prednisone (Prednisone IR) in Subjects Suffering From Polymyalgia R [NCT01821040] | Phase 3 | 62 participants (Actual) | Interventional | 2013-03-31 | Terminated |
Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis [NCT01837433] | Phase 4 | 40 participants (Actual) | Interventional | 2013-03-31 | Completed |
An Exploratory Evaluation of Early Use of Everolimus (EVE) on Tacrolimus (TAC)-Based Immunosuppressive Regiment vs. Mycophenolate Sodium (MPS) on Cytomegalovirus (CMV) Infection in Renal Transplant Recipients. [NCT01927588] | Phase 4 | 50 participants (Anticipated) | Interventional | 2013-08-31 | Not yet recruiting |
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy [NCT01451710] | | 30 participants (Actual) | Interventional | 2011-03-31 | Completed |
Phase 2 Trial Pembrolizumab or Pembrolizumab in Combination With Intratumoral SD-101 Therapy in Patients With Hormone-Naïve Oligometastatic Prostate Cancer Receiving Stereotactic Body Radiation Therapy and Intermittent Androgen Deprivation Therapy [NCT03007732] | Phase 2 | 23 participants (Actual) | Interventional | 2017-05-17 | Active, not recruiting |
Use of Oral Steroids Before Circumferential Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation to Improve Outcomes [NCT01206452] | Phase 4 | 60 participants (Actual) | Interventional | 2010-09-30 | Completed |
A Randomized Clinical Trial Comparing 7 Days Treatment With Corticosteroids Versus Placebo for Early COVID-19 [NCT04795583] | Phase 3 | 0 participants (Actual) | Interventional | 2021-08-01 | Withdrawn(stopped due to Funding Issues) |
A Phase 1b, Open-Label, Dose-Escalation, Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors [NCT05084859] | Phase 1 | 30 participants (Actual) | Interventional | 2021-11-03 | Active, not recruiting |
A Phase I/II Trial of VR-CHOP for Patients With Untreated Follicular Lymphoma and Other Low Grade B-Cell Lymphomas [NCT00634179] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2008-02-29 | Completed |
A Randomized Phase II Trial of EPOCH Given Either Concurrently or Sequentially With Rituximab in Patients With Intermediate- or High-Grade HIV-Associated B-cell Non-Hodgkin's Lymphoma [NCT00049036] | Phase 2 | 106 participants (Actual) | Interventional | 2003-03-31 | Completed |
Phase I/II Trial to Establish the Safety and Preliminary Efficacy of the Combination of Docetaxel, Prednisone, and SOM 230 (Pasireotide) in Metastatic Castrate Resistant Prostate Cancer (CRPC). [NCT01468532] | Phase 1/Phase 2 | 18 participants (Actual) | Interventional | 2011-10-31 | Completed |
A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (O-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated [NCT06091865] | Phase 3 | 904 participants (Anticipated) | Interventional | 2023-12-11 | Recruiting |
An Open Label Study of the Effects of a Combination of NeoRecormon, CellCept and Prednisone on Hematological Parameters and Cytogenesis in Patients With Low or Intermediate Risk Myelodysplastic Syndromes.¿ [NCT00551291] | Phase 2 | 10 participants (Actual) | Interventional | 2007-08-31 | Completed |
A Prospective Clinical Study of the Safety and Efficacy of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of High-risk or Very High-risk Localized Prostate Cancer [NCT05376722] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-02-22 | Recruiting |
Open Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell Arteritis [NCT02955147] | Phase 1/Phase 2 | 13 participants (Actual) | Interventional | 2016-12-01 | Terminated(stopped due to Inefficacy) |
A Multicentre, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group Study to Determine the Efficacy and Safety of Nebulized Fluticasone Propionate 1mg Twice Daily Compared With Oral Prednisone Administered for 7 Days to Chinese Pediat [NCT01687296] | Phase 3 | 261 participants (Actual) | Interventional | 2012-11-12 | Completed |
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Sublingual Immunotherapy With SCH 697243 (Phleum Pratense) in Children 5 to <18 Years of Age With a History of Grass Pollen Induced Rhinoconjunctivi [NCT00550550] | Phase 3 | 345 participants (Actual) | Interventional | 2007-11-30 | Completed |
A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study [NCT01517802] | Phase 3 | 32 participants (Actual) | Interventional | 2012-03-28 | Completed |
Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013) [NCT01888952] | Early Phase 1 | 10 participants (Actual) | Interventional | 2013-07-31 | Completed |
Effect of Short-Term Prednisone Therapy on C-reactive Protein Change in Emergency Department Patients With Acute Heart Failure and Elevated Inflammatory Markers [NCT05916586] | | 120 participants (Anticipated) | Interventional | 2023-08-11 | Recruiting |
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Sa [NCT05039619] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-05-12 | Recruiting |
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN) [NCT00000819] | Phase 2 | 54 participants | Interventional | | Completed |
A Phase II, Randomized, Placebo-Controlled Study of the Immunologic and Virologic Effects of Prednisone on HIV-1 Infection [NCT00000921] | Phase 2 | 118 participants | Interventional | 1996-08-31 | Completed |
Corticosteroid Treatment for Community-Acquired Pneumonia to Improve Long-term Cognition: A Pilot Randomized Controlled Trial [NCT04652414] | Phase 2 | 0 participants (Actual) | Interventional | 2020-12-01 | Withdrawn(stopped due to Limited enrollment due to the COVID-19 pandemic. Sponsor withdrew funding.) |
Phase II Study of Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP) as Primary Therapy in Infants or Young Children With Primitive Neuroectodermal Tumors or High-Grade Astrocytoma [NCT00002463] | Phase 2 | 4 participants (Actual) | Interventional | 1989-02-28 | Completed |
TREATMENT OF ALL IN FIRST BONE MARROW RELAPSE AFTER BFM PROTOCOLS [NCT00002499] | Phase 2/Phase 3 | 0 participants | Interventional | 1990-01-31 | Active, not recruiting |
"RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY (ATT) VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5" [NCT00002565] | Phase 3 | 61 participants (Actual) | Interventional | 1994-05-25 | Completed |
Study of Promace-Cytabom With Trimethoprim Sulfamethoxazole, Zidovudine (AZT), and Granulocyte Colony Stimulating Factor (G-CSF) in Patients With AIDS-Related Lymphoma, Phase II [NCT00002571] | Phase 2 | 52 participants (Actual) | Interventional | 1994-06-30 | Completed |
A Phase II Pilot Study of Short Term (12 Week) Combination Chemotherapy (Stanford V) in Unfavorable Hodgkin's Disease [NCT00002715] | Phase 2 | 50 participants (Anticipated) | Interventional | 1989-04-30 | Completed |
FAB LMB 96 -- Treatment of Mature B-CELL Lymphoma/Leukemia: A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study [NCT00002757] | Phase 3 | 1,148 participants (Actual) | Interventional | 2001-06-30 | Completed |
Do We Need to Taper Down Steroid Therapy for Bell's Palsy: A Prospective Randomized Controlled Trial [NCT04406376] | Phase 4 | 124 participants (Anticipated) | Interventional | 2020-05-12 | Recruiting |
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma [NCT03758989] | Phase 2 | 40 participants (Anticipated) | Interventional | 2019-05-08 | Recruiting |
Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP (L-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT04922567] | Phase 2 | 289 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
Once Daily Dosing to Improve Medication Adherence and Patient Satisfaction in Kidney Transplant Recipients: A Pilot Study [NCT02426502] | | 76 participants (Actual) | Interventional | 2016-04-30 | Active, not recruiting |
A Randomized Phase III Trial of ABVD Versus Stanford V (+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease [NCT00003389] | Phase 3 | 854 participants (Actual) | Interventional | 1999-06-17 | Completed |
Early Adalimumab Induction for Treatment of Steroid Dependent Immune Checkpoint Inhibitor Associated Inflammatory Arthritis: A Pragmatic Randomized Clinical Trial [NCT06037811] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-11-30 | Not yet recruiting |
Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination) [NCT05401214] | | 0 participants | Expanded Access | | Approved for marketing |
High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases [NCT00716066] | Phase 2 | 80 participants (Anticipated) | Interventional | 2008-06-30 | Recruiting |
A Randomized Phase III Study - Conventional Androgen Deprivation Therapy With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and Androgen Deprivation Therapy [NCT03777982] | Phase 3 | 400 participants (Anticipated) | Interventional | 2020-04-20 | Active, not recruiting |
A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma [NCT01468740] | Phase 2 | 130 participants (Anticipated) | Interventional | 2004-03-31 | Recruiting |
Phase I/II Trial of Dose-Adjusted EPOCH Chemotherapy With Bortezomib Combined With Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia Lymphoma [NCT01000285] | Phase 1/Phase 2 | 18 participants (Actual) | Interventional | 2010-09-30 | Completed |
A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus Plus Prednisone and Sirolimus/Calcineurin Inhibitor Plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease (BMT CTN Protocol #0801) [NCT01106833] | Phase 2/Phase 3 | 151 participants (Actual) | Interventional | 2010-04-30 | Completed |
A Prospective Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma [NCT05506410] | | 100 participants (Anticipated) | Observational [Patient Registry] | 2022-08-12 | Recruiting |
Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases: Clinical Testing and Feasibility of a Serum-based Metabolomics Profile [NCT02758132] | Phase 2 | 1 participants (Actual) | Interventional | 2016-03-01 | Terminated(stopped due to Low accruals) |
A Randomized, Controlled, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer [NCT04992026] | Phase 2 | 128 participants (Anticipated) | Interventional | 2021-01-01 | Active, not recruiting |
A Phase I/II Study of Bevacizumab and Erlotinib in Combination With Docetaxel and Prednisone for Patients With Hormone Refractory Prostate Cancer [NCT00996502] | Phase 1/Phase 2 | 4 participants (Actual) | Interventional | 2006-07-31 | Terminated(stopped due to Poor enrollment; PI left the institution) |
Multicenter Trial of Prednisone in Alzheimer's Disease [NCT00000178] | Phase 3 | 0 participants | Interventional | | Completed |
Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis [NCT02169219] | Phase 4 | 20 participants (Actual) | Interventional | 2014-06-30 | Completed |
HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR DIFFUSE SMALL NONCLEAVED CELL LYMPHOMA AND THE L-3 SUBTYPE OF ALL: A PILOT STUDY OF A MULTIDRUG REGIMEN [NCT00002494] | Phase 2 | 134 participants (Actual) | Interventional | 1992-05-31 | Completed |
Pilot Study in AIDS-Related Lymphomas [NCT00002524] | Phase 2 | 46 participants (Actual) | Interventional | 1993-06-30 | Completed |
Standard Dose Versus Myeloablative Therapy for Previously Untreated Symptomatic Multiple Myeloma, A Phase III Intergroup Study [NCT00002548] | Phase 3 | 899 participants (Actual) | Interventional | 1994-01-31 | Completed |
A Pilot Study For The Treatment of Newly-Diagnosed Disseminated Anaplastic Large Cell Ki-1 Lymphoma and T-Large Cell Lymphoma [NCT00002590] | Phase 2 | 221 participants (Actual) | Interventional | 1994-07-31 | Completed |
Phase II to Treat Multiple Myeloma Patients With Cytoxan and Vincristine After Cycling Myeloma Cells With rHuGM-CSF [NCT00003490] | Phase 2 | 30 participants (Anticipated) | Interventional | 1998-10-31 | Completed |
Treatment of Patients With Acute Lymphoblastic Leukemia With Unfavorable Features: A Phase III Group-wide Study [NCT00002812] | Phase 3 | 2,078 participants (Actual) | Interventional | 1996-09-30 | Completed |
"Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: Stanford V Regimen For Low Risk Patients, EBVP Regimen For High Risk Patients" [NCT00003262] | Phase 2 | 30 participants (Anticipated) | Interventional | 1997-05-31 | Active, not recruiting |
Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction, and Cytarabine During Consolidation, Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradia [NCT00003700] | Phase 2 | 163 participants (Actual) | Interventional | 1999-01-31 | Completed |
A Phase II Pilot Trial of CHOP Followed by Iodine-131-Labeled Monoclonal Anti-B1 Antibody for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas [NCT00003784] | Phase 2 | 102 participants (Actual) | Interventional | 1999-05-31 | Completed |
Sudden Hearing Loss Multicenter Treatment Trial [NCT00097448] | Phase 3 | 255 participants (Actual) | Interventional | 2004-12-31 | Completed |
A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL [NCT04025593] | Phase 2 | 128 participants (Anticipated) | Interventional | 2019-07-17 | Recruiting |
Community Care for Croup (RCT) [NCT01042145] | Phase 4 | 87 participants (Actual) | Interventional | 2009-10-31 | Completed |
Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer [NCT03565835] | Phase 2 | 32 participants (Actual) | Interventional | 2018-06-13 | Active, not recruiting |
A Study to Evaluate the Efficacy of CellCept, Administered in a Sequential Treatment Scheme, in Delaying Progressive Renal Damage in Patients With Lupus Nephritis [NCT02081183] | Phase 3 | 16 participants (Actual) | Interventional | 2006-03-31 | Terminated |
Monoinstitutional Phase II Trial Addressing Tolerability and Activity of RCHOP Chemoimmunotherapy Preceded by BBB Permeabilization by t-NGR Necrosis Factor in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma [NCT03536039] | Phase 2 | 28 participants (Actual) | Interventional | 2016-01-27 | Completed |
A Two-Part, Randomized Clinical Trial to Study the Effects of a Single Dose of Prednisone on Biomarkers of Allergen Responses in Asthmatics [NCT01193049] | Phase 1 | 11 participants (Actual) | Interventional | 2010-08-31 | Completed |
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednis [NCT01974440] | Phase 3 | 405 participants (Actual) | Interventional | 2014-01-31 | Completed |
Bevacizumab and CHOP (A-CHOP) in Combination for Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms [NCT00217425] | Phase 2 | 46 participants (Actual) | Interventional | 2006-09-14 | Completed |
A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Docetaxel to Placebo in Combination With Docetaxel in First Line Metastatic Cast [NCT03761225] | Phase 3 | 714 participants (Actual) | Interventional | 2014-09-30 | Completed |
A Corticosteroid Taper for Acute Sciatica Treatment (The ACT FAST Study) [NCT00668434] | Phase 2 | 269 participants (Actual) | Interventional | 2008-11-30 | Completed |
Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial [NCT04553003] | Phase 4 | 80 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
Intracanalicular Dexamethasone Used in Conjunction With ILUX for the Treatment of Meibomian Gland Dysfunction (MGD) in Patients With Evaporative Dry Eye and Evidence of Clinically Significant Inflammation. [NCT04658927] | Phase 4 | 30 participants (Actual) | Interventional | 2021-01-04 | Completed |
A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No [NCT01471340] | Phase 4 | 11,744 participants (Actual) | Interventional | 2012-01-09 | Completed |
A Prospective Institutional Study for the Treatment of Children With Newly Diagnosed Langerhans Cell Histiocytosis Using a Cytarabine Contained Protocol [NCT04773366] | Phase 3 | 200 participants (Anticipated) | Interventional | 2018-07-01 | Recruiting |
A Phase II Trial of Docetaxel, Thalidomide, Prednisone and Bevacizumab in Patients With Androgen-Independent Prostate Cancer [NCT00089609] | Phase 2 | 73 participants (Actual) | Interventional | 2005-04-19 | Completed |
Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis [NCT01671423] | | 42 participants (Actual) | Interventional | 2012-08-31 | Completed |
PS-341 and PS-341 + Epoch Chemotherapy and Molecular Profiling in Relapsed or Refractory Diffuse Large B-Cell Lymphomas [NCT00054665] | Phase 2 | 50 participants (Actual) | Interventional | 2003-02-28 | Completed |
Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index II or III Diffuse Large B Cell Lymphoma [NCT00039195] | Phase 2 | 98 participants (Actual) | Interventional | 2006-11-30 | Completed |
A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohn's Disease [NCT00109473] | Phase 2 | 22 participants (Actual) | Interventional | 2005-04-30 | Completed |
A Phase II Trial of Abiraterone Acetate, Radiotherapy and Short-Term Androgen Deprivation in Men With Unfavorable Risk Localized Prostate Cancer [NCT01717053] | Phase 2 | 37 participants (Actual) | Interventional | 2014-01-17 | Completed |
The Pacific Clinical Trial: A Randomized Phase II Study Evaluating OGX-427 in Patients With Metastatic Castrate-Resistant Prostate Cancer (MCRPC)Who Have Prostate-Specific Antigen (PSA) Progression While Receiving Abiraterone: Hoosier Oncology Group GU12- [NCT01681433] | Phase 2 | 72 participants (Actual) | Interventional | 2012-12-31 | Terminated(stopped due to lack of accrual) |
A Prospective Phase II Study of Bendamustine in Patients Aged Over 60 Years With Classical Hodgkin Lymphoma Treated by Prednisone, Vinblastine and Doxorubicin [NCT02414568] | Phase 2 | 90 participants (Actual) | Interventional | 2015-07-17 | Completed |
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus [NCT00137969] | Phase 2/Phase 3 | 262 participants (Actual) | Interventional | 2005-05-10 | Completed |
The Effect of Low-dose Corticosteroids and Theophylline on the Risk of Acute Exacerbations of COPD: the TASCS Randomised Clinical Trial [NCT02261727] | Phase 4 | 1,670 participants (Actual) | Interventional | 2014-06-30 | Completed |
A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgki [NCT03677141] | Phase 1/Phase 2 | 117 participants (Actual) | Interventional | 2019-03-08 | Completed |
Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Azacitidine and Chidamide Combined With CHOP (AC-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma With T-follicular Helper Phenotype (PTCL-TFH) [NCT05678933] | Phase 3 | 200 participants (Anticipated) | Interventional | 2023-01-01 | Enrolling by invitation |
Lenalidomide Combined With Anti-CD20 Monoclonal Antibodies-CHOP in Untreated Diffuse Large B-Cell Lymphoma Patients With MYC and BCL2 Co-expression : An Open-lable,Multicenter,Phase II Study [NCT04842487] | Phase 2 | 80 participants (Anticipated) | Interventional | 2021-04-10 | Not yet recruiting |
A Phase 1b/2 Study of the Oral CDK4/6 Inhibitor LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in Metastatic Castration Resistant Prostate Cancer [NCT02494921] | Phase 1/Phase 2 | 43 participants (Actual) | Interventional | 2015-11-20 | Completed |
A Therapeutic Trial of Decitabine and Vorinostat in Combination With Chemotherapy (Vincristine, Prednisone, Doxorubicin and PEG-Asparaginase) for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) [NCT00882206] | Phase 2 | 15 participants (Actual) | Interventional | 2009-04-30 | Terminated(stopped due to Slow accrual) |
A Multi-Center, Randomized Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in the Initial Therapy of Thrombotic Thrombocytopenic Purpura (TTP) [NCT00713193] | Phase 3 | 26 participants (Actual) | Interventional | 2007-11-30 | Completed |
Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure [NCT01559727] | Phase 3 | 40 participants (Actual) | Interventional | 2012-03-31 | Completed |
A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma [NCT00365274] | Phase 2 | 6 participants (Actual) | Interventional | 2006-08-31 | Terminated |
Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia. [NCT01579110] | Phase 2 | 100 participants (Anticipated) | Interventional | 2012-04-30 | Active, not recruiting |
A Single-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation [NCT05167175] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-03-01 | Recruiting |
A Phase I Study of Cabazitaxel, Mitoxantrone, and Prednisone (CAMP) for Patients With Metastatic Castration-Resistant Prostate Cancer and no Prior Chemotherapy [NCT01594918] | Phase 1 | 25 participants (Actual) | Interventional | 2012-06-30 | Completed |
A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma [NCT01746173] | Phase 2 | 5 participants (Actual) | Interventional | 2013-07-31 | Terminated(stopped due to Slow accrual and futility) |
Belatacept Therapy for the Failing Renal Allograft [NCT01921218] | Phase 3 | 13 participants (Actual) | Interventional | 2013-08-31 | Completed |
Randomized, Phase II Trial of CHOP vs. Oral Chemotherapy With Concomitant Antiretroviral Therapy in Patients With HIV-Associated Lymphoma in Sub-Saharan Africa [NCT01775475] | Phase 2 | 7 participants (Actual) | Interventional | 2016-09-15 | Completed |
A Multi-center, Prospective Clinical Study of Zanubrutinib, Rituximab and Combination Chemotherapy in Patients With Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma [NCT05164770] | Phase 3 | 160 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China [NCT02405676] | Phase 2/Phase 3 | 200 participants (Anticipated) | Interventional | 2015-01-31 | Active, not recruiting |
Novel Form of Acquired Long QT Syndrome [NCT04169100] | Phase 4 | 25 participants (Anticipated) | Interventional | 2011-09-28 | Recruiting |
A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients [NCT00195429] | Phase 4 | 47 participants (Actual) | Interventional | 2005-08-31 | Completed |
Oral Steroids in the Treatment of Acute Sciatica A Randomized Controlled Study [NCT00317447] | Phase 3 | 160 participants | Interventional | 2002-02-28 | Completed |
A Multicenter Phase I/II Trial of Abiraterone Acetate + BEZ235 in Metastatic, Castration-Resistant Prostate Cancer [NCT01717898] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 2013-01-31 | Terminated(stopped due to Dose limiting toxicities on lowest dose level) |
Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results [NCT00324467] | Phase 2 | 150 participants (Actual) | Interventional | 2006-08-31 | Active, not recruiting |
Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia in Grand Ouest Interregion France [NCT04359511] | Phase 3 | 0 participants (Actual) | Interventional | 2020-07-03 | Withdrawn(stopped due to COMPETITOR TEST (RECOVERY)) |
[NCT00425724] | Phase 4 | 20 participants (Anticipated) | Interventional | 2000-01-31 | Completed |
Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer [NCT03016741] | Phase 4 | 100 participants (Anticipated) | Interventional | 2017-03-31 | Recruiting |
A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL [NCT02626455] | Phase 3 | 547 participants (Actual) | Interventional | 2016-01-06 | Terminated(stopped due to The study did not meet the primary endpoint. The addition of copanlisib to standard immunochemo therapy did not improve progression-free survival compared to the control arm. Base on the study results, company decided to terminate the study.) |
An Open Trial of the Efficacy of Glucocorticoids and Methotrexate (MTX) in the Treatment of Systemic Vasculitis [NCT00001256] | Phase 2 | 100 participants | Interventional | 1990-03-31 | Completed |
Comparative Study of Dexamethasone vs Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone vs no Additional Treatment as Maintenance Therapy in Non-Progressing [NCT00002678] | Phase 3 | 595 participants (Actual) | Interventional | 1995-06-02 | Completed |
A 2-week Single-blind, Randomized, 3-arm Proof of Concept Study of the Effects of AIN457 (Anti-IL17 Antibody), ACZ885 (Canakinumab, Anti-IL1b Antibody), or Corticosteroids in Patients With Polymyalgia Rheumatica, Followed by an Open Label Phase to Assess [NCT01364389] | Phase 2 | 16 participants (Actual) | Interventional | 2011-02-14 | Terminated(stopped due to Data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period.) |
A Pilot Phase I/II Study to Evaluate the Effects of Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients With Biochemical Relapse [NCT00879619] | Phase 1/Phase 2 | 4 participants (Actual) | Interventional | 2009-07-31 | Terminated(stopped due to Terminated due to slow accrual.) |
Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19) [NCT02495077] | Phase 2 | 290 participants (Actual) | Interventional | 2015-11-02 | Completed |
Marrow-Ablative Chemo-Radiotherapy and Autologous Stem Cell Transplantation Followed by Interferon-Alpha Maintenance Treatment Versus Interferon-Alpha Maintenance Treatment Alone After a Chemotherapy-Induced Remission in Patients With Stages III or IV Fol [NCT00003152] | Phase 3 | 469 participants (Anticipated) | Interventional | 1997-03-31 | Terminated(stopped due to low accrual) |
MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL [NCT00002599] | Phase 3 | 750 participants (Anticipated) | Interventional | 1994-09-30 | Active, not recruiting |
The Clinical Features and Pregnancy Outcomes of Patients With Rheumatoid Arthritis :a Prospective Cohort Study [NCT05651373] | | 100 participants (Anticipated) | Observational | 2021-07-30 | Recruiting |
VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE [NCT00002653] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 1993-09-30 | Active, not recruiting |
TREATMENT OF ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: PHASE II TRIALS OF AN INDUCTION REGIMEN INCLUDING PEG-L-ASPARAGINASE, WITH OR WITHOUT PIXY, IN PREVIOUSLY UNTREATED PATIENTS, FOLLOWED BY ALLOGENEIC BONE MARROW TRANSPLANTATION OR FURTHER CHEMOTHERAPY IN FI [NCT00002665] | Phase 2 | 50 participants (Anticipated) | Interventional | 1995-07-31 | Completed |
Pilot Study for the Treatment of Children With Newly Diagnosed Advanced Stage Hodgkin's Disease: Upfront Dose Intensive Chemotherapy [NCT00004010] | Phase 2 | 99 participants (Actual) | Interventional | 1999-10-31 | Completed |
Rituxan in the Management of Multiple Myeloma [NCT00003554] | Phase 2 | 0 participants | Interventional | 1998-11-30 | Completed |
A Randomized Trial to Evaluate Early High Dose Therapy and Autologous Bone Marrow Transplantation as Part of Planned Initial Therapy for Poor Risk Intermediate/High Grade NHL [NCT00003578] | Phase 3 | 500 participants (Anticipated) | Interventional | 1993-01-31 | Active, not recruiting |
A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent, Advanced and Metastatic Renal Cell Carcinoma [NCT00003584] | Phase 2 | 35 participants (Anticipated) | Interventional | 1998-07-31 | Completed |
A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting [NCT02287610] | | 75 participants (Actual) | Observational | 2014-11-30 | Completed |
Phase III Study of Combination Chemotherapy in Children With T Cell and Pre-B Cell Non-Hodgkin's Lymphoma [NCT00003650] | Phase 3 | 179 participants (Actual) | Interventional | 1997-02-28 | Completed |
Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Infants Less Than 1 Year of Age. [NCT00002785] | Phase 2 | 0 participants | Interventional | 1996-07-31 | Completed |
Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies [NCT00004232] | Phase 1 | 0 participants | Interventional | 1999-10-31 | Completed |
[NCT00004436] | | 30 participants | Interventional | 1993-07-31 | Completed |
[NCT00004448] | Phase 2 | 123 participants | Interventional | 1997-11-30 | Completed |
[NCT00004646] | Phase 3 | 20 participants | Interventional | 1995-04-30 | Completed |
Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China [NCT04569890] | | 100 participants (Anticipated) | Interventional | 2020-12-01 | Not yet recruiting |
High Dose Combined Modality Therapy With Peripheral Blood Progenitor Cell Transplantation as Primary Treatment for Patients With Mantle Cell Lymphoma [NCT00003541] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 1998-06-30 | Completed |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis [NCT02531633] | Phase 3 | 161 participants (Actual) | Interventional | 2015-10-16 | Terminated(stopped due to GSK decision to return rights to sirukumab to Janssen and discontinue sirukumab development in giant cell arteritis.) |
Randomized Trial of CHOP Chemotherapy With or Without Rituximab (Chimeric Anti-CD20 Antibody) for HIV-Associated Non-Hodgkin's Lymphoma [NCT00003595] | Phase 3 | 120 participants (Actual) | Interventional | 1999-01-31 | Completed |
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Matrix Metalloprotease Inhibitor AG3340 in Combination With Mitoxantrone and Prednisone With Provision for Subsequent Change in Therapy in Patients Having Hormone-Refractory Prostate C [NCT00003343] | Phase 3 | 525 participants (Anticipated) | Interventional | 1998-03-31 | Completed |
Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized Aggressive Histologies of Non-Hodgkin's Lymphoma [NCT00005089] | Phase 2 | 71 participants (Actual) | Interventional | 2000-04-30 | Completed |
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly [NCT01855750] | Phase 3 | 838 participants (Actual) | Interventional | 2013-09-03 | Completed |
A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)-Targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD) [NCT02485691] | Phase 4 | 255 participants (Actual) | Interventional | 2015-11-09 | Completed |
Bone Marrow Transplantation and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance (ITN054ST) [NCT02029638] | Phase 2 | 4 participants (Actual) | Interventional | 2014-01-07 | Terminated(stopped due to Slow accrual) |
Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma [NCT02419469] | Phase 2 | 1 participants (Actual) | Interventional | 2015-11-13 | Terminated(stopped due to Slow Accrual) |
Repeat Emergency Department Visits Among Patients With Asthma and COPD [NCT02499887] | | 6 participants (Actual) | Interventional | 2016-01-31 | Terminated(stopped due to Exclusion criteria prevented enrollment of adequate # of participants) |
Phase 3 Study Investigating the Efficacy and Safety of TAVT-45 (Abiraterone Acetate) Granules for Oral Suspension (Novel Abiraterone Acetate Formulation) Relative to a Reference Abiraterone Acetate Formulation in Patients With mCSPC & mCRPC [NCT04887506] | Phase 3 | 107 participants (Actual) | Interventional | 2021-04-14 | Completed |
Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia [NCT05522465] | Phase 4 | 608 participants (Anticipated) | Interventional | 2022-10-11 | Recruiting |
A Phase I/II Trial of Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma [NCT04083898] | Phase 1 | 15 participants (Actual) | Interventional | 2020-04-03 | Active, not recruiting |
De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study [NCT02909335] | Phase 3 | 0 participants (Actual) | Interventional | 2016-11-30 | Withdrawn |
Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI) [NCT02260934] | Phase 2 | 43 participants (Actual) | Interventional | 2015-07-09 | Completed |
A Phase I/II Study of Alisertib in Combination With Abiraterone and Prednisone for Patients With Castration-Resistant Prostate Cancer After Progression on Abiraterone [NCT01848067] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2013-08-14 | Completed |
A Phase I and Randomized Phase II Multicenter Study of Cabozantinib (XL184) Plus Docetaxel and Prednisone in Metastatic Castrate Resistant Prostate Cancer [NCT01683994] | Phase 1/Phase 2 | 49 participants (Actual) | Interventional | 2012-09-07 | Completed |
Effectiveness and Safety of Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis: A Real-world Study [NCT04768465] | | 160 participants (Anticipated) | Observational [Patient Registry] | 2021-01-01 | Recruiting |
Phase 2/3, Randomized, Open Study to Compare the Efficacy and Safety of Colchicine and Glucocorticoids Compared With the Standard of Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in [NCT04492358] | Phase 2/Phase 3 | 54 participants (Actual) | Interventional | 2020-10-22 | Terminated(stopped due to No candidates for the recruitment) |
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids [NCT03023891] | Phase 1 | 25 participants (Actual) | Interventional | 2017-02-15 | Completed |
A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares [NCT02392286] | Phase 4 | 15 participants (Actual) | Interventional | 2015-03-31 | Terminated(stopped due to insufficient enrollment) |
A Phase 2 Trial of the Efficacy and Safety of the Interleukin-17A Inhibitor Izokibep (ABY-035) in the Treatment of Non-infectious Intermediate, Posterior or Pan-uveitis (LINNAEA) [NCT04706741] | Phase 2 | 7 participants (Actual) | Interventional | 2022-01-06 | Completed |
A Multicenter, Open-Label Feasibility Study of Daratumumab With Dose-Adjusted EPOCH in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV [NCT04139304] | Early Phase 1 | 15 participants (Anticipated) | Interventional | 2021-05-24 | Recruiting |
A Phase ll Study Evaluating the Efficacy and Safety of Metformin in Combination With Standard Induction Therapy (RM-CHOP) for Previously Untreated Aggressive Diffuse Large B-cell Lymphoma [NCT02531308] | Phase 2 | 5 participants (Actual) | Interventional | 2015-07-31 | Terminated(stopped due to poor accrual) |
A Phase I/II Trial of Concurrent Chemohormonal Therapy Using Enzalutamide (MDV-3100) and Cabazitaxel in Patients With Metastatic Castration Resistant Prostate Cancer [NCT02522715] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2015-10-13 | Active, not recruiting |
Initiation of a Deceased Donor Uterine Transplantation Program at the University of Nebraska Medical Center [NCT02409147] | | 0 participants (Actual) | Interventional | 2016-01-31 | Withdrawn(stopped due to Lack of funding) |
Short-Course EPOCH - Rituximab in Untreated CD-20+ HIV-Associated Lymphomas [NCT00006436] | Phase 2 | 68 participants (Actual) | Interventional | 2001-01-29 | Active, not recruiting |
Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome Unresponsive to 8 Weeks of High Dose Prednisone [NCT03298698] | Phase 3 | 40 participants (Anticipated) | Interventional | 2018-08-22 | Recruiting |
An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation [NCT05922761] | Phase 2 | 45 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) When Placed Within the Lower Eye Lid Canaliculus or Both the Upper and Lower Canaliculi for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Foll [NCT04501367] | Phase 4 | 60 participants (Anticipated) | Interventional | 2021-04-27 | Recruiting |
A RANDOMIZED, MULTICENTER, OPEN LABEL STUDY COMPARING TWO STANDARD TREATMENTS, BORTEZOMIB-MELPHALAN-PREDNISONE (VMP) WITH OR WITHOUT DARATUMUMAB (Dara-VMP) VS LENALIDOMIDE-DEXAMETHASONE (Rd) WITH OR WITHOUT DARATUMUMAB (Dara-Rd) IN AUTOLOGOUS STEM CELL TR [NCT03829371] | Phase 4 | 450 participants (Anticipated) | Interventional | 2019-01-03 | Recruiting |
Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL) [NCT01390584] | Phase 2 | 6 participants (Actual) | Interventional | 2013-05-24 | Terminated(stopped due to slow accrual) |
A Phase I/II, Multi-center, Open Label Study of Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma Relapsed and/or Refractory to Lenalidomide [NCT01166113] | Phase 1/Phase 2 | 67 participants (Actual) | Interventional | 2010-07-31 | Completed |
A Multicenter, Open Label Study Of Oral Revlimid And Prednisone (Rp) Followed By Oral Revlimid Melphalan And Prednisone (Mpr) In Newly Diagnosed Elderly Multiple Myeloma Patients [NCT01160107] | Phase 2 | 46 participants (Actual) | Interventional | 2008-07-31 | Completed |
A PHASE III, MULTI-CENTER, RANDOMIZED OPEN LABEL STUDY OF VELCADE, MELPHALAN, PREDNISONE AND THALIDOMIDE (V-MPT) Versus VELCADE, MELPHALAN, PREDNISONE (V-MP) IN ELDERLY UNTREATED MULTIPLE MYELOMA PATIENTS [NCT01063179] | Phase 3 | 511 participants (Actual) | Interventional | 2006-05-31 | Completed |
A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF LENALIDOMIDE, MELPHALAN AND PREDNISONE (MPR) Versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTS [NCT00551928] | Phase 3 | 402 participants (Actual) | Interventional | 2007-06-30 | Active, not recruiting |
Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [18F] FDG-PET Scanning [NCT00274924] | Phase 2 | 100 participants (Actual) | Interventional | 2006-09-26 | Completed |
Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia [NCT00060346] | Phase 2 | 16 participants (Actual) | Interventional | 2004-10-05 | Terminated(stopped due to slow accrual) |
Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation: a Randomized, Double Blinded, Multicenter Study [NCT04844814] | Phase 2 | 204 participants (Anticipated) | Interventional | 2022-06-02 | Recruiting |
Phase II Study of CHOP/Rituxan Plus VELCADE in Mediastinal Large B-cell Lymphoma [NCT00361621] | Phase 2 | 3 participants (Actual) | Interventional | 2006-07-31 | Terminated(stopped due to Closed due to slow accrual) |
Donor-derived Mesenchymal Stromal Cells, Alemtuzumab, Co-stimulation Blockade and Sirolimus for Tolerance Induction in Adult Kidney Allograft Recipients (ITN062ST) [NCT03504241] | Phase 1 | 8 participants (Actual) | Interventional | 2018-07-30 | Active, not recruiting |
Treatment of Prostate Cancer by Induction of Alternate Cell Death Pathways: A Phase I Trial of Docetaxel, Estramustine, Mitoxantrone and Prednisone [NCT00003633] | Phase 1 | 12 participants (Anticipated) | Interventional | 1998-08-31 | Active, not recruiting |
A Randomized, Open-Label Phase II/III Study of SU101 Plus Mitoxantrone/Prednisone Compared to Mitoxantrone/Prednisone Alone in Patients With Hormone-Refractory Prostate Cancer [NCT00004071] | Phase 2/Phase 3 | 0 participants | Interventional | 1999-08-31 | Completed |
Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study [NCT00004179] | Phase 3 | 475 participants (Actual) | Interventional | 1999-05-31 | Completed |
ALinC 17: Continuous Intensification for Very High Risk Acute Lymphocytic Leukemia (A.L.L.): A Pediatric Oncology Group Pilot Study [NCT00003783] | Phase 2 | 36 participants (Actual) | Interventional | 1999-03-31 | Completed |
MK-3475 in Combination With Standard RCHOP Therapy for Previously Untreated Diffuse Large B-Cell Lymphoma [NCT02541565] | Phase 1 | 30 participants (Actual) | Interventional | 2015-11-24 | Completed |
Randomized Controlled Trial Testing the Effect of Hydroxychloroquine Combined With Low-dose Corticosteroid Therapy in Pulmonary Sarcoidosis [NCT05247554] | Phase 3 | 200 participants (Anticipated) | Interventional | 2022-03-01 | Not yet recruiting |
Characterization of Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy - Influence of Corticosteroids and Betablockers [NCT04740554] | | 40 participants (Actual) | Observational | 2013-03-01 | Completed |
Beijing Children's Hospital, Capital Medical University [NCT03598725] | Phase 4 | 55 participants (Anticipated) | Interventional | 2016-01-01 | Recruiting |
Clinical and Angiographic Outcome of Patients Treated With Bare Metal Stent (BMS) Implantation Compared With Drug Eluting Stents or BMS Plus Systemic Prednisone Therapy. A Randomized, Multicentre Study. [NCT00369356] | Phase 2/Phase 3 | 375 participants (Actual) | Interventional | 2006-10-31 | Completed |
Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure [NCT00369044] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2006-10-31 | Suspended |
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Immunosuppression in Biopsy-proven Virus Negative Myocarditis or Inflammatory Cardiomyopathy [NCT04654988] | Phase 4 | 100 participants (Anticipated) | Interventional | 2022-05-01 | Not yet recruiting |
Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients [NCT02954198] | | 40 participants (Actual) | Interventional | 2016-12-01 | Completed |
Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone Acetate and Apalutamide (ARN-509) for Rising PSA After Radical Prostatectomy With Adverse Features.(FORMULA-509 Trial) [NCT03141671] | Phase 2 | 345 participants (Actual) | Interventional | 2017-11-24 | Active, not recruiting |
Thalidomide, Cyclophosphamide and Prednisone in Newly Diagnosed Multicentric Castleman's Disease: a Prospective, Single-center, Single-arm, Phase-II Pilot Trial [NCT03043105] | Phase 2 | 25 participants (Actual) | Interventional | 2017-01-01 | Active, not recruiting |
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients Converted From Twice-daily Tacrolimus [NCT02953873] | Phase 4 | 25 participants (Actual) | Interventional | 2017-05-05 | Completed |
A Phase 2 Study of Docetaxel Plus Apalutamide in Castration-Resistant Prostate Cancer Patients Post Abiraterone Acetate [NCT03093272] | Phase 2 | 9 participants (Actual) | Interventional | 2017-06-23 | Terminated(stopped due to Safety concerns) |
Phase II Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease [NCT02133924] | Phase 2 | 76 participants (Actual) | Interventional | 2016-08-31 | Completed |
A Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With Local Standard-of-Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castlem [NCT03864419] | Phase 1 | 40 participants (Anticipated) | Interventional | 2019-10-24 | Recruiting |
A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01549951] | Phase 2 | 50 participants (Actual) | Interventional | 2012-05-31 | Completed |
Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice [NCT02330952] | Phase 4 | 189 participants (Actual) | Interventional | 2015-02-10 | Completed |
Radiation Enhancement of Local and Systemic Anti-Prostate Cancer Immune Responses [NCT03649841] | Phase 2 | 10 participants (Actual) | Interventional | 2020-06-29 | Terminated(stopped due to Terminated due to low accrual.) |
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis [NCT02550652] | Phase 2 | 126 participants (Actual) | Interventional | 2015-11-13 | Completed |
Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers [NCT00576069] | | 60 participants (Anticipated) | Observational | 2007-10-25 | Recruiting |
Open Label Pharmacodynamic Study of Abiraterone Acetate in the Treatment of Metastatic, Castration Resistant Prostate Cancer [NCT01503229] | Phase 2 | 32 participants (Actual) | Interventional | 2012-12-31 | Completed |
A Multicenter, Open-Label Study to Estimate the Effect Sizes of HRCT Endpoints in Response to GLUCOCORTICOID Induction Therapy in Subjects With Pulmonary Sarcoidosis [NCT03324503] | | 8 participants (Actual) | Interventional | 2017-12-08 | Completed |
Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial] [NCT00379041] | Phase 3 | 1,158 participants (Anticipated) | Interventional | 1993-09-01 | Active, not recruiting |
NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma [NCT01451515] | Phase 2 | 23 participants (Actual) | Interventional | 2012-05-25 | Completed |
SHR0302 and Prednisone as First Line Therapy for Chronic Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation [NCT04146207] | Early Phase 1 | 73 participants (Anticipated) | Interventional | 2020-04-02 | Recruiting |
CHemotherapy Plus Enzalutamide In First Line Therapy for Castration Resistant prOstate caNcer [NCT02453009] | Phase 2 | 232 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
A Randomized, Multicenter Study of Belatacept, Everolimus, rATG and Early Steroid Withdrawal Versus Belatacept, Mycophenolate, rATG and Chronic Steroids in Renal Transplantation [NCT04849533] | Phase 4 | 120 participants (Anticipated) | Interventional | 2021-04-09 | Recruiting |
A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE [NCT00002714] | Phase 2 | 0 participants | Interventional | 1995-04-30 | Completed |
A Phase IB/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus CHOP in Patients With Follicular Lymphoma or Rituximab Plus CHOP in Patients With Diffuse Large B-Cell Ly [NCT02596971] | Phase 1/Phase 2 | 91 participants (Actual) | Interventional | 2015-12-22 | Completed |
Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin (R-CHOP) Versus in Combination With Pegylated-liposomal Doxorubicin (R-CDOP) as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma: a Random [NCT02428751] | Phase 3 | 216 participants (Anticipated) | Interventional | 2015-09-30 | Recruiting |
A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell [NCT02055820] | Phase 1/Phase 2 | 267 participants (Actual) | Interventional | 2013-11-17 | Completed |
A Randomized Gene Fusion Stratified Phase 2 Trial of Abiraterone With or Without ABT-888 for Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01576172] | Phase 2 | 159 participants (Actual) | Interventional | 2012-03-30 | Completed |
A Phase II Study of Dovitinib (TKI258) Combined With Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer Evaluating Markers of FGF and AR Signaling in Bone Marrow and Plasma [NCT01994590] | Phase 2 | 4 participants (Actual) | Interventional | 2014-05-19 | Terminated(stopped due to Sponsor stopped supplying study drug) |
Efficacy of Consolidative Involved-site Radiotherapy Following Sufficient Chemotherapy for Patients With Limited-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center -NHL03 Trial [NCT02449265] | Phase 3 | 160 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3872386 in Healthy Participants, a Multiple-Ascending Dose Study of LY3872386 in Patients With Atopic Dermatitis, and an Open-Label Multiple-Dose Evalua [NCT06119529] | Phase 1 | 179 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma [NCT06072131] | Phase 3 | 504 participants (Anticipated) | Interventional | 2023-10-04 | Recruiting |
A Prospective, Two-center, Clinical Study to Optimize the Treatment for Allergic Bronchopulmonary Aspergillosis (ABPA) [NCT05129033] | | 100 participants (Anticipated) | Interventional | 2021-11-15 | Not yet recruiting |
A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma [NCT05899621] | | 332 participants (Anticipated) | Observational | 2023-06-01 | Recruiting |
Immunostart: Prephase Tafasitamab, Retifanlimab, and Rituximab (TRR), Followed by TRR-CHOP, for Previously Untreated Diffuse Large B-Cell Lymphoma [NCT05455697] | Phase 1/Phase 2 | 35 participants (Anticipated) | Interventional | 2023-01-26 | Recruiting |
Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14. [NCT05049473] | Phase 2 | 100 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
A Randomized Controlled Study of Dasatinib Combined With Reduced Intensive Consolidation Chemotherapy in Newly Diagosed Philadelphia Chromesome Positive Adult Lymphoblastic Leukemia [NCT05026229] | | 60 participants (Anticipated) | Interventional | 2021-09-06 | Recruiting |
Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer [NCT03678025] | Phase 3 | 1,273 participants (Anticipated) | Interventional | 2018-09-24 | Recruiting |
Cabazitaxel With Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial [NCT03419234] | Phase 2 | 223 participants (Actual) | Interventional | 2018-04-26 | Active, not recruiting |
A Phase II Study of Doxil (Liposomal Doxorubicin), Cyclophosphamide, Vincristine and Prednisone for AIDS-Related Systemic Lymphoma [NCT00003388] | Phase 2 | 38 participants (Anticipated) | Interventional | 1999-07-26 | Completed |
The Effectivity of Anti Tuberculosis Therapy in Idiopathic Uveitis With Positive Interferon Gamma Release Assay (IGRA): A Randomized Clinical Trial [NCT05005637] | Phase 2 | 80 participants (Anticipated) | Interventional | 2021-07-27 | Enrolling by invitation |
Tocilizumab Plus a Short Prednisone Taper for Giant Cell Arteritis (GCA) [NCT03726749] | Phase 4 | 30 participants (Actual) | Interventional | 2018-11-28 | Completed |
Immune Monitoring and Calcineurin Inhibitor (CNI) Withdrawal in Low Risk Recipients of Kidney Transplantation [NCT01517984] | Phase 2 | 52 participants (Actual) | Interventional | 2010-11-30 | Terminated(stopped due to Absence of equipoise on the basis of predetermined stopping rules.) |
Concurrent Ponatinib With Chemotherapy for Young Adults With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia [NCT02776605] | Phase 2 | 30 participants (Actual) | Interventional | 2016-06-30 | Active, not recruiting |
A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy [NCT01414855] | Phase 2 | 100 participants (Actual) | Interventional | 2011-08-31 | Completed |
The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss [NCT02990403] | Phase 4 | 500 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy [NCT03218852] | Phase 4 | 133 participants (Actual) | Interventional | 2016-12-31 | Active, not recruiting |
Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie [NCT04376216] | Phase 4 | 110 participants (Anticipated) | Interventional | 2017-09-01 | Recruiting |
Open, Non-Interventional, Multicenter Trial of MabThera in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma [NCT02486952] | | 154 participants (Actual) | Observational | 2005-08-31 | Completed |
A Phase 2 Trial of Bevacizumab, Lenalidomide, Docetaxel, and Prednisone (ART-P) for Treatment of Metastatic Castrate-Resistant Prostate Cancer [NCT00942578] | Phase 2 | 63 participants (Actual) | Interventional | 2009-07-16 | Completed |
Intratympanic Steroid Injection for Treatment of Idiopathic Facial Nerve Paralysis [NCT03508440] | Phase 2/Phase 3 | 11 participants (Actual) | Interventional | 2018-01-31 | Completed |
A Randomized, Controlled Trial to Evaluate Leflunomide Plus Low Dose Corticosteroid Therapy in Progressive IgA Nephropathy With Renal Insufficiency [NCT04020328] | Phase 4 | 70 participants (Anticipated) | Interventional | 2019-09-12 | Recruiting |
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy [NCT01695135] | Phase 3 | 214 participants (Actual) | Interventional | 2012-08-09 | Completed |
A Pre-Operative Study to Assess the Effects of Apalutamide Plus LHRH Agonist or Apalutamide Plus Abiraterone Acetate Plus LHRH Agonist for Six Months for Prostate Cancer Patients at High Risk for Recurrence [NCT03279250] | Phase 2 | 86 participants (Actual) | Interventional | 2017-10-13 | Completed |
A Phase 3, Intergroup Multicentre, Randomized, Controlled 3 Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide in Combination With Dexamethasone (RD) Versus Melphalan, Prednisone and Lenalidomide (MPR) Versus Cyclophosphamide, P [NCT01093196] | Phase 3 | 660 participants (Anticipated) | Interventional | 2009-10-31 | Active, not recruiting |
Phase I Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas [NCT03036904] | Phase 1 | 31 participants (Actual) | Interventional | 2017-02-06 | Completed |
Phase II Study of Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for Patients With High-Risk Localized Prostate Cancer Prior to Radical Prostatectomy [NCT02789878] | Phase 2 | 64 participants (Actual) | Interventional | 2019-01-24 | Completed |
Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN) [NCT01893658] | Phase 2 | 0 participants (Actual) | Interventional | 2018-06-01 | Withdrawn(stopped due to Lack of patients with a condition of interest that resulted in failure to recruit) |
A Novel Immunosuppression Intervention for the Treatment of Amyotrophic Lateral Sclerosis (ALS) [NCT01884571] | Phase 2 | 31 participants (Actual) | Interventional | 2013-10-31 | Completed |
A 12-Month, Open Label Study of Extended Release Tacrolimus (Envarsus XR®, LCPT) With Mycophenolate, Rabbit Antithymocyte Globulin (rATG) and Early Steroid Withdrawal in de Novo Kidney Transplant Recipients [NCT03828682] | Phase 4 | 60 participants (Anticipated) | Interventional | 2019-06-21 | Recruiting |
Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism) [NCT01452100] | Phase 2 | 39 participants (Actual) | Interventional | 2011-06-30 | Terminated(stopped due to Inclusion default) |
Dasatinib Plus Multi-agent Chemotherapy for New Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia [NCT02523976] | Phase 2 | 30 participants (Actual) | Interventional | 2015-08-01 | Completed |
MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial [NCT03892785] | Phase 3 | 230 participants (Anticipated) | Interventional | 2020-01-27 | Recruiting |
Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus [NCT05666336] | Phase 4 | 30 participants (Anticipated) | Interventional | 2022-12-31 | Recruiting |
An Open-Label Phase 1/2 Multi-Arm Study of DS-1594b as a Single-Agent and in Combination With Azacitidine and Venetoclax or Mini-HCVD for the Treatment of Patients With Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) [NCT04752163] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2021-03-25 | Completed |
Phase II Randomized Study Of Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide For Intermediate-High Risk Prostate Cancer Undergoing Prostatectomy [NCT02903368] | Phase 2 | 118 participants (Actual) | Interventional | 2016-10-19 | Active, not recruiting |
BRCAAway: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects [NCT03012321] | Phase 2 | 70 participants (Anticipated) | Interventional | 2017-01-12 | Active, not recruiting |
A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer [NCT01522443] | Phase 3 | 119 participants (Actual) | Interventional | 2012-03-31 | Terminated(stopped due to Stopped after the outcome of cabozantinib Phase 3 CRPC study XL184-307.) |
Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring. [NCT00458848] | Phase 2 | 470 participants (Actual) | Interventional | 2004-10-31 | Completed |
A Phase II Trial of Doxil, Rituximab, Cyclophosphamide, Vincristine, and Prednisone (DR-COP) in Patients With Newly Diagnosed AIDS-Associated B-Cell Non-Hodgkin's Lymphoma [NCT00389818] | Phase 2 | 43 participants (Actual) | Interventional | 2007-01-31 | Completed |
A Randomized Trial of Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia [NCT02334813] | Phase 3 | 26 participants (Actual) | Interventional | 2002-07-31 | Completed |
Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in T and NK-Cell Lymphomas [NCT01445535] | Phase 1 | 15 participants (Actual) | Interventional | 2009-01-13 | Completed |
Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS [NCT00520468] | Phase 2 | 15 participants (Actual) | Interventional | 2004-06-30 | Completed |
Demonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation [NCT03591471] | Phase 1/Phase 2 | 500 participants (Anticipated) | Interventional | 2014-09-30 | Recruiting |
Focal Radiation With Pulsed Systemic Therapy of Abiraterone, ADT, Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON): A Phase II, Single Arm, Single Institution Study [NCT04748042] | Phase 2 | 29 participants (Anticipated) | Interventional | 2021-05-28 | Recruiting |
Phase 1/2a, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer [NCT04729114] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2021-06-14 | Recruiting |
Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 [NCT03755804] | Phase 2 | 250 participants (Anticipated) | Interventional | 2018-12-12 | Recruiting |
Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma [NCT03117751] | Phase 2/Phase 3 | 790 participants (Actual) | Interventional | 2017-03-29 | Active, not recruiting |
A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations [NCT02883049] | Phase 3 | 5,937 participants (Actual) | Interventional | 2012-02-29 | Active, not recruiting |
Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer [NCT01949337] | Phase 3 | 1,311 participants (Actual) | Interventional | 2014-01-22 | Active, not recruiting |
Emergency Department (ED) Use of Nebulized Budesonide as an Adjunct to Standardized Therapy in Acutely Ill Adults With Refractory Asthma: a Randomized, Double-blinded, Placebo-controlled Trial [NCT00588406] | Phase 3 | 95 participants (Actual) | Interventional | 2007-09-30 | Completed |
A Prospective, Randomised, Assessor-blind, Multicenter Study of Efficacy and Safety of Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With Polymyositis and Dermatomyositis. [NCT00651040] | Phase 3 | 31 participants (Actual) | Interventional | 2008-05-31 | Completed |
A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid Arthritis [NCT00746512] | Phase 1 | 45 participants (Actual) | Interventional | 2008-09-30 | Completed |
A Rand. Trial Comp Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine, and Prednisone) in Patients With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment [NCT00774202] | Phase 2/Phase 3 | 17 participants (Actual) | Interventional | 2003-11-30 | Completed |
Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement [NCT01782859] | | 40 participants (Actual) | Interventional | 2012-10-31 | Completed |
A Pre-Operative Study to Assess the Effects of Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide for Six Months for Prostate Cancer Patients at High-Risk for Recurrence [NCT01946165] | Phase 2 | 69 participants (Actual) | Interventional | 2013-10-31 | Completed |
A Single Arm, Multicentre, Phase IIIB Study to Evaluate Safety, Efficacy and Pharmacokinetic (PK) of Subcutaneous (SC) Rituximab Administered During Induction Phase or Maintenance in Previously Untreated Patients With CD20+ Diffuse Large B Cell Lymphoma ( [NCT01889069] | Phase 3 | 159 participants (Actual) | Interventional | 2013-07-31 | Completed |
Mature B-Cell Lymphoma And Leukemia Study III [NCT01046825] | Phase 2/Phase 3 | 128 participants (Actual) | Interventional | 2010-09-09 | Active, not recruiting |
A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients With Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma [NCT00088881] | Phase 2 | 62 participants (Actual) | Interventional | 2004-12-31 | Terminated |
A Phase II, Prospective, Open Label Study (PO-MMM-PI-0011) to Determine the Safety and Efficacy of Pomalidomide (CC-4047) in Subjects With Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF; Post-PV MF, or Post-ET MF) [NCT00946270] | Phase 2 | 70 participants (Actual) | Interventional | 2009-07-22 | Completed |
Efficacy of Prednisone In the Treatment of Ocular Myasthenia: The EPITOME' Study [NCT00995722] | Phase 3 | 11 participants (Actual) | Interventional | 2011-12-31 | Terminated(stopped due to Slow recruitment rate) |
Phase II Trial of Carboplatin and Everolimus (RAD001) in Metastatic Castrate Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Chemotherapy. [NCT01051570] | Phase 2 | 26 participants (Actual) | Interventional | 2010-02-28 | Completed |
Comparison of Pharmocokinetics of Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Calcineurininhibitor-free Treated Patients After Renal Transplantation [NCT01033864] | Phase 4 | 23 participants (Actual) | Interventional | 2009-11-30 | Completed |
A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia [NCT06124157] | Phase 3 | 680 participants (Anticipated) | Interventional | 2024-01-22 | Not yet recruiting |
A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of LY3884963 in Patients With Fronto-Temporal Dementia With Progranulin Mutations (FTD-GRN) [NCT04408625] | Phase 1/Phase 2 | 23 participants (Anticipated) | Interventional | 2020-11-09 | Recruiting |
BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma [NCT00049595] | Phase 3 | 552 participants (Actual) | Interventional | 2002-08-31 | Completed |
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia [NCT01117441] | Phase 3 | 6,136 participants (Actual) | Interventional | 2010-06-30 | Completed |
Phase II Study of Infliximab for the Treatment of Ipilimumab Colitis [NCT04305145] | Phase 2 | 42 participants (Anticipated) | Interventional | 2020-08-31 | Recruiting |
Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis, Compared With Adalimumab Plus High Dose Oral Glucocorticosteroid, a Non-inferior, Multi-center, Randomized Controlled Trial. [NCT05105347] | Phase 4 | 130 participants (Anticipated) | Interventional | 2021-11-10 | Not yet recruiting |
A Multicenter Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol [NCT00136435] | Phase 2 | 100 participants (Anticipated) | Interventional | 2002-06-30 | Active, not recruiting |
A Randomized Trial Using a Modified COG ABFM Regimen Backbone to Investigate Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL) [NCT05681260] | Phase 3 | 200 participants (Anticipated) | Interventional | 2023-02-06 | Recruiting |
The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I. [NCT03466801] | | 6 participants (Actual) | Interventional | 2018-03-20 | Terminated(stopped due to the clinical significance is little) |
Fluzoparib and Abiraterone in the preSurgery Treatment of Prostate Cancer: FAST Trial [NCT05223582] | Phase 2 | 34 participants (Anticipated) | Interventional | 2021-05-01 | Active, not recruiting |
Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population [NCT03819296] | Phase 1/Phase 2 | 800 participants (Anticipated) | Interventional | 2021-02-21 | Recruiting |
Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas [NCT00118209] | Phase 3 | 524 participants (Actual) | Interventional | 2005-05-31 | Completed |
Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer [NCT00004001] | Phase 3 | 770 participants (Actual) | Interventional | 1999-10-31 | Completed |
A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy [NCT01485861] | Phase 1/Phase 2 | 298 participants (Actual) | Interventional | 2012-01-11 | Completed |
ALinC 17: Protocol for Patients With Newly Diagnosed High Risk Acute Lymphoblastic Leukemia (ALL) - Evaluation of the Augmented BFM Regimen: A Phase III Study [NCT00005603] | Phase 3 | 276 participants (Actual) | Interventional | 2000-03-31 | Completed |
A Phase 1 Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT125329 in Healthy Subjects, With an Optional Pharmacological Effects [NCT04672512] | Phase 1 | 115 participants (Actual) | Interventional | 2020-10-23 | Completed |
A Phase Ib Trial of Zanubrutinib in Combination With R-CHOP (ZaR-CHOP) for Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma [NCT04850495] | Phase 1 | 24 participants (Anticipated) | Interventional | 2021-11-16 | Suspended(stopped due to Pending amendment) |
An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE) [NCT01946880] | Phase 2 | 102 participants (Actual) | Interventional | 2013-11-20 | Terminated(stopped due to Slow enrollment.) |
A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-naïve and Metastatic Castration-resistant Prostate Cancer (mCRPC) Pati [NCT01867710] | Phase 2 | 164 participants (Actual) | Interventional | 2013-07-16 | Completed |
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma [NCT02528214] | Phase 3 | 210 participants (Actual) | Interventional | 2015-10-15 | Completed |
Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study [NCT05123040] | Phase 1/Phase 2 | 55 participants (Anticipated) | Interventional | 2023-06-05 | Recruiting |
A Phase II, Randomized, Clinical Trial Assessing Efficacy And Safety Of Oral Prednisolone vs Intravenous Vincristine In The Treatment Of Infantile [NCT00555464] | Phase 2 | 8 participants (Actual) | Interventional | 2007-11-30 | Terminated(stopped due to The introduction of oral propranolol as a highly efficacious agent for infantile hemangiomas) |
A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis [NCT00650078] | Phase 3 | 350 participants (Actual) | Interventional | 2008-03-31 | Completed |
Phase I/II Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma. [NCT01279694] | Phase 1/Phase 2 | 72 participants (Actual) | Interventional | 2010-10-31 | Completed |
A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis [NCT01369745] | Phase 2 | 294 participants (Actual) | Interventional | 2011-06-30 | Completed |
A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis [NCT01791153] | Phase 3 | 251 participants (Actual) | Interventional | 2013-07-22 | Completed |
A Phase 2 Study of Brentuximab Vedotin in Combination With Standard of Care Treatment (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [RCHOP]) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) as Front-line Therapy [NCT01925612] | Phase 2 | 87 participants (Actual) | Interventional | 2013-08-31 | Terminated(stopped due to Sponsor decision based on portfolio prioritization and changing treatment landscape in frontline DLBCL) |
A Two-part Study Exploring the Efficacy, Safety, and Pharmacodynamics of Acthar in Systemic Lupus Erythematosus Patients With a History of Persistently Active Disease [NCT01753401] | Phase 4 | 38 participants (Actual) | Interventional | 2013-01-31 | Completed |
Clinical Trial of a Rapidly Cycling, Non-Cross Reactive Regimen of Approved Therapeutic Agents to Treat Prostate Cancer [NCT02903160] | Phase 2 | 40 participants (Actual) | Interventional | 2017-01-13 | Completed |
A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma [NCT05800366] | Phase 2 | 40 participants (Anticipated) | Interventional | 2023-04-06 | Recruiting |
The Impact of Prednisone on Semen Parameters and Pregnancy Rates Post Vasectomy Reversal: A Randomized, Controlled Trial [NCT04788823] | Phase 4 | 100 participants (Anticipated) | Interventional | 2021-02-24 | Active, not recruiting |
Anti-PD-1 Antibody (Camrelizumab) Plus R-CHOP Regimen for the Primary Extranodal Treatment-Naive Diffuse Large B Cell Lymphoma (CREDIT): a Prospective, Multicenter, Single-Arm, Phase II Trial [NCT05093140] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-06-01 | Not yet recruiting |
Phase Ib/II Study of Toripalimab In Combination With Rituximab Followed by R-CHOP Regimen (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) for Elderly Naïve Patients With Diffuse Large B-cell Lymphoma [NCT04058470] | Phase 1/Phase 2 | 140 participants (Anticipated) | Interventional | 2020-04-24 | Recruiting |
A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgki [NCT01724021] | Phase 3 | 743 participants (Actual) | Interventional | 2012-12-31 | Completed |
Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor [NCT03440515] | Phase 2 | 29 participants (Actual) | Interventional | 2014-08-31 | Completed |
Risk-stratified Sequential Treatment of Post-transplant Lymphoproliferative Disease (PTLD) With 4 Courses of Rituximab SC Followed by 4 Courses of Rituximab SC, 4 Courses of Rituximab SC Combined With CHOP-21 or 6 Courses of Rituximab SC Combined With Alt [NCT02042391] | Phase 2 | 60 participants (Actual) | Interventional | 2015-02-03 | Completed |
A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults With Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia [NCT05303792] | Phase 2 | 66 participants (Anticipated) | Interventional | 2023-02-27 | Recruiting |
A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas [NCT04803201] | Phase 2 | 170 participants (Anticipated) | Interventional | 2021-07-30 | Recruiting |
A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types [NCT04300556] | Phase 1/Phase 2 | 142 participants (Anticipated) | Interventional | 2020-08-06 | Recruiting |
The Effect of Prednisone on Atherogenesis as Studied in the Macrophage Foam Cell Formation Model System. [NCT03367663] | Early Phase 1 | 10 participants (Actual) | Interventional | 2018-01-17 | Completed |
A Phase 2 Study of PCM-075 (Onvansertib) in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer [NCT03414034] | Phase 2 | 72 participants (Actual) | Interventional | 2018-06-18 | Completed |
A Phase 2 Study of Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib [NCT02294357] | Phase 2 | 45 participants (Anticipated) | Interventional | 2014-12-31 | Terminated(stopped due to Early termination due to the difficulties to enroll subjects.) |
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas [NCT01777152] | Phase 3 | 452 participants (Actual) | Interventional | 2013-01-31 | Completed |
A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair [NCT03834519] | Phase 3 | 793 participants (Actual) | Interventional | 2019-05-02 | Active, not recruiting |
Phase I/II Study of the Combination of Low-Intensity Chemotherapy and Venetoclax (ABT-199) in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) [NCT03808610] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2019-04-03 | Recruiting |
MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects With Severe Refractory Asthma [NCT01691508] | Phase 3 | 135 participants (Actual) | Interventional | 2012-10-31 | Completed |
An Open-labeled, Multi-center, Randomized, Prospective Phase III Study Comparing CMAB304 in Combination With CHOP to CHOP Alone With CMAB304 Maintenance in Patients With DLBCL [NCT01459887] | Phase 3 | 278 participants (Actual) | Interventional | 2006-09-30 | Completed |
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Prog [NCT03834506] | Phase 3 | 1,030 participants (Actual) | Interventional | 2019-05-02 | Completed |
A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer [NCT02985957] | Phase 2 | 351 participants (Actual) | Interventional | 2017-03-26 | Active, not recruiting |
Induction Therapy With Bortezomib-melphalan and Prednisone (VMP) Followed by Lenalidomide and Dexamethasone (Rd) Versus Carfilzomib, Lenalidomide and Dexamethasone (KRd) Plus/Minus Daratumumab, 18 Cycles, Followed by Consolidation and Maintenance Therapy [NCT03742297] | Phase 3 | 462 participants (Actual) | Interventional | 2018-10-22 | Active, not recruiting |
Compared the Efficacy and Safety of CDOP Combined With Chidamide and CDOP in de Novo Peripheral T Cell Lymphoma Patients [NCT03023358] | Phase 3 | 174 participants (Anticipated) | Interventional | 2017-02-28 | Not yet recruiting |
A Phase 3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincr [NCT02162771] | Phase 3 | 140 participants (Actual) | Interventional | 2014-07-14 | Completed |
A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ [NCT03589326] | Phase 3 | 245 participants (Actual) | Interventional | 2018-10-04 | Active, not recruiting |
Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD [NCT02298283] | Phase 2 | 40 participants (Actual) | Interventional | 2015-04-30 | Completed |
A Multicenter Open Label Phase 2 Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma [NCT02302495] | Phase 2 | 80 participants (Anticipated) | Interventional | 2014-01-31 | Active, not recruiting |
The Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Male Subjects (A Randomized, Double-blind, Placebo-controlled, Two Period, Two-way Cross-over Study) [NCT02268149] | Phase 1 | 20 participants (Actual) | Interventional | 2000-04-30 | Completed |
Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated [NCT02285062] | Phase 3 | 570 participants (Actual) | Interventional | 2015-02-17 | Completed |
A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mi [NCT00833495] | Phase 2 | 155 participants (Actual) | Interventional | 2009-01-31 | Completed |
Effect of Pre-operative Oral Steroids on Blood Loss in Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Polyps [NCT05095961] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2023-03-31 | Withdrawn(stopped due to Technical difficulties encountered with recording intraoperative blood loss; unable to proceed with study.) |
A National Prospective Study of Patients With Hepatitis Induced by Immune Checkpoint Inhibitors; Characterization of Liver Injury, Outcome of Therapy and Randomization to Either Prednisolone or Mycophenolate Mofetil Treatment in Case of Relapse [NCT04810156] | Phase 2 | 60 participants (Anticipated) | Interventional | 2021-04-07 | Recruiting |
A Prospective Observational Study to Assess the Efficacy an Safety of Glucocorticoid Therapy in the Treatment of Adult Idiopathic Nephrotic Syndrome [NCT02298335] | | 235 participants (Actual) | Interventional | 2014-05-13 | Completed |
Duchenne Muscular Dystrophy: Double-blind Randomized Trial to Find Optimum Steroid Regimen [NCT01603407] | Phase 3 | 196 participants (Actual) | Interventional | 2013-01-31 | Completed |
The Efficacy of Thalidomide Plus Prednisone and Methotrexate for the Symptomatic Large Granular Lymphocytic Leukemia - a Prospective Multicenter Clinical Trial From China [NCT04453345] | Phase 2/Phase 3 | 42 participants (Anticipated) | Interventional | 2013-05-20 | Recruiting |
A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a [NCT03424733] | Phase 4 | 50 participants (Anticipated) | Interventional | 2017-09-25 | Recruiting |
Phase 2 Study of CJNJ-67652000 (Niraparib/Abiraterone Acetate Fixed-Dose Combination) and Prednisone for Metastatic Castration-Resistant Prostate Cancer Associated With SPOP Mutation With or Without Homologous Recombination Deficiency [NCT05689021] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-07-07 | Recruiting |
Phase II Trial of Primary Radiotherapy With Androgen Ablation With or Without Adjuvant Niraparib for Selected High-Risk Locoregional Prostate Cancer [NCT04947254] | Phase 2 | 200 participants (Anticipated) | Interventional | 2021-08-05 | Recruiting |
A Randomized Phase II Pilot of Tailored Prednisone Reduction Versus Usual Care for the Treatment of Hyperglycemia During R-CHOP Chemotherapy [NCT03505762] | Phase 2 | 80 participants (Anticipated) | Interventional | 2018-07-19 | Recruiting |
A Prospective Study of Bortezomib in Combination With Melphalan and Prednisone for Patients With Previously Untreated Multiple Myeloma [NCT00734149] | Phase 2 | 45 participants (Actual) | Interventional | 2004-07-31 | Completed |
The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Initial Treatment of Patients With Diffuse Large B-cell Lymphoma [NCT03022123] | | 270 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) [NCT03895801] | Phase 2 | 57 participants (Actual) | Interventional | 2019-04-03 | Completed |
[NCT01274403] | Phase 2 | 130 participants (Actual) | Interventional | | Completed |
A Randomized, Double-Masked and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sarilumab Administered Subcutaneously Every 2 Weeks in Patients With Non-Infectious, Intermediate, Posterior or Pan-Uveitis (NIU) [NCT01900431] | Phase 2 | 58 participants (Actual) | Interventional | 2013-10-31 | Completed |
First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial [NCT01829295] | Phase 3 | 216 participants (Actual) | Interventional | 2013-08-31 | Completed |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant P [NCT04691804] | Phase 3 | 804 participants (Anticipated) | Interventional | 2021-03-18 | Recruiting |
A Randomized, Open-label Study to Assess the Efficacy and Safety of Olaparib Versus Enzalutamide or Abiraterone Acetate in Chinese Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have [NCT05457257] | Phase 4 | 42 participants (Anticipated) | Interventional | 2022-07-29 | Recruiting |
A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE) [NCT05406401] | Phase 2 | 60 participants (Anticipated) | Interventional | 2022-07-14 | Recruiting |
A Randomized Controlled Pilot Trial of Cyclosporine vs Steroids in DRESS [NCT04988256] | Early Phase 1 | 50 participants (Anticipated) | Interventional | 2021-09-27 | Enrolling by invitation |
An Randomized, Open-label, Phase III Study Comparing Thalidomide Combined With R-CHOP and R-CHOP in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients [NCT03318835] | Phase 3 | 162 participants (Anticipated) | Interventional | 2017-08-22 | Recruiting |
A Prospective, Open-label, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone(VMP) for Initial Treatment in Patients With Multiple Myeloma Who do Not Undergo Autologous Stem Cell Transplantation [NCT02474563] | | 171 participants (Actual) | Observational | 2011-05-31 | Completed |
A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus [NCT03098823] | Phase 4 | 62 participants (Actual) | Interventional | 2017-09-12 | Completed |
Phase II Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia [NCT05645718] | Phase 2 | 27 participants (Anticipated) | Interventional | 2023-07-14 | Recruiting |
Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) +/- Rituximab (R) + Tafasitamab-cxix for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative (Ph-) B-cell Lymphoblastic Lymphoma/Leuke [NCT05453500] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-03-27 | Recruiting |
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100 [NCT01605227] | Phase 3 | 1,028 participants (Actual) | Interventional | 2012-07-31 | Completed |
The Palliative Benefit of Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center - NHL04 Trial [NCT02449278] | Phase 3 | 120 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
Synergistic Effect of Exclusive Enteral Nutrition Formula in Addition to Corticosteroids Therapy to Induce Clinical Remission in Patients With Crohn's Disease: a Pilot Study Involving a Multidimensional Assessment of Potential Mechanisms [NCT03833596] | Phase 4 | 3 participants (Actual) | Interventional | 2018-10-25 | Terminated(stopped due to Low recruitment) |
Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis [NCT02097303] | Phase 2 | 36 participants (Actual) | Interventional | 2014-03-31 | Completed |
Phase 2 Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL [NCT04594798] | Phase 2 | 39 participants (Anticipated) | Interventional | 2021-09-20 | Recruiting |
A Multicenter, Prospective Clinical Study of Olverembatinib Combined With Chemotherapy in the Treatment of de Novo Adult Philadelphia Chromosome-positive Acute Lymphoid Leukemia [NCT05466175] | Phase 2 | 55 participants (Anticipated) | Interventional | 2022-10-01 | Not yet recruiting |
Possible Role of Chloroquine in Conjunction to Prednisone to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial [NCT02463331] | Phase 4 | 57 participants (Actual) | Interventional | 2003-05-31 | Completed |
Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Liver Transplantation (RTB-002) [NCT02188719] | Phase 1 | 15 participants (Actual) | Interventional | 2014-12-17 | Terminated(stopped due to The trial could not be completed within the grant timeline.) |
A Phase 2 Study Determining Safety and Tolerability of Enzalutamide (Formerly MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients [NCT01650194] | Phase 2 | 60 participants (Actual) | Interventional | 2012-07-09 | Completed |
Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial [NCT02324699] | Phase 4 | 1 participants (Actual) | Interventional | 2016-04-30 | Terminated(stopped due to Difficult recruitment) |
An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer [NCT04869488] | Phase 2 | 93 participants (Actual) | Interventional | 2021-07-26 | Active, not recruiting |
Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL [NCT04835870] | Phase 2 | 78 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (CRPC) [NCT01637402] | Phase 2 | 41 participants (Actual) | Interventional | 2013-03-13 | Completed |
A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness [NCT02072200] | Phase 4 | 147 participants (Actual) | Interventional | 2013-09-30 | Completed |
Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer, Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy [NCT02217566] | Phase 2 | 46 participants (Actual) | Interventional | 2014-09-23 | Completed |
A Phase II Multicenter Study of AMG 386 and Abiraterone in Metastatic Castration Resistant Prostate Cancer [NCT01553188] | Phase 2 | 36 participants (Actual) | Interventional | 2012-02-08 | Completed |
A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation [NCT01950819] | Phase 4 | 2,037 participants (Actual) | Interventional | 2013-12-03 | Completed |
A Phase I/II Study of Cabazitaxel Combined With Abiraterone Acetate and Prednisone in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC) Whose Disease Has Progressed After Docetaxel Chemotherapy [NCT01511536] | Phase 1/Phase 2 | 38 participants (Actual) | Interventional | 2012-03-31 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00002766 (1) [back to overview] | Complete Remission (CR) |
NCT00003389 (3) [back to overview] | Failure-free Survival at 5 Years |
NCT00003389 (3) [back to overview] | 5-year Overall Survival |
NCT00003389 (3) [back to overview] | Incidence of Second Cancers |
NCT00003910 (2) [back to overview] | Proportion of Patients With Complete or Partial Response to Treatment With MTX |
NCT00003910 (2) [back to overview] | Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX |
NCT00004031 (3) [back to overview] | 2-year Overall Survival Rates |
NCT00004031 (3) [back to overview] | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs |
NCT00004031 (3) [back to overview] | 2 Year Progression-free Survival |
NCT00004124 (3) [back to overview] | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients |
NCT00004124 (3) [back to overview] | Overall Survival |
NCT00004124 (3) [back to overview] | Disease Free Survival |
NCT00004228 (2) [back to overview] | Percentage of Patients With Overall Survival as Assessed by Time to Death |
NCT00004228 (2) [back to overview] | Event-free Survival |
NCT00005780 (10) [back to overview] | Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine |
NCT00005780 (10) [back to overview] | Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH) |
NCT00005780 (10) [back to overview] | Percentage of Participants With an Antibody Response to Idiotype Vaccine |
NCT00005780 (10) [back to overview] | Median Progression-free Survival (PFS) in Participants Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) |
NCT00005780 (10) [back to overview] | Percentage of Participants With Induction of Type 1 Cytokine T-cell Response |
NCT00005780 (10) [back to overview] | Time to Recovery of CD4 T Lymphocytes (CD4+) |
NCT00005780 (10) [back to overview] | Overall Survival (OS) |
NCT00005780 (10) [back to overview] | Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine |
NCT00005780 (10) [back to overview] | Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0). |
NCT00005780 (10) [back to overview] | Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) |
NCT00006184 (2) [back to overview] | Immune Response |
NCT00006184 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00006436 (16) [back to overview] | Median Duration of Complete Response/Complete Response Unconfirmed |
NCT00006436 (16) [back to overview] | Median Overall Survival |
NCT00006436 (16) [back to overview] | 1 Year Overall Survival |
NCT00006436 (16) [back to overview] | Median Progression Free Survival (PFS) |
NCT00006436 (16) [back to overview] | Number of Participants With at Least One Hematologic Toxicity Event of Febrile Neutropenia |
NCT00006436 (16) [back to overview] | Recovery of CD4 T Cells (CD4) Counts |
NCT00006436 (16) [back to overview] | Recovery of Human Immunodeficiency Virus (HIV) Viral Load |
NCT00006436 (16) [back to overview] | 1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS) |
NCT00006436 (16) [back to overview] | Number of Cycles of Hematologic Toxicity |
NCT00006436 (16) [back to overview] | Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity |
NCT00006436 (16) [back to overview] | Overall Response |
NCT00006436 (16) [back to overview] | Percentage of Participants With Complete Response |
NCT00006436 (16) [back to overview] | Median Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS) |
NCT00006436 (16) [back to overview] | Percentage of Participants With CR/CRu Lasting 1 Year |
NCT00006436 (16) [back to overview] | Progression Free Survival at 1 Year |
NCT00006436 (16) [back to overview] | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0) |
NCT00006721 (6) [back to overview] | Overall Survival at 2 Years |
NCT00006721 (6) [back to overview] | Overall Survival at 5 Years |
NCT00006721 (6) [back to overview] | Objective Response (Confirmed and Unconfirmed Complete and Partial Responses) |
NCT00006721 (6) [back to overview] | Progression-free Survival at 5 Years |
NCT00006721 (6) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
NCT00006721 (6) [back to overview] | Progression-free Survival at 2 Years |
NCT00024167 (2) [back to overview] | Overall Survival From Registration |
NCT00024167 (2) [back to overview] | Overall Survival From Randomization |
NCT00025259 (4) [back to overview] | Disease Response Assessed by Modified RECIST Criteria |
NCT00025259 (4) [back to overview] | Event-free Survival |
NCT00025259 (4) [back to overview] | Overall Survival |
NCT00025259 (4) [back to overview] | Grade 3 or 4 Non-hematologic Toxicity |
NCT00026208 (7) [back to overview] | Early Treatment-related Toxicity |
NCT00026208 (7) [back to overview] | Second Hodgkin's Disease Progression |
NCT00026208 (7) [back to overview] | Late Treatment-related Toxicity |
NCT00026208 (7) [back to overview] | Survival at 5 and 10 Years |
NCT00026208 (7) [back to overview] | Progression-free Survival (PFS) |
NCT00026208 (7) [back to overview] | Overall Survival (OS) |
NCT00026208 (7) [back to overview] | Frequency of Complete Response |
NCT00033293 (5) [back to overview] | Number of Responders |
NCT00033293 (5) [back to overview] | Tumor Outcome in Terms of Overall Survival (OS) Rate |
NCT00033293 (5) [back to overview] | Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death |
NCT00033293 (5) [back to overview] | Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing |
NCT00033293 (5) [back to overview] | Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS) |
NCT00039130 (3) [back to overview] | 2 Year Overall Survival |
NCT00039130 (3) [back to overview] | 2 Year Event Free Survival |
NCT00039130 (3) [back to overview] | Complete Response Rate |
NCT00039195 (1) [back to overview] | Progression Free Survival |
NCT00040937 (2) [back to overview] | Overall Survival |
NCT00040937 (2) [back to overview] | Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen. |
NCT00043979 (14) [back to overview] | Early Post Transplantation Relapse |
NCT00043979 (14) [back to overview] | Median Time to Reach Absolute Neutrophil Count of 500/mm(3) |
NCT00043979 (14) [back to overview] | Median Progression Free Survival |
NCT00043979 (14) [back to overview] | Median Time to Reach a Platelet Count of 50,000/mm(3) |
NCT00043979 (14) [back to overview] | Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant |
NCT00043979 (14) [back to overview] | Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy |
NCT00043979 (14) [back to overview] | Number of Participants With Acute and Chronic GVHD |
NCT00043979 (14) [back to overview] | Cluster of Differentiation 4 (CD4) Reconstitution |
NCT00043979 (14) [back to overview] | Number of Participants to Complete Conversion to >95% Donor Chimerism |
NCT00043979 (14) [back to overview] | Median Survival From Date of Progression |
NCT00043979 (14) [back to overview] | Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin) |
NCT00043979 (14) [back to overview] | Toxicity |
NCT00043979 (14) [back to overview] | Number of Participants With Engraftment |
NCT00043979 (14) [back to overview] | Number of Participants Who Experienced Graft Versus Tumor Effect (GVT) |
NCT00049036 (1) [back to overview] | Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment |
NCT00051311 (9) [back to overview] | Median Cycles of Induction Chemotherapy With Fludarabine, Cyclophosphamide, Etoposide, Doxorubicin, Vincristine, and Prednisone Given to Recipients |
NCT00051311 (9) [back to overview] | Median Time to Neutrophil Recovery |
NCT00051311 (9) [back to overview] | Number of Recipients With a Response to Reduced-intensity Stem Cell Transplantation (RIST) |
NCT00051311 (9) [back to overview] | Number of Recipients Who Developed Grades I-IV Acute Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis |
NCT00051311 (9) [back to overview] | Percentage of Recipients Who Achieved Donor Chimerism at Day +14 |
NCT00051311 (9) [back to overview] | Number of Recipients With Non-serious Adverse Events |
NCT00051311 (9) [back to overview] | Number of Recipients Who Developed Chronic Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis |
NCT00051311 (9) [back to overview] | Number of Recipients Evaluable Who Achieved Full Donor Chimerism at Day+100 |
NCT00051311 (9) [back to overview] | Median Time to Platelet Recovery |
NCT00054665 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00054665 (2) [back to overview] | Clinical Response Rate |
NCT00057811 (4) [back to overview] | Minimal Residual Disease |
NCT00057811 (4) [back to overview] | Response Rate |
NCT00057811 (4) [back to overview] | Grade ≥ 3 Stomatitis |
NCT00057811 (4) [back to overview] | Toxic Death |
NCT00058422 (1) [back to overview] | Incidence of Adverse Experiences |
NCT00059839 (1) [back to overview] | Event-free Survival (EFS) |
NCT00060346 (1) [back to overview] | Objective Response to Treatment |
NCT00066469 (1) [back to overview] | Event-free Survival |
NCT00069238 (2) [back to overview] | Maximum Tolerated Dose (MTD) of Alemtuzumab |
NCT00069238 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00070018 (1) [back to overview] | Progression-free Survival |
NCT00074490 (4) [back to overview] | Percentage of Patients With Opportunistic Infection |
NCT00074490 (4) [back to overview] | Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD) |
NCT00074490 (4) [back to overview] | Percentage of Patients to Receive T Cell Infusion |
NCT00074490 (4) [back to overview] | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0) |
NCT00075725 (7) [back to overview] | Correlation of Early Marrow Response Status With MRD Negative. |
NCT00075725 (7) [back to overview] | Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions |
NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS) |
NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS) |
NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS). |
NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS). |
NCT00075725 (7) [back to overview] | Correlation of Early Marrow Response Status With MRD Positive. |
NCT00088530 (4) [back to overview] | Overall Response Rate (ORR) Lasting at Least 4 Months |
NCT00088530 (4) [back to overview] | Overall Survival |
NCT00088530 (4) [back to overview] | Progression-Free Survival (PFS) |
NCT00088530 (4) [back to overview] | Complete Response (CR) and Complete Response Unconfirmed (CRu) |
NCT00088881 (4) [back to overview] | Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™. |
NCT00088881 (4) [back to overview] | Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™. |
NCT00088881 (4) [back to overview] | 3-year Overall Survival (OS) Rate |
NCT00088881 (4) [back to overview] | 3-year Time to Treatment Failure (TTF) Rate |
NCT00089609 (6) [back to overview] | Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA) |
NCT00089609 (6) [back to overview] | Time to Progression Using Bubley Criteria |
NCT00089609 (6) [back to overview] | Number of Participants With Adverse Events |
NCT00089609 (6) [back to overview] | Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level |
NCT00089609 (6) [back to overview] | Number of Participants Who Had a Prostate-specific Antigen (PSA) Response |
NCT00089609 (6) [back to overview] | Number of Participants Who Died After a Follow Up of 34 Months Following Treatment |
NCT00097448 (1) [back to overview] | Hearing Improvement |
NCT00098839 (4) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% |
NCT00098839 (4) [back to overview] | Remission Re-induction (CR2) Rate |
NCT00098839 (4) [back to overview] | Event-free Survival Rate |
NCT00098839 (4) [back to overview] | Pharmacokinetics |
NCT00101010 (2) [back to overview] | Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses |
NCT00101010 (2) [back to overview] | Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses |
NCT00101101 (3) [back to overview] | Median Event Free Survival (EFS) |
NCT00101101 (3) [back to overview] | Rate of Immunological Response to Vaccination |
NCT00101101 (3) [back to overview] | Occurrence of Related Serious Adverse Events (SAEs) |
NCT00104299 (8) [back to overview] | Disease Remission |
NCT00104299 (8) [back to overview] | Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization |
NCT00104299 (8) [back to overview] | Number of Subjects Experiencing Serious Adverse Events |
NCT00104299 (8) [back to overview] | Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy |
NCT00104299 (8) [back to overview] | The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups |
NCT00104299 (8) [back to overview] | The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups |
NCT00104299 (8) [back to overview] | Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups |
NCT00104299 (8) [back to overview] | Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups |
NCT00107198 (5) [back to overview] | Event-free Survival |
NCT00107198 (5) [back to overview] | Grade 3 or 4 Toxicity |
NCT00107198 (5) [back to overview] | Cure by Surgery Alone in Stage I Resected Patients |
NCT00107198 (5) [back to overview] | Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients |
NCT00107198 (5) [back to overview] | Failure-free Survival (FFS) |
NCT00107380 (3) [back to overview] | Response Rate (Complete, Complete Unconfirmed, and Partial) |
NCT00107380 (3) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
NCT00107380 (3) [back to overview] | Progression-free Survival (PFS) at 2 Years |
NCT00109473 (8) [back to overview] | Crohn's Disease Endoscopic Index of Severity (CDEIS) |
NCT00109473 (8) [back to overview] | Crohn's Disease Histologic Index of Severity (CDHIS) |
NCT00109473 (8) [back to overview] | Fecal Calprotectin |
NCT00109473 (8) [back to overview] | Pediatric Crohn's Disease Activity Index (PCDAI) |
NCT00109473 (8) [back to overview] | Serum IGF-1 (Insulin-like Growth Factor 1)z Score |
NCT00109473 (8) [back to overview] | Total Corticosteroid Use |
NCT00109473 (8) [back to overview] | IMPACT III Score |
NCT00109473 (8) [back to overview] | Height Velocity |
NCT00109837 (2) [back to overview] | Continuous Complete Remission at 1 Year |
NCT00109837 (2) [back to overview] | Toxicity |
NCT00110214 (4) [back to overview] | Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline |
NCT00110214 (4) [back to overview] | Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities |
NCT00110214 (4) [back to overview] | Progression-free Survival (PFS) |
NCT00110214 (4) [back to overview] | Overall Survival |
NCT00118209 (3) [back to overview] | Progression-Free Survival Rate at 2 and 5 Years |
NCT00118209 (3) [back to overview] | Overall Survival Rate at 2 and 5 Years |
NCT00118209 (3) [back to overview] | Response Rate |
NCT00119678 (23) [back to overview] | OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) |
NCT00119678 (23) [back to overview] | OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine |
NCT00119678 (23) [back to overview] | OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides |
NCT00119678 (23) [back to overview] | OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total) |
NCT00119678 (23) [back to overview] | Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs |
NCT00119678 (23) [back to overview] | OL; Number of Participants With Significant AEs of Special Interest |
NCT00119678 (23) [back to overview] | OL; Number of Participants With MAs in Urinalysis |
NCT00119678 (23) [back to overview] | OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment |
NCT00119678 (23) [back to overview] | DB; Median Number of Days to the First Occurrence of a New SLE Flare |
NCT00119678 (23) [back to overview] | DB; Number of Participants With a New SLE Flare During the Initial 6 Months |
NCT00119678 (23) [back to overview] | DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment |
NCT00119678 (23) [back to overview] | Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare |
NCT00119678 (23) [back to overview] | DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs |
NCT00119678 (23) [back to overview] | DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline |
NCT00119678 (23) [back to overview] | DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count |
NCT00119678 (23) [back to overview] | DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) |
NCT00119678 (23) [back to overview] | DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides |
NCT00119678 (23) [back to overview] | DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total) |
NCT00119678 (23) [back to overview] | DB; Number of Participants With MAs in Urinalysis |
NCT00119678 (23) [back to overview] | DB; Number of Participants With Significant AEs of Special Interest |
NCT00119678 (23) [back to overview] | DB; Total Number of New SLE Flares Each Participant Experienced |
NCT00119678 (23) [back to overview] | DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine |
NCT00119678 (23) [back to overview] | OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count |
NCT00121199 (4) [back to overview] | Progression-free Survival at 1 Year |
NCT00121199 (4) [back to overview] | Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)) |
NCT00121199 (4) [back to overview] | Progression-free Survival at 2 Year |
NCT00121199 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
NCT00132301 (1) [back to overview] | Number of Participants With Progression-Free Survival |
NCT00133991 (5) [back to overview] | Percentage of Participants Experiencing Grade 3-5 Toxicity |
NCT00133991 (5) [back to overview] | Event-free Survival |
NCT00133991 (5) [back to overview] | Overall Response Rate |
NCT00133991 (5) [back to overview] | Overall Survival |
NCT00133991 (5) [back to overview] | Relapse Pattern |
NCT00134056 (7) [back to overview] | Compare Qualitative and Quantitative Toxicity Between the Two Study Arms |
NCT00134056 (7) [back to overview] | Number of Patients With a Change in Functional Status |
NCT00134056 (7) [back to overview] | Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI) |
NCT00134056 (7) [back to overview] | Compare Pain Progression Between the Two Study Arms. |
NCT00134056 (7) [back to overview] | Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. |
NCT00134056 (7) [back to overview] | Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm. |
NCT00134056 (7) [back to overview] | Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. |
NCT00135694 (8) [back to overview] | Number of Participants Who Qualify for Random Assignment |
NCT00135694 (8) [back to overview] | Total Immunosuppression From Month 21 to Month 24 Post-randomization |
NCT00135694 (8) [back to overview] | Number of Hepatitis C Infected Participants With Progression of Hepatitis C Related Liver Disease, Defined as Stage 4 or Higher Fibrosis on the Ishak Scale |
NCT00135694 (8) [back to overview] | Immunosuppression-free Duration |
NCT00135694 (8) [back to overview] | Number of Participants Experiencing Graft Loss or Death |
NCT00135694 (8) [back to overview] | Total Burden of Immunosuppression From Random Assignment to Month 24 |
NCT00135694 (8) [back to overview] | Number of Participants With Clinical Complications Usually Attributed to Immunosuppression |
NCT00135694 (8) [back to overview] | Number of Participants Who Successfully Stop Taking Immunosuppression for at Least 6 Months |
NCT00136084 (7) [back to overview] | Relationship of Inhibition of DNA Synthesis and Clinical Response |
NCT00136084 (7) [back to overview] | To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy |
NCT00136084 (7) [back to overview] | To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy |
NCT00136084 (7) [back to overview] | Minimal Residual Disease (MRD). |
NCT00136084 (7) [back to overview] | Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO) |
NCT00136084 (7) [back to overview] | Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO |
NCT00136084 (7) [back to overview] | Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO. |
NCT00137111 (7) [back to overview] | Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells |
NCT00137111 (7) [back to overview] | Overall Event-free Survival (EFS) |
NCT00137111 (7) [back to overview] | Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours). |
NCT00137111 (7) [back to overview] | Continuous Complete Remission Since Week 56 Therapy. |
NCT00137111 (7) [back to overview] | Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours) |
NCT00137111 (7) [back to overview] | Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells |
NCT00137111 (7) [back to overview] | Minimal Residual Disease (MRD) |
NCT00137436 (13) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale) |
NCT00137436 (13) [back to overview] | Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G) |
NCT00137436 (13) [back to overview] | Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC |
NCT00137436 (13) [back to overview] | Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC |
NCT00137436 (13) [back to overview] | Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2 |
NCT00137436 (13) [back to overview] | Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3 |
NCT00137436 (13) [back to overview] | Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2 |
NCT00137436 (13) [back to overview] | Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3 |
NCT00137436 (13) [back to overview] | Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5) |
NCT00137436 (13) [back to overview] | Duration of PSA Response (DPR) |
NCT00137436 (13) [back to overview] | Percentage of Participants With Objective Response Rate (ORR) |
NCT00137436 (13) [back to overview] | Time to PSA Progression |
NCT00137436 (13) [back to overview] | Percentage of Participants With Prostate Specific Antigen (PSA) Response |
NCT00137969 (8) [back to overview] | Time to First Moderate or Severe Flare |
NCT00137969 (8) [back to overview] | Number of Participants Who Achieved an MCR in The ITT Population |
NCT00137969 (8) [back to overview] | Number of Participants Who Achieved an MCR (Excluding PCR) |
NCT00137969 (8) [back to overview] | Number of Participants Who Achieved a BILAG C or Better in All Domains |
NCT00137969 (8) [back to overview] | Change in SLE Expanded Health Survey Physical Function Score From Baseline |
NCT00137969 (8) [back to overview] | Number of Participants Who Achieved a PCR (Including MCR) |
NCT00137969 (8) [back to overview] | Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period |
NCT00137969 (8) [back to overview] | Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period |
NCT00141037 (2) [back to overview] | Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation |
NCT00141037 (2) [back to overview] | The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation |
NCT00146640 (8) [back to overview] | Relative Change From Baseline in Quality of Sleep at Week 12 |
NCT00146640 (8) [back to overview] | Relative Change From Baseline in Pain Intensity at Week 12 |
NCT00146640 (8) [back to overview] | Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 |
NCT00146640 (8) [back to overview] | Relative Change From Baseline in Duration of Morning Stiffness at Week 12 |
NCT00146640 (8) [back to overview] | Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12 |
NCT00146640 (8) [back to overview] | Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12 |
NCT00146640 (8) [back to overview] | Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12 |
NCT00146640 (8) [back to overview] | Percentage of Participants With Recurrence of Joint Stiffness at Week 12 |
NCT00149994 (1) [back to overview] | Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation. |
NCT00151281 (4) [back to overview] | Overall Survival and Progression Free Survival |
NCT00151281 (4) [back to overview] | Asses the Toxicity Profiles |
NCT00151281 (4) [back to overview] | The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment |
NCT00151281 (4) [back to overview] | Dynamic Levels of Plasma VEGF |
NCT00154284 (4) [back to overview] | Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up |
NCT00154284 (4) [back to overview] | Calculated Creatinine Clearance at 6 Month and 12 Month |
NCT00154284 (4) [back to overview] | Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula) |
NCT00154284 (4) [back to overview] | Serum Creatinine at Month 6 and 12 |
NCT00157014 (36) [back to overview] | Mean Cases of Acute Rejection (MCAR) Per Patient |
NCT00157014 (36) [back to overview] | The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population) |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen |
NCT00157014 (36) [back to overview] | Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population) |
NCT00157014 (36) [back to overview] | Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection |
NCT00157014 (36) [back to overview] | Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population) |
NCT00157014 (36) [back to overview] | Number of Cardiac Rejection Episodes Requiring Treatment |
NCT00157014 (36) [back to overview] | Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population) |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM |
NCT00157014 (36) [back to overview] | Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population) |
NCT00157014 (36) [back to overview] | Time to First Acute Rejection Episode Following de Novo Cardiac Transplant |
NCT00157014 (36) [back to overview] | Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population) |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population) |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1 |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6 |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18 |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population) |
NCT00157014 (36) [back to overview] | Number of Patients With Treatment Failure and Crossover for Treatment Failure |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP |
NCT00157014 (36) [back to overview] | Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population) |
NCT00157014 (36) [back to overview] | The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies |
NCT00157014 (36) [back to overview] | Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population) |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population) |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T |
NCT00157014 (36) [back to overview] | Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars |
NCT00157014 (36) [back to overview] | Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria |
NCT00157014 (36) [back to overview] | Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population) |
NCT00184002 (2) [back to overview] | Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability |
NCT00184002 (2) [back to overview] | Percentage of Patients With Complete Response to the Combination Chemotherapy |
NCT00193479 (1) [back to overview] | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
NCT00194987 (3) [back to overview] | Number of Newborns With a Birth Platelet Count > 50,000/uL |
NCT00194987 (3) [back to overview] | Number of Fetal Platelet Counts > 50,000/uL |
NCT00194987 (3) [back to overview] | Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study |
NCT00195429 (2) [back to overview] | Creatinine Clearance Rate |
NCT00195429 (2) [back to overview] | Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. |
NCT00203047 (4) [back to overview] | Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions |
NCT00203047 (4) [back to overview] | Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method |
NCT00203047 (4) [back to overview] | Cumulative Number of Enhancing Lesions at Months 12, 24 and 36 |
NCT00203047 (4) [back to overview] | Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions |
NCT00204737 (9) [back to overview] | Change in Salivary Cortisol (First 6 Participants) |
NCT00204737 (9) [back to overview] | Number of Other Adverse Events |
NCT00204737 (9) [back to overview] | Number of Participants Achieving CAPS Response |
NCT00204737 (9) [back to overview] | Change in Clinical Global Impression Severity (CGI-S) Score |
NCT00204737 (9) [back to overview] | Change in Clinician-Administered PTSD Scale (CAPS) |
NCT00204737 (9) [back to overview] | Change in Dehydroepiandrosterone Sulfate (DHEA-S) |
NCT00204737 (9) [back to overview] | Change in Hamilton Depression Rating Scale (HAM-D) |
NCT00204737 (9) [back to overview] | Change in PCL-PTSD Score |
NCT00204737 (9) [back to overview] | Change in Salivary Cortisol (Last 6 Participants) |
NCT00211185 (9) [back to overview] | Progression-Free Survival |
NCT00211185 (9) [back to overview] | Percentage of Participants With Overall Survival |
NCT00211185 (9) [back to overview] | Duration of Response |
NCT00211185 (9) [back to overview] | Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants |
NCT00211185 (9) [back to overview] | Summary of All Treatment-Related Adverse Events by Frequency in Greater Than 10% of Treated Participants |
NCT00211185 (9) [back to overview] | Overall Response in the Intent To Treat (ITT) Population |
NCT00211185 (9) [back to overview] | Overall Response in the Efficacy Analyzable (EA) Population |
NCT00211185 (9) [back to overview] | Summary of Treatment-Related Adverse Events Greater Than or Equal to Grade 3 by System Organ Class |
NCT00211185 (9) [back to overview] | Summary of Study Drug-Related (Possible, Probable, or Definite) Serious Adverse Events |
NCT00217425 (3) [back to overview] | 3-Year Overall Survival |
NCT00217425 (3) [back to overview] | 12-Month Progression-Free Survival (PFS) |
NCT00217425 (3) [back to overview] | Overall Response Rate |
NCT00227591 (1) [back to overview] | Overall Response Rate |
NCT00274924 (2) [back to overview] | 5-year Overall Survival |
NCT00274924 (2) [back to overview] | 2-year Progression-Free Survival (PFS) |
NCT00275509 (3) [back to overview] | 6-month Cumulative Rejection Incidence (Either CMR, AMR or Both) |
NCT00275509 (3) [back to overview] | 6-month Acute Cellular-mediated Rejection Rate (CMR) |
NCT00275509 (3) [back to overview] | 6-month Acute Antibody-mediated Rejection Rate (AMR) |
NCT00282347 (9) [back to overview] | Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52 |
NCT00282347 (9) [back to overview] | Change From Baseline in Anti-double-stranded DNA at Week 52 |
NCT00282347 (9) [back to overview] | British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks |
NCT00282347 (9) [back to overview] | Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52 |
NCT00282347 (9) [back to overview] | Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52 |
NCT00282347 (9) [back to overview] | Change From Baseline in C3 and C4 Complement Levels at Week 52 |
NCT00282347 (9) [back to overview] | Time to Achieve a Complete Renal Response |
NCT00282347 (9) [back to overview] | Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52 |
NCT00282347 (9) [back to overview] | Percentage of Participants Who Achieved a Complete Renal Response at Week 52 |
NCT00284934 (4) [back to overview] | Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR) |
NCT00284934 (4) [back to overview] | Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months |
NCT00284934 (4) [back to overview] | Number of Participants With Graft and Patient Survivals at 6 Months |
NCT00284934 (4) [back to overview] | Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR) |
NCT00288080 (6) [back to overview] | Incidence of Adverse Events |
NCT00288080 (6) [back to overview] | Overall Survival |
NCT00288080 (6) [back to overview] | Local Control |
NCT00288080 (6) [back to overview] | Distant Metastasis |
NCT00288080 (6) [back to overview] | Disease-free Survival |
NCT00288080 (6) [back to overview] | Biochemical Control |
NCT00288626 (20) [back to overview] | Survival From MS-Related Mortality |
NCT00288626 (20) [back to overview] | Survival From Treatment-Related Mortality |
NCT00288626 (20) [back to overview] | Percent of Participants Who Experienced All-Cause Morbidity Within 12 Months of Post-HCT |
NCT00288626 (20) [back to overview] | Percent of Participants Who Experienced All-Cause Morbidity |
NCT00288626 (20) [back to overview] | Overall Survival |
NCT00288626 (20) [back to overview] | Event-Free Survival Probability During the 5 Years After Transplant |
NCT00288626 (20) [back to overview] | Number of New T2-Weighted Lesions From Baseline |
NCT00288626 (20) [back to overview] | Event-Free Survival Probability During the 3 Years After Transplant |
NCT00288626 (20) [back to overview] | Percent Change From Screening in Brain Volume |
NCT00288626 (20) [back to overview] | MS Relapse-Free Survival Probability After Transplant |
NCT00288626 (20) [back to overview] | MS Progression-Free Survival Probability After Transplant |
NCT00288626 (20) [back to overview] | MRI Activity-Free Survival Probability After Transplant |
NCT00288626 (20) [back to overview] | Event-Free Survival Probability After Transplant |
NCT00288626 (20) [back to overview] | Disease-Modifying Therapy Survival Probability After Transplant |
NCT00288626 (20) [back to overview] | Change From Baseline in T2-Weighted Lesion Volume |
NCT00288626 (20) [back to overview] | Change From Baseline in T1-Weighted Lesion Volume |
NCT00288626 (20) [back to overview] | Change From Baseline in Number of Gadolinium-Enhanced Lesions |
NCT00288626 (20) [back to overview] | Change From Baseline in Extended Disability Status Scale (EDSS) |
NCT00288626 (20) [back to overview] | Time to Neutrophil Engraftment |
NCT00288626 (20) [back to overview] | Time to Platelet Engraftment |
NCT00290498 (2) [back to overview] | Response Rate R-HCVAD vs. R-CHOP |
NCT00290498 (2) [back to overview] | Progression Free Survival (Rate) |
NCT00294658 (29) [back to overview] | Time-Weighted Average MG Activity of Daily Living (MG-ADL) |
NCT00294658 (29) [back to overview] | Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years |
NCT00294658 (29) [back to overview] | Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine) |
NCT00294658 (29) [back to overview] | Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine) |
NCT00294658 (29) [back to overview] | Number of Serious Adverse Events |
NCT00294658 (29) [back to overview] | Number of Patients With at Least One Serious Adverse Events |
NCT00294658 (29) [back to overview] | Intravenous Immunoglobulin Use |
NCT00294658 (29) [back to overview] | Cumulative Number of Hospital Days |
NCT00294658 (29) [back to overview] | Cumulative Days in Hospital for Myasthenia Gravis Exacerbation |
NCT00294658 (29) [back to overview] | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment |
NCT00294658 (29) [back to overview] | Azathioprine Use |
NCT00294658 (29) [back to overview] | Treatment Associated Symptoms (TAS) |
NCT00294658 (29) [back to overview] | Hospitalization for Exacerbation of Myasthenia Gravis |
NCT00294658 (29) [back to overview] | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset |
NCT00294658 (29) [back to overview] | Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset |
NCT00294658 (29) [back to overview] | Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex |
NCT00294658 (29) [back to overview] | Short Form-36 Standardized Physical Component |
NCT00294658 (29) [back to overview] | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex |
NCT00294658 (29) [back to overview] | Short Form-36 Standardized Mental Component |
NCT00294658 (29) [back to overview] | Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term |
NCT00294658 (29) [back to overview] | Minimal Manifestation (MM) Status at Month 12, 24 and 36 |
NCT00294658 (29) [back to overview] | Classification of Serious Adverse Events |
NCT00294658 (29) [back to overview] | Plasma Exchange Use |
NCT00294658 (29) [back to overview] | Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years |
NCT00294658 (29) [back to overview] | Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg) |
NCT00294658 (29) [back to overview] | Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36 |
NCT00294658 (29) [back to overview] | Cumulative Days in Hospital for Myasthenia Gravis Exacerbation |
NCT00294658 (29) [back to overview] | Treatment Associated Complications (TAC) |
NCT00294658 (29) [back to overview] | Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment |
NCT00295932 (2) [back to overview] | Maximum Tolerated Dose |
NCT00295932 (2) [back to overview] | Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma |
NCT00296244 (6) [back to overview] | New-onset Diabetes Mellitus (NODM) as Secondary Outcome |
NCT00296244 (6) [back to overview] | Infection as an Adverse Effect of Steroids |
NCT00296244 (6) [back to overview] | Incidence and Severity of HCV Recurrence Post-OLT |
NCT00296244 (6) [back to overview] | Patient Survival Rate |
NCT00296244 (6) [back to overview] | Graft Survival Rate |
NCT00296244 (6) [back to overview] | Acute Rejection Rate |
NCT00301821 (4) [back to overview] | Progression-free Survival (PFS) |
NCT00301821 (4) [back to overview] | Overall Survival |
NCT00301821 (4) [back to overview] | Overall Response Rate (ORR) |
NCT00301821 (4) [back to overview] | Event-free Survival After 12 Months |
NCT00302003 (4) [back to overview] | Intensive Therapy Free Survival (ITFS). |
NCT00302003 (4) [back to overview] | Event Free Survival (EFS) |
NCT00302003 (4) [back to overview] | Overall Survival |
NCT00302003 (4) [back to overview] | Event Free Survival Without Receiving Radiation Therapy (EFSnoRT). |
NCT00306670 (1) [back to overview] | To Evaluate the Total Number of Circulating Lymphocytes and Lymphocyte Phenotypes and to Correlate With the Effectiveness of Rituximab and Oral Cyclophosphamide to Achieve and Preserve Complete Eradication of the Refractory Autoantibody. |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Number of Participants Who Used Anti-hypertensive Medications |
NCT00311311 (21) [back to overview] | Number of Participants Who Used Lipid Lowering Therapies |
NCT00311311 (21) [back to overview] | Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant |
NCT00311311 (21) [back to overview] | CIMT at Pre-conversion Baseline |
NCT00311311 (21) [back to overview] | TPV at Pre-conversion Baseline |
NCT00311311 (21) [back to overview] | Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant |
NCT00311311 (21) [back to overview] | Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant |
NCT00311311 (21) [back to overview] | Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant |
NCT00313781 (6) [back to overview] | Total Number of Circulation Tumor Cells (CTCs) |
NCT00313781 (6) [back to overview] | Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1) |
NCT00313781 (6) [back to overview] | Human Anti-human Antibody (HAHA) at the Last Follow-up Visit |
NCT00313781 (6) [back to overview] | Percentage of Participants With Prostate Specific Antigen (PSA) Best Response |
NCT00313781 (6) [back to overview] | Progression Free Survival (PFS) |
NCT00313781 (6) [back to overview] | Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs |
NCT00331344 (4) [back to overview] | Proportion Responding to Treatment With of the Combination of Ixabepilone and Mitoxantrone Hydrochloride With Prednisone in Hormone Refractory Prostate Cancer Patients Who Have Had Prior Taxane Chemotherapy Based Upon a PSA Decline of > 50% (Phase II) |
NCT00331344 (4) [back to overview] | Safety of the Combination of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I) |
NCT00331344 (4) [back to overview] | Time to Progression (Phase II) |
NCT00331344 (4) [back to overview] | Dose Limiting Toxicities for Each Dose Level of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I). |
NCT00337987 (2) [back to overview] | Number of Patients That Achieved a Complete Response (CR) |
NCT00337987 (2) [back to overview] | Number of Patients That Achieved a Complete Response or a Partial Response (PR) |
NCT00345046 (1) [back to overview] | Percent Change in Flare at Resolution |
NCT00348816 (2) [back to overview] | Progression-free Survival Based on PSA Progression |
NCT00348816 (2) [back to overview] | Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention. |
NCT00350545 (5) [back to overview] | Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial |
NCT00350545 (5) [back to overview] | Overall Survival |
NCT00350545 (5) [back to overview] | Number of Participants With Complete and/or Partial GVHD Response |
NCT00350545 (5) [back to overview] | Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation |
NCT00350545 (5) [back to overview] | Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose. |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems |
NCT00352027 (76) [back to overview] | 3-year Overall Survival (OS) Probability |
NCT00352027 (76) [back to overview] | 3-year Local Failure-free Survival Probability |
NCT00352027 (76) [back to overview] | 3-year Event-Free Survival Probability |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), Symptom Distress Scale |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.4.0: Total Score |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Worry |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Total Score |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Nausea |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication |
NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems |
NCT00352027 (76) [back to overview] | Disease Failure Rate Within Radiation Fields |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication |
NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry |
NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety |
NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Communication |
NCT00352027 (76) [back to overview] | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH) |
NCT00352027 (76) [back to overview] | 3-year Event-free Survival (EFS) Probability |
NCT00352027 (76) [back to overview] | Toxicities With Grade >1 |
NCT00352027 (76) [back to overview] | Prognostic Factors for Treatment Failure: Stage |
NCT00352027 (76) [back to overview] | Prognostic Factors for Treatment Failure: Histology |
NCT00352027 (76) [back to overview] | Prognostic Factors for Treatment Failure: Gender |
NCT00352027 (76) [back to overview] | Local and Distant Failure for Children Treated With Tailored-field Radiation |
NCT00352027 (76) [back to overview] | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function) |
NCT00352027 (76) [back to overview] | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram) |
NCT00352027 (76) [back to overview] | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram) |
NCT00352027 (76) [back to overview] | Prognostic Factors for Treatment Failure: Age |
NCT00352794 (1) [back to overview] | Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement) |
NCT00365274 (1) [back to overview] | Objective Response Rate (ORR) |
NCT00371826 (39) [back to overview] | Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Mean Serum Creatinine (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Erythropoietin Usage (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Erythropoietin Usage (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Any Wound Problems (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Employment Status (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Wound Problems(12 Months Analysis) |
NCT00371826 (39) [back to overview] | Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Mean Serum Creatinine (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Patient Survival and Graft Survival (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Patient Survival and Graft Survival (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Employment Status (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis) |
NCT00371826 (39) [back to overview] | Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis) |
NCT00374231 (3) [back to overview] | Patient Survival. |
NCT00374231 (3) [back to overview] | Time Post Transplant Corticosteroid Withdrawal |
NCT00374231 (3) [back to overview] | Incidence of Biopsy Confirmed Acute Rejection at 12 Months. |
NCT00376961 (4) [back to overview] | Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). |
NCT00376961 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
NCT00376961 (4) [back to overview] | 2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) |
NCT00376961 (4) [back to overview] | 2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) |
NCT00381680 (6) [back to overview] | Event Free Survival. EFS |
NCT00381680 (6) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 |
NCT00381680 (6) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3 |
NCT00381680 (6) [back to overview] | Adjusted Event Free Survival |
NCT00381680 (6) [back to overview] | Frequency and Severity of Adverse Effects |
NCT00381680 (6) [back to overview] | Event Free Survival (EFS) |
NCT00385827 (5) [back to overview] | Part 2: Progression Free Survival (PFS) |
NCT00385827 (5) [back to overview] | Number of Participants With Prostate Specific Antigen (PSA) Response |
NCT00385827 (5) [back to overview] | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT00385827 (5) [back to overview] | Time to Clinical Deterioration (TtCD) |
NCT00385827 (5) [back to overview] | Overall Survival (OS) |
NCT00388362 (2) [back to overview] | Clinical Activity |
NCT00388362 (2) [back to overview] | Overall Survival |
NCT00389818 (1) [back to overview] | Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI . |
NCT00393367 (12) [back to overview] | Serious Adverse Events |
NCT00393367 (12) [back to overview] | Number of Participants With Adverse Events (Non-serious). |
NCT00393367 (12) [back to overview] | Relapse / Readmission Numbers. |
NCT00393367 (12) [back to overview] | Oxygen Saturation. |
NCT00393367 (12) [back to overview] | Number of Subjects Remaining in the Severe Asthma Category |
NCT00393367 (12) [back to overview] | Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category |
NCT00393367 (12) [back to overview] | Number of Subjects Moving From the Severe Asthma to Mild Asthma Category |
NCT00393367 (12) [back to overview] | Number of Patients Hospitalized |
NCT00393367 (12) [back to overview] | Mean Change in Respiratory Rate. |
NCT00393367 (12) [back to overview] | Mean Change in Asthma Score at 2 Hours |
NCT00393367 (12) [back to overview] | Median Change in Asthma Score 2 Hours After Intervention |
NCT00393367 (12) [back to overview] | Change in Mean Heart Rate |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale |
NCT00405756 (28) [back to overview] | Time to First Response |
NCT00405756 (28) [back to overview] | Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC) |
NCT00405756 (28) [back to overview] | Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC) |
NCT00405756 (28) [back to overview] | Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC) |
NCT00405756 (28) [back to overview] | Kaplan Meier Estimates of Overall Survival (OS) |
NCT00405756 (28) [back to overview] | Kaplan Meier Estimates for Time to Next Antimyeloma Therapy |
NCT00405756 (28) [back to overview] | Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC) |
NCT00405756 (28) [back to overview] | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period |
NCT00405756 (28) [back to overview] | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale |
NCT00405756 (28) [back to overview] | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale |
NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort |
NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV) |
NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV) |
NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort |
NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV) |
NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV) |
NCT00408005 (8) [back to overview] | Cumulative Incidence of CNS Relapse for T-ALL by Risk Group |
NCT00408005 (8) [back to overview] | Cumulative Incidence of CNS Relapse for T-ALL by Risk Group |
NCT00413920 (6) [back to overview] | Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months |
NCT00413920 (6) [back to overview] | Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status |
NCT00413920 (6) [back to overview] | Number of Participants With Subclinical Histological Rejections |
NCT00413920 (6) [back to overview] | Number of Participants Requiring Steroids in Non-steroid Treatment Group |
NCT00413920 (6) [back to overview] | Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation |
NCT00413920 (6) [back to overview] | The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months |
NCT00417079 (8) [back to overview] | Time to Pain Progression |
NCT00417079 (8) [back to overview] | Time to Progression Free Survival (PFS) |
NCT00417079 (8) [back to overview] | Time to Prostatic Specific Antigen (PSA) Progression |
NCT00417079 (8) [back to overview] | Time to Tumor Progression |
NCT00417079 (8) [back to overview] | Pain Response |
NCT00417079 (8) [back to overview] | Overall Survival |
NCT00417079 (8) [back to overview] | Overall Tumor Response |
NCT00417079 (8) [back to overview] | PSA (Prostate-Specific Antigen) Response |
NCT00419926 (3) [back to overview] | Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit |
NCT00419926 (3) [back to overview] | Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death |
NCT00419926 (3) [back to overview] | Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death |
NCT00423098 (10) [back to overview] | Number of Patients With Complete Remission |
NCT00423098 (10) [back to overview] | Number of Patients With Complete Remission |
NCT00423098 (10) [back to overview] | Number of Patients With Adverse Events and Infections |
NCT00423098 (10) [back to overview] | Cumulative Dose of Prednisone Equivalent Corticosteroids (CS) |
NCT00423098 (10) [back to overview] | Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) |
NCT00423098 (10) [back to overview] | Number of Patients With Partial Remission |
NCT00423098 (10) [back to overview] | Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG) |
NCT00423098 (10) [back to overview] | Duration of Exposure to Study Medication |
NCT00423098 (10) [back to overview] | Number of Patients With Moderate to Severe Flares |
NCT00423098 (10) [back to overview] | Number of Patients With Treatment Failure |
NCT00424749 (2) [back to overview] | Participants With Remission of Renal Disease Activity at 3 Months |
NCT00424749 (2) [back to overview] | Participants With Normalization of Eosinophil Count at 6 Months |
NCT00430677 (42) [back to overview] | Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period |
NCT00430677 (42) [back to overview] | Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology) |
NCT00430677 (42) [back to overview] | Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period |
NCT00430677 (42) [back to overview] | Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period |
NCT00430677 (42) [back to overview] | Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period |
NCT00430677 (42) [back to overview] | Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period |
NCT00430677 (42) [back to overview] | Baseline Mental Component Summary of the Short SF-36 During Short-term Period |
NCT00430677 (42) [back to overview] | Baseline Quantitative Immunoglobulins During the Short-term Period |
NCT00430677 (42) [back to overview] | Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period |
NCT00430677 (42) [back to overview] | Baseline Renal Function Over Time During Short-term Period |
NCT00430677 (42) [back to overview] | Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period |
NCT00430677 (42) [back to overview] | Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period |
NCT00430677 (42) [back to overview] | Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period |
NCT00430677 (42) [back to overview] | Change in Quantitative Immunoglobulin From Baseline During Short-term Period |
NCT00430677 (42) [back to overview] | Change in Renal Function From Baseline Over Time During Short-term Period |
NCT00430677 (42) [back to overview] | Mean Change From Baseline in SLICC/ACR Damage Index |
NCT00430677 (42) [back to overview] | Number of Participants Achieving Complete Response by ACCESS Definition |
NCT00430677 (42) [back to overview] | Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis |
NCT00430677 (42) [back to overview] | Number of Participants Achieving Renal Response |
NCT00430677 (42) [back to overview] | Number of Participants With Death, Serious Adverse Events (SAE), Treatment-related Adverse Events SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs During Long-term Extension Period |
NCT00430677 (42) [back to overview] | Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period |
NCT00430677 (42) [back to overview] | Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) |
NCT00430677 (42) [back to overview] | Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) |
NCT00430677 (42) [back to overview] | Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period |
NCT00430677 (42) [back to overview] | Vital Signs Summary During the Short-term Period: Heart Rate |
NCT00430677 (42) [back to overview] | Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) |
NCT00430677 (42) [back to overview] | Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period |
NCT00430677 (42) [back to overview] | Participants With AEs of Special Interest During the Short-term Period |
NCT00430677 (42) [back to overview] | Participants With Marked Abnormalities Urinalysis During the Short-term Period |
NCT00430677 (42) [back to overview] | Participants With Marked Hematology Abnormalities During the Short-term Period |
NCT00430677 (42) [back to overview] | Participants With Marked Laboratory Abnormalities During the Short-term Period |
NCT00430677 (42) [back to overview] | Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period |
NCT00430677 (42) [back to overview] | Vital Signs Summary During the Short-term Period: Temperature |
NCT00430677 (42) [back to overview] | Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period |
NCT00430677 (42) [back to overview] | Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period |
NCT00430677 (42) [back to overview] | Change in SLICC/ACR Damage Index From Baseline During Short-term Period |
NCT00430677 (42) [back to overview] | Number of Months CRR Was Maintained During Short-term Period |
NCT00430677 (42) [back to overview] | Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period |
NCT00430677 (42) [back to overview] | Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period |
NCT00430677 (42) [back to overview] | Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period |
NCT00430677 (42) [back to overview] | Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period |
NCT00430677 (42) [back to overview] | Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) |
NCT00436956 (7) [back to overview] | Percent Probability of Participants With 6-month Progression-free Survival (PFS) |
NCT00436956 (7) [back to overview] | Number of Grade 3 Toxicities |
NCT00436956 (7) [back to overview] | Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) |
NCT00436956 (7) [back to overview] | Median Overall Survival |
NCT00436956 (7) [back to overview] | Number of Grade 2 Toxicities |
NCT00436956 (7) [back to overview] | Number of Participants With Adverse Events |
NCT00436956 (7) [back to overview] | Median Progression Free Survival (PFS) |
NCT00443430 (3) [back to overview] | Clinical Remission on Medication |
NCT00443430 (3) [back to overview] | Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events |
NCT00443430 (3) [back to overview] | Proportion of Participants Who Attain Inactive Disease by 6 Months |
NCT00450385 (1) [back to overview] | Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies. |
NCT00451178 (11) [back to overview] | PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS |
NCT00451178 (11) [back to overview] | Percentage of Participants With Complete Response (CR and CRu) and Objective Response [CR, CRu, and Partial Response (PR)] (Overall Response Rate) |
NCT00451178 (11) [back to overview] | Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died (Evaluate Toxicity and Tolerability of R-CHOP Plus Enzastaurin) |
NCT00451178 (11) [back to overview] | Progression-Free Survival (PFS) Time |
NCT00451178 (11) [back to overview] | Percentage of Participants With a PET-Negative Scan (PET-Negative Rate) |
NCT00451178 (11) [back to overview] | Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate) |
NCT00451178 (11) [back to overview] | Overall Survival (OS) |
NCT00451178 (11) [back to overview] | Event-Free Survival (EFS) |
NCT00451178 (11) [back to overview] | Duration of Complete Response (CR or CRu) |
NCT00451178 (11) [back to overview] | Percentage of Participants With Complete Response (CR/CRu) and/or Post-Baseline PET-Negative Scan (Concordance Between Response and PET Scan) |
NCT00451178 (11) [back to overview] | PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS |
NCT00452387 (3) [back to overview] | Median Overall Survival (OS) |
NCT00452387 (3) [back to overview] | Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging |
NCT00452387 (3) [back to overview] | Quality of Life (QoL) |
NCT00458848 (3) [back to overview] | Percentage of Participants Reaching Overall Survival |
NCT00458848 (3) [back to overview] | Number of Patients Reaching Complete Hematological Response After Induction Therapy |
NCT00458848 (3) [back to overview] | Percentage of Participants Reaching Disease Free Survival |
NCT00459186 (2) [back to overview] | Response Based on PET Scan |
NCT00459186 (2) [back to overview] | Number of Patients Free of Dose Limiting Toxicity |
NCT00463385 (10) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT00463385 (10) [back to overview] | Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment |
NCT00463385 (10) [back to overview] | Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment |
NCT00463385 (10) [back to overview] | Duration of First Clinical Response |
NCT00463385 (10) [back to overview] | Change From Baseline in Hemoglobin Concentration for Responders |
NCT00463385 (10) [back to overview] | Change From Baseline in Hemoglobin Concentration for Non-Responders |
NCT00463385 (10) [back to overview] | Change From Baseline in Likert Abdominal Pain Scale |
NCT00463385 (10) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores |
NCT00463385 (10) [back to overview] | Time to the First Clinical Response |
NCT00463385 (10) [back to overview] | Percentage of Participants With Clinical Response by Baseline JAK2 Assessment |
NCT00466440 (12) [back to overview] | Part 2: Progression Free Survival (PFS) |
NCT00466440 (12) [back to overview] | Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Docetaxel |
NCT00466440 (12) [back to overview] | Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Docetaxel |
NCT00466440 (12) [back to overview] | Prostate-Specific Androgen (PSA) Velocity at 2 Months |
NCT00466440 (12) [back to overview] | Prostate-Specific Androgen (PSA) Velocity at 3 Months |
NCT00466440 (12) [back to overview] | Part I: Pharmacokinetic (PK) Parameter: Maximum Observed Drug Concentration During a Dosing Interval at Steady State (Cmax,ss) of Enzastaurin, LSN326020, and Total Analyte (Enzastaurin + LSN326020) |
NCT00466440 (12) [back to overview] | Percentage of Participants Exhibiting a Decline in Prostate-Specific Androgen (PSA) From Baseline ≥30% Within First 3 Months of Treatment |
NCT00466440 (12) [back to overview] | Pharmacokinetic (PK) Parameter: Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin, LSN326020, and Total Analyte (Enzastaurin + LSN326020) |
NCT00466440 (12) [back to overview] | Part 2: Duration of Response |
NCT00466440 (12) [back to overview] | Part 2: Overall Survival (OS) |
NCT00466440 (12) [back to overview] | Part 2: Percentage of Participants With Objective Tumor Response (Response Rate) |
NCT00466440 (12) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT00472030 (5) [back to overview] | Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters. |
NCT00472030 (5) [back to overview] | Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24. |
NCT00472030 (5) [back to overview] | Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16 |
NCT00472030 (5) [back to overview] | Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab. |
NCT00472030 (5) [back to overview] | Decrease in Eosinophil Levels Following Treatment With Omalizumab. |
NCT00473746 (17) [back to overview] | Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate |
NCT00473746 (17) [back to overview] | Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score |
NCT00473746 (17) [back to overview] | Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate |
NCT00473746 (17) [back to overview] | Phase 2: Duration of Objective Response |
NCT00473746 (17) [back to overview] | Phase 2: Duration of PSA Response |
NCT00473746 (17) [back to overview] | Phase 2: Overall Survival |
NCT00473746 (17) [back to overview] | Phase 2: PSA Progression Free Survival (PSA-PFS) |
NCT00473746 (17) [back to overview] | Phase 2: Time to PSA Progression |
NCT00473746 (17) [back to overview] | Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate |
NCT00473746 (17) [back to overview] | Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate |
NCT00473746 (17) [back to overview] | Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate |
NCT00473746 (17) [back to overview] | Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA) |
NCT00473746 (17) [back to overview] | Phase 2: Radiographic Progression Free Survival (RAD-PFS) |
NCT00473746 (17) [back to overview] | Phase 2: Radiographic Objective Response Rate (RAD-ORR) |
NCT00473746 (17) [back to overview] | Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate |
NCT00473746 (17) [back to overview] | Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate |
NCT00473746 (17) [back to overview] | Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate |
NCT00477750 (5) [back to overview] | Patients With Overall Confirmed Response |
NCT00477750 (5) [back to overview] | Progression-free Survival |
NCT00477750 (5) [back to overview] | Percentage of Participants With Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) |
NCT00477750 (5) [back to overview] | Duration of Response (DOR) |
NCT00477750 (5) [back to overview] | Overall Survival (OS) at 3 Years |
NCT00485303 (9) [back to overview] | Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS) |
NCT00485303 (9) [back to overview] | Time to Radiographic Progression |
NCT00485303 (9) [back to overview] | Time to PSA Progression |
NCT00485303 (9) [back to overview] | Radiographic Progression Free Survival (PFS) |
NCT00485303 (9) [back to overview] | Percentage of Participants With Clinical Benefit |
NCT00485303 (9) [back to overview] | Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score |
NCT00485303 (9) [back to overview] | Percentage of Participants With Prostate Specific Antigen (PSA) Response |
NCT00485303 (9) [back to overview] | Overall Survival (OS) |
NCT00485303 (9) [back to overview] | Percentage of Participants With Objective Radiographic Response |
NCT00494780 (15) [back to overview] | Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab) |
NCT00494780 (15) [back to overview] | Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33 |
NCT00494780 (15) [back to overview] | Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) |
NCT00494780 (15) [back to overview] | Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab) |
NCT00494780 (15) [back to overview] | CL After the Sixth Infusion (Week 15, Visit 22) |
NCT00494780 (15) [back to overview] | AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22) |
NCT00494780 (15) [back to overview] | Duration of Response |
NCT00494780 (15) [back to overview] | Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22) |
NCT00494780 (15) [back to overview] | Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22 |
NCT00494780 (15) [back to overview] | Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion) |
NCT00494780 (15) [back to overview] | Number of Participants With Complete Remission (CR) at Visit 26 |
NCT00494780 (15) [back to overview] | Progression-Free Survival (PFS) |
NCT00494780 (15) [back to overview] | Time to New Anti-follicular Lymphoma (FL) Therapy |
NCT00494780 (15) [back to overview] | Vss at the Sixth Infusion (Week 15, Visit 22) |
NCT00494780 (15) [back to overview] | Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22) |
NCT00503984 (8) [back to overview] | Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone) |
NCT00503984 (8) [back to overview] | Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel) |
NCT00503984 (8) [back to overview] | Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy. |
NCT00503984 (8) [back to overview] | Progression-Free Survival (PFS) |
NCT00503984 (8) [back to overview] | Overall Survival (OS) |
NCT00503984 (8) [back to overview] | Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy. |
NCT00503984 (8) [back to overview] | Number of Participants Achieving Prostate-specific Antigen (PSA) Response. |
NCT00503984 (8) [back to overview] | Duration of Response |
NCT00507416 (8) [back to overview] | Duration of Response |
NCT00507416 (8) [back to overview] | Overall Survival |
NCT00507416 (8) [back to overview] | Percentage of Participants With a Complete Response |
NCT00507416 (8) [back to overview] | Percentage of Participants With a Complete Response or a Very Good Partial Response |
NCT00507416 (8) [back to overview] | Percentage of Participants With an Overall Response |
NCT00507416 (8) [back to overview] | Progression Free Survival (PFS) |
NCT00507416 (8) [back to overview] | Time to Alternative Therapy |
NCT00507416 (8) [back to overview] | Change From Baseline in EORTC QLQ-C30 - Global Health Status |
NCT00519285 (11) [back to overview] | Time to Skeletal Related Events |
NCT00519285 (11) [back to overview] | Tumor Response Rate in Participants With Measurable Disease |
NCT00519285 (11) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life |
NCT00519285 (11) [back to overview] | Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept |
NCT00519285 (11) [back to overview] | Number of Participants With Adverse Events as a Measure of Safety |
NCT00519285 (11) [back to overview] | Overall Survival Time |
NCT00519285 (11) [back to overview] | Pain Progression-free Survival Time |
NCT00519285 (11) [back to overview] | Pain Response Rate |
NCT00519285 (11) [back to overview] | Progression Free Survival Time |
NCT00519285 (11) [back to overview] | Prostate Specific Antigen Progression-free Survival Time |
NCT00519285 (11) [back to overview] | Prostate Specific Antigen Response Rate |
NCT00520468 (1) [back to overview] | Number of Participants With Response |
NCT00527124 (5) [back to overview] | 6-month Progression-free Survival (PFS) Proportion |
NCT00527124 (5) [back to overview] | Time to Progression |
NCT00527124 (5) [back to overview] | Overall Response Rate Evaluated by the RECIST Criteria |
NCT00527124 (5) [back to overview] | Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group |
NCT00527124 (5) [back to overview] | Overall Survival |
NCT00537381 (7) [back to overview] | Number of Participants With Prostate Specific Antigen (PSA) Response |
NCT00537381 (7) [back to overview] | Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration |
NCT00537381 (7) [back to overview] | Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration |
NCT00537381 (7) [back to overview] | Overall Survival |
NCT00537381 (7) [back to overview] | Number of Participants With Best Overall Response (OR) |
NCT00537381 (7) [back to overview] | Progression-Free Survival (PFS) |
NCT00537381 (7) [back to overview] | Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration |
NCT00540644 (3) [back to overview] | Quality of Life Using the FACT-G Data |
NCT00540644 (3) [back to overview] | Treatment Related Adverse Events Grade 3 or Higher |
NCT00540644 (3) [back to overview] | Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria |
NCT00544440 (2) [back to overview] | Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter) |
NCT00544440 (2) [back to overview] | Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter) |
NCT00549848 (6) [back to overview] | Probability of CNS Relapse |
NCT00549848 (6) [back to overview] | Probability of Event-free Survival |
NCT00549848 (6) [back to overview] | Probability of Overall Survival |
NCT00549848 (6) [back to overview] | Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase. |
NCT00549848 (6) [back to overview] | Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5% |
NCT00549848 (6) [back to overview] | Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01% |
NCT00550550 (4) [back to overview] | Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS |
NCT00550550 (4) [back to overview] | Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS |
NCT00550550 (4) [back to overview] | Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS) |
NCT00550550 (4) [back to overview] | Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS |
NCT00551291 (3) [back to overview] | Mean Number of Blood Transfusions Per Visit |
NCT00551291 (3) [back to overview] | Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement |
NCT00551291 (3) [back to overview] | Percentage of Participants With at Least One Adverse Event (AE) |
NCT00555464 (2) [back to overview] | Response of Hemangioma (IH) to Treatment |
NCT00555464 (2) [back to overview] | Toxicity to Medications |
NCT00557193 (10) [back to overview] | Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts |
NCT00557193 (10) [back to overview] | Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts |
NCT00557193 (10) [back to overview] | Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts |
NCT00557193 (10) [back to overview] | Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts |
NCT00557193 (10) [back to overview] | Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT) |
NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) for Patients on Arm A |
NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2) |
NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2 |
NCT00557193 (10) [back to overview] | Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm |
NCT00557193 (10) [back to overview] | Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy |
NCT00562159 (4) [back to overview] | Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS) |
NCT00562159 (4) [back to overview] | Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS |
NCT00562159 (4) [back to overview] | Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS |
NCT00562159 (4) [back to overview] | Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS |
NCT00562965 (7) [back to overview] | Percentage of Participants With Objective Response (OR) |
NCT00562965 (7) [back to overview] | Progression-Free Survival (PFS) |
NCT00562965 (7) [back to overview] | Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings |
NCT00562965 (7) [back to overview] | Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings |
NCT00562965 (7) [back to overview] | Number of Participants With Clinically Significant Change From Baseline in Vital Signs |
NCT00562965 (7) [back to overview] | Overall Survival Probability at Months 6, 12 and 24 |
NCT00562965 (7) [back to overview] | Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs) |
NCT00574496 (3) [back to overview] | Overall Survival |
NCT00574496 (3) [back to overview] | Progression-free Survival at 1 Year |
NCT00574496 (3) [back to overview] | Disease Relapse or Progression as Measured by CT Scan or PET |
NCT00577993 (2) [back to overview] | Number of Participants With Progression Free Survival (10 Years) by Treatment |
NCT00577993 (2) [back to overview] | Number of Participants With Overall Survival (10 Years) by Treatment |
NCT00580229 (3) [back to overview] | Adverse Infusion Reactions Within 24 Hours Following the Second Rituximab Infusion. |
NCT00580229 (3) [back to overview] | Adverse Events Assessed From Day 15 Through Week 26. |
NCT00580229 (3) [back to overview] | Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion |
NCT00588406 (2) [back to overview] | FEV1 Percent Predicted |
NCT00588406 (2) [back to overview] | Hospitalization |
NCT00602641 (4) [back to overview] | Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12 |
NCT00602641 (4) [back to overview] | Very Good Partial Response (VGPR) Rate |
NCT00602641 (4) [back to overview] | Progression-Free Survival (PFS) |
NCT00602641 (4) [back to overview] | Overall Survival |
NCT00608894 (3) [back to overview] | Biochemical Remission of (AIH) at Month 6. |
NCT00608894 (3) [back to overview] | Biochemical Remission by Month 3. |
NCT00608894 (3) [back to overview] | Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months |
NCT00623766 (9) [back to overview] | Overall Survival (OS) |
NCT00623766 (9) [back to overview] | Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC) |
NCT00623766 (9) [back to overview] | Disease Control Rate by Immune-related Response Criteria (irRC) |
NCT00623766 (9) [back to overview] | Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria |
NCT00623766 (9) [back to overview] | Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC) |
NCT00623766 (9) [back to overview] | Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate) |
NCT00623766 (9) [back to overview] | Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation |
NCT00623766 (9) [back to overview] | Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC) |
NCT00623766 (9) [back to overview] | Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC) |
NCT00633919 (5) [back to overview] | Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008 |
NCT00633919 (5) [back to overview] | Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008 |
NCT00633919 (5) [back to overview] | Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007 |
NCT00633919 (5) [back to overview] | Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008 |
NCT00633919 (5) [back to overview] | Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007 |
NCT00634179 (2) [back to overview] | An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria |
NCT00634179 (2) [back to overview] | Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I) |
NCT00634647 (3) [back to overview] | Progression Free Survival. |
NCT00634647 (3) [back to overview] | Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0) |
NCT00634647 (3) [back to overview] | Median Overall Survival (OS) |
NCT00634933 (12) [back to overview] | Visual Analogue Scale for Pain (VAS-pain) |
NCT00634933 (12) [back to overview] | Physician Global Assessment (PGA) of Disease Activity |
NCT00634933 (12) [back to overview] | Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 |
NCT00634933 (12) [back to overview] | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response |
NCT00634933 (12) [back to overview] | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response |
NCT00634933 (12) [back to overview] | Patient Global Assessment (PtGA) of Disease Activity |
NCT00634933 (12) [back to overview] | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response |
NCT00634933 (12) [back to overview] | Number of Tender Joints |
NCT00634933 (12) [back to overview] | Number of Swollen Joints |
NCT00634933 (12) [back to overview] | Health Assessment Questionnaire Disability Index (HAQ-DI) |
NCT00634933 (12) [back to overview] | Disease Activity Score Based on 28-joints Count (DAS28) |
NCT00634933 (12) [back to overview] | Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24 |
NCT00638690 (4) [back to overview] | Number of Patients Achieving a Prostate-Specific Antigen Decline >=50% |
NCT00638690 (4) [back to overview] | Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria |
NCT00638690 (4) [back to overview] | Overall Survival |
NCT00638690 (4) [back to overview] | Radiographic Progression-free Survival |
NCT00642018 (12) [back to overview] | Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate) |
NCT00642018 (12) [back to overview] | Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment |
NCT00642018 (12) [back to overview] | Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes) |
NCT00642018 (12) [back to overview] | Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms) |
NCT00642018 (12) [back to overview] | Estimate Overall Survival |
NCT00642018 (12) [back to overview] | Estimate Duration of Overall Response |
NCT00642018 (12) [back to overview] | Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses) |
NCT00642018 (12) [back to overview] | Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone |
NCT00642018 (12) [back to overview] | Percentage of Participants With Complete Response or Partial Response (Overall Response Rate) |
NCT00642018 (12) [back to overview] | Number of Participants With Adverse Events (Safety) |
NCT00642018 (12) [back to overview] | Adverse Event Profile |
NCT00642018 (12) [back to overview] | Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity) |
NCT00650078 (2) [back to overview] | ACR 20 Response Rate at Visit 4 |
NCT00650078 (2) [back to overview] | Relative Reduction of Morning Stiffness |
NCT00651040 (1) [back to overview] | The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment. |
NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group |
NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group |
NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group |
NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group |
NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group |
NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group |
NCT00667615 (2) [back to overview] | Complete Response Rate to Rituximab and a Combination of Vorinostat With Cyclophosphamide, Etoposide, and Prednisone in Elderly Pts With Relapsed Diffuse Large B-cell Lymphoma Who Aren't Candidates for Autologous Stem Cell Transplantation. |
NCT00667615 (2) [back to overview] | Maximum Tolerated Dose (MTD) of Vorinostat Given Orally for 10 Days in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma |
NCT00668434 (4) [back to overview] | Oswestry Disability Index, v2 |
NCT00668434 (4) [back to overview] | Oswestry Disability Index, v2 |
NCT00668434 (4) [back to overview] | Pain Numerical Rating Scale |
NCT00668434 (4) [back to overview] | Pain Numerical Rating Scale |
NCT00670358 (3) [back to overview] | Event-free > Survival at 12 Months (Phase 2, DLBCL/Mixed Dose Level 3) |
NCT00670358 (3) [back to overview] | Toxicity as Assessed by NCI CTCAE v3.0 (Phase I) |
NCT00670358 (3) [back to overview] | Progression-free > Survival at 24 Months (Phase 2, Transformed/Composite) |
NCT00671034 (9) [back to overview] | Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy) |
NCT00671034 (9) [back to overview] | Pharmacodynamics (PD) |
NCT00671034 (9) [back to overview] | Asparaginase Level |
NCT00671034 (9) [back to overview] | Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction |
NCT00671034 (9) [back to overview] | Percentage of Participants With Complete Remission at the End of Induction |
NCT00671034 (9) [back to overview] | Immunogenicity |
NCT00671034 (9) [back to overview] | Percentage of Participants With Event-free Survival (EFS) |
NCT00671034 (9) [back to overview] | Plasma and CSF Concentrations of Asparagine in ug/ml |
NCT00671034 (9) [back to overview] | Toxicities During Post Induction Intensification Therapy (All Grades) |
NCT00676650 (3) [back to overview] | Percent of Participants With Objective Response (OR) |
NCT00676650 (3) [back to overview] | Overall Survival (OS) |
NCT00676650 (3) [back to overview] | Progression-Free Survival (PFS) |
NCT00683475 (9) [back to overview] | Composite Progression-free Survival (cPFS) at 6-months |
NCT00683475 (9) [back to overview] | Composite Progression-free Survival (cPFS) at 12-months |
NCT00683475 (9) [back to overview] | Prostate Specific Antigen (PSA) Response Rate |
NCT00683475 (9) [back to overview] | Overall Survival (OS) |
NCT00683475 (9) [back to overview] | Composite Progression-free Survival (cPFS) |
NCT00683475 (9) [back to overview] | Objective Response Rate (ORR) |
NCT00683475 (9) [back to overview] | Composite Progression-free Survival (cPFS) at 9-months |
NCT00683475 (9) [back to overview] | Summary Listing of Participants Reporting Treatment-Emergent Adverse Events |
NCT00683475 (9) [back to overview] | Time to Radiographic Evidence of Disease Progression |
NCT00686335 (1) [back to overview] | Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment |
NCT00689936 (43) [back to overview] | Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) |
NCT00689936 (43) [back to overview] | Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review. |
NCT00689936 (43) [back to overview] | Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review |
NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis |
NCT00689936 (43) [back to overview] | Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review |
NCT00689936 (43) [back to overview] | Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis |
NCT00689936 (43) [back to overview] | Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review |
NCT00689936 (43) [back to overview] | Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis |
NCT00689936 (43) [back to overview] | Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis |
NCT00689936 (43) [back to overview] | Percentage of Participants With an Objective Response Based on IRAC Review |
NCT00689936 (43) [back to overview] | Time to First Response Based on the Investigator Assessment at the Time of Final Analysis |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Constipation Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain |
NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC |
NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Time to Treatment Failure (TTF) |
NCT00689936 (43) [back to overview] | Time to First Response Based on the Review by the IRAC |
NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis |
NCT00689936 (43) [back to overview] | Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT) |
NCT00689936 (43) [back to overview] | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. |
NCT00689936 (43) [back to overview] | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase |
NCT00689936 (43) [back to overview] | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase |
NCT00689936 (43) [back to overview] | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase |
NCT00689936 (43) [back to overview] | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase |
NCT00689936 (43) [back to overview] | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score |
NCT00689936 (43) [back to overview] | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale |
NCT00689936 (43) [back to overview] | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale |
NCT00689936 (43) [back to overview] | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale |
NCT00689936 (43) [back to overview] | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale |
NCT00689936 (43) [back to overview] | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Pain Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain |
NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain |
NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) |
NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis |
NCT00691704 (5) [back to overview] | Progression Free Survival |
NCT00691704 (5) [back to overview] | Overall Survival |
NCT00691704 (5) [back to overview] | Time to Response |
NCT00691704 (5) [back to overview] | Duration of Response |
NCT00691704 (5) [back to overview] | Time to Progression |
NCT00699803 (1) [back to overview] | Mean Aqueous Humor Prednisolone Acetate Concentration |
NCT00707759 (1) [back to overview] | Stimulation of Growth After 12 Months (Delta Z-score) |
NCT00713193 (2) [back to overview] | Time in Days to Achieve a Clinical Response, Comparing the CSA/PEX Arm to the Steroids/PEX Arm. |
NCT00713193 (2) [back to overview] | Number of Participants With Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm |
NCT00715208 (5) [back to overview] | Number of Patients Who Experienced at Least One Serious Adverse Event |
NCT00715208 (5) [back to overview] | Percentage of Participants With Progression-free Survival (PFS) at 1 Year |
NCT00715208 (5) [back to overview] | Number of Patients With Complete Response (CR) |
NCT00715208 (5) [back to overview] | Number of Participants With Overall Response (OR) |
NCT00715208 (5) [back to overview] | Duration of Response |
NCT00719472 (6) [back to overview] | Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study) |
NCT00719472 (6) [back to overview] | Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle) |
NCT00719472 (6) [back to overview] | Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8) |
NCT00719472 (6) [back to overview] | Duration of Rituximab Infusion Including Dose Interruption Times |
NCT00719472 (6) [back to overview] | Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1 |
NCT00719472 (6) [back to overview] | Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2 |
NCT00720109 (5) [back to overview] | Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events |
NCT00720109 (5) [back to overview] | Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation |
NCT00720109 (5) [back to overview] | Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy |
NCT00720109 (5) [back to overview] | Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib) |
NCT00720109 (5) [back to overview] | Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy |
NCT00722137 (11) [back to overview] | Overall Complete Response (CR + CRu) |
NCT00722137 (11) [back to overview] | Number of Participants Experiencing an Adverse Event (AE) |
NCT00722137 (11) [back to overview] | 18-Month Survival |
NCT00722137 (11) [back to overview] | Duration of Response |
NCT00722137 (11) [back to overview] | Treatment-free Interval (TFI) |
NCT00722137 (11) [back to overview] | Time to Progression (TTP) |
NCT00722137 (11) [back to overview] | Time to Next Anti-lymphoma Treatment (TTNT) |
NCT00722137 (11) [back to overview] | Progression Free Survival (PFS) |
NCT00722137 (11) [back to overview] | Overall Survival (OS) in Long Term Follow-up Period |
NCT00722137 (11) [back to overview] | Overall Survival (OS) |
NCT00722137 (11) [back to overview] | Overall Response Rate (ORR) |
NCT00734149 (3) [back to overview] | Median Duration of Response |
NCT00734149 (3) [back to overview] | Number of Patients With Any Grade or Severe Adverse Event |
NCT00734149 (3) [back to overview] | Response |
NCT00736450 (2) [back to overview] | Time to Perform Microarray Study After Receipt of Tissue |
NCT00736450 (2) [back to overview] | Number of Participants With Microarray Testing Results Are Completed Within 7 Days. |
NCT00744497 (15) [back to overview] | Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST) |
NCT00744497 (15) [back to overview] | Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline |
NCT00744497 (15) [back to overview] | Percentage of Participants With a Reduction in Pain Intensity From Baseline |
NCT00744497 (15) [back to overview] | Overall Survival: Time From Randomization to Date of Death |
NCT00744497 (15) [back to overview] | Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval |
NCT00744497 (15) [back to overview] | Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths |
NCT00744497 (15) [back to overview] | Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest |
NCT00744497 (15) [back to overview] | Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study |
NCT00744497 (15) [back to overview] | Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology |
NCT00744497 (15) [back to overview] | Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes |
NCT00744497 (15) [back to overview] | Number of Participants With Abnormal Results in Urinalysis |
NCT00744497 (15) [back to overview] | Number of Participants by Maximal On-study Fridericia-corrected QTc Interval |
NCT00744497 (15) [back to overview] | Time to Prostate Specific Antigen (PSA) Progression |
NCT00744497 (15) [back to overview] | Time to First Skeletal-related Event (SRE) |
NCT00744497 (15) [back to overview] | Progression-free Survival (PFS) |
NCT00746512 (2) [back to overview] | Synovial Blood Flow |
NCT00746512 (2) [back to overview] | Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP]) |
NCT00770224 (4) [back to overview] | Percentage of Participants With 3-year Progression-free Survival (PFS) |
NCT00770224 (4) [back to overview] | 5-year Overall Survival |
NCT00770224 (4) [back to overview] | 5-year Progression-free Survival |
NCT00770224 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
NCT00772668 (3) [back to overview] | Overall Survival (OS) |
NCT00772668 (3) [back to overview] | Progression-free Survival (PFS) |
NCT00772668 (3) [back to overview] | Rate of Toxicity in Study Participants |
NCT00774202 (2) [back to overview] | Relative Efficacy of the 2 Groups |
NCT00774202 (2) [back to overview] | Number of Participants With SAEs |
NCT00774852 (17) [back to overview] | Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study |
NCT00774852 (17) [back to overview] | Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52 |
NCT00774852 (17) [back to overview] | Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response |
NCT00774852 (17) [back to overview] | Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response |
NCT00774852 (17) [back to overview] | Lupus Disease Activity - Total BILAG-2004 |
NCT00774852 (17) [back to overview] | Number of Participants With a Complete or Partial Response |
NCT00774852 (17) [back to overview] | Lupus Disease Activity - Patient Global Assessment |
NCT00774852 (17) [back to overview] | Number of Participants With Complete Response |
NCT00774852 (17) [back to overview] | Number of Participants With Partial Response |
NCT00774852 (17) [back to overview] | Lupus Disease Activity - Frequency of Flares |
NCT00774852 (17) [back to overview] | Lupus Disease Activity - Presence of Hypocomplementemia |
NCT00774852 (17) [back to overview] | Lupus Disease Activity - SF-36 Scores |
NCT00774852 (17) [back to overview] | Lupus Disease Activity - SF-36 Scores Percent Change From Baseline |
NCT00774852 (17) [back to overview] | Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104 |
NCT00774852 (17) [back to overview] | Proportion of Vaccinated Participants With a Competent Immune Response |
NCT00774852 (17) [back to overview] | Lupus Disease Activity - Patient Global Assessment Percent Change From Baseline |
NCT00774852 (17) [back to overview] | Lupus Disease Activity - Negative Anti-dsDNA |
NCT00787527 (3) [back to overview] | Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat |
NCT00787527 (3) [back to overview] | Phase II MTD of Vorinostat |
NCT00787527 (3) [back to overview] | Phase I Maximum Tolerated Dose (MTD) of Vorinostat |
NCT00789997 (2) [back to overview] | Number of Participants With Treatment Failure by 90 Days Assignment |
NCT00789997 (2) [back to overview] | Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) |
NCT00792948 (3) [back to overview] | Overall Survival (OS) |
NCT00792948 (3) [back to overview] | Continuous Complete Remission (CCR) Rate |
NCT00792948 (3) [back to overview] | Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation |
NCT00801632 (8) [back to overview] | Change in Renal Function |
NCT00801632 (8) [back to overview] | Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks |
NCT00801632 (8) [back to overview] | Percentage of Participants Experiencing Acute Rejection |
NCT00801632 (8) [back to overview] | Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection |
NCT00801632 (8) [back to overview] | Time to Platelet Recovery Following Transplant |
NCT00801632 (8) [back to overview] | Time to Neutrophil Recovery Following Transplant |
NCT00801632 (8) [back to overview] | Percentage of Participants With Graft Survival Through 156 Weeks |
NCT00801632 (8) [back to overview] | Percentage of Participants Surviving Through 156 Weeks |
NCT00815919 (5) [back to overview] | Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD |
NCT00815919 (5) [back to overview] | Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD |
NCT00815919 (5) [back to overview] | Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy |
NCT00815919 (5) [back to overview] | The Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD |
NCT00815919 (5) [back to overview] | Overall and cGVHD Progression-free Survival by 1 Year After Therapy |
NCT00822120 (8) [back to overview] | Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging |
NCT00822120 (8) [back to overview] | Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS |
NCT00822120 (8) [back to overview] | Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD |
NCT00822120 (8) [back to overview] | Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging. |
NCT00822120 (8) [back to overview] | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
NCT00822120 (8) [back to overview] | Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. |
NCT00822120 (8) [back to overview] | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
NCT00822120 (8) [back to overview] | Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. |
NCT00828061 (2) [back to overview] | Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration |
NCT00828061 (2) [back to overview] | Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils |
NCT00836810 (6) [back to overview] | Percentage Change in Morning Stiffness |
NCT00836810 (6) [back to overview] | Change in Peak Serum IL-6 Concentration |
NCT00836810 (6) [back to overview] | Pain (Severity) |
NCT00836810 (6) [back to overview] | Clinician's Opinion of Disease Activity. |
NCT00836810 (6) [back to overview] | Change in Area Under the Curve (AUC) of Plasma IL-6 |
NCT00836810 (6) [back to overview] | Patient's Opinion of Condition |
NCT00854061 (1) [back to overview] | Means Aqueous Humor Prednisolone Acetate Concentration |
NCT00866307 (2) [back to overview] | AALL08P1 Safety Outcome |
NCT00866307 (2) [back to overview] | AALL08P1 Feasibility Outcome |
NCT00873093 (7) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 |
NCT00873093 (7) [back to overview] | Severe Adverse Events (SAE) Rate. |
NCT00873093 (7) [back to overview] | Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy |
NCT00873093 (7) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3 |
NCT00873093 (7) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2 |
NCT00873093 (7) [back to overview] | Toxic Death Rate |
NCT00873093 (7) [back to overview] | Event Free Survival |
NCT00877006 (17) [back to overview] | Worst Overall CTCAE Grade for Hematology Laboratory Test Results |
NCT00877006 (17) [back to overview] | Kaplan-Meier Estimate for Duration of Response (DOR) |
NCT00877006 (17) [back to overview] | Kaplan-Meier Estimate for Event-free Survival (EFS) |
NCT00877006 (17) [back to overview] | Kaplan-Meier Estimate for Progression-free Survival (PFS) |
NCT00877006 (17) [back to overview] | Overall Survival (OS) |
NCT00877006 (17) [back to overview] | Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period |
NCT00877006 (17) [back to overview] | Percentage of Participants With Complete Response (CR) at End of Treatment Period |
NCT00877006 (17) [back to overview] | Percentage of Participants With Overall Response at End of Treatment Period |
NCT00877006 (17) [back to overview] | Clinically Significant Abnormal Vital Signs |
NCT00877006 (17) [back to overview] | Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period |
NCT00877006 (17) [back to overview] | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period |
NCT00877006 (17) [back to overview] | Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period |
NCT00877006 (17) [back to overview] | Potentially Clinically Significant Abnormal Weight |
NCT00877006 (17) [back to overview] | Therapeutic Classification of Concomitant Medications |
NCT00877006 (17) [back to overview] | Therapeutic Classification of Prior Medications |
NCT00877006 (17) [back to overview] | Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results |
NCT00877006 (17) [back to overview] | Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30) |
NCT00882206 (4) [back to overview] | Response to Treatment |
NCT00882206 (4) [back to overview] | Level of Methylation |
NCT00882206 (4) [back to overview] | Level of Methylation |
NCT00882206 (4) [back to overview] | Level of Methylation |
NCT00887198 (7) [back to overview] | Number of Participants With Treatment Emergent Adverse Events |
NCT00887198 (7) [back to overview] | Radiographic Progression-free Survival (rPFS) |
NCT00887198 (7) [back to overview] | Time to Opiate Use for Prostate Cancer Pain |
NCT00887198 (7) [back to overview] | Overall Survival |
NCT00887198 (7) [back to overview] | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point |
NCT00887198 (7) [back to overview] | Time to Prostate-specific Antigen (PSA) Progression |
NCT00887198 (7) [back to overview] | Time to Initiation of Cytotoxic Chemotherapy |
NCT00890617 (1) [back to overview] | The Number of Patients With a Response (Complete Response and Partial Response) |
NCT00911183 (4) [back to overview] | Progression-free Survival Time |
NCT00911183 (4) [back to overview] | Number of Participants in Complete Remission 6 Months After Randomization |
NCT00911183 (4) [back to overview] | Number of Participants With Severe Toxicity |
NCT00911183 (4) [back to overview] | Overall Survival Time |
NCT00911859 (9) [back to overview] | Overall Survival |
NCT00911859 (9) [back to overview] | Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria |
NCT00911859 (9) [back to overview] | Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria |
NCT00911859 (9) [back to overview] | Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria |
NCT00911859 (9) [back to overview] | Progression-Free Survival (PFS) |
NCT00911859 (9) [back to overview] | 1-year Survival Rate |
NCT00911859 (9) [back to overview] | Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) |
NCT00911859 (9) [back to overview] | Duration of Response (DOR) |
NCT00911859 (9) [back to overview] | 1-year Progression-Free Survival (PFS) Rate |
NCT00924469 (7) [back to overview] | Testosterone Concentration in Prostate Tissue |
NCT00924469 (7) [back to overview] | Dihydrotestosterone (DHT) Concentration in Prostate Tissue |
NCT00924469 (7) [back to overview] | Percentage of Participants With Pathologic Complete Response (CR) |
NCT00924469 (7) [back to overview] | Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue |
NCT00924469 (7) [back to overview] | Percentage of Participants With Prostate-specific Antigen (PSA) Response |
NCT00924469 (7) [back to overview] | Serum Levels of Androgens |
NCT00924469 (7) [back to overview] | Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue |
NCT00929695 (12) [back to overview] | Prednisone-associated Toxicity as Assessed by Hyperglycemia |
NCT00929695 (12) [back to overview] | Prednisone-associated Toxicity as Assessed by Hypertension |
NCT00929695 (12) [back to overview] | Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral) |
NCT00929695 (12) [back to overview] | Non-relapse Mortality |
NCT00929695 (12) [back to overview] | Chronic Extensive GVHD |
NCT00929695 (12) [back to overview] | Prednisone-associated Toxicity as Assessed by Quality of Life |
NCT00929695 (12) [back to overview] | Progression to Grade III-IV Acute GVHD |
NCT00929695 (12) [back to overview] | Recurrent or Progressive Malignancy |
NCT00929695 (12) [back to overview] | Secondary Therapy for Acute GVHD Beyond Prednisone |
NCT00929695 (12) [back to overview] | Prednisone-associated Toxicity as Assessed by Myopathy |
NCT00929695 (12) [back to overview] | Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment |
NCT00929695 (12) [back to overview] | Overall Survival |
NCT00931918 (10) [back to overview] | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category |
NCT00931918 (10) [back to overview] | Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher |
NCT00931918 (10) [back to overview] | Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate |
NCT00931918 (10) [back to overview] | Duration of Response |
NCT00931918 (10) [back to overview] | Overall Response Rate (ORR) |
NCT00931918 (10) [back to overview] | Complete Response Rate |
NCT00931918 (10) [back to overview] | Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL) |
NCT00931918 (10) [back to overview] | Progression-Free Survival Rate |
NCT00931918 (10) [back to overview] | Time to Progression (TTP) |
NCT00931918 (10) [back to overview] | Overall Survival |
NCT00938587 (28) [back to overview] | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 |
NCT00938587 (28) [back to overview] | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 |
NCT00938587 (28) [back to overview] | Change From Baseline in Body Weight at Day 7 and 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in Adiponectin Level at Day 7 and 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 |
NCT00938587 (28) [back to overview] | Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate |
NCT00938587 (28) [back to overview] | Number of Participants With Clinically Significant Vital Signs Abnormalities |
NCT00938587 (28) [back to overview] | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities |
NCT00938587 (28) [back to overview] | Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities |
NCT00938587 (28) [back to overview] | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7 |
NCT00938587 (28) [back to overview] | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 |
NCT00938587 (28) [back to overview] | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 |
NCT00938587 (28) [back to overview] | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 |
NCT00938587 (28) [back to overview] | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 |
NCT00938587 (28) [back to overview] | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 |
NCT00938587 (28) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT00938587 (28) [back to overview] | Change From Baseline in Tender Joints Count at Day 7, 14, 42 |
NCT00938587 (28) [back to overview] | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 |
NCT00938587 (28) [back to overview] | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 |
NCT00938587 (28) [back to overview] | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 |
NCT00942578 (10) [back to overview] | Count of Participants With a Radiologic Response |
NCT00942578 (10) [back to overview] | Survival Based on Expression of T Cell Immunoglobulin and Mucin Domain (TIM-3) on Cluster of Differentiation 8 (CD8) + T Cells |
NCT00942578 (10) [back to overview] | Survival Based on Expression of Programmed Cell Death Protein 1 (PD-1) on Cluster of Differentiation 8 (CD8) + T Cells |
NCT00942578 (10) [back to overview] | Count of Participants With Prostatic Antigen-Specific (PSA) Declines |
NCT00942578 (10) [back to overview] | Count of Participants With Changes in Circulating Apoptotic Endothelial Cells (CAEC) From Baseline After Drug Administration |
NCT00942578 (10) [back to overview] | Recommended Phase 2 Dose (RP2D) |
NCT00942578 (10) [back to overview] | Median Time to Progression (TTP) |
NCT00942578 (10) [back to overview] | Median Overall Survival of Patients Studied |
NCT00942578 (10) [back to overview] | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered the Four-Drug Combination |
NCT00942578 (10) [back to overview] | Count of Participants With Dose-Limiting Toxicities (DLT) |
NCT00946270 (1) [back to overview] | Number of Participants With Best Overall Response |
NCT00972478 (5) [back to overview] | Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL |
NCT00972478 (5) [back to overview] | Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I) |
NCT00972478 (5) [back to overview] | Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II) |
NCT00972478 (5) [back to overview] | Progression-free Survival (Phase II) |
NCT00972478 (5) [back to overview] | Overall Survival (Phase II) |
NCT00973752 (1) [back to overview] | Overall Survival at One Year |
NCT00988208 (7) [back to overview] | Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial |
NCT00988208 (7) [back to overview] | Time to Onset of Secondary Primary Malignancies |
NCT00988208 (7) [back to overview] | Progression-Free Survival (PFS) |
NCT00988208 (7) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (AEs) |
NCT00988208 (7) [back to overview] | Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria |
NCT00988208 (7) [back to overview] | Percentage of Participants Who Received Post-Study Therapies |
NCT00988208 (7) [back to overview] | Overall Survival (OS) |
NCT00991939 (1) [back to overview] | The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry. |
NCT00995722 (5) [back to overview] | Change in Quality of Life as Measured by the 10-Item Neuro-ophthalmological Supplement to the NEI-VFQ-25 |
NCT00995722 (5) [back to overview] | Treatment Failure |
NCT00995722 (5) [back to overview] | Change in Quality of Life as Measured by the MG-QOL-15 Score |
NCT00995722 (5) [back to overview] | Change in Ocular Quantitative Myasthenia Score From Baseline to Week 16 |
NCT00995722 (5) [back to overview] | Change in Quality of Life as Measured by the NEI-VFQ-25 Measures |
NCT01000285 (8) [back to overview] | Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads |
NCT01000285 (8) [back to overview] | Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA |
NCT01000285 (8) [back to overview] | Effects of HTLV-1 Integration Sites After Treatment |
NCT01000285 (8) [back to overview] | Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence |
NCT01000285 (8) [back to overview] | Time to Progression |
NCT01000285 (8) [back to overview] | Relation of NFκB Gene Expression Profile on Response |
NCT01000285 (8) [back to overview] | Efficacy of Treatment as Measured by Best Overall Response |
NCT01000285 (8) [back to overview] | Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events |
NCT01002339 (16) [back to overview] | Blood Pressure |
NCT01002339 (16) [back to overview] | Blood Pressure |
NCT01002339 (16) [back to overview] | Changes of Carotid Intima-media Thickness Over Time |
NCT01002339 (16) [back to overview] | Lipidic Profile (Cholesterol) |
NCT01002339 (16) [back to overview] | Lipidic Profile (HDL-c) |
NCT01002339 (16) [back to overview] | Lipidic Profile (LDL-c) |
NCT01002339 (16) [back to overview] | Lipidic Profile (Triglycerides) |
NCT01002339 (16) [back to overview] | "Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)" |
NCT01002339 (16) [back to overview] | Number of Antihypertensive Drugs Patients Reported Taking. |
NCT01002339 (16) [back to overview] | Patients Treated With Insulin or Oral Antidiabetic Drugs |
NCT01002339 (16) [back to overview] | Percentage of Patients Using Acetylsalicylic Acid (ASA) |
NCT01002339 (16) [back to overview] | Percentage of Patients Using Statins |
NCT01002339 (16) [back to overview] | Primary Outcome Measure (Glucose Intolerance) |
NCT01002339 (16) [back to overview] | Proteinuria |
NCT01002339 (16) [back to overview] | Rejection |
NCT01002339 (16) [back to overview] | Renal Function |
NCT01004991 (1) [back to overview] | Complete Response |
NCT01005316 (17) [back to overview] | Percentage of Participants Positive for de Novo Donor-Specific Alloantibody Production in the First Year Post-Transplantation |
NCT01005316 (17) [back to overview] | Percentage of Participants Experiencing Acute Rejection |
NCT01005316 (17) [back to overview] | Percentage of Participants With the Presence of Anti-MICA Antibodies by Luminex TM Assay |
NCT01005316 (17) [back to overview] | Percentage of Participants -Quantification of Anti-HLA IgG Antibodies by Luminex SA Testing |
NCT01005316 (17) [back to overview] | Percentage of Participants With the Presence of Anti-HLA IgG Antibodies by Luminex SA Testing |
NCT01005316 (17) [back to overview] | Percentage of Participants With Occurrence of Re-Hospitalization(s) |
NCT01005316 (17) [back to overview] | Time to Production of Post-Transplant de Novo Donor-specific Alloantibodies |
NCT01005316 (17) [back to overview] | Time to Post-Transplantation Lymphoproliferative Disorder |
NCT01005316 (17) [back to overview] | Time to New-Onset Diabetes Mellitus |
NCT01005316 (17) [back to overview] | Time to Diagnosis of Chronic Rejection |
NCT01005316 (17) [back to overview] | Time to Acute Rejection |
NCT01005316 (17) [back to overview] | Time From Participant Listing on Organ Wait-List to Receiving Organ Transplant, Death or De-Listing |
NCT01005316 (17) [back to overview] | Presence of C4d on Endomyocardial Biopsy (EMB) |
NCT01005316 (17) [back to overview] | Percentage of Participants- Mortality While on Transplantation Wait-List |
NCT01005316 (17) [back to overview] | Percentage of Participants Positive for Severe Infection(s) |
NCT01005316 (17) [back to overview] | Percentage of Participants Positive for Event of Death, Graft Loss or Rejection With Hemodynamic Compromise at 12 Months Post-Transplantation |
NCT01005316 (17) [back to overview] | Percentage of Participants -Overall Participant and Graft Survival |
NCT01023061 (3) [back to overview] | Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 |
NCT01023061 (3) [back to overview] | Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry |
NCT01023061 (3) [back to overview] | Median Time to Prostate Specific Antigen Progression |
NCT01026220 (7) [back to overview] | Overall Survival |
NCT01026220 (7) [back to overview] | Relapse-free Survival |
NCT01026220 (7) [back to overview] | Safety Analysis and Monitoring of Toxic Death |
NCT01026220 (7) [back to overview] | Second-event-free Survival |
NCT01026220 (7) [back to overview] | Event Free Survival |
NCT01026220 (7) [back to overview] | Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative |
NCT01026220 (7) [back to overview] | Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy |
NCT01030900 (4) [back to overview] | Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC) |
NCT01030900 (4) [back to overview] | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) |
NCT01030900 (4) [back to overview] | Overall Survival (OS) |
NCT01030900 (4) [back to overview] | Progression Free Survival (PFS) |
NCT01033864 (10) [back to overview] | Dose-Normalized C0 |
NCT01033864 (10) [back to overview] | Percentage of Participants By Time to Maximum Plasma Concentration (Tmax) |
NCT01033864 (10) [back to overview] | Pre-dose Trough Concentration (C0) |
NCT01033864 (10) [back to overview] | MPA Area Under the Curve From 0 to 12 Hours (AUC0-12) |
NCT01033864 (10) [back to overview] | Minimum Plasma Concentration (Cmin) |
NCT01033864 (10) [back to overview] | Maximum Plasma Concentration (Cmax) |
NCT01033864 (10) [back to overview] | Dose-Normalized MPA AUC0-12 |
NCT01033864 (10) [back to overview] | Dose-Normalized Cmin |
NCT01033864 (10) [back to overview] | Dose-Normalized Cmax (mg/L) |
NCT01033864 (10) [back to overview] | Regression Coefficients For Participants Receiving MMF |
NCT01040871 (7) [back to overview] | Subsequent Anti-lymphoma Therapy Rate at 1-year |
NCT01040871 (7) [back to overview] | Rate of Durable Response |
NCT01040871 (7) [back to overview] | Rate of Durable Complete Response |
NCT01040871 (7) [back to overview] | Progression-free Survival (PFS)Rate at 1-year |
NCT01040871 (7) [back to overview] | Overall Survival Rate at 1-year |
NCT01040871 (7) [back to overview] | Complete Response (CR) Rate |
NCT01040871 (7) [back to overview] | Overall Response Rate |
NCT01042145 (6) [back to overview] | Number of Participants With Reported Side Effects |
NCT01042145 (6) [back to overview] | Time Missed From Work |
NCT01042145 (6) [back to overview] | Parental Stress |
NCT01042145 (6) [back to overview] | Additional Health Care |
NCT01042145 (6) [back to overview] | Duration of Croup Symptoms |
NCT01042145 (6) [back to overview] | Nights With Disturbed Sleep |
NCT01051570 (6) [back to overview] | Number of Participants With Toxicity as Measured by NCI CTCAE v3.0 Criteria |
NCT01051570 (6) [back to overview] | Association of PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6) |
NCT01051570 (6) [back to overview] | PSA Response Rate |
NCT01051570 (6) [back to overview] | Pharmacokinetics: Observed Carboplatin AUC Was Estimated Based on the Concentration in the 2.75-h Sample. |
NCT01051570 (6) [back to overview] | Overall Survival |
NCT01051570 (6) [back to overview] | Time to Progression (TTP) |
NCT01054144 (5) [back to overview] | Single Agent - Median Progressive Free Survival (PFS) |
NCT01054144 (5) [back to overview] | Response Rate |
NCT01054144 (5) [back to overview] | Combined Therapy - Median Progression Free Survival |
NCT01054144 (5) [back to overview] | Number of Participants With 1 Year Overall Survival (OS) |
NCT01054144 (5) [back to overview] | Number of Participants With Serious Adverse Events |
NCT01055496 (17) [back to overview] | Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1 |
NCT01055496 (17) [back to overview] | Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts |
NCT01055496 (17) [back to overview] | Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts |
NCT01055496 (17) [back to overview] | Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts |
NCT01055496 (17) [back to overview] | Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts |
NCT01055496 (17) [back to overview] | Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts |
NCT01055496 (17) [back to overview] | Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts |
NCT01055496 (17) [back to overview] | Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts. |
NCT01055496 (17) [back to overview] | Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts |
NCT01055496 (17) [back to overview] | Mean Inotuzumab Ozogamicin Serum Concentrations |
NCT01055496 (17) [back to overview] | Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy |
NCT01055496 (17) [back to overview] | Percentage of Participants With a Treatment Emergent AE |
NCT01055496 (17) [back to overview] | Mean Inotuzumab Ozogamicin Serum Concentrations |
NCT01055496 (17) [back to overview] | Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy |
NCT01055496 (17) [back to overview] | Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts |
NCT01055496 (17) [back to overview] | Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts |
NCT01055496 (17) [back to overview] | Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2 |
NCT01084655 (14) [back to overview] | Phase 2: Time to Radiographic Disease Progression |
NCT01084655 (14) [back to overview] | Phase 2: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel |
NCT01084655 (14) [back to overview] | Phase 2: Best PSA Response |
NCT01084655 (14) [back to overview] | Phase 2: Time to PSA Progression |
NCT01084655 (14) [back to overview] | Phase 2: Cmax: Maximum Observed Plasma Concentration for Docetaxel |
NCT01084655 (14) [back to overview] | Phase 2: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for Orteronel |
NCT01084655 (14) [back to overview] | Phase 2: AUC 0-tau: Area Under the Plasma Concentration Versus Time Curve Zero to the Time of the End of the Dosing Interval for Orteronel |
NCT01084655 (14) [back to overview] | Phase 2: Percentage of Participants With Prostate-specific Antigen (PSA) Response of 30 Percent (%), 50%, and 90% |
NCT01084655 (14) [back to overview] | Phase 2: Percentage of Participants With Objective Measurable Disease Response |
NCT01084655 (14) [back to overview] | Phase 2: Change From Baseline in Circulating Tumor Cells (CTCs) |
NCT01084655 (14) [back to overview] | Number of Participants With TEAEs Related to Vital Signs |
NCT01084655 (14) [back to overview] | Number of Participants With TEAEs Related to Hematology and Serum Chemistry |
NCT01084655 (14) [back to overview] | Number of Participants With TEAEs Related to Electrocardiogram (ECG) |
NCT01084655 (14) [back to overview] | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE) |
NCT01085097 (2) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT01085097 (2) [back to overview] | Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24 |
NCT01086540 (19) [back to overview] | All-Cause Mortality: From Treatment Initiation to Week 104 |
NCT01086540 (19) [back to overview] | Time to Clinical Worsening |
NCT01086540 (19) [back to overview] | Change From Baseline in Distance Walked During a Six Minute Walk Test |
NCT01086540 (19) [back to overview] | Treatment-Related Mortality: From Treatment Initiation to Week 48 |
NCT01086540 (19) [back to overview] | Change in Carbon Monoxide Diffusing Capacity (DLCO) |
NCT01086540 (19) [back to overview] | Time to the Change or Addition of New Pulmonary Arterial Hypertension (PAH) Therapeutic Medications |
NCT01086540 (19) [back to overview] | Change in Quality of Life as Measured by the Disability Index of the Scleroderma Health Assessment Questionnaire (HAQ-DI) |
NCT01086540 (19) [back to overview] | Change in Severity of Raynaud's Phenomenon |
NCT01086540 (19) [back to overview] | Number of Grade 3 or Higher Adverse Events (AEs) Through Week 48 |
NCT01086540 (19) [back to overview] | Number of Infusion-Related Toxicities |
NCT01086540 (19) [back to overview] | Oxygen Saturation Levels at Week 24 and Week 48 |
NCT01086540 (19) [back to overview] | Percent Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization |
NCT01086540 (19) [back to overview] | Number of Infection-Related Adverse Events (AEs) Through Week 48 |
NCT01086540 (19) [back to overview] | Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization at Week 24 |
NCT01086540 (19) [back to overview] | Number of New Digital Ulcers |
NCT01086540 (19) [back to overview] | Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Physical Component Summary Score |
NCT01086540 (19) [back to overview] | Change From Baseline in Distance Walked During a Six Minute Walk Test at Week 24 and Week 48 |
NCT01086540 (19) [back to overview] | Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Mental Component Summary Score |
NCT01086540 (19) [back to overview] | All-Cause Mortality: From Treatment Initiation to Week 48 |
NCT01088529 (3) [back to overview] | Number of Participants With a Positive Surgical Margin at Radical Prostatectomy |
NCT01088529 (3) [back to overview] | Number of Participants With Prostate-Specific Antigen Response |
NCT01088529 (3) [back to overview] | Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2) |
NCT01092182 (5) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) |
NCT01092182 (5) [back to overview] | Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval |
NCT01092182 (5) [back to overview] | Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2 |
NCT01092182 (5) [back to overview] | Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval |
NCT01092182 (5) [back to overview] | Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval |
NCT01106833 (17) [back to overview] | SF-36 Physical Component Summary |
NCT01106833 (17) [back to overview] | Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years |
NCT01106833 (17) [back to overview] | Percentage of Participants With Overall Survival |
NCT01106833 (17) [back to overview] | Percentage of Participants With Progression-free Survival |
NCT01106833 (17) [back to overview] | Prednisone Dose |
NCT01106833 (17) [back to overview] | Provider-reported Chronic GVHD Severity |
NCT01106833 (17) [back to overview] | Proportion of Participants With Treatment Success |
NCT01106833 (17) [back to overview] | Patient-reported Chronic GVHD Severity |
NCT01106833 (17) [back to overview] | NIH Consensus Criteria Chronic GVHD Severity |
NCT01106833 (17) [back to overview] | Percentage of Participants With Relapse |
NCT01106833 (17) [back to overview] | SF-36 Mental Component Summary |
NCT01106833 (17) [back to overview] | Serum Creatinine Level |
NCT01106833 (17) [back to overview] | Percentage of Participants With Secondary Immunosuppressive Therapy Initiated |
NCT01106833 (17) [back to overview] | Change in Prednisone Dose From Baseline |
NCT01106833 (17) [back to overview] | Change in Serum Creatinine Level From Baseline |
NCT01106833 (17) [back to overview] | Percentage of Participants With Failure-free Survival |
NCT01106833 (17) [back to overview] | FACT-BMT Score |
NCT01124838 (10) [back to overview] | Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit |
NCT01124838 (10) [back to overview] | Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit. |
NCT01124838 (10) [back to overview] | Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit |
NCT01124838 (10) [back to overview] | Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit |
NCT01124838 (10) [back to overview] | Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit |
NCT01124838 (10) [back to overview] | Time to Treatment Failure on or After Week 2 |
NCT01124838 (10) [back to overview] | Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2 |
NCT01124838 (10) [back to overview] | Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit |
NCT01124838 (10) [back to overview] | Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit |
NCT01124838 (10) [back to overview] | Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit |
NCT01132807 (3) [back to overview] | 36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation. |
NCT01132807 (3) [back to overview] | Complete Response Rate |
NCT01132807 (3) [back to overview] | Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD |
NCT01133275 (2) [back to overview] | Number of Participants With Erythroid Response |
NCT01133275 (2) [back to overview] | Number of Participants With Grade 3 or 4 Adverse Events Possibly Related to Treatment |
NCT01133626 (1) [back to overview] | The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment |
NCT01138657 (10) [back to overview] | Time to Treatment Failure on or After Week 6 |
NCT01138657 (10) [back to overview] | Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit |
NCT01138657 (10) [back to overview] | Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit |
NCT01138657 (10) [back to overview] | Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit |
NCT01138657 (10) [back to overview] | Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit |
NCT01138657 (10) [back to overview] | Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6 |
NCT01138657 (10) [back to overview] | Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit |
NCT01138657 (10) [back to overview] | Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit |
NCT01138657 (10) [back to overview] | Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit |
NCT01138657 (10) [back to overview] | Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit |
NCT01145508 (1) [back to overview] | Overall Survival |
NCT01172639 (7) [back to overview] | Remission According to DAS28-CRP at Week 16 |
NCT01172639 (7) [back to overview] | Remission According to DAS28-CRP at Week 104 |
NCT01172639 (7) [back to overview] | Clinically Significant Change in HAQ Score |
NCT01172639 (7) [back to overview] | Remission According to SDAI at Week 52 |
NCT01172639 (7) [back to overview] | Remission According to SDAI at Week 104 |
NCT01172639 (7) [back to overview] | Remission According to SDAI (Simple Disease Activity Index) at Week 16 |
NCT01172639 (7) [back to overview] | Remission According to DAS28-CRP at Week 52 |
NCT01193049 (8) [back to overview] | Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
NCT01193049 (8) [back to overview] | Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
NCT01193049 (8) [back to overview] | Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
NCT01193049 (8) [back to overview] | Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
NCT01193049 (8) [back to overview] | Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
NCT01193049 (8) [back to overview] | Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
NCT01193049 (8) [back to overview] | Geometric Mean Fold Change From Baseline in RNA Expression for Genes Encoding IL-5 and IL-13 From Sputum at 7 Hours Post-allergen Challenge |
NCT01193049 (8) [back to overview] | Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge |
NCT01193244 (23) [back to overview] | Time to Deterioration in Global Health Status |
NCT01193244 (23) [back to overview] | Time to Docetaxel Chemotherapy |
NCT01193244 (23) [back to overview] | Time to Pain Progression |
NCT01193244 (23) [back to overview] | Time to PSA Progression |
NCT01193244 (23) [back to overview] | Time to SRE |
NCT01193244 (23) [back to overview] | Overall Survival |
NCT01193244 (23) [back to overview] | Time to Subsequent Antineoplastic Therapy |
NCT01193244 (23) [back to overview] | Worst Change From Baseline Over Time in Cardiac Ejection Fraction |
NCT01193244 (23) [back to overview] | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
NCT01193244 (23) [back to overview] | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation |
NCT01193244 (23) [back to overview] | Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings |
NCT01193244 (23) [back to overview] | Radiographic Progression-free Survival (rPFS) |
NCT01193244 (23) [back to overview] | Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12 |
NCT01193244 (23) [back to overview] | Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12 |
NCT01193244 (23) [back to overview] | Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12 |
NCT01193244 (23) [back to overview] | Percentage of Participants With Objective Response |
NCT01193244 (23) [back to overview] | Number of Participants With TEAEs Related to Vital Signs |
NCT01193244 (23) [back to overview] | Percentage of Participants With Skeletal Related Events (SRE) |
NCT01193244 (23) [back to overview] | Percentage of Participants Achieving PSA50 Response at Any Time During the Study |
NCT01193244 (23) [back to overview] | Percentage of Participants Achieving PSA90 Response at Any Time During the Study |
NCT01193244 (23) [back to overview] | Number of Participants With TEAEs Related to Weight |
NCT01193244 (23) [back to overview] | Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3 |
NCT01193244 (23) [back to overview] | Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status |
NCT01193257 (21) [back to overview] | Time to Pain Progression |
NCT01193257 (21) [back to overview] | Radiographic Progression-free Survival (rPFS) |
NCT01193257 (21) [back to overview] | Time to Pain Response |
NCT01193257 (21) [back to overview] | Time to PSA Progression |
NCT01193257 (21) [back to overview] | Percentage of Participants With Pain Response at Week 12 |
NCT01193257 (21) [back to overview] | Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC) |
NCT01193257 (21) [back to overview] | Number of Participants With TEAEs Related to Vital Signs |
NCT01193257 (21) [back to overview] | Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings |
NCT01193257 (21) [back to overview] | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) |
NCT01193257 (21) [back to overview] | Percentage of Participants With Objective Response |
NCT01193257 (21) [back to overview] | Number of Participants With TEAEs Related to Weight |
NCT01193257 (21) [back to overview] | Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12 |
NCT01193257 (21) [back to overview] | Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status |
NCT01193257 (21) [back to overview] | Number of Participants With Abnormal Physical Examination Findings |
NCT01193257 (21) [back to overview] | Overall Survival |
NCT01193257 (21) [back to overview] | Percentage of Participants With Health-related Quality of Life (HRQOL) Response at Week 12 |
NCT01193257 (21) [back to overview] | Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12 |
NCT01193257 (21) [back to overview] | Percentage of Participants Achieving PSA50 Response at Any Time During the Study |
NCT01193257 (21) [back to overview] | Percentage of Participants Achieving PSA90 Response at Any Time During the Study |
NCT01193257 (21) [back to overview] | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel |
NCT01193257 (21) [back to overview] | Number of Participants With Best Pain Response |
NCT01193842 (14) [back to overview] | Tumor Response (Phase I) |
NCT01193842 (14) [back to overview] | Pharmacokinetic Clearance (Phase I) |
NCT01193842 (14) [back to overview] | Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) |
NCT01193842 (14) [back to overview] | Changes in Human Immunodeficiency Virus (HIV) Viral Load |
NCT01193842 (14) [back to overview] | Changes in Absolute CD4 Cell Counts (Phase I) |
NCT01193842 (14) [back to overview] | Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I) |
NCT01193842 (14) [back to overview] | Change in CD8 Cell Counts (Phase I) |
NCT01193842 (14) [back to overview] | Event-free Survival (EFS) (Phase II) |
NCT01193842 (14) [back to overview] | Overall Survival (OS) (Phase II) |
NCT01193842 (14) [back to overview] | Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I) |
NCT01193842 (14) [back to overview] | Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II) |
NCT01193842 (14) [back to overview] | Changes in Human Herpes Virus (HHV)-8 Viral Load |
NCT01193842 (14) [back to overview] | Changes in Human Herpes Virus (HHV)-8 Viral Load |
NCT01193842 (14) [back to overview] | Changes in Epstein-Barr Virus (EBV) Viral Load |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL |
NCT01200758 (26) [back to overview] | Percentage of Participants Who Died |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL |
NCT01200758 (26) [back to overview] | Overall Survival (OS) |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL |
NCT01200758 (26) [back to overview] | Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion |
NCT01200758 (26) [back to overview] | Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL |
NCT01200758 (26) [back to overview] | Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase |
NCT01200758 (26) [back to overview] | Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL) |
NCT01200758 (26) [back to overview] | Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL |
NCT01200758 (26) [back to overview] | Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL |
NCT01200758 (26) [back to overview] | Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle |
NCT01200758 (26) [back to overview] | Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL |
NCT01200758 (26) [back to overview] | Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL |
NCT01200758 (26) [back to overview] | Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20 |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab |
NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle |
NCT01204710 (11) [back to overview] | OS Based on Baseline CTC Counts |
NCT01204710 (11) [back to overview] | Progression-Free Survival (PFS) |
NCT01204710 (11) [back to overview] | Number of Participants Who Died During Study |
NCT01204710 (11) [back to overview] | Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC) |
NCT01204710 (11) [back to overview] | Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) |
NCT01204710 (11) [back to overview] | Overall Survival (OS) |
NCT01204710 (11) [back to overview] | Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] |
NCT01204710 (11) [back to overview] | Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity) |
NCT01204710 (11) [back to overview] | PFS Based on Baseline Circulating Tumor Cells (CTC) Counts |
NCT01204710 (11) [back to overview] | Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12 |
NCT01204710 (11) [back to overview] | Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time |
NCT01206452 (5) [back to overview] | Inflammatory Cytokine Response to Ablation Procedure |
NCT01206452 (5) [back to overview] | Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months |
NCT01206452 (5) [back to overview] | Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months |
NCT01206452 (5) [back to overview] | Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months |
NCT01206452 (5) [back to overview] | Inflammatory Cytokine Response to Ablation Procedure |
NCT01235689 (31) [back to overview] | Percentage of Participants With Endoscopic Response 48 Weeks After Randomization |
NCT01235689 (31) [back to overview] | Change From Baseline in CDAI Over Time |
NCT01235689 (31) [back to overview] | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Over Time |
NCT01235689 (31) [back to overview] | Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores |
NCT01235689 (31) [back to overview] | Change From Baseline in Work Productivity Activity Index - Crohn's Disease (WPAI:CD) |
NCT01235689 (31) [back to overview] | Percentage of Participants in Clinical Remission Over Time |
NCT01235689 (31) [back to overview] | Percentage of Participants in Steroid-free Remission Over Time |
NCT01235689 (31) [back to overview] | Percentage of Participants With Complete Mucosal Healing 48 Weeks After Randomization |
NCT01235689 (31) [back to overview] | Percentage of Participants in Deep Remission 48 Weeks After Randomization |
NCT01235689 (31) [back to overview] | Percentage of Participants in Biologic Remission 48 Weeks After Randomization |
NCT01235689 (31) [back to overview] | Percentage of Participants With Mucosal Healing 48 Weeks After Randomization |
NCT01235689 (31) [back to overview] | Percentage of Participants With Mucosal Healing and CDEIS < 4 in Every Segment 48 Weeks After Randomization |
NCT01235689 (31) [back to overview] | Percentage of Participants With Mucosal Healing and No Deep Ulcerations |
NCT01235689 (31) [back to overview] | Number of Major Crohn's Disease-related Surgeries After Randomization |
NCT01235689 (31) [back to overview] | Number of Crohn's Disease-related Surgical Procedures After Randomization |
NCT01235689 (31) [back to overview] | Number of Crohn's Disease-related Hospitalizations Due to Emergency |
NCT01235689 (31) [back to overview] | Number of Crohn's Disease-related Hospitalizations After Randomization |
NCT01235689 (31) [back to overview] | Number of All-cause Hospitalizations After Randomization |
NCT01235689 (31) [back to overview] | Change From Baseline in Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score |
NCT01235689 (31) [back to overview] | Change From Baseline in Patient Health Questionnaire - 9 (PHQ9) |
NCT01235689 (31) [back to overview] | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score |
NCT01235689 (31) [back to overview] | Change From Baseline in CDEIS at 48 Weeks After Randomization |
NCT01235689 (31) [back to overview] | Time to All-cause Hospitalization |
NCT01235689 (31) [back to overview] | Time to Clinical Remission |
NCT01235689 (31) [back to overview] | Time to Crohn's Disease Flare |
NCT01235689 (31) [back to overview] | Time to Crohn's Disease-related Hospitalization Due to Emergency |
NCT01235689 (31) [back to overview] | Time to Crohn's Disease-related Hospitalization or Hospitalization Due to Adverse Event Relating to Study Medication |
NCT01235689 (31) [back to overview] | Time to Steroid-free Remission |
NCT01235689 (31) [back to overview] | Total Dose of Prednisone |
NCT01235689 (31) [back to overview] | Total Length of Stay in Hospital for All-cause Hospitalizations |
NCT01235689 (31) [back to overview] | Total Length of Stay in Hospital for Crohn's Disease-related Hospitalizations |
NCT01287741 (18) [back to overview] | Duration of Response (DOR), Investigator-Assessed |
NCT01287741 (18) [back to overview] | Median Time to Overall Survival (OS) |
NCT01287741 (18) [back to overview] | Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL) |
NCT01287741 (18) [back to overview] | Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab |
NCT01287741 (18) [back to overview] | Time to Next Anti-Lymphoma Treatment (TTNALT) |
NCT01287741 (18) [back to overview] | Overall Response Rate (ORR), IRC-Assessed |
NCT01287741 (18) [back to overview] | Median Time to Progression-Free Survival (PFS), Investigator-Assessed |
NCT01287741 (18) [back to overview] | Percentage of Participants With Adverse Events (AEs) |
NCT01287741 (18) [back to overview] | Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed |
NCT01287741 (18) [back to overview] | Overall Response Rate (ORR), Investigator-Assessed |
NCT01287741 (18) [back to overview] | Complete Response (CR) at the End of Treatment, IRC-Assessed |
NCT01287741 (18) [back to overview] | Complete Response (CR) at the End of Treatment, Investigator-Assessed |
NCT01287741 (18) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score |
NCT01287741 (18) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores |
NCT01287741 (18) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score |
NCT01287741 (18) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores |
NCT01287741 (18) [back to overview] | Median Time to Event-Free Survival (EFS), Investigator-Assessed |
NCT01287741 (18) [back to overview] | Median Time to Disease-Free Survival (DFS), Investigator-Assessed |
NCT01308567 (11) [back to overview] | Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS) |
NCT01308567 (11) [back to overview] | Time to Tumor Progression Free Survival |
NCT01308567 (11) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL) |
NCT01308567 (11) [back to overview] | Percentage of Participants With PSA Response |
NCT01308567 (11) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL |
NCT01308567 (11) [back to overview] | Time to Pain Progression Free Survival (Pain PFS) |
NCT01308567 (11) [back to overview] | Percentage of Participants With Pain Response |
NCT01308567 (11) [back to overview] | Percentage of Participants With Overall Objective Tumor Response |
NCT01308567 (11) [back to overview] | Overall Survival (OS) |
NCT01308567 (11) [back to overview] | Progression Free Survival (PFS) |
NCT01308567 (11) [back to overview] | Skeletal Related Events (SRE) Free Survival |
NCT01308580 (18) [back to overview] | Percentage of Participants With FACT-P Total Score Response |
NCT01308580 (18) [back to overview] | Plasma Clearance (CL) for Cabazitaxel |
NCT01308580 (18) [back to overview] | Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel |
NCT01308580 (18) [back to overview] | Progression Free Survival (PFS) |
NCT01308580 (18) [back to overview] | Time to Definitive Deterioration of ECOG PS Score From Baseline |
NCT01308580 (18) [back to overview] | Time to First Definitive Consumption of Narcotic Medication |
NCT01308580 (18) [back to overview] | Time to Pain Progression |
NCT01308580 (18) [back to overview] | Time to PSA Progression |
NCT01308580 (18) [back to overview] | Time to Tumor Progression |
NCT01308580 (18) [back to overview] | Percentage of Participants With Pain Response |
NCT01308580 (18) [back to overview] | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
NCT01308580 (18) [back to overview] | Time to Definitive Weight Loss by 5% and 10% From Baseline |
NCT01308580 (18) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL) |
NCT01308580 (18) [back to overview] | Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales |
NCT01308580 (18) [back to overview] | Overall Survival (OS) |
NCT01308580 (18) [back to overview] | Change From Baseline in FACT-P:Total Score as a Measure of HRQoL |
NCT01308580 (18) [back to overview] | Percentage of Participants With PSA Response |
NCT01308580 (18) [back to overview] | Percentage of Participants With Overall Objective Tumor Response |
NCT01309672 (5) [back to overview] | Overall Survival |
NCT01309672 (5) [back to overview] | Number of Patients With Toxicity of Abiraterone Acetate |
NCT01309672 (5) [back to overview] | Number of Patients With PSA Partial Response |
NCT01309672 (5) [back to overview] | Number of Patients With Undetectable PSA |
NCT01309672 (5) [back to overview] | Objective Progression-free Survival |
NCT01314118 (4) [back to overview] | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment |
NCT01314118 (4) [back to overview] | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study |
NCT01314118 (4) [back to overview] | Time to Radiographic Evidence of Disease Progression (TTRP) |
NCT01314118 (4) [back to overview] | Time to Prostate-Specific Antigen (PSA) Progression |
NCT01332097 (2) [back to overview] | Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO |
NCT01332097 (2) [back to overview] | Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second |
NCT01332968 (32) [back to overview] | Overall Survival (Follicular Lymphoma Population) |
NCT01332968 (32) [back to overview] | Event-Free Survival (Overall Study Population) |
NCT01332968 (32) [back to overview] | Overall Survival (Overall Study Population) |
NCT01332968 (32) [back to overview] | Disease-Free Survival (Follicular Lymphoma Population) |
NCT01332968 (32) [back to overview] | Percentage of Participants With Adverse Events |
NCT01332968 (32) [back to overview] | Overall Response (Overall Study Population), IRC-Assessed |
NCT01332968 (32) [back to overview] | Overall Response (Overall Study Population), Investigator-Assessed |
NCT01332968 (32) [back to overview] | Overall Response (Follicular Lymphoma Population), IRC-Assessed |
NCT01332968 (32) [back to overview] | Overall Response (Follicular Lymphoma Population), Investigator-Assessed |
NCT01332968 (32) [back to overview] | Complete Response (Overall Study Population), IRC-Assessed |
NCT01332968 (32) [back to overview] | Complete Response (Overall Study Population), Investigator-Assessed |
NCT01332968 (32) [back to overview] | Complete Response (Follicular Lymphoma Population), IRC-Assessed |
NCT01332968 (32) [back to overview] | Complete Response (Follicular Lymphoma Population), Investigator-Assessed |
NCT01332968 (32) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) |
NCT01332968 (32) [back to overview] | Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) |
NCT01332968 (32) [back to overview] | Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) |
NCT01332968 (32) [back to overview] | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase |
NCT01332968 (32) [back to overview] | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase |
NCT01332968 (32) [back to overview] | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase |
NCT01332968 (32) [back to overview] | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase |
NCT01332968 (32) [back to overview] | Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) |
NCT01332968 (32) [back to overview] | Time to Next Anti-Lymphoma Treatment (Overall Study Population) |
NCT01332968 (32) [back to overview] | Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population) |
NCT01332968 (32) [back to overview] | Progression-Free Survival in the Overall Study Population, Investigator-Assessed |
NCT01332968 (32) [back to overview] | Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed |
NCT01332968 (32) [back to overview] | Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC) |
NCT01332968 (32) [back to overview] | Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed |
NCT01332968 (32) [back to overview] | Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed |
NCT01332968 (32) [back to overview] | Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed |
NCT01332968 (32) [back to overview] | Duration of Response (DOR) (Overall Study Population), Investigator-Assessed |
NCT01332968 (32) [back to overview] | Event-Free Survival (Follicular Lymphoma Population) |
NCT01332968 (32) [back to overview] | Disease-Free Survival (Overall Study Population) |
NCT01335685 (27) [back to overview] | Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Overall Response Rate (ORR) |
NCT01335685 (27) [back to overview] | Overall Survival (Phase 2) |
NCT01335685 (27) [back to overview] | Progression Free Survival (Phase 2) |
NCT01335685 (27) [back to overview] | Time to First Response (Phase 2) |
NCT01335685 (27) [back to overview] | Time to Progression (TTP) (Phase 2) |
NCT01335685 (27) [back to overview] | Very Good Partial Response (VGPR) or Better Response Rate (Phase 2) |
NCT01335685 (27) [back to overview] | AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
NCT01335685 (27) [back to overview] | Observed Accumulation Ratio for AUCtau (Rac) (Phase 1) |
NCT01335685 (27) [back to overview] | Observed Accumulation Ratio for AUCtau (Rac) (Phase 1) |
NCT01335685 (27) [back to overview] | Observed Accumulation Ratio for AUCtau (Rac) (Phase 1) |
NCT01335685 (27) [back to overview] | Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1) |
NCT01335685 (27) [back to overview] | Duration of Response (DOR) (Phase 2) |
NCT01336933 (6) [back to overview] | Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment |
NCT01336933 (6) [back to overview] | Event Free Survival (EFS) |
NCT01336933 (6) [back to overview] | Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR)) |
NCT01336933 (6) [back to overview] | To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events |
NCT01336933 (6) [back to overview] | Percent of Patients Who Proceeded With Transplant |
NCT01336933 (6) [back to overview] | Overall Survival (OS) |
NCT01359592 (4) [back to overview] | Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) |
NCT01359592 (4) [back to overview] | Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL) |
NCT01359592 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
NCT01359592 (4) [back to overview] | Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) |
NCT01364389 (16) [back to overview] | Polymyalgia Rheumatica Activity Score (PMR-AS) |
NCT01364389 (16) [back to overview] | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) - % Change From Baseline in the Standard Disability Score at EOS / Month 6 |
NCT01364389 (16) [back to overview] | Mean Steroid Dose Over a 6 Month Period |
NCT01364389 (16) [back to overview] | Number of Flares Over a 6 Month Period |
NCT01364389 (16) [back to overview] | Pharmacokinetics of AIN457 and ACZ885 - CL |
NCT01364389 (16) [back to overview] | Time to Complete Clinical Response |
NCT01364389 (16) [back to overview] | Pharmacokinetics of AIN457 and ACZ885 - T1/2 |
NCT01364389 (16) [back to overview] | Pharmacokinetics of AIN457 and ACZ885 - Tmax |
NCT01364389 (16) [back to overview] | Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast |
NCT01364389 (16) [back to overview] | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths |
NCT01364389 (16) [back to overview] | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire |
NCT01364389 (16) [back to overview] | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) |
NCT01364389 (16) [back to overview] | Pharmacokinetics of AIN457 and ACZ885 - Vz |
NCT01364389 (16) [back to overview] | Time to First Flare |
NCT01364389 (16) [back to overview] | Time to Partial Clinical Response |
NCT01364389 (16) [back to overview] | Pharmacokinetics of AIN457 and ACZ885 - Cmax |
NCT01369745 (1) [back to overview] | Change From Baseline in DAS28-CRP at 12 Weeks |
NCT01375140 (1) [back to overview] | Participants With Objective Response |
NCT01381874 (7) [back to overview] | Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment |
NCT01381874 (7) [back to overview] | Progression-Free Survival (PFS) |
NCT01381874 (7) [back to overview] | Overall Survival (OS) |
NCT01381874 (7) [back to overview] | Overall Response Rate (ORR) |
NCT01381874 (7) [back to overview] | Duration of Response |
NCT01381874 (7) [back to overview] | Clinical Benefit Rate |
NCT01381874 (7) [back to overview] | Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment |
NCT01390584 (5) [back to overview] | Progression-free Survival Rate |
NCT01390584 (5) [back to overview] | Overall Survival |
NCT01390584 (5) [back to overview] | Proportion of Patients Who Are PET Negative After Induction Treatment |
NCT01390584 (5) [back to overview] | Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment |
NCT01390584 (5) [back to overview] | Complete Response (CR) Rate After Induction Treatment |
NCT01393730 (8) [back to overview] | Best Overall Response |
NCT01393730 (8) [back to overview] | Change in Serum Androgen Levels |
NCT01393730 (8) [back to overview] | Change in Serum Levels of Testosterone |
NCT01393730 (8) [back to overview] | Number of Participants With Androgen Receptor (AR) Related Mutations |
NCT01393730 (8) [back to overview] | Presence of AR Amplification |
NCT01393730 (8) [back to overview] | Prostate-Specific Antigen (PSA) Response |
NCT01393730 (8) [back to overview] | Time to Progression (TTP) |
NCT01393730 (8) [back to overview] | Time to PSA Progression |
NCT01414855 (13) [back to overview] | Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab |
NCT01414855 (13) [back to overview] | Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab |
NCT01414855 (13) [back to overview] | Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment |
NCT01414855 (13) [back to overview] | Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment |
NCT01414855 (13) [back to overview] | Duration of Response (DOR) |
NCT01414855 (13) [back to overview] | Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment |
NCT01414855 (13) [back to overview] | Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment |
NCT01414855 (13) [back to overview] | Percentage of Participants With Adverse Events as a Measure of Safety |
NCT01414855 (13) [back to overview] | Progression-Free Survival (PFS) as Assessed by the Investigator |
NCT01414855 (13) [back to overview] | Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI) |
NCT01414855 (13) [back to overview] | Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab |
NCT01414855 (13) [back to overview] | Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day) |
NCT01414855 (13) [back to overview] | Pharmacokinetics: Clearance (Cl) for Obinutuzumab |
NCT01424930 (4) [back to overview] | Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication |
NCT01424930 (4) [back to overview] | Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) |
NCT01424930 (4) [back to overview] | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone |
NCT01424930 (4) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Abiraterone |
NCT01445535 (6) [back to overview] | Overall Progression Free Survival (PFS) |
NCT01445535 (6) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events |
NCT01445535 (6) [back to overview] | Number of Dose-Limiting Toxicities (DLT) |
NCT01445535 (6) [back to overview] | Number of Participants With a Response to Therapy |
NCT01445535 (6) [back to overview] | Maximum Tolerated Dose (MTD) of Siplizumab |
NCT01445535 (6) [back to overview] | Overall Survival (OS) |
NCT01451515 (4) [back to overview] | Probability of Event-free Survival (EFS) |
NCT01451515 (4) [back to overview] | Probability of Overall Survival (OS) |
NCT01451515 (4) [back to overview] | Minimal Residual Disease (MRD) |
NCT01451515 (4) [back to overview] | Minimal Disseminated Disease (MDD) |
NCT01464164 (2) [back to overview] | Number of Participants With Complete Response and Partial Response |
NCT01464164 (2) [back to overview] | Severe Adverse Events Attributable to Study Drug |
NCT01468532 (9) [back to overview] | Maximum Tolerated Dose (MTD) of Pasireotide in Combination With Docetaxel and Prednisone by the Occurrence of Adverse Events and the Associated Grade Per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
NCT01468532 (9) [back to overview] | The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0 |
NCT01468532 (9) [back to overview] | Pharmacokinetics (PK) of SOM230 |
NCT01468532 (9) [back to overview] | Percentage Prostate-specific Antigen (PSA) Change Noted |
NCT01468532 (9) [back to overview] | Measurements of CTC Counts, the Change Between Time-points Pre-therapy, Post-therapy |
NCT01468532 (9) [back to overview] | Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy |
NCT01468532 (9) [back to overview] | Time to Progression (TTP) |
NCT01468532 (9) [back to overview] | Overall Survival (OS) |
NCT01468532 (9) [back to overview] | Measurements of Tumor Using Response Evaluation Criteria In Solid Tumors (RECIST) Criteria Before and After Treatment With the Combination of Pasireotide in Combination With Docetaxel |
NCT01471340 (3) [back to overview] | Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms |
NCT01471340 (3) [back to overview] | Number of SAO Components in MF/F Participants vs MF Participants |
NCT01471340 (3) [back to overview] | Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms |
NCT01485861 (46) [back to overview] | Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss |
NCT01485861 (46) [back to overview] | Phase II: Overall Survival (ITT Population) |
NCT01485861 (46) [back to overview] | Phase II: Overall Survival in Participants With ICR IHC PTEN Loss |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With Adverse Events (AEs) |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population) |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With CTC Conversion (ITT Population) |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With Objective Response (ITT Population) |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With Pain Progression (ITT Population) |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With PSA Progression (ITT Population) |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With PSA Response (ITT Population) |
NCT01485861 (46) [back to overview] | Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss |
NCT01485861 (46) [back to overview] | Phase II: Radiographic Progression Free Survival (rPFS) (Intent-To-Treat [ITT] Population) |
NCT01485861 (46) [back to overview] | Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss |
NCT01485861 (46) [back to overview] | Phase II: Time to Pain Progression (ITT Population) |
NCT01485861 (46) [back to overview] | Phase II: Time to Pain Progression in Participants With ICR PTEN Loss |
NCT01485861 (46) [back to overview] | Phase II: Time to PSA Progression (ITT Population) |
NCT01485861 (46) [back to overview] | Phase II: Time to PSA Progression in Participants With ICR PTEN Loss |
NCT01485861 (46) [back to overview] | Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone |
NCT01485861 (46) [back to overview] | Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib |
NCT01485861 (46) [back to overview] | Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone |
NCT01485861 (46) [back to overview] | Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib) |
NCT01485861 (46) [back to overview] | Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib |
NCT01485861 (46) [back to overview] | Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone |
NCT01485861 (46) [back to overview] | Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib) |
NCT01485861 (46) [back to overview] | Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone |
NCT01485861 (46) [back to overview] | Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib |
NCT01485861 (46) [back to overview] | Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib |
NCT01485861 (46) [back to overview] | Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib |
NCT01485861 (46) [back to overview] | Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone |
NCT01485861 (46) [back to overview] | Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib |
NCT01485861 (46) [back to overview] | Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone |
NCT01485861 (46) [back to overview] | Phase Ib: Tmax of G-037720 (Metabolite of Ipatasertib) |
NCT01485861 (46) [back to overview] | Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations |
NCT01485861 (46) [back to overview] | Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone |
NCT01485861 (46) [back to overview] | Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs) |
NCT01485861 (46) [back to overview] | Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone |
NCT01485861 (46) [back to overview] | Phase II: Duration of Tumor Response (ITT Population) |
NCT01485861 (46) [back to overview] | Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib |
NCT01485861 (46) [back to overview] | Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib) |
NCT01485861 (46) [back to overview] | Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone |
NCT01485861 (46) [back to overview] | Phase Ib: Percentage of Participants With Adverse Events (AEs) |
NCT01503229 (1) [back to overview] | Change in Tissue Testosterone and Dihydrotestosterone |
NCT01511536 (15) [back to overview] | Phase 2: PSA Progression Free Survival |
NCT01511536 (15) [back to overview] | Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate |
NCT01511536 (15) [back to overview] | Phase 2: Objective Progression Free Survival (PFS) |
NCT01511536 (15) [back to overview] | Phase 2: Overall Survival |
NCT01511536 (15) [back to overview] | Phase 2: Percentage of Participants With Objective Response |
NCT01511536 (15) [back to overview] | Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response |
NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24) |
NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss) |
NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax) |
NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax) |
NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC) |
NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax) |
NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z) |
NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL) |
NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss) |
NCT01517802 (1) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) |
NCT01517984 (6) [back to overview] | Percentage of Participants With New Donor Specific Antibodies (DSAs) |
NCT01517984 (6) [back to overview] | Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation |
NCT01517984 (6) [back to overview] | Incidence of Acute Rejection |
NCT01517984 (6) [back to overview] | Percentage of Participants in the Experimental Arm Off Tacrolimus |
NCT01517984 (6) [back to overview] | Participant Survival Rate |
NCT01517984 (6) [back to overview] | Allograft Survival Rate |
NCT01522443 (3) [back to overview] | Bone Scan Response (BSR) |
NCT01522443 (3) [back to overview] | Overall Survival (OS) |
NCT01522443 (3) [back to overview] | Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported |
NCT01524536 (9) [back to overview] | Participants With Glucocorticoid Responsiveness - Cardiac Involvement |
NCT01524536 (9) [back to overview] | Participants With Glucocorticoid Responsiveness - LHES Variant |
NCT01524536 (9) [back to overview] | Participants With Glucocorticoid Responsiveness - Overlap HES Subtypes |
NCT01524536 (9) [back to overview] | Participants With Glucocorticoid Responsiveness - Pulmonary Involvement |
NCT01524536 (9) [back to overview] | Participants With Glucocorticoid Responsiveness - MHES Variant |
NCT01524536 (9) [back to overview] | Mean Baseline Absolute Eosinophil Count |
NCT01524536 (9) [back to overview] | Participants With Glucocorticoid Responsiveness - IHES Variant |
NCT01524536 (9) [back to overview] | Mean Percent Change in Eosinophil Count After Glucocorticoid Challenge |
NCT01524536 (9) [back to overview] | Mean Baseline IgE Level |
NCT01536535 (3) [back to overview] | Number of Participants Who Needed Additional Therapy or Colectomy |
NCT01536535 (3) [back to overview] | Number of Participants With Corticosteroid Free Remission (SFR) |
NCT01536535 (3) [back to overview] | Number of Participants Receiving a Colectomy |
NCT01549951 (13) [back to overview] | Number of Participants Reporting Change From Baseline in ECG Morphology |
NCT01549951 (13) [back to overview] | Number of Participants Reporting One or More Treatment-emergent Adverse Events |
NCT01549951 (13) [back to overview] | AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite |
NCT01549951 (13) [back to overview] | Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite |
NCT01549951 (13) [back to overview] | Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval |
NCT01549951 (13) [back to overview] | Number of Participants Reporting Clinically Significant Abnormalities in ECG |
NCT01549951 (13) [back to overview] | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite |
NCT01549951 (13) [back to overview] | Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method |
NCT01549951 (13) [back to overview] | Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings |
NCT01549951 (13) [back to overview] | Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs |
NCT01549951 (13) [back to overview] | Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values |
NCT01549951 (13) [back to overview] | Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel |
NCT01549951 (13) [back to overview] | Changes From Baseline in Heart Rate |
NCT01553188 (6) [back to overview] | Radiographic Progression Free Survival |
NCT01553188 (6) [back to overview] | Progression Free Survival (PFS) |
NCT01553188 (6) [back to overview] | Overall Survival |
NCT01553188 (6) [back to overview] | Dose Limiting Toxicity (DLT) |
NCT01553188 (6) [back to overview] | Count of Participants With Serious and Non-serious Adverse Events |
NCT01553188 (6) [back to overview] | Maximum Tolerated Dose (MTD) |
NCT01576172 (5) [back to overview] | Rates of PSA Decline |
NCT01576172 (5) [back to overview] | Progression-free Survival (PFS) |
NCT01576172 (5) [back to overview] | Objective Response Rates in Patients With Measurable Disease. |
NCT01576172 (5) [back to overview] | Confirmed Prostate-specific Antigen (PSA) Response Rate |
NCT01576172 (5) [back to overview] | Grade 4 or 5 Adverse Events |
NCT01603407 (17) [back to overview] | Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction With Treatment Score |
NCT01603407 (17) [back to overview] | Rise From the Floor Velocity |
NCT01603407 (17) [back to overview] | Range of Motion (Goniometry) of Right Ankle |
NCT01603407 (17) [back to overview] | Range of Motion (Goniometry) of Left Ankle |
NCT01603407 (17) [back to overview] | Quality of Life- Child |
NCT01603407 (17) [back to overview] | Quality of Life - Parent |
NCT01603407 (17) [back to overview] | PR Interval |
NCT01603407 (17) [back to overview] | Participant Weight |
NCT01603407 (17) [back to overview] | Participant Height |
NCT01603407 (17) [back to overview] | Participant Body Mass Index |
NCT01603407 (17) [back to overview] | Number of Participants Who Tolerated the Regimen |
NCT01603407 (17) [back to overview] | North Star Ambulatory Assessment (NSAA) Score |
NCT01603407 (17) [back to overview] | Left Ventricular Ejection Fraction Percent |
NCT01603407 (17) [back to overview] | Heart Rate |
NCT01603407 (17) [back to overview] | Forced Vital Capacity |
NCT01603407 (17) [back to overview] | 6 Minute Walk Test |
NCT01603407 (17) [back to overview] | Fractional Shortening Percent |
NCT01605227 (3) [back to overview] | Progression-free Survival (PFS) |
NCT01605227 (3) [back to overview] | Bone Scan Response (BSR) |
NCT01605227 (3) [back to overview] | Overall Survival (OS) |
NCT01637402 (9) [back to overview] | Comparison of Circulating Androstenedione Levels Between Primary-Resistant Patients and Responders |
NCT01637402 (9) [back to overview] | Comparison of Circulating DHEA-S Levels Between Primary-Resistant Patients and Responders |
NCT01637402 (9) [back to overview] | Comparison of Circulating Testosterone Levels Between Primary-Resistant Patients and Responders |
NCT01637402 (9) [back to overview] | Correlation of Circulating Dehydroepiandrosterone (DHEA) Levels From Baseline to Week 12 |
NCT01637402 (9) [back to overview] | Number of Patients With PSA Response From Dose Escalation |
NCT01637402 (9) [back to overview] | Serum Concentration Levels of Abiraterone Acetate Over Time |
NCT01637402 (9) [back to overview] | Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group |
NCT01637402 (9) [back to overview] | Time to PSA Progression for Dose Escalation Cohort |
NCT01637402 (9) [back to overview] | Comparison of Circulating DHEA Levels Between Primary-Resistant and Responders |
NCT01650194 (17) [back to overview] | Change From Baseline to EoT in Bone Specific Alkaline Phosphatase |
NCT01650194 (17) [back to overview] | Change From Baseline in Progesterone Concentration in Blood |
NCT01650194 (17) [back to overview] | Change From Baseline in Pregnenolone in Bone Marrow Aspirate |
NCT01650194 (17) [back to overview] | Change From Baseline in Pregnenolone Concentration in Blood |
NCT01650194 (17) [back to overview] | Percentage of Participants With Objective Response for Soft Tissue Lesions According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) |
NCT01650194 (17) [back to overview] | Progression Free Survival (PFS) |
NCT01650194 (17) [back to overview] | Bone Scan Response at EoT |
NCT01650194 (17) [back to overview] | Change From Baseline in Cortisol in Bone Marrow Aspirate |
NCT01650194 (17) [back to overview] | Change From Baseline in Androstenedione Concentration in Blood |
NCT01650194 (17) [back to overview] | Change From Baseline in Cortisol Concentration in Blood |
NCT01650194 (17) [back to overview] | Change From Baseline to End-of-Treatment (EoT) in Prostate-Specific Antigen (PSA) Levels |
NCT01650194 (17) [back to overview] | Change From Baseline in Progesterone in Bone Marrow Aspirate |
NCT01650194 (17) [back to overview] | Change From Baseline in Testosterone Concentration in Blood |
NCT01650194 (17) [back to overview] | Change From Baseline in Testosterone Concentration in Bone Marrow Aspirate |
NCT01650194 (17) [back to overview] | Change From Baseline in Urine N-Telopeptide |
NCT01650194 (17) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT01650194 (17) [back to overview] | Change From Baseline in Androstenedione in Bone Marrow Aspirate |
NCT01666314 (22) [back to overview] | Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment |
NCT01666314 (22) [back to overview] | Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment |
NCT01666314 (22) [back to overview] | Absolute Values for Prostate-Specific Antigen (PSA) |
NCT01666314 (22) [back to overview] | AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite |
NCT01666314 (22) [back to overview] | AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite |
NCT01666314 (22) [back to overview] | Absolute Values for Testosterone |
NCT01666314 (22) [back to overview] | Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S) |
NCT01666314 (22) [back to overview] | Absolute Values for Cortisol |
NCT01666314 (22) [back to overview] | Absolute Values for Corticosterone |
NCT01666314 (22) [back to overview] | Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment |
NCT01666314 (22) [back to overview] | Absolute Values for Adrenocorticotropic Hormone (ACTH) |
NCT01666314 (22) [back to overview] | Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan |
NCT01666314 (22) [back to overview] | Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan |
NCT01666314 (22) [back to overview] | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite |
NCT01666314 (22) [back to overview] | Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite |
NCT01666314 (22) [back to overview] | Rac: Accumulation Index for Orteronel and M-I Metabolite |
NCT01666314 (22) [back to overview] | Percentage of Participants With PSA50 After 12 Weeks of Treatment |
NCT01666314 (22) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT01666314 (22) [back to overview] | Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite |
NCT01666314 (22) [back to overview] | Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite |
NCT01666314 (22) [back to overview] | Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite |
NCT01666314 (22) [back to overview] | AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite |
NCT01671423 (2) [back to overview] | Amount of Pain Medication - Day 1 to 48 Hours |
NCT01671423 (2) [back to overview] | Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours |
NCT01676415 (3) [back to overview] | SNOT-22 Questionnaire |
NCT01676415 (3) [back to overview] | Medication Side-effect and Compliance Inventory |
NCT01676415 (3) [back to overview] | Taskforce Symptom Inventory |
NCT01681433 (5) [back to overview] | Time to Disease Progression |
NCT01681433 (5) [back to overview] | PSA Response |
NCT01681433 (5) [back to overview] | Objective Response |
NCT01681433 (5) [back to overview] | Circulating Tumor Cell (CTC) Counts |
NCT01681433 (5) [back to overview] | Progression-Free Survival |
NCT01683994 (5) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) |
NCT01683994 (5) [back to overview] | Progression Free Survival (PFS) of Cabozantinib + Docetaxel + Prednisone Compared to Docetaxel + Prednisone Alone |
NCT01683994 (5) [back to overview] | Number of Participants Achieving Prostatic-Specific Antigen (PSA) Decline of 30% or 50% From Baseline |
NCT01683994 (5) [back to overview] | Number of Participants With a Dose Limiting Toxicities (DLTs) |
NCT01683994 (5) [back to overview] | Maximum Tolerated Dose (MTD) |
NCT01687296 (8) [back to overview] | Mean Global Evaluation for Efficacy by Participant/Parent and Investigator |
NCT01687296 (8) [back to overview] | Mean Evening PEF on Diary Card Over the Treatment Assessment Period |
NCT01687296 (8) [back to overview] | Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population |
NCT01687296 (8) [back to overview] | Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population |
NCT01687296 (8) [back to overview] | Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period |
NCT01687296 (8) [back to overview] | Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period |
NCT01687296 (8) [back to overview] | Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8 |
NCT01687296 (8) [back to overview] | Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period |
NCT01691508 (5) [back to overview] | Number of Participants Who Achieved a Reduction of Their Daily OCS Dose to <=5.0 mg During Weeks 20 to 24 While Maintaining Asthma Control |
NCT01691508 (5) [back to overview] | Median Percentage Change From Baseline in Daily OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control |
NCT01691508 (5) [back to overview] | Number of Participants Who Achieved a Reduction of >=50% in Their Daily Oral Corticosteroid (OCS) Dose Compared With Baseline Dose, During Weeks 20 to 24 While Maintaining Asthma Control |
NCT01691508 (5) [back to overview] | Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control |
NCT01691508 (5) [back to overview] | Number of Participants Who Achieved a Total Reduction of OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control |
NCT01695135 (8) [back to overview] | DB Phase: Objective Response Rate (ORR) |
NCT01695135 (8) [back to overview] | DB Phase: Overall Survival |
NCT01695135 (8) [back to overview] | DB Phase: Percentage of Participants Experiencing Pain Palliation |
NCT01695135 (8) [back to overview] | DB Phase: Percentage of Participants Who Achieved PSA Response |
NCT01695135 (8) [back to overview] | DB Phase: Time to Pain Progression |
NCT01695135 (8) [back to overview] | DB Phase: Time to Prostate-Specific Antigen Progression (PSA) |
NCT01695135 (8) [back to overview] | DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment |
NCT01695135 (8) [back to overview] | DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment |
NCT01714817 (45) [back to overview] | AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval |
NCT01714817 (45) [back to overview] | Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants |
NCT01714817 (45) [back to overview] | Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population |
NCT01714817 (45) [back to overview] | Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period |
NCT01714817 (45) [back to overview] | Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood) |
NCT01714817 (45) [back to overview] | Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period |
NCT01714817 (45) [back to overview] | Summary Statistics for Systolic Blood Pressure |
NCT01714817 (45) [back to overview] | Summary Statistics for Heart Rate |
NCT01714817 (45) [back to overview] | Summary Statistics for Diastolic Blood Pressure |
NCT01714817 (45) [back to overview] | Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period |
NCT01714817 (45) [back to overview] | Percentage of Participants in Treatment Failure Over Time During the Double-blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension |
NCT01714817 (45) [back to overview] | Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period |
NCT01714817 (45) [back to overview] | Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period |
NCT01714817 (45) [back to overview] | Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants |
NCT01714817 (45) [back to overview] | Median Time to Partial Renal Response During the Double-blind Period in All Participants |
NCT01714817 (45) [back to overview] | Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period |
NCT01714817 (45) [back to overview] | Median Time to First Sustained Change to No Response During the Double-blind Period |
NCT01714817 (45) [back to overview] | Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants |
NCT01714817 (45) [back to overview] | Median Time to Complete Renal Response During the Double-blind Period in All Participants |
NCT01714817 (45) [back to overview] | Median Percent Change From Baseline in UPCR Over Time |
NCT01714817 (45) [back to overview] | Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L) |
NCT01714817 (45) [back to overview] | Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L) |
NCT01714817 (45) [back to overview] | Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L) |
NCT01714817 (45) [back to overview] | Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L) |
NCT01714817 (45) [back to overview] | Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion |
NCT01714817 (45) [back to overview] | Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV |
NCT01714817 (45) [back to overview] | Adjusted Mean Change From Baseline in UPCR Over Time |
NCT01714817 (45) [back to overview] | Adjusted Mean Change From Baseline in eGFR Over Time |
NCT01714817 (45) [back to overview] | Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period |
NCT01714817 (45) [back to overview] | Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period |
NCT01714817 (45) [back to overview] | Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period |
NCT01714817 (45) [back to overview] | Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period |
NCT01714817 (45) [back to overview] | Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L) |
NCT01715285 (7) [back to overview] | Time to Prostate-Specific Antigen (PSA) Progression |
NCT01715285 (7) [back to overview] | Time to Skeletal-Related Event |
NCT01715285 (7) [back to overview] | Time to Subsequent Therapy for Prostate Cancer |
NCT01715285 (7) [back to overview] | Time to Pain Progression |
NCT01715285 (7) [back to overview] | Overall Survival (OS) |
NCT01715285 (7) [back to overview] | Radiographic Progression-Free Survival (PFS) |
NCT01715285 (7) [back to overview] | Time to Initiation of Chemotherapy |
NCT01717053 (8) [back to overview] | Metastasis or Systemic Therapy |
NCT01717053 (8) [back to overview] | Safety and Tolerability |
NCT01717053 (8) [back to overview] | Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year |
NCT01717053 (8) [back to overview] | Testosterone Recovery |
NCT01717053 (8) [back to overview] | Time to PSA Nadir |
NCT01717053 (8) [back to overview] | Percentage of Participants With Biochemical Progression-free Survival (BPFS) |
NCT01717053 (8) [back to overview] | PSA < 1.5ng/ml in Setting of Non-castrate Testosterone |
NCT01717053 (8) [back to overview] | PSA Nadir Value |
NCT01717898 (3) [back to overview] | Number of Reported Dose Limiting Toxicities When Combining BEZ235 With Abiraterone Acetate (Phase I). |
NCT01717898 (3) [back to overview] | Maximum Tolerated Dose for BEZ235 + Abiraterone Acetate (Phase I). |
NCT01717898 (3) [back to overview] | Anti-tumor Responses as Defined by a Decline in PSA of > 50% |
NCT01718353 (9) [back to overview] | Radiographic Progression-free Survival (rPFS) |
NCT01718353 (9) [back to overview] | Clinical Progression-free Survival (cPFS) |
NCT01718353 (9) [back to overview] | Drug-target Engagement in Circulating Tumor Cells (CTCs): Change From Baseline at Cycle 1 Day 8 in Percent Androgen Receptor Nuclear Localization (%ARNL) by Categories of PSA Decrease From Baseline (≥50%, Not ≥50%) After Cycle 4 |
NCT01718353 (9) [back to overview] | Drug-target Engagement in CTCs: Change From Baseline at Cycle 1 Day 8 in MTB by Categories of PSA Decrease From Baseline (≥30%, Not ≥30%) After Cycle 4 |
NCT01718353 (9) [back to overview] | Overall Survival |
NCT01718353 (9) [back to overview] | Percentage of Participants With ≥30% and ≥50% Reduction in PSA Response |
NCT01718353 (9) [back to overview] | Percentage of Participants With PSA Response |
NCT01718353 (9) [back to overview] | Progression Free Survival (PFS) |
NCT01718353 (9) [back to overview] | PSA Progression Free Survival |
NCT01724021 (14) [back to overview] | Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV]) |
NCT01724021 (14) [back to overview] | Cancer Therapy Satisfaction Questionnaire (CTSQ) Score |
NCT01724021 (14) [back to overview] | Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time |
NCT01724021 (14) [back to overview] | Percentage of Participants With Anti-Rituximab Antibodies Over Time |
NCT01724021 (14) [back to overview] | Rituximab Administration Satisfaction Questionnaire (RASQ) Score |
NCT01724021 (14) [back to overview] | Summary of Observed Serum Rituximab Concentration |
NCT01724021 (14) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (AEs) |
NCT01724021 (14) [back to overview] | Event-free Survival (EFS) |
NCT01724021 (14) [back to overview] | Disease-free Survival (DFS) |
NCT01724021 (14) [back to overview] | Complete Response (CR) Rate |
NCT01724021 (14) [back to overview] | Overall Survival (OS) |
NCT01724021 (14) [back to overview] | Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6 |
NCT01724021 (14) [back to overview] | Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8 |
NCT01724021 (14) [back to overview] | Progression-free Survival (PFS) |
NCT01729494 (21) [back to overview] | Steroid Therapy |
NCT01729494 (21) [back to overview] | eGFR (MRDRD) < 45 ml/Min/1.73m2 |
NCT01729494 (21) [back to overview] | New Onset Diabetes After Transplantation (NODAT) |
NCT01729494 (21) [back to overview] | Delayed Graft Function |
NCT01729494 (21) [back to overview] | Discontinuation of Mycophenolate |
NCT01729494 (21) [back to overview] | Requirement of T-cell Depleting Therapy for Biopsy Proven Acute Rejection (BPAR) |
NCT01729494 (21) [back to overview] | Time to First BPAR |
NCT01729494 (21) [back to overview] | Mean eGFR (MDRD) (ml/Min/1.73m2) |
NCT01729494 (21) [back to overview] | Discontinuation of Study Treatment (Belatacept or Tacrolimus) |
NCT01729494 (21) [back to overview] | Leukopenia (WBC < 2000/mm3) |
NCT01729494 (21) [back to overview] | Proteinuria UPC Ratio > 0.8 |
NCT01729494 (21) [back to overview] | Patient Death |
NCT01729494 (21) [back to overview] | Biopsy Proven Mixed Acute Rejection |
NCT01729494 (21) [back to overview] | Biopsy Proven Acute Rejection |
NCT01729494 (21) [back to overview] | # of Patients Developing Denovo Donor Specific Antibody (DSA) Post-transplant |
NCT01729494 (21) [back to overview] | # Patients Experiencing a First Biopsy-proven ACR With Severity Banff > or = 2a Grade |
NCT01729494 (21) [back to overview] | # Patients Experiencing a Graft Loss But Not Including Patients Who Died With Functioning Graft (Death-censored Graft Loss) |
NCT01729494 (21) [back to overview] | # Patients With Composite Endpoint of Either Experiencing Death, Graft Loss, or eGFR < 45ml/Min at 24 Months |
NCT01729494 (21) [back to overview] | # Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min |
NCT01729494 (21) [back to overview] | Biopsy Proven Acute Antibody Mediated Rejection |
NCT01729494 (21) [back to overview] | Biopsy Proven Acute Cellular Rejection |
NCT01746173 (2) [back to overview] | Induction Response |
NCT01746173 (2) [back to overview] | 24-month Progression-Free Survival Rate |
NCT01753401 (17) [back to overview] | Mean Score on the Mental Component Scale (MCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks |
NCT01753401 (17) [back to overview] | Krupp Fatigue Severity Score (FSS) Within 8 Weeks |
NCT01753401 (17) [back to overview] | Number of Participants Who Meet the Definition of a Responder Within 4 Weeks |
NCT01753401 (17) [back to overview] | Number of Participants Who Meet the Definition of a Responder Within 8 Weeks |
NCT01753401 (17) [back to overview] | Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Within 8 Weeks |
NCT01753401 (17) [back to overview] | Number of Participants With a Relapse Within 52 Weeks |
NCT01753401 (17) [back to overview] | Number of Tender or Swollen Joints at Week 52 |
NCT01753401 (17) [back to overview] | Score on the SELENA-SLEDAI at Week 52 |
NCT01753401 (17) [back to overview] | Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52 |
NCT01753401 (17) [back to overview] | Mean Score on the Mental Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52 |
NCT01753401 (17) [back to overview] | BILAG Total Score Within 8 Weeks |
NCT01753401 (17) [back to overview] | Krupp Fatigue Severity Score (FSS) at Week 52 |
NCT01753401 (17) [back to overview] | Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) at Week 52 |
NCT01753401 (17) [back to overview] | Number of Participants Who Meet the Definition of a Responder at Week 52 |
NCT01753401 (17) [back to overview] | Number of Tender or Swollen Joints Within 8 Weeks |
NCT01753401 (17) [back to overview] | Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks |
NCT01753401 (17) [back to overview] | Score on the SELENA-SLEDAI Within 8 Weeks |
NCT01775475 (8) [back to overview] | Change in Absolute CD4 Count From Baseline to Post-treatment |
NCT01775475 (8) [back to overview] | Participants Who Experienced an Adverse Event |
NCT01775475 (8) [back to overview] | Progression-free Survival |
NCT01775475 (8) [back to overview] | Proportion of Patients Who Are Adherent to Chemotherapy |
NCT01775475 (8) [back to overview] | Proportion of Patients Who Are Adherent to Antiretroviral Therapy |
NCT01775475 (8) [back to overview] | Overall Response Rate |
NCT01775475 (8) [back to overview] | Overall Survival |
NCT01775475 (8) [back to overview] | Number of Patients Who Complete Treatment |
NCT01777152 (7) [back to overview] | Objective Response Rate (ORR) Per IRF at End of Treatment |
NCT01777152 (7) [back to overview] | Complete Remission (CR) Rate Per IRF at End of Treatment (EOT) |
NCT01777152 (7) [back to overview] | Overall Survival (OS) |
NCT01777152 (7) [back to overview] | Progression-free Survival Per Independent Review Facility (IRF) |
NCT01777152 (7) [back to overview] | Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL) |
NCT01777152 (7) [back to overview] | Incidence of Adverse Events (AEs) |
NCT01777152 (7) [back to overview] | Incidence of Laboratory Abnormalities |
NCT01782859 (4) [back to overview] | Serum Prothrombin Fragment 1 and 2 (PF 1.2) |
NCT01782859 (4) [back to overview] | Plasmin-a 2 Antiplasmin Complex (PAP) |
NCT01782859 (4) [back to overview] | Pain at 3 Months Post-op |
NCT01782859 (4) [back to overview] | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) |
NCT01791153 (15) [back to overview] | Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab |
NCT01791153 (15) [back to overview] | Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) |
NCT01791153 (15) [back to overview] | Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper) |
NCT01791153 (15) [back to overview] | Percentage of Participants With Anti-Tocilizumab Antibodies |
NCT01791153 (15) [back to overview] | Serum Interleukin-6 (IL-6) Level |
NCT01791153 (15) [back to overview] | Serum Soluble IL-6 Receptor (sIL-6R) Level |
NCT01791153 (15) [back to overview] | Minimum Observed Serum Concentration (Ctrough) of Tocilizumab |
NCT01791153 (15) [back to overview] | Erythrocyte Sedimentation Rate (ESR) |
NCT01791153 (15) [back to overview] | Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52 |
NCT01791153 (15) [back to overview] | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52 |
NCT01791153 (15) [back to overview] | C-Reactive Protein (CRP) Level |
NCT01791153 (15) [back to overview] | Total Cumulative Prednisone Dose |
NCT01791153 (15) [back to overview] | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab |
NCT01791153 (15) [back to overview] | Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab |
NCT01791153 (15) [back to overview] | Time to First GCA Disease Flare |
NCT01818752 (7) [back to overview] | Overall Survival (OS) |
NCT01818752 (7) [back to overview] | Complete Response Rate |
NCT01818752 (7) [back to overview] | Overall Response Rate |
NCT01818752 (7) [back to overview] | Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy |
NCT01818752 (7) [back to overview] | Progression-Free Survival (PFS) |
NCT01818752 (7) [back to overview] | European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores |
NCT01818752 (7) [back to overview] | Number of Participants With Adverse Events |
NCT01829295 (3) [back to overview] | Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months) |
NCT01829295 (3) [back to overview] | Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months) |
NCT01829295 (3) [back to overview] | Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months) |
NCT01848067 (2) [back to overview] | Number of Participants With a PSA Value Equal to or Greater Than 25% |
NCT01848067 (2) [back to overview] | Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1 |
NCT01855750 (6) [back to overview] | Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population |
NCT01855750 (6) [back to overview] | Event-Free Survival (EFS) - Activated B-Cell (ABC) Population |
NCT01855750 (6) [back to overview] | Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) |
NCT01855750 (6) [back to overview] | Progression-Free Survival (PFS) |
NCT01855750 (6) [back to overview] | Percentage of Participants Who Achieved Complete Response (CR) |
NCT01855750 (6) [back to overview] | Overall Survival |
NCT01856192 (4) [back to overview] | Proportion of Patients With Complete Response |
NCT01856192 (4) [back to overview] | Overall Survival Rate at 3 Years |
NCT01856192 (4) [back to overview] | 3-year Progression-free Survival Rate |
NCT01856192 (4) [back to overview] | Proportion of Patients With Response |
NCT01867710 (15) [back to overview] | Time to Opiate Use for Cancer-related Pain |
NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale |
NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain |
NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS |
NCT01867710 (15) [back to overview] | Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment |
NCT01867710 (15) [back to overview] | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point |
NCT01867710 (15) [back to overview] | Progression-Free Survival (PFS) |
NCT01867710 (15) [back to overview] | Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12 |
NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score |
NCT01867710 (15) [back to overview] | Time to Prostate-Specific Antigen (PSA) Progression |
NCT01867710 (15) [back to overview] | Overall Survival |
NCT01867710 (15) [back to overview] | Objective Response Rate (ORR) |
NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score |
NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale |
NCT01867710 (15) [back to overview] | Time to Next Prostate Cancer Therapy |
NCT01884571 (8) [back to overview] | Mean Rate of Change in Grip Strength Treatment Compared to Pre-Treatment |
NCT01884571 (8) [back to overview] | Mean Rate of Change of ALSFRS-R Scores During Treatment Compared to Pre-Treatment |
NCT01884571 (8) [back to overview] | Collection of Cerebrospinal Fluid for Future Analysis of Cytokine Levels |
NCT01884571 (8) [back to overview] | Mean Rate of Change of Hand-Held Dynamometry (HHD) During Treatment Compared to Pre-Treatment |
NCT01884571 (8) [back to overview] | Mean Rate of Change of Slow Vital Capacity (SVC) During Treatment Compared to Pre-Treatment |
NCT01884571 (8) [back to overview] | Mean Rate of Change of T-cell Subsets in Blood Treatment Compared to Pre-Treatment |
NCT01884571 (8) [back to overview] | Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month |
NCT01884571 (8) [back to overview] | Collection of Blood for Future Analysis of Peripheral Blood Mononuclear Cells (PBMCs) |
NCT01888952 (1) [back to overview] | Total Number of Adverse Events. |
NCT01889069 (23) [back to overview] | DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21 |
NCT01889069 (23) [back to overview] | DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21 |
NCT01889069 (23) [back to overview] | Percentage of Participants With Progression-Free Survival (PFS) According to IWG Response Criteria |
NCT01889069 (23) [back to overview] | Percentage of Participants With Overall Survival (OS) |
NCT01889069 (23) [back to overview] | Percentage of Participants With Event-Free Survival (EFS) According to IWG Response Criteria |
NCT01889069 (23) [back to overview] | Percentage of Participants With Disease-Free Survival (DFS) According to IWG Response Criteria |
NCT01889069 (23) [back to overview] | Percentage of Participants With Complete Response (CR) According to IWG Response Criteria |
NCT01889069 (23) [back to overview] | Percentage of Participants With At Least One Treatment-Emergent Serious Adverse Events |
NCT01889069 (23) [back to overview] | Percentage of Participants With At Least One Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) |
NCT01889069 (23) [back to overview] | Percentage of Participants With At Least One Grade ≥ 3 Infusion/ Injection Related Reactions (IIRRs) |
NCT01889069 (23) [back to overview] | FL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab |
NCT01889069 (23) [back to overview] | DLBCL: Maximum Plasma Concentration (Cmax) of Rituximab |
NCT01889069 (23) [back to overview] | DLBCL: Apparent Total Clearance (CL/F) of Rituximab |
NCT01889069 (23) [back to overview] | DLBCL: Area Under the Plasma Concentration-Time Curve (AUC) of Rituximab |
NCT01889069 (23) [back to overview] | Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores |
NCT01889069 (23) [back to overview] | DLBCL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab |
NCT01889069 (23) [back to overview] | FL: Plasma Trough Concentrations of Rituximab |
NCT01889069 (23) [back to overview] | Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores |
NCT01889069 (23) [back to overview] | Percentage of Participants With Administration-Associated Reactions (AAR) |
NCT01889069 (23) [back to overview] | FL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu) |
NCT01889069 (23) [back to overview] | DLBCL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu) |
NCT01889069 (23) [back to overview] | DLBCL: Plasma Trough Concentrations of Rituximab |
NCT01889069 (23) [back to overview] | DLBCL: Plasma Concentrations of Rituximab |
NCT01900431 (8) [back to overview] | Change From Baseline in Central Retinal Thickness (CRT) At Week 16 |
NCT01900431 (8) [back to overview] | Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16 |
NCT01900431 (8) [back to overview] | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16 |
NCT01900431 (8) [back to overview] | Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16 |
NCT01900431 (8) [back to overview] | Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16 |
NCT01900431 (8) [back to overview] | Percent Change From Baseline in CRT at Week 16 |
NCT01900431 (8) [back to overview] | Change From Baseline in VH Scale at Week 16 |
NCT01900431 (8) [back to overview] | Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration |
NCT01920932 (11) [back to overview] | Descriptive of Hematological Adverse Events |
NCT01920932 (11) [back to overview] | Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control |
NCT01920932 (11) [back to overview] | Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control |
NCT01920932 (11) [back to overview] | Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac. |
NCT01920932 (11) [back to overview] | Descriptive of Infectious Adverse Events |
NCT01920932 (11) [back to overview] | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) |
NCT01920932 (11) [back to overview] | Complete Response Rate Estimate for All Evaluable Participants |
NCT01920932 (11) [back to overview] | Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2). |
NCT01920932 (11) [back to overview] | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) |
NCT01920932 (11) [back to overview] | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) |
NCT01920932 (11) [back to overview] | Descriptive of Neuropathic Adverse Events |
NCT01921218 (6) [back to overview] | Number of Infectious Complications |
NCT01921218 (6) [back to overview] | Number of Participants With Donor-specific Antibody Formation |
NCT01921218 (6) [back to overview] | Glomerular Filtration Rate (GFR) |
NCT01921218 (6) [back to overview] | Glomerular Filtration Rate (GFR) |
NCT01921218 (6) [back to overview] | Time to Initiation of Dialysis |
NCT01921218 (6) [back to overview] | Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies |
NCT01925131 (3) [back to overview] | MTD of Inotuzumab Ozogamicin With CVP for Patients With Relapsed or Refractory CD22+ Acute Leukemia |
NCT01925131 (3) [back to overview] | Frequency and Severity of Toxicities |
NCT01925131 (3) [back to overview] | Response Rate (CR+CRi) Among Expansion Cohort |
NCT01925612 (6) [back to overview] | Complete Remission Rate |
NCT01925612 (6) [back to overview] | Incidence of Adverse Events |
NCT01925612 (6) [back to overview] | Objective Response Rate |
NCT01925612 (6) [back to overview] | Incidence of Laboratory Abnormalities |
NCT01925612 (6) [back to overview] | Progression-free Survival |
NCT01925612 (6) [back to overview] | Overall Survival |
NCT01940276 (6) [back to overview] | Change in PSA Response |
NCT01940276 (6) [back to overview] | Overall Survival |
NCT01940276 (6) [back to overview] | Median Radiographic Progression Free Survival (PFS) |
NCT01940276 (6) [back to overview] | Median Time to PSA Progression |
NCT01940276 (6) [back to overview] | Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml |
NCT01940276 (6) [back to overview] | Percent of Subjects Experiencing Hypertension |
NCT01946165 (2) [back to overview] | Proportion of Participants With Pathologic Stage Less Than or Equal to ypT2N0 |
NCT01946165 (2) [back to overview] | Proportion of Participants With Positive Surgical Margins |
NCT01946880 (36) [back to overview] | Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs). |
NCT01946880 (36) [back to overview] | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Systemic Lupus Erythematosus (SLE) |
NCT01946880 (36) [back to overview] | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Mycophenolate Mofetil (MMF) |
NCT01946880 (36) [back to overview] | Number of Grade 3, 4, or 5 Adverse Events (AEs) |
NCT01946880 (36) [back to overview] | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score |
NCT01946880 (36) [back to overview] | Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score |
NCT01946880 (36) [back to overview] | Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score |
NCT01946880 (36) [back to overview] | Change From Baseline in the Lupus Quality of Life (QoL)Score |
NCT01946880 (36) [back to overview] | Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score |
NCT01946880 (36) [back to overview] | Time to First Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare |
NCT01946880 (36) [back to overview] | Time to First Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare |
NCT01946880 (36) [back to overview] | Time to Clinically Significant Disease Reactivation |
NCT01946880 (36) [back to overview] | Time From Clinically Significant Disease Reactivation to Return to Pre-Flare Steroid Dose |
NCT01946880 (36) [back to overview] | Time From Clinically Significant Disease Reactivation to Recovery to Baseline British Isles Lupus Assessment Group (BILAG) Score or BILAG C |
NCT01946880 (36) [back to overview] | Time From Clinically Significant Disease Reactivation to Improvement in British Isles Lupus Assessment Group (BILAG) From Maximum Level During Flare |
NCT01946880 (36) [back to overview] | The Addition of Aggressive Adjunctive Therapy to Mycophenolate Mofetil (MMF) or Change in MMF Therapy to Cytotoxic Drug Due to Flare by Week 60 |
NCT01946880 (36) [back to overview] | Number of Serious Adverse Events (SAEs). |
NCT01946880 (36) [back to overview] | Number of Participants in the Lupus Nephritis Subgroup Experiencing a British Isles Lupus Assessment Group (BILAG) A Renal Flare by Week 60 |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF <2000 mg/Day Subgroup |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing Clinically Significant Disease Reactivation by Week 60 |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing Any British Isles Lupus Assessment Group (BILAG) A Flare by Week 60 |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup |
NCT01946880 (36) [back to overview] | Number of Malignancies Reported as Adverse Events (AEs). |
NCT01946880 (36) [back to overview] | Number of Infection-Related Adverse Events (AEs) |
NCT01946880 (36) [back to overview] | Mortality Related to Systemic Lupus Erythematosus (SLE) |
NCT01946880 (36) [back to overview] | Cumulative Systemic Steroid Dose by Week 60 |
NCT01946880 (36) [back to overview] | Cumulative Excess Systemic Steroid Dose From Time of Clinically Significant Disease Reactivation to Return to Pre-Flare Dose or End of Trial Participation |
NCT01946880 (36) [back to overview] | All-Cause Mortality |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF<2000 mg/Day Subgroup |
NCT01946880 (36) [back to overview] | Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup |
NCT01949337 (2) [back to overview] | Overall Survival (OS) |
NCT01949337 (2) [back to overview] | Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment) |
NCT01950819 (22) [back to overview] | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported |
NCT01950819 (22) [back to overview] | Evolution of Renal Function, as eGFR, Over Time by Slope Analysis. |
NCT01950819 (22) [back to overview] | Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation. |
NCT01950819 (22) [back to overview] | Incidence of Major Cardiovascular Events. |
NCT01950819 (22) [back to overview] | Incidence of Malignancies. |
NCT01950819 (22) [back to overview] | Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup |
NCT01950819 (22) [back to overview] | Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. |
NCT01950819 (22) [back to overview] | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection |
NCT01950819 (22) [back to overview] | Incidence of Failure on the Composite Endpoint of Graft Loss or Death. |
NCT01950819 (22) [back to overview] | Incidence of eGFR < 50 mL/Min/1.73m2 |
NCT01950819 (22) [back to overview] | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. |
NCT01950819 (22) [back to overview] | Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 |
NCT01950819 (22) [back to overview] | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death |
NCT01950819 (22) [back to overview] | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. |
NCT01950819 (22) [back to overview] | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up |
NCT01950819 (22) [back to overview] | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects. |
NCT01950819 (22) [back to overview] | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) |
NCT01950819 (22) [back to overview] | Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2 |
NCT01950819 (22) [back to overview] | Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections |
NCT01950819 (22) [back to overview] | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) |
NCT01950819 (22) [back to overview] | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR |
NCT01950819 (22) [back to overview] | Renal Function Assessed by Creatinine Lab Values |
NCT01972217 (28) [back to overview] | Part A: Percentage of Patients Experiencing Adverse Events (AEs) |
NCT01972217 (28) [back to overview] | Part A PK: Abiraterone Tmax,ss |
NCT01972217 (28) [back to overview] | Part A PK: Abiraterone Tmax,ss |
NCT01972217 (28) [back to overview] | Part A PK: Abiraterone Cmin,ss |
NCT01972217 (28) [back to overview] | Part A PK: Abiraterone Cmin,ss |
NCT01972217 (28) [back to overview] | Part A PK: Abiraterone Cmax,ss |
NCT01972217 (28) [back to overview] | Part A PK: Abiraterone Cmax,ss |
NCT01972217 (28) [back to overview] | Part A PK: Abiraterone AUCss |
NCT01972217 (28) [back to overview] | Part A PK Analysis: Olaparib Time to Reach Maximum Plasma Concentration at Steady State (Tmax,ss) |
NCT01972217 (28) [back to overview] | Part A PK Analysis: Olaparib Time to Reach Maximum Plasma Concentration at Steady State (Tmax,ss) |
NCT01972217 (28) [back to overview] | Part A PK Analysis: Olaparib Minimum Plasma Concentration at Steady State (Cmin,ss) |
NCT01972217 (28) [back to overview] | Part A PK Analysis: Olaparib Minimum Plasma Concentration at Steady State (Cmin,ss) |
NCT01972217 (28) [back to overview] | Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss) |
NCT01972217 (28) [back to overview] | Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss) |
NCT01972217 (28) [back to overview] | Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss) |
NCT01972217 (28) [back to overview] | Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss) |
NCT01972217 (28) [back to overview] | Part B: Median Overall Survival (OS) |
NCT01972217 (28) [back to overview] | Part B: Percentage of Patients With Progression Events or Death (rPFS) |
NCT01972217 (28) [back to overview] | Part A PK: Abiraterone AUCss |
NCT01972217 (28) [back to overview] | Part B: Percentage of Patients With PSA Responses |
NCT01972217 (28) [back to overview] | Part B: Percentage of Patients Experiencing AEs |
NCT01972217 (28) [back to overview] | Part B: Median Radiological Progression-Free Survival (rPFS) Time |
NCT01972217 (28) [back to overview] | Part B: Percentage of Patients With at Least One Objective Response (Objective Response Rate [ORR]) |
NCT01972217 (28) [back to overview] | Part B: Median Time to Second Progression or Death (PFS2) |
NCT01972217 (28) [back to overview] | Part B: Median Best Percentage Change From Baseline in Prostate Specific Antigen (PSA) Levels |
NCT01972217 (28) [back to overview] | Part B: Median Best Percentage Change From Baseline in Circulating Tumour Cell (CTC) Level |
NCT01972217 (28) [back to overview] | Part A: Number of Patients With Dose Limiting Toxicities (DLTs) |
NCT01972217 (28) [back to overview] | Median Time to First Subsequent Therapy (TFST) and Median Time to Second Subsequent Therapy (TSST) |
NCT01974440 (14) [back to overview] | Primary Analysis: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
NCT01974440 (14) [back to overview] | Primary Analysis: Overall Response Rate (ORR): Stratified Analysis |
NCT01974440 (14) [back to overview] | Primary Analysis: Overall Survival (OS): Stratified Analysis |
NCT01974440 (14) [back to overview] | Primary Analysis: Progression Free Survival (PFS): Stratified Analysis |
NCT01974440 (14) [back to overview] | Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL |
NCT01974440 (14) [back to overview] | Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire |
NCT01974440 (14) [back to overview] | Supplementary Analysis: Number of Participants With TEAEs: Participants With MZL |
NCT01974440 (14) [back to overview] | Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL |
NCT01974440 (14) [back to overview] | Primary Analysis: Complete Response Rate (CRR): Stratified Analysis |
NCT01974440 (14) [back to overview] | Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL) |
NCT01974440 (14) [back to overview] | Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL |
NCT01974440 (14) [back to overview] | Primary Analysis: Duration of Response (DOR): Stratified Analysis |
NCT01974440 (14) [back to overview] | Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL |
NCT01974440 (14) [back to overview] | Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL |
NCT01992653 (29) [back to overview] | Number of Participants With DLTs in Non-DLBCL Population |
NCT01992653 (29) [back to overview] | Number of Participants With Anti-Polatuzumab Vedotin Antibodies |
NCT01992653 (29) [back to overview] | Number of Participants With Anti-Obinutuzumab Antibodies |
NCT01992653 (29) [back to overview] | Number of Participants With Adverse Events in Non-DLBCL Population |
NCT01992653 (29) [back to overview] | Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population |
NCT01992653 (29) [back to overview] | Maximum Concentration (Cmax) of Polatuzumab Vedotin |
NCT01992653 (29) [back to overview] | Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population |
NCT01992653 (29) [back to overview] | Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population |
NCT01992653 (29) [back to overview] | Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population |
NCT01992653 (29) [back to overview] | Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population |
NCT01992653 (29) [back to overview] | Clearance (CL) of Polatuzumab Vedotin |
NCT01992653 (29) [back to overview] | Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin |
NCT01992653 (29) [back to overview] | Plasma Levels of Cyclophosphamide |
NCT01992653 (29) [back to overview] | Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score |
NCT01992653 (29) [back to overview] | Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score |
NCT01992653 (29) [back to overview] | Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score |
NCT01992653 (29) [back to overview] | Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score |
NCT01992653 (29) [back to overview] | Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population |
NCT01992653 (29) [back to overview] | Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population |
NCT01992653 (29) [back to overview] | Terminal Half-Life (t1/2) of Polatuzumab Vedotin |
NCT01992653 (29) [back to overview] | Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin |
NCT01992653 (29) [back to overview] | Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population |
NCT01992653 (29) [back to overview] | Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population |
NCT01992653 (29) [back to overview] | Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population |
NCT01992653 (29) [back to overview] | Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population |
NCT01992653 (29) [back to overview] | Overall Survival for Non-DLBCL Population |
NCT01992653 (29) [back to overview] | Overall Survival for DLBCL Population |
NCT01992653 (29) [back to overview] | Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population |
NCT01992653 (29) [back to overview] | Plasma Levels of Doxorubicin |
NCT01994590 (1) [back to overview] | Safety and Tolerability |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores |
NCT01995513 (27) [back to overview] | Percentage of Participants With Adverse Events (AEs) Leading to Death |
NCT01995513 (27) [back to overview] | Progression Free Survival (PFS) |
NCT01995513 (27) [back to overview] | Rate of Pain Progression |
NCT01995513 (27) [back to overview] | Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score |
NCT01995513 (27) [back to overview] | Time to First Use of New Antineoplastic Therapy for Prostate Cancer |
NCT01995513 (27) [back to overview] | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT01995513 (27) [back to overview] | Prostate Specific Antigen (PSA) Response Rate |
NCT01995513 (27) [back to overview] | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT01995513 (27) [back to overview] | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT01995513 (27) [back to overview] | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores |
NCT01995513 (27) [back to overview] | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT01995513 (27) [back to overview] | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores |
NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores |
NCT01995513 (27) [back to overview] | Objective Response Rate (ORR) |
NCT01995513 (27) [back to overview] | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation |
NCT01995513 (27) [back to overview] | Time to Prostate Specific Antigen (PSA) Progression |
NCT02029638 (18) [back to overview] | Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment |
NCT02029638 (18) [back to overview] | Number of Days From Transplant to Platelet Count Recovery |
NCT02029638 (18) [back to overview] | Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery |
NCT02029638 (18) [back to overview] | Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy |
NCT02029638 (18) [back to overview] | Percent of Participants Who Achieved Operational Tolerance |
NCT02029638 (18) [back to overview] | Duration in Days of Graft-versus-Host Disease in Transplanted Participants |
NCT02029638 (18) [back to overview] | Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology |
NCT02029638 (18) [back to overview] | Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal |
NCT02029638 (18) [back to overview] | Number of Participants Free From Return to Immunosuppression for the Duration of the Study |
NCT02029638 (18) [back to overview] | Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants With Engraftment Syndrome |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants With Acute Renal Allograft Rejection |
NCT02029638 (18) [back to overview] | Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Died |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed |
NCT02034552 (8) [back to overview] | Time to Radiological Progression |
NCT02034552 (8) [back to overview] | Time to Radiological Bone Progression |
NCT02034552 (8) [back to overview] | Time to First Symptomatic Skeletal Event |
NCT02034552 (8) [back to overview] | Symptomatic Skeletal Event-free Survival |
NCT02034552 (8) [back to overview] | Radiological Progression Free Survival |
NCT02034552 (8) [back to overview] | Overall Survival |
NCT02034552 (8) [back to overview] | Bone Scan Lesion Area |
NCT02034552 (8) [back to overview] | Patient Bone Scan Response Rate |
NCT02039115 (1) [back to overview] | Stricture Formation |
NCT02043678 (14) [back to overview] | Number of Participants With Treatment-emergent Bone Fractures |
NCT02043678 (14) [back to overview] | Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity |
NCT02043678 (14) [back to overview] | Time to Pain Progression |
NCT02043678 (14) [back to overview] | Time to Opiate Use for Cancer Pain |
NCT02043678 (14) [back to overview] | Symptomatic Skeletal Event Free Survival (SSE-FS) |
NCT02043678 (14) [back to overview] | Radiological Progression Free Survival (rPFS) |
NCT02043678 (14) [back to overview] | Overall Survival (OS) |
NCT02043678 (14) [back to overview] | Number of Participants With Any Treatment-emergent Additional Primary Malignancies |
NCT02043678 (14) [back to overview] | Time to Cytotoxic Chemotherapy |
NCT02043678 (14) [back to overview] | Number of Participants With Post-treatment Adverse Events |
NCT02043678 (14) [back to overview] | Number of Participants With Treatment-emergent Adverse Events |
NCT02043678 (14) [back to overview] | Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders |
NCT02043678 (14) [back to overview] | Number of Participants With Post-treatment Bone Fractures |
NCT02043678 (14) [back to overview] | Number of Subjects With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity |
NCT02055820 (22) [back to overview] | Cyclophosphamide PK: Cmax |
NCT02055820 (22) [back to overview] | Doxorubicin PK: Cmax |
NCT02055820 (22) [back to overview] | Prednisone Plasma PK: Cmax |
NCT02055820 (22) [back to overview] | Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy |
NCT02055820 (22) [back to overview] | Relative Dose Intensity of Venetoclax |
NCT02055820 (22) [back to overview] | Prednisone Plasma PK: Tmax |
NCT02055820 (22) [back to overview] | Prednisone Plasma PK: AUC |
NCT02055820 (22) [back to overview] | Vincristine PK: Cmax |
NCT02055820 (22) [back to overview] | Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax) |
NCT02055820 (22) [back to overview] | Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval |
NCT02055820 (22) [back to overview] | Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax) |
NCT02055820 (22) [back to overview] | Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC) |
NCT02055820 (22) [back to overview] | Safety: Percentage of Participants With Adverse Events |
NCT02055820 (22) [back to overview] | Safety: Number of Participants With Dose-Limiting Toxicities (DLTs) |
NCT02055820 (22) [back to overview] | Rituximab PK: Cmin Within the Dosing Interval |
NCT02055820 (22) [back to overview] | Rituximab PK: Cmax |
NCT02055820 (22) [back to overview] | Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC) |
NCT02055820 (22) [back to overview] | Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC |
NCT02055820 (22) [back to overview] | Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC |
NCT02055820 (22) [back to overview] | Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification |
NCT02055820 (22) [back to overview] | Percentage of Participants Who Are Alive and Without Disease Progression at Month 12 |
NCT02055820 (22) [back to overview] | Obinutuzumab PK: Cmax |
NCT02072200 (3) [back to overview] | Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary |
NCT02072200 (3) [back to overview] | Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale |
NCT02072200 (3) [back to overview] | Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12 |
NCT02097303 (7) [back to overview] | Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment |
NCT02097303 (7) [back to overview] | Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported. |
NCT02097303 (7) [back to overview] | Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment |
NCT02097303 (7) [back to overview] | Overall Response Rate |
NCT02097303 (7) [back to overview] | Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment) |
NCT02097303 (7) [back to overview] | Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria |
NCT02097303 (7) [back to overview] | Bone Imaging Response (Number of Participants With Progression and Stable Disease) |
NCT02133924 (8) [back to overview] | Time to Discontinuation of Steroid Therapy |
NCT02133924 (8) [back to overview] | Number of Participants With Non-Relapse Mortality (NRM) |
NCT02133924 (8) [back to overview] | Number of Participants Who Received Additional GVHD Therapies |
NCT02133924 (8) [back to overview] | Number of Participants With Complete Response (CR) |
NCT02133924 (8) [back to overview] | Number of Participants With Overall Response Rate (CR + PR) |
NCT02133924 (8) [back to overview] | Number of Participants With Overall Survival (OS) |
NCT02133924 (8) [back to overview] | Number of Participants With SR GVHD |
NCT02133924 (8) [back to overview] | Number of Serious Infections |
NCT02137239 (28) [back to overview] | Absolute Calculated Glomerular Filtration Rate (cGFR): Mean |
NCT02137239 (28) [back to overview] | Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR). |
NCT02137239 (28) [back to overview] | Treatment Differences in Therapeutic Modalities |
NCT02137239 (28) [back to overview] | Number of Participants Who Experience Graft Loss Post Transplant |
NCT02137239 (28) [back to overview] | Percentage of Participants With Serious Adverse Events (SAEs) |
NCT02137239 (28) [back to overview] | Number of Participants Who Survive With a Functioning Graft |
NCT02137239 (28) [back to overview] | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection |
NCT02137239 (28) [back to overview] | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) |
NCT02137239 (28) [back to overview] | Absolute Values of Blood Pressure: Mean |
NCT02137239 (28) [back to overview] | Absolute Values of Blood Pressure: Median |
NCT02137239 (28) [back to overview] | Absolute Values of Fasting Lipid Values: Mean |
NCT02137239 (28) [back to overview] | Absolute Values of Fasting Lipid Values: Median |
NCT02137239 (28) [back to overview] | Mean and Mean Change From Baseline in Blood Glucose |
NCT02137239 (28) [back to overview] | Mean and Mean Change From Baseline in Whole Blood HbA1c |
NCT02137239 (28) [back to overview] | Mean Change From Month 3 in cGFR |
NCT02137239 (28) [back to overview] | Mean Changes From Baseline Values for Blood Pressure |
NCT02137239 (28) [back to overview] | Mean Changes From Baseline Values of Lipid Values |
NCT02137239 (28) [back to overview] | Median Calculated Glomerular Filtration Rate (cGFR) |
NCT02137239 (28) [back to overview] | Percentage of Participants With Adverse Events (AEs) |
NCT02137239 (28) [back to overview] | Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months |
NCT02137239 (28) [back to overview] | Number of Participants Deaths Post Transplant |
NCT02137239 (28) [back to overview] | Time to Event: Graft Loss and Death |
NCT02137239 (28) [back to overview] | Urine Protein Creatinine Ratio (UPr/Cr) |
NCT02137239 (28) [back to overview] | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) |
NCT02137239 (28) [back to overview] | Percentage of Participants With Events of Special Interest (ESIs) |
NCT02137239 (28) [back to overview] | Percentage of Participants With New Onset Diabetes After Transplant |
NCT02137239 (28) [back to overview] | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) |
NCT02137239 (28) [back to overview] | Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months |
NCT02143414 (6) [back to overview] | Disease-free Survival (Cohort II) |
NCT02143414 (6) [back to overview] | Overall Survival Rate (Cohort I) |
NCT02143414 (6) [back to overview] | Complete Response Rate (Cohort I) |
NCT02143414 (6) [back to overview] | Incidence of Dose-limiting Toxicity (Cohort II) |
NCT02143414 (6) [back to overview] | Minimal Residual Disease Negativity |
NCT02143414 (6) [back to overview] | Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs |
NCT02162771 (4) [back to overview] | B-cell Kinetics (B-cell Depletion and Recovery) |
NCT02162771 (4) [back to overview] | Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria |
NCT02162771 (4) [back to overview] | Maximum Serum Concentration at Steady State (Cmax,ss) |
NCT02162771 (4) [back to overview] | Area Under the Serum Concentration-time Curve at Steady State (AUCtau) |
NCT02166463 (3) [back to overview] | Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death |
NCT02166463 (3) [back to overview] | Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review |
NCT02166463 (3) [back to overview] | Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale |
NCT02169219 (8) [back to overview] | Vasculitis Damage Index (VDI) |
NCT02169219 (8) [back to overview] | Sustained Complete Remission |
NCT02169219 (8) [back to overview] | Severe Flares |
NCT02169219 (8) [back to overview] | Partial Remission |
NCT02169219 (8) [back to overview] | Limited Flares |
NCT02169219 (8) [back to overview] | Early Treatment Failures |
NCT02169219 (8) [back to overview] | Disease Response |
NCT02169219 (8) [back to overview] | Complete Remission |
NCT02188719 (5) [back to overview] | Percent of Participants With Grade 3 or Higher Wound Complication(s) Adverse Event(s) |
NCT02188719 (5) [back to overview] | Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection |
NCT02188719 (5) [back to overview] | Percent of Participants With Grade 2 or Higher Hematologic Adverse Events (AEs) of Anemia, Neutropenia, and/or Thrombocytopenia |
NCT02188719 (5) [back to overview] | Percent of Participants With Adverse Events (AEs) Attributable to the Donor Alloantigen Reactive Tregs (darTregs) Infusion |
NCT02188719 (5) [back to overview] | Percent of Participants With Grade 3 or Higher Infectious Adverse Event(s) |
NCT02195479 (16) [back to overview] | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score |
NCT02195479 (16) [back to overview] | Time to Response |
NCT02195479 (16) [back to overview] | Time to Next Treatment (TNT) |
NCT02195479 (16) [back to overview] | Time to Disease Progression (TTP) |
NCT02195479 (16) [back to overview] | Progression Free Survival on Next Line of Therapy (PFS2) |
NCT02195479 (16) [back to overview] | Progression Free Survival (PFS) |
NCT02195479 (16) [back to overview] | Percentage of Participants With Very Good Partial Response (VGPR) or Better |
NCT02195479 (16) [back to overview] | Percentage of Participants With Stringent Complete Response (sCR) |
NCT02195479 (16) [back to overview] | Percentage of Participants With Negative Minimal Residual Disease (MRD) |
NCT02195479 (16) [back to overview] | Percentage of Participants With Complete Response (CR) or Better |
NCT02195479 (16) [back to overview] | Overall Response Rate (ORR) |
NCT02195479 (16) [back to overview] | Duration of Response (DOR) |
NCT02195479 (16) [back to overview] | Overall Survival (OS) |
NCT02195479 (16) [back to overview] | Percentage of Participants With Best M-protein Response |
NCT02195479 (16) [back to overview] | Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS) |
NCT02195479 (16) [back to overview] | Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score |
NCT02217566 (6) [back to overview] | Overall Survival |
NCT02217566 (6) [back to overview] | Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response |
NCT02217566 (6) [back to overview] | Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score |
NCT02217566 (6) [back to overview] | Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score |
NCT02217566 (6) [back to overview] | Time to Prostate-specific Antigen (PSA) Progression |
NCT02217566 (6) [back to overview] | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT02257736 (5) [back to overview] | Radiographic Progression-free Survival (rPFS) |
NCT02257736 (5) [back to overview] | Overall Survival (OS) |
NCT02257736 (5) [back to overview] | Time to Chronic Opioid Use |
NCT02257736 (5) [back to overview] | Time to Initiation of Cytotoxic Chemotherapy |
NCT02257736 (5) [back to overview] | Time to Pain Progression |
NCT02260934 (15) [back to overview] | Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96 |
NCT02260934 (15) [back to overview] | Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96 |
NCT02260934 (15) [back to overview] | Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96 |
NCT02260934 (15) [back to overview] | Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96 |
NCT02260934 (15) [back to overview] | Frequency of Specific Adverse Events of Interest By Event by Week 96 |
NCT02260934 (15) [back to overview] | Frequency of Specific Adverse Events of Interest By Participant, By Week 96 |
NCT02260934 (15) [back to overview] | Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96 |
NCT02260934 (15) [back to overview] | Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96 |
NCT02260934 (15) [back to overview] | Count of Participants: Frequency of Non-renal Flares by Week 96 |
NCT02260934 (15) [back to overview] | Count of Participants: Frequency of Non-renal Flares by Week 48 |
NCT02260934 (15) [back to overview] | Count of Participants: Frequency of Non-renal Flares by Week 24 |
NCT02260934 (15) [back to overview] | Percentage of Participants With a Sustained Complete Response |
NCT02260934 (15) [back to overview] | Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96 |
NCT02260934 (15) [back to overview] | Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96 |
NCT02260934 (15) [back to overview] | Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96 |
NCT02261727 (6) [back to overview] | Post Bronchodilator FEV1 |
NCT02261727 (6) [back to overview] | Change in COPD Assessment Test (CAT) Score |
NCT02261727 (6) [back to overview] | Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ) |
NCT02261727 (6) [back to overview] | Total COPD Exacerbation Rate |
NCT02261727 (6) [back to overview] | Time to First COPD Exacerbation |
NCT02261727 (6) [back to overview] | Hospitalisations |
NCT02268175 (4) [back to overview] | Median Prostate Specific Antigen (PSA) Nadir |
NCT02268175 (4) [back to overview] | Participants With Pathologic Complete Response (pCR) |
NCT02268175 (4) [back to overview] | Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD) |
NCT02268175 (4) [back to overview] | Residual Cancer Burden (RCB) |
NCT02284464 (11) [back to overview] | Renal Function |
NCT02284464 (11) [back to overview] | Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups |
NCT02284464 (11) [back to overview] | Number of Participants With Acute Rejection Lesions |
NCT02284464 (11) [back to overview] | Mean Score on the Protocol Biopsies in the Two Treatment Groups |
NCT02284464 (11) [back to overview] | Patient Survival |
NCT02284464 (11) [back to overview] | Graft Survival |
NCT02284464 (11) [back to overview] | Cases of Kidney Transplant Patients With DSA |
NCT02284464 (11) [back to overview] | Lipid Profile |
NCT02284464 (11) [back to overview] | Blood Pressure |
NCT02284464 (11) [back to overview] | Renal Function |
NCT02284464 (11) [back to overview] | Incidence of Diabetes Mellitus |
NCT02285062 (15) [back to overview] | Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS) |
NCT02285062 (15) [back to overview] | Kaplan-Meier Estimate of Progression Free Survival (PFS) |
NCT02285062 (15) [back to overview] | Percentage of Participants Who Achieved a Complete Response (CR) |
NCT02285062 (15) [back to overview] | Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS) |
NCT02285062 (15) [back to overview] | Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score |
NCT02285062 (15) [back to overview] | Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale |
NCT02285062 (15) [back to overview] | Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale |
NCT02285062 (15) [back to overview] | Percentage of Participants Who Achieved an Objective Response |
NCT02285062 (15) [back to overview] | K-M Estimate of Overall Survival (OS) |
NCT02285062 (15) [back to overview] | Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI) |
NCT02285062 (15) [back to overview] | Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire |
NCT02285062 (15) [back to overview] | Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire |
NCT02285062 (15) [back to overview] | Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale |
NCT02285062 (15) [back to overview] | K-M Estimate of Duration of Complete Response |
NCT02285062 (15) [back to overview] | K-M Estimate of Time to Next Lymphoma Therapy (TTNLT) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) the Rheumatoid Arthritis Disease Activity Index (RADAI) Patient Self-report Joint Count (PTJT) Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit |
NCT02287610 (29) [back to overview] | Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | ACR-N From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Physician's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | "Change in Multidimensional Health Assessment Questionnaire (MDHAQ) How do You Feel Today (Compared to One Week Ago) Component From Baseline to Final Visit (Final Follow-up Visit)" |
NCT02287610 (29) [back to overview] | Change in Patient's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit) |
NCT02287610 (29) [back to overview] | Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit) |
NCT02287610 (29) [back to overview] | Assessment of Unsolicited Serious Adverse Events |
NCT02287610 (29) [back to overview] | Assessment of Unsolicited Adverse Events |
NCT02324699 (3) [back to overview] | Crohn's Disease Activity Index (CDAI) |
NCT02324699 (3) [back to overview] | Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) |
NCT02324699 (3) [back to overview] | Change in C-Reactive Protein (CRP) |
NCT02334813 (1) [back to overview] | Remission Duration |
NCT02392286 (6) [back to overview] | Number of Participants With Response or Remission at End of 4 Weeks |
NCT02392286 (6) [back to overview] | Number of Participants With Response at End of 2 Weeks |
NCT02392286 (6) [back to overview] | Number of Participants With Response or Remission at End of 1 Week |
NCT02392286 (6) [back to overview] | Number of Participants in Remission at End of 2 Weeks |
NCT02392286 (6) [back to overview] | Number of Participants With Corticosteroid-associated Side Effects |
NCT02392286 (6) [back to overview] | Number of Participants With Response or Remission at End of 12 Weeks |
NCT02419469 (1) [back to overview] | Event Free Survival (EFS) |
NCT02420717 (4) [back to overview] | Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I) |
NCT02420717 (4) [back to overview] | Overall Survival |
NCT02420717 (4) [back to overview] | Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II) |
NCT02420717 (4) [back to overview] | Progression-free Survival |
NCT02463331 (2) [back to overview] | Histopathological Response to Therapy |
NCT02463331 (2) [back to overview] | Biochemical Response to Therapy |
NCT02481310 (2) [back to overview] | 12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II) |
NCT02481310 (2) [back to overview] | To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R. |
NCT02485691 (14) [back to overview] | Radiographic Progression-Free Survival (rPFS) |
NCT02485691 (14) [back to overview] | Time to Pain Progression |
NCT02485691 (14) [back to overview] | Time to PSA Progression (TTPP) |
NCT02485691 (14) [back to overview] | Time to Symptomatic Skeletal Event |
NCT02485691 (14) [back to overview] | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Utility Single Index and Visual Analogue Scale (VAS) Scores at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment |
NCT02485691 (14) [back to overview] | Health-Related Quality of Life (HRQOL): Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment |
NCT02485691 (14) [back to overview] | Radiographic Progression-Free Survival (rPFS) in Participants With Presence and Absence of Biomarker |
NCT02485691 (14) [back to overview] | Percentage of Participants With Prostate Specific Antigen (PSA) Response |
NCT02485691 (14) [back to overview] | Progression Free Survival (PFS) |
NCT02485691 (14) [back to overview] | Percentage of Participants With Overall Objective Tumor Response |
NCT02485691 (14) [back to overview] | Duration of Tumor Response |
NCT02485691 (14) [back to overview] | Number of Symptomatic Skeletal Events (SSE) |
NCT02485691 (14) [back to overview] | Overall Survival (OS) |
NCT02485691 (14) [back to overview] | Percentage of Participants Achieving Pain Response Assessed Using Brief Pain Inventory-Short Form (BPI-SF) Pain Intensity Score |
NCT02486952 (2) [back to overview] | Probability of Event Free Survival (EFS) |
NCT02486952 (2) [back to overview] | Percentage of Participants Who Were Alive |
NCT02494921 (13) [back to overview] | Number of Participants With Treatment-Related Adverse Events |
NCT02494921 (13) [back to overview] | Objective Response Rate (ORR) (Phase1b/2 RP2D) |
NCT02494921 (13) [back to overview] | RP2D of Docetaxel (Phase 1b) |
NCT02494921 (13) [back to overview] | Prostate-Specific Antigen (PSA) Response Rate (Phase 1b/2 RP2D) |
NCT02494921 (13) [back to overview] | Percentage of Participants With Radiographic Progression-free Survival at 6 Months (Phase 1b/2 RP2D) |
NCT02494921 (13) [back to overview] | Maximally Tolerated Dose (MTD) (Phase 1b) |
NCT02494921 (13) [back to overview] | Mean Maximum Serum Concentration of Ribociclib (Cmax) (Phase 1b) |
NCT02494921 (13) [back to overview] | Mean Maximum Serum Concentration of Ribociclib (Cmax) (Phase 1b) |
NCT02494921 (13) [back to overview] | Mean Area Under Curve (AUC) 0-24 Hour (Phase 1b) |
NCT02494921 (13) [back to overview] | Median Duration of Response (Phase1b/2 RP2D) |
NCT02494921 (13) [back to overview] | Median PSA Progression-Free Survival (Phase 1b/2 RP2D) |
NCT02494921 (13) [back to overview] | Median Radiographic Progression-free Survival (Phase1b/2 RP2D) |
NCT02494921 (13) [back to overview] | Mean Area Under Curve (AUC) 0-24 Hour (Phase 1b) |
NCT02495077 (44) [back to overview] | Percent of Participants With Death or Graft Failure. |
NCT02495077 (44) [back to overview] | Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision |
NCT02495077 (44) [back to overview] | Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings. |
NCT02495077 (44) [back to overview] | Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings. |
NCT02495077 (44) [back to overview] | Percent of Participants With Malignancy. |
NCT02495077 (44) [back to overview] | Percent of Participants With Mycobacterial or Fungal Infections |
NCT02495077 (44) [back to overview] | Percent of Participants With Only Graft Failure. |
NCT02495077 (44) [back to overview] | Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months. |
NCT02495077 (44) [back to overview] | The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups. |
NCT02495077 (44) [back to overview] | The Percent of Participants Who Need Dialysis After Week 1. |
NCT02495077 (44) [back to overview] | The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%. |
NCT02495077 (44) [back to overview] | The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%. |
NCT02495077 (44) [back to overview] | The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL. |
NCT02495077 (44) [back to overview] | Change From Baseline (Immediately After Surgery) in Serum Creatinine. |
NCT02495077 (44) [back to overview] | eGFR Values as Measured by CKD-EPI |
NCT02495077 (44) [back to overview] | eGFR Values as Measured by MDRD |
NCT02495077 (44) [back to overview] | BANFF Grades of First AMR. |
NCT02495077 (44) [back to overview] | Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI |
NCT02495077 (44) [back to overview] | Change in eGFR Between 3 Months and 24 Months as Measured by MDRD |
NCT02495077 (44) [back to overview] | Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI |
NCT02495077 (44) [back to overview] | Change in eGFR Between 6 Months and 24 Months as Measured by MDRD |
NCT02495077 (44) [back to overview] | Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI |
NCT02495077 (44) [back to overview] | Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD |
NCT02495077 (44) [back to overview] | Percent of Participants That Required at Least One Dialysis Treatment. |
NCT02495077 (44) [back to overview] | Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery |
NCT02495077 (44) [back to overview] | Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery. |
NCT02495077 (44) [back to overview] | Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy) |
NCT02495077 (44) [back to overview] | Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment. |
NCT02495077 (44) [back to overview] | eGFR Values as Measured by CKD-EPI |
NCT02495077 (44) [back to overview] | eGFR Values as Measured by MDRD |
NCT02495077 (44) [back to overview] | Number of Dialysis Sessions. |
NCT02495077 (44) [back to overview] | Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death. |
NCT02495077 (44) [back to overview] | Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy. |
NCT02495077 (44) [back to overview] | Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR) |
NCT02495077 (44) [back to overview] | Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR). |
NCT02495077 (44) [back to overview] | Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR |
NCT02495077 (44) [back to overview] | Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR. |
NCT02495077 (44) [back to overview] | Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) |
NCT02495077 (44) [back to overview] | Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection |
NCT02495077 (44) [back to overview] | Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection. |
NCT02495077 (44) [back to overview] | Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR). |
NCT02495077 (44) [back to overview] | Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site. |
NCT02495077 (44) [back to overview] | Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site |
NCT02495077 (44) [back to overview] | Percent of Participants With de Novo DSA. |
NCT02506192 (2) [back to overview] | Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks |
NCT02506192 (2) [back to overview] | Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks |
NCT02522715 (4) [back to overview] | Percentage of Participants With Dose Limiting ToxicitiesGgraded by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (Phase I) |
NCT02522715 (4) [back to overview] | PSA Response 1, Defined as >= 90% PSA Decline From Baseline |
NCT02522715 (4) [back to overview] | PSA Response 2, Defined as >= 50% PSA Decline From Baseline |
NCT02522715 (4) [back to overview] | PSA Response 3, Defined as >= 30% PSA Decline From Baseline |
NCT02528214 (14) [back to overview] | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 12 and Week 24 |
NCT02528214 (14) [back to overview] | Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24 |
NCT02528214 (14) [back to overview] | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12 and Week 24 |
NCT02528214 (14) [back to overview] | Change From Baseline in Sino Nasal Outcome Test-22 (SNOT-22) Global Score at Week 12 and Week 24 |
NCT02528214 (14) [back to overview] | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Week 12 and Week 24 |
NCT02528214 (14) [back to overview] | Annualized Rate of Severe Exacerbation Events During The 24-Week Treatment Period |
NCT02528214 (14) [back to overview] | Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control |
NCT02528214 (14) [back to overview] | Percentage of Participants Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control |
NCT02528214 (14) [back to overview] | Percentage of Participants Achieving Maximum Possible Reduction in Oral Corticosteroids Dose Per Protocol at Week 24 While Maintaining Asthma Control |
NCT02528214 (14) [back to overview] | Percentage of Participants Who No Longer Required Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control |
NCT02528214 (14) [back to overview] | Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control |
NCT02528214 (14) [back to overview] | Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control |
NCT02528214 (14) [back to overview] | Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control |
NCT02528214 (14) [back to overview] | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24 |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Number of Disease Flares Over Time |
NCT02531633 (196) [back to overview] | Part B: Number of Disease Flares Over Time |
NCT02531633 (196) [back to overview] | Part B: Number of Disease Flares Over Time |
NCT02531633 (196) [back to overview] | Part B: Number of Disease Flares Over Time |
NCT02531633 (196) [back to overview] | Part B: Number of Disease Flares Over Time |
NCT02531633 (196) [back to overview] | Part B: Number of Participants in Sustained Remission Over Time |
NCT02531633 (196) [back to overview] | Part B: Number of Participants in Sustained Remission Over Time |
NCT02531633 (196) [back to overview] | Part B: Number of Participants in Sustained Remission Over Time |
NCT02531633 (196) [back to overview] | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time |
NCT02531633 (196) [back to overview] | Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 |
NCT02531633 (196) [back to overview] | Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare |
NCT02531633 (196) [back to overview] | Part B: Number of Hospitalizations for Disease Flare Over Time |
NCT02531633 (196) [back to overview] | Part A: Time to First Disease Flare After Clinical Remission |
NCT02531633 (196) [back to overview] | Part B: Time to First Disease Flare for Participants in Sustained Remission |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea |
NCT02531633 (196) [back to overview] | Part A: Number of Participants in Sustained Remission at Week 52 |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Hematology Parameter-Hematocrit |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Pulse Rate |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time |
NCT02531633 (196) [back to overview] | Part A: Change From Baseline in Temperature |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part A: Cumulative Prednisone Dose Over Time |
NCT02531633 (196) [back to overview] | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time |
NCT02531633 (196) [back to overview] | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time |
NCT02531633 (196) [back to overview] | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time |
NCT02531633 (196) [back to overview] | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time |
NCT02531633 (196) [back to overview] | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time |
NCT02531633 (196) [back to overview] | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time |
NCT02531633 (196) [back to overview] | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time |
NCT02531633 (196) [back to overview] | Part A: Number of Disease Flares Over Time |
NCT02531633 (196) [back to overview] | Part A: Number of Hospitalizations for Disease Flare Over Time |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part A: Number of Participants With at Least One Hospitalization for Disease Flare |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part A:Change From Baseline in Hematology Parameter- Erythrocytes |
NCT02531633 (196) [back to overview] | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B |
NCT02531633 (196) [back to overview] | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B |
NCT02541565 (1) [back to overview] | Number of Participants With a Grade 3 or Higher Toxicity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
NCT02550652 (22) [back to overview] | Terminal Plasma Half-Life (t1/2) of Obinutuzumab |
NCT02550652 (22) [back to overview] | Volume of Distribution Under Steady State (Vss) of Obinutuzumab |
NCT02550652 (22) [back to overview] | Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52 |
NCT02550652 (22) [back to overview] | Change From Baseline in C4 Levels at Week 52 |
NCT02550652 (22) [back to overview] | Change From Baseline in Complement Component 3 (C3) Levels at Week 52 |
NCT02550652 (22) [back to overview] | Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52 |
NCT02550652 (22) [back to overview] | Percentage of Participants Who Achieve Protocol Defined CRR at Week 24 |
NCT02550652 (22) [back to overview] | Percentage of Participants Who Achieve Protocol Defined Modified CRR (mCRR1) at Week 52 |
NCT02550652 (22) [back to overview] | Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52 |
NCT02550652 (22) [back to overview] | Percentage of Participants Who Achieve Protocol Defined Partial Renal Response (PRR) at Week 52 |
NCT02550652 (22) [back to overview] | Percentage of Participants Who Achieve Protocol Defined Second mCRR (mCRR2) at Week 52 |
NCT02550652 (22) [back to overview] | Percentage of Participants Who Achieve Protocol Defined Third mCRR (mCRR3) at Week 52 |
NCT02550652 (22) [back to overview] | Percentage of Participants With Anti-Drug Antibody (ADA) to Obinutuzumab |
NCT02550652 (22) [back to overview] | Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab |
NCT02550652 (22) [back to overview] | Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score |
NCT02550652 (22) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab |
NCT02550652 (22) [back to overview] | Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels |
NCT02550652 (22) [back to overview] | Percentage of Participants With Adverse Events (AEs) |
NCT02550652 (22) [back to overview] | Percentage of Participants With Adverse Events of Special Interest: Infusion Related Reactions, Grade 3 or Higher Infections, Drug-related Neutropenia and Drug-related Thrombocytopenia |
NCT02550652 (22) [back to overview] | Percentage of Participants With First Protocol Defined CRR Over the Course of 52 Weeks |
NCT02550652 (22) [back to overview] | Percentage of Participants With First Protocol Defined Overall Response Over the Course of 52 Weeks |
NCT02550652 (22) [back to overview] | Systemic Clearance of Obinutuzumab |
NCT02561273 (7) [back to overview] | Number of Participants With Adverse Events Graded According to CTC (Phase II) |
NCT02561273 (7) [back to overview] | Complete Response Rate (Phase II) |
NCT02561273 (7) [back to overview] | Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP |
NCT02561273 (7) [back to overview] | Overall Response Rate |
NCT02561273 (7) [back to overview] | Overall Survival |
NCT02561273 (7) [back to overview] | Progression-free Survival |
NCT02561273 (7) [back to overview] | Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) |
NCT02562924 (3) [back to overview] | Change in Lund-Kennedy Endoscopic Scores |
NCT02562924 (3) [back to overview] | Change in SNOT-22 Nasal Symptom Scores |
NCT02562924 (3) [back to overview] | Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score |
NCT02573012 (23) [back to overview] | Treatment Success |
NCT02573012 (23) [back to overview] | Changes From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Score |
NCT02573012 (23) [back to overview] | Cumulative Prednisone Exposure (Dose) |
NCT02573012 (23) [back to overview] | Number of Administrations of Flare Rescue Medication |
NCT02573012 (23) [back to overview] | Percentage of Participants Who Maintain LDA (DAS28 ESR Score <=3.2) or Remission (DAS28 ESR Score <2.6) and the Percentage of Participants Who Maintain the Baseline Disease Activity Level |
NCT02573012 (23) [back to overview] | Time to First RA Flare |
NCT02573012 (23) [back to overview] | Percentage of Participants With >=1 Flare |
NCT02573012 (23) [back to overview] | Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Tender 68 Joint Counts |
NCT02573012 (23) [back to overview] | Changes From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Final Score |
NCT02573012 (23) [back to overview] | Percentage of Participants Who Permanently Discontinue Study Treatment Due to Insufficient Flare Control |
NCT02573012 (23) [back to overview] | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24 |
NCT02573012 (23) [back to overview] | Time to First Administration of Flare Rescue Medication |
NCT02573012 (23) [back to overview] | Change From Baseline in Disease Activity Score in 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24 Post-randomization |
NCT02573012 (23) [back to overview] | Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 24 |
NCT02573012 (23) [back to overview] | Percentage of Participants With >=1 Administration of Flare Rescue Medication |
NCT02573012 (23) [back to overview] | Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Patient's Global Assessment of Disease Activity |
NCT02573012 (23) [back to overview] | Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Patient's Assessment of Pain |
NCT02573012 (23) [back to overview] | Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: High Sensitivity C-Reactive Protein (hsCRP) |
NCT02573012 (23) [back to overview] | Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Health Assessment Questionnaire-Disability Index (HAQ-DI) |
NCT02573012 (23) [back to overview] | Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Erythrocyte Sedimentation Rate (ESR) |
NCT02573012 (23) [back to overview] | Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Physician's Global Assessment of Disease Activity |
NCT02573012 (23) [back to overview] | Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Swollen 66 Joint Counts |
NCT02573012 (23) [back to overview] | Percentage of Visits With RA Flares |
NCT02596971 (18) [back to overview] | Observed Serum Rituximab Concentration |
NCT02596971 (18) [back to overview] | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab |
NCT02596971 (18) [back to overview] | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab |
NCT02596971 (18) [back to overview] | Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab |
NCT02596971 (18) [back to overview] | Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab |
NCT02596971 (18) [back to overview] | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria |
NCT02596971 (18) [back to overview] | Percentage of Participants With Adverse Events |
NCT02596971 (18) [back to overview] | Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria |
NCT02596971 (18) [back to overview] | Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria |
NCT02596971 (18) [back to overview] | Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria |
NCT02596971 (18) [back to overview] | Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria |
NCT02596971 (18) [back to overview] | Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria |
NCT02596971 (18) [back to overview] | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria |
NCT02596971 (18) [back to overview] | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria |
NCT02596971 (18) [back to overview] | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria |
NCT02596971 (18) [back to overview] | Observed Serum Atezolizumab Concentration |
NCT02596971 (18) [back to overview] | Observed Serum Atezolizumab Concentration |
NCT02596971 (18) [back to overview] | Observed Serum Obinutuzumab Concentration |
NCT02613910 (11) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI) |
NCT02613910 (11) [back to overview] | Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD) |
NCT02613910 (11) [back to overview] | Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities |
NCT02613910 (11) [back to overview] | Number of Participants With Adverse Events Related to Ofatumumab SC |
NCT02613910 (11) [back to overview] | Number of Participants With Injection Site Reactions |
NCT02613910 (11) [back to overview] | Number of Participants Withdrawn Due to Treatment-related AEs |
NCT02613910 (11) [back to overview] | Number of Participants With Vital Signs of Clinical Concern |
NCT02613910 (11) [back to overview] | Number of Participants With Severe Adverse Events |
NCT02613910 (11) [back to overview] | Number of Participants With Post-injection Systemic Reactions |
NCT02613910 (11) [back to overview] | Number of Participants With Laboratory Results of Potential Clinical Concern |
NCT02613910 (11) [back to overview] | Number of Participants With Infections |
NCT02617485 (12) [back to overview] | Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4]) |
NCT02617485 (12) [back to overview] | Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26]) |
NCT02617485 (12) [back to overview] | AUC (W1-W26) |
NCT02617485 (12) [back to overview] | AUC (W1-W26) B-cell |
NCT02617485 (12) [back to overview] | Ctrough (Before 8th Infusion) |
NCT02617485 (12) [back to overview] | Adverse Events |
NCT02617485 (12) [back to overview] | Efficacy Assessment at Week 26 |
NCT02617485 (12) [back to overview] | Cmax (Post 5th and 8th Infusion) |
NCT02617485 (12) [back to overview] | T1/2 (Post 5th and 8th Infusions) |
NCT02617485 (12) [back to overview] | Kel (Post 5th and 8th Infusions) |
NCT02617485 (12) [back to overview] | CLss (Post 5th and 8th Infusions) |
NCT02617485 (12) [back to overview] | Immunogenicity |
NCT02685267 (3) [back to overview] | PSA Response in the Standard Treatment Arm and Experimental Treatment Arm |
NCT02685267 (3) [back to overview] | Overall Survival |
NCT02685267 (3) [back to overview] | Progression-free Survival (Radiographic or Per PCWG2 Criteria) |
NCT02716818 (6) [back to overview] | Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP |
NCT02716818 (6) [back to overview] | Number of Participants With 17-OHP and A4 Levels in the Optimal Range at 9:00 at Week 24 Visit |
NCT02716818 (6) [back to overview] | Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass) |
NCT02716818 (6) [back to overview] | Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Bone Mineral Density) - Measured at All Sites Except Germany. |
NCT02716818 (6) [back to overview] | 17-OHP and A4 by Individual Baseline Treatment Strata. |
NCT02716818 (6) [back to overview] | Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4 |
NCT02741271 (13) [back to overview] | Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate |
NCT02741271 (13) [back to overview] | Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment |
NCT02741271 (13) [back to overview] | Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment |
NCT02741271 (13) [back to overview] | Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period |
NCT02741271 (13) [back to overview] | Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last) |
NCT02741271 (13) [back to overview] | Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE |
NCT02741271 (13) [back to overview] | Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE) |
NCT02741271 (13) [back to overview] | Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment |
NCT02741271 (13) [back to overview] | Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60 |
NCT02741271 (13) [back to overview] | Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment |
NCT02741271 (13) [back to overview] | Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12) |
NCT02741271 (13) [back to overview] | Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period |
NCT02741271 (13) [back to overview] | Maximum Plasma Concentration (Cmax) of Mometsone Furoate |
NCT02748070 (2) [back to overview] | Lund Kennedy Endoscopy Score Over Time |
NCT02748070 (2) [back to overview] | Sino-nasal Outcome Test (SNOT-22) Over Time |
NCT02806947 (11) [back to overview] | Percentage of Participants With Overall Survival |
NCT02806947 (11) [back to overview] | Percentage of Participants With Complete or Partial Response (CR/PR) to Acute GVHD Treatment |
NCT02806947 (11) [back to overview] | Percentage of Participants With Non-relapse Mortality |
NCT02806947 (11) [back to overview] | Percentage of Participants With Malignancy Relapse |
NCT02806947 (11) [back to overview] | Acute GVHD Response |
NCT02806947 (11) [back to overview] | Percentage of Participants With Chronic GVHD |
NCT02806947 (11) [back to overview] | Proportion of Participants With Event-free Survival |
NCT02806947 (11) [back to overview] | Percentage of Participants With Treatment Failure |
NCT02806947 (11) [back to overview] | Percentage of Participants With Serious Infections |
NCT02806947 (11) [back to overview] | Percentage of Participants With Disease-free Survival |
NCT02806947 (11) [back to overview] | Percentage of Participants With GVHD-free Survival |
NCT02836496 (5) [back to overview] | Number of HES Flares Per Participant Per Year |
NCT02836496 (5) [back to overview] | Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period |
NCT02836496 (5) [back to overview] | Number of Participants With Change From Baseline in Fatigue Severity Based on Brief Fatigue Inventory (BFI) in Item 3 (Worst Level of Fatigue During Past 24 Hours) at Week 32 by Category |
NCT02836496 (5) [back to overview] | Time to First HES Flare |
NCT02836496 (5) [back to overview] | Percentage of Participants Who Experienced a HES Flare or Who Withdrew From the Study During Week 20 Through Week 32 |
NCT02844582 (2) [back to overview] | PSA Response Rate, Defined as >= 50% Decline in PSA From Baseline Maintained for at Least 3 Weeks and Measured by the Same Laboratory, and Without Evidence of Other Disease Progression Documented at Time of Confirmatory Values |
NCT02844582 (2) [back to overview] | Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 |
NCT02849990 (7) [back to overview] | Number of Participants Without Biochemical Failure at 2 Years |
NCT02849990 (7) [back to overview] | Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment |
NCT02849990 (7) [back to overview] | Number of Patients With Pathologic T3 Disease After 3 Months of Treatment. |
NCT02849990 (7) [back to overview] | Overall Survival (OS) |
NCT02849990 (7) [back to overview] | Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment |
NCT02849990 (7) [back to overview] | The Proportion of Men Who Receive Adjuvant Radiation Therapy |
NCT02849990 (7) [back to overview] | Number of Patients With no Nodal Metastases After 3 Months of Treatment. |
NCT02855359 (2) [back to overview] | Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities |
NCT02855359 (2) [back to overview] | Part A and Part B Outcome Measure: Incidence of Adverse Events |
NCT02903368 (17) [back to overview] | Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2] |
NCT02903368 (17) [back to overview] | Rate of Freedom From Further Anti-cancer Therapy at 2-years Post RP (Part 2) |
NCT02903368 (17) [back to overview] | Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1) |
NCT02903368 (17) [back to overview] | Median of Residual Cancer Burden (RCB) at RP (Part 1) |
NCT02903368 (17) [back to overview] | Combined pCR or MRD Rate [Part 1] |
NCT02903368 (17) [back to overview] | Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2) |
NCT02903368 (17) [back to overview] | Frequency of Presenting Intraductal Carcinoma at RP (Part 1) |
NCT02903368 (17) [back to overview] | Frequency of Presenting Intra-operative Complications Following RP (Part 1) |
NCT02903368 (17) [back to overview] | Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2] |
NCT02903368 (17) [back to overview] | Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2] |
NCT02903368 (17) [back to overview] | Frequency of Presenting Cribriform at RP (Part 1) |
NCT02903368 (17) [back to overview] | Frequency of Positive Surgical Margins at RP (Part 1) |
NCT02903368 (17) [back to overview] | Rate of Freedom From Further Anti-cancer Therapy at 3-years Post RP (Part 2) |
NCT02903368 (17) [back to overview] | Rate of Freedom From Further Anti-cancer Therapy at 4-years Post RP (Part 2) |
NCT02903368 (17) [back to overview] | Rate of pCR at RP (Part 1) |
NCT02903368 (17) [back to overview] | Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2) |
NCT02903368 (17) [back to overview] | Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2) |
NCT02921789 (5) [back to overview] | Percentage of Participants With Recurrence of Focal Segmental Glomerulosclerosis (rFSGS) or Death or Graft Loss or Lost to Follow-up Through 3 Months Post Transplant |
NCT02921789 (5) [back to overview] | Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant |
NCT02921789 (5) [back to overview] | Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant |
NCT02921789 (5) [back to overview] | Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant |
NCT02921789 (5) [back to overview] | Percentage of Participants With Efficacy Failure Through 12 Months Post Transplant |
NCT02927834 (3) [back to overview] | CT Scan Changes |
NCT02927834 (3) [back to overview] | Nasal Endoscopy |
NCT02927834 (3) [back to overview] | Sinonasal Outcome Test (SNOT 20) |
NCT02953678 (10) [back to overview] | Nonrelapse Mortality (NRM) |
NCT02953678 (10) [back to overview] | Relapse Rate |
NCT02953678 (10) [back to overview] | Relapse-related Mortality Rate |
NCT02953678 (10) [back to overview] | Overall Response Rate (ORR) at Day 28 |
NCT02953678 (10) [back to overview] | Failure-free Survival (FFS) |
NCT02953678 (10) [back to overview] | Overall Survival (OS) |
NCT02953678 (10) [back to overview] | Overall Response Rate (ORR) |
NCT02953678 (10) [back to overview] | Percentage of Participants With Six-month Duration of Response (DOR) |
NCT02953678 (10) [back to overview] | Percentage of Participants With Three-month DOR |
NCT02953678 (10) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs |
NCT02953873 (5) [back to overview] | Weight-Based Dose Requirement |
NCT02953873 (5) [back to overview] | Total Daily Dose |
NCT02953873 (5) [back to overview] | Number of Days to Reach Therapeutic Trough Goal |
NCT02953873 (5) [back to overview] | Dose-normalized Trough |
NCT02953873 (5) [back to overview] | Dose Modifications |
NCT02954198 (4) [back to overview] | Self-reported Medication Adherence From Baseline to 6 Months. |
NCT02954198 (4) [back to overview] | Subject Specific Change on Medication Side Effect Scale |
NCT02954198 (4) [back to overview] | Percent of Participants Who Experienced Kidney Transplant Graft Loss |
NCT02954198 (4) [back to overview] | Percent of Participants Experiencing Acute Allograft Rejection |
NCT02955147 (4) [back to overview] | Number of Participants With Disease Flare |
NCT02955147 (4) [back to overview] | Percentage of Patients in Glucocorticoid-free Remission |
NCT02955147 (4) [back to overview] | Cumulative Prednisone Dose |
NCT02955147 (4) [back to overview] | Number of Participants With at Least One Adverse Event |
NCT02959944 (19) [back to overview] | Final Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days |
NCT02959944 (19) [back to overview] | Final Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits |
NCT02959944 (19) [back to overview] | Final Analysis: Response Rate at 24 Weeks |
NCT02959944 (19) [back to overview] | Final Analysis: Response Rate at 48 Weeks |
NCT02959944 (19) [back to overview] | Primary Analysis: Duration of Response (DOR) for Participants Who Had PR or CR at Any Time |
NCT02959944 (19) [back to overview] | Primary Analysis: Overall Survival (OS) |
NCT02959944 (19) [back to overview] | Primary Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days |
NCT02959944 (19) [back to overview] | Primary Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits |
NCT02959944 (19) [back to overview] | Primary Analysis: Response Rate at 24 Weeks |
NCT02959944 (19) [back to overview] | Primary Analysis: Response Rate at 48 Weeks |
NCT02959944 (19) [back to overview] | Final Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD |
NCT02959944 (19) [back to overview] | Final Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants |
NCT02959944 (19) [back to overview] | Final Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone |
NCT02959944 (19) [back to overview] | Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD |
NCT02959944 (19) [back to overview] | Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD |
NCT02959944 (19) [back to overview] | Primary Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants |
NCT02959944 (19) [back to overview] | Primary Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone |
NCT02959944 (19) [back to overview] | Final Analysis: DOR for Participants Who Had PR or CR at Any Time |
NCT02959944 (19) [back to overview] | Final Analysis: OS |
NCT02985957 (33) [back to overview] | Objective Response Rate (ORR) Cohorts B and C Per BICR |
NCT02985957 (33) [back to overview] | Objective Response Rate (ORR) Cohort D |
NCT02985957 (33) [back to overview] | Overall Survival (OS) Cohorts B and C |
NCT02985957 (33) [back to overview] | The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D |
NCT02985957 (33) [back to overview] | The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D |
NCT02985957 (33) [back to overview] | The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C |
NCT02985957 (33) [back to overview] | Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D |
NCT02985957 (33) [back to overview] | Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C |
NCT02985957 (33) [back to overview] | The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D |
NCT02985957 (33) [back to overview] | The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C |
NCT02985957 (33) [back to overview] | The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C |
NCT02985957 (33) [back to overview] | The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D |
NCT02985957 (33) [back to overview] | The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D |
NCT02985957 (33) [back to overview] | The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C |
NCT02985957 (33) [back to overview] | The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D |
NCT02985957 (33) [back to overview] | The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C |
NCT02985957 (33) [back to overview] | The Number of Participants Experiencing Adverse Events (AEs) in Cohort D |
NCT02985957 (33) [back to overview] | Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C |
NCT02985957 (33) [back to overview] | Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D |
NCT02985957 (33) [back to overview] | Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D |
NCT02985957 (33) [back to overview] | Radiographic Progression-Free Survival (rPFS) for Cohort D |
NCT02985957 (33) [back to overview] | Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR |
NCT02985957 (33) [back to overview] | Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C |
NCT02985957 (33) [back to overview] | Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D |
NCT02985957 (33) [back to overview] | Overall Survival (OS) Cohort D |
NCT02985957 (33) [back to overview] | The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C |
NCT02985957 (33) [back to overview] | The Number of Participants Who Died in Cohort D |
NCT02985957 (33) [back to overview] | The Number of Participants Who Died in Cohorts A, B and C |
NCT02985957 (33) [back to overview] | The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C |
NCT02985957 (33) [back to overview] | Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D |
NCT02985957 (33) [back to overview] | Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C |
NCT02985957 (33) [back to overview] | The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D |
NCT02985957 (33) [back to overview] | The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C |
NCT02994927 (28) [back to overview] | Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity |
NCT02994927 (28) [back to overview] | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period |
NCT02994927 (28) [back to overview] | Percentage of Subjects Achieving Sustained Disease Remission at Week 52 |
NCT02994927 (28) [back to overview] | Percentage of Subjects Achieving Disease Remission at Week 26 |
NCT02994927 (28) [back to overview] | Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC |
NCT02994927 (28) [back to overview] | Number of Subjects With Clinically Significant ECG Changes From Baseline |
NCT02994927 (28) [back to overview] | Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study |
NCT02994927 (28) [back to overview] | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study |
NCT02994927 (28) [back to overview] | Change From Baseline in Vital Signs (4/5) |
NCT02994927 (28) [back to overview] | Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs |
NCT02994927 (28) [back to overview] | Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator |
NCT02994927 (28) [back to overview] | In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks |
NCT02994927 (28) [back to overview] | In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks |
NCT02994927 (28) [back to overview] | In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks |
NCT02994927 (28) [back to overview] | Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI |
NCT02994927 (28) [back to overview] | Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points |
NCT02994927 (28) [back to overview] | Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index |
NCT02994927 (28) [back to overview] | Change From Baseline in Vital Signs (5/5) |
NCT02994927 (28) [back to overview] | Change From Baseline in Vital Signs (3/5) |
NCT02994927 (28) [back to overview] | Change From Baseline in Vital Signs (2/5) |
NCT02994927 (28) [back to overview] | Change From Baseline in Vital Signs (1/5) |
NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2) |
NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2) |
NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5) |
NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5) |
NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5) |
NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5) |
NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5) |
NCT03003520 (8) [back to overview] | Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Total Percentage |
NCT03003520 (8) [back to overview] | Percentage of Participants Who Responded During Induction and Continued Into Consolidation Therapy (Database Cutoff Date: 02-Aug-2018) |
NCT03003520 (8) [back to overview] | Participants With Treatment Emergent Adverse Events (TEAE) |
NCT03003520 (8) [back to overview] | Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Percentage of Tumor Cells |
NCT03003520 (8) [back to overview] | Percentage of Participants Who Achieved a Complete Response (CR) at the End of Induction Therapy |
NCT03003520 (8) [back to overview] | Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for the Interferon Gamma Score (IFNG-Score) From Ribonucleic Acid (RNA)-Sequencing Data |
NCT03003520 (8) [back to overview] | Participants With Treatment Emergent Adverse Events (TEAE) |
NCT03003520 (8) [back to overview] | Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) CD8 T-Cell Density |
NCT03023046 (5) [back to overview] | Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate |
NCT03023046 (5) [back to overview] | Overall Survival |
NCT03023046 (5) [back to overview] | Number of Participants With Morphological Complete Response Rate |
NCT03023046 (5) [back to overview] | Number of Participants With Adverse Events |
NCT03023046 (5) [back to overview] | Event-free Survival |
NCT03023891 (4) [back to overview] | Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels |
NCT03023891 (4) [back to overview] | Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels |
NCT03023891 (4) [back to overview] | White Blood Cell Counts |
NCT03023891 (4) [back to overview] | Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose |
NCT03043105 (6) [back to overview] | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade) |
NCT03043105 (6) [back to overview] | Number of Participants With Treatment-related Serious Adverse Events as Assessed by CTCAE v4.0 ( ≥3 Grade) |
NCT03043105 (6) [back to overview] | Number of Patients With Durable Tumor and Symptomatic Response |
NCT03043105 (6) [back to overview] | Overall Survival |
NCT03043105 (6) [back to overview] | Progression-free Survival |
NCT03043105 (6) [back to overview] | Change in SF-36 Score |
NCT03072238 (4) [back to overview] | Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (Intent-To-Treat (ITT) Population) |
NCT03072238 (4) [back to overview] | Plasma Concentrations of Abiraterone at Specified Timepoints |
NCT03072238 (4) [back to overview] | Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (PTEN Loss Population) |
NCT03072238 (4) [back to overview] | Plasma Concentrations of Ipatasertib at Specified Timepoints |
NCT03093272 (5) [back to overview] | To Evaluate Progression-free Survival on the Combination of Docetaxel Plus Apalutamide |
NCT03093272 (5) [back to overview] | Serum PSA Change From Baseline to 12 Weeks on Treatment |
NCT03093272 (5) [back to overview] | Maximum Blood Concentration (Cmax) for Docetaxel Pharmacokinetic Analysis |
NCT03093272 (5) [back to overview] | Area Under the Curve (AUC) for Docetaxel Pharmacokinetic Analysis |
NCT03093272 (5) [back to overview] | Overall Survival |
NCT03113500 (2) [back to overview] | Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy |
NCT03113500 (2) [back to overview] | Overall Survival at 1 Year |
NCT03139604 (20) [back to overview] | Incidence Rate of aGVHD Flares |
NCT03139604 (20) [back to overview] | Failure-free Survival |
NCT03139604 (20) [back to overview] | Duration of Response |
NCT03139604 (20) [back to overview] | Time to Response |
NCT03139604 (20) [back to overview] | Number of Treatment-emergent Adverse Events With INCB39110 |
NCT03139604 (20) [back to overview] | Cmin of Itacitinib When Administered in Combination With Corticosteroids |
NCT03139604 (20) [back to overview] | Cmax of Itacitinib When Administered in Combination With Corticosteroids |
NCT03139604 (20) [back to overview] | CL/F of Itacitinib When Administered in Combination With Corticosteroids |
NCT03139604 (20) [back to overview] | AUC of Itacitinib When Administered in Combination With Corticosteroids |
NCT03139604 (20) [back to overview] | Proportion of Subjects Who Discontinue Corticosteroids |
NCT03139604 (20) [back to overview] | Objective Response Rate |
NCT03139604 (20) [back to overview] | Nonrelapse Mortality |
NCT03139604 (20) [back to overview] | Incidence Rate of cGVHD |
NCT03139604 (20) [back to overview] | Tmax of Itacitinib When Administered in Combination With Corticosteroids |
NCT03139604 (20) [back to overview] | Relapse Rate of Malignant and Nonmalignant Hematologic Disease |
NCT03139604 (20) [back to overview] | Overall Survival (OS) |
NCT03139604 (20) [back to overview] | Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index |
NCT03139604 (20) [back to overview] | Proportion of Subjects Who Discontinue Immunosuppressive Medications |
NCT03139604 (20) [back to overview] | Malignancy Relapse-related Mortality Rate |
NCT03139604 (20) [back to overview] | Incidence Rate of Secondary Graft Failure |
NCT03150056 (39) [back to overview] | Number of Participants With AEs Leading to Any Dose Reduction or Delays Until End of the Study |
NCT03150056 (39) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS) |
NCT03150056 (39) [back to overview] | Cmax of Abiraterone |
NCT03150056 (39) [back to overview] | Ctrough of Enzalutamide |
NCT03150056 (39) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246 |
NCT03150056 (39) [back to overview] | Number of Participants With AEs Leading to Any Dose Reduction or Delays |
NCT03150056 (39) [back to overview] | Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment Until End of the Study |
NCT03150056 (39) [back to overview] | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Until End of the Study |
NCT03150056 (39) [back to overview] | Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status |
NCT03150056 (39) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS) |
NCT03150056 (39) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS) |
NCT03150056 (39) [back to overview] | Cmax of Enzalutamide |
NCT03150056 (39) [back to overview] | Circulating Tumor Cells (CTC) Response Rate |
NCT03150056 (39) [back to overview] | AUC(0-tau) of Enzalutamide |
NCT03150056 (39) [back to overview] | Ctrough of Abiraterone |
NCT03150056 (39) [back to overview] | Prostate-specific Antigen (PSA) Response Rate at Week 4 |
NCT03150056 (39) [back to overview] | Radiographic Progression-free Survival (rPFS) |
NCT03150056 (39) [back to overview] | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT03150056 (39) [back to overview] | Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment |
NCT03150056 (39) [back to overview] | Tmax of Enzalutamide |
NCT03150056 (39) [back to overview] | Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246 |
NCT03150056 (39) [back to overview] | Tmax of Abiraterone |
NCT03150056 (39) [back to overview] | Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246 |
NCT03150056 (39) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246 |
NCT03150056 (39) [back to overview] | Disease Control Rate at Week 24 |
NCT03150056 (39) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246 |
NCT03150056 (39) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS) |
NCT03150056 (39) [back to overview] | Time to Disease Progression |
NCT03150056 (39) [back to overview] | Objective Response Rate |
NCT03150056 (39) [back to overview] | Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246 |
NCT03150056 (39) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS) |
NCT03150056 (39) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS) |
NCT03150056 (39) [back to overview] | Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours |
NCT03150056 (39) [back to overview] | Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours |
NCT03150056 (39) [back to overview] | Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours |
NCT03150056 (39) [back to overview] | Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours |
NCT03150056 (39) [back to overview] | AUC(0-tau) of Abiraterone |
NCT03150056 (39) [back to overview] | Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50) |
NCT03150056 (39) [back to overview] | Composite Response Rate |
NCT03207815 (9) [back to overview] | Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 |
NCT03207815 (9) [back to overview] | Time to Development of Macular Edema in At Least One Eye on or After Week 6 |
NCT03207815 (9) [back to overview] | Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET |
NCT03207815 (9) [back to overview] | Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET |
NCT03207815 (9) [back to overview] | Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET) |
NCT03207815 (9) [back to overview] | Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET |
NCT03207815 (9) [back to overview] | Plasma Concentration of Filgotinib |
NCT03207815 (9) [back to overview] | Plasma Concentration of Metabolite, GS-829845 |
NCT03207815 (9) [back to overview] | Time to Treatment Failure on or After Week 6 |
NCT03279250 (2) [back to overview] | The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy |
NCT03279250 (2) [back to overview] | Number of Participants With Incidence of Adverse Events |
NCT03304626 (4) [back to overview] | Number of Participants With Acute Cellular Rejection Between Study and Control Groups |
NCT03304626 (4) [back to overview] | Rate of New Onset Diabetes After Transplant |
NCT03304626 (4) [back to overview] | Number of Participants With Adrenal Suppression |
NCT03304626 (4) [back to overview] | Number of Participants With Adverse Events |
NCT03338790 (9) [back to overview] | Number of Participants With Laboratory Values Change From Baseline |
NCT03338790 (9) [back to overview] | Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) |
NCT03338790 (9) [back to overview] | Prostate-Specific Antigen Response Rate (RR-PSA) |
NCT03338790 (9) [back to overview] | Number of Deaths |
NCT03338790 (9) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT03338790 (9) [back to overview] | Number of Participants With Laboratory Abnormalities in Specific Liver Tests |
NCT03338790 (9) [back to overview] | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests |
NCT03338790 (9) [back to overview] | Number of Participants With Laboratory Values Change From Baseline |
NCT03338790 (9) [back to overview] | Number of Participants With Laboratory Values Change From Baseline |
NCT03384654 (13) [back to overview] | Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL) |
NCT03384654 (13) [back to overview] | Overall Response Rate (ORR) |
NCT03384654 (13) [back to overview] | Concentration of Daratumumab in Cerebrospinal Fluid (CSF) |
NCT03384654 (13) [back to overview] | Concentration of Daratumumab in Cerebrospinal Fluid (CSF) |
NCT03384654 (13) [back to overview] | Minimum Observed Serum Concentration (Cmin) of Daratumumab |
NCT03384654 (13) [back to overview] | Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL |
NCT03384654 (13) [back to overview] | Event-free Survival (EFS) |
NCT03384654 (13) [back to overview] | Maximum Observed Serum Concentration (Cmax) of Daratumumab |
NCT03384654 (13) [back to overview] | Minimal Residual Disease (MRD) Negative Rate |
NCT03384654 (13) [back to overview] | Overall Survival (OS) |
NCT03384654 (13) [back to overview] | Number of Participants With Anti-daratumumab Antibodies |
NCT03384654 (13) [back to overview] | Relapse-free Survival (RFS) |
NCT03384654 (13) [back to overview] | Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) |
NCT03388008 (1) [back to overview] | Donor-specific HLA Antibodies, Re-transplantation, or Death |
NCT03412565 (14) [back to overview] | Maximum Observed Serum Concentration (Cmax) of Daratumumab |
NCT03412565 (14) [back to overview] | Maximum Observed Serum Concentration (Cmax) of Daratumumab |
NCT03412565 (14) [back to overview] | Maximum Observed Serum Concentration (Cmax) of Daratumumab |
NCT03412565 (14) [back to overview] | Maximum Observed Serum Concentration (Cmax) of Daratumumab |
NCT03412565 (14) [back to overview] | D-VRd Cohort: Overall Response Rate (ORR) |
NCT03412565 (14) [back to overview] | D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response |
NCT03412565 (14) [back to overview] | D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate |
NCT03412565 (14) [back to overview] | D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR) |
NCT03412565 (14) [back to overview] | D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR) |
NCT03412565 (14) [back to overview] | D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response |
NCT03412565 (14) [back to overview] | Percentage of Participants With CR or Better Response |
NCT03412565 (14) [back to overview] | Percentage of Participants With Anti-rHuPH20 Antibodies |
NCT03412565 (14) [back to overview] | Percentage of Participants With Infusion-Related Reactions (IRRs) |
NCT03412565 (14) [back to overview] | Percentage of Participants With Anti-Daratumumab Antibodies |
NCT03431350 (11) [back to overview] | Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose |
NCT03431350 (11) [back to overview] | Combination 1: Part 2: Objective Response Rate (ORR) |
NCT03431350 (11) [back to overview] | Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity |
NCT03431350 (11) [back to overview] | Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity |
NCT03431350 (11) [back to overview] | Combination 1: Part 2: Number of Participants With Adverse Events (AEs) |
NCT03431350 (11) [back to overview] | Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose |
NCT03431350 (11) [back to overview] | Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose |
NCT03431350 (11) [back to overview] | Combination 2: Composite Response Rate (RR) |
NCT03431350 (11) [back to overview] | Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose |
NCT03431350 (11) [back to overview] | Combination 2: Number of Participants With Adverse Events (AEs) |
NCT03431350 (11) [back to overview] | Combination 1: Part 1: Number of Participants With Specified Toxicity |
NCT03439670 (1) [back to overview] | Efficacy Measured by Time to Stand Test (TTSTAND) Velocity in Rises/Second Change From Baseline |
NCT03488225 (5) [back to overview] | Number of Participants With Minimal Residual Disease (MRD) Negativity |
NCT03488225 (5) [back to overview] | Overall Survival |
NCT03488225 (5) [back to overview] | Event-Free Survival |
NCT03488225 (5) [back to overview] | Participants to Achieve Complete Remission (CR): |
NCT03488225 (5) [back to overview] | Number of Participants With Adverse Events |
NCT03589326 (1) [back to overview] | Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase |
NCT03600805 (24) [back to overview] | Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population |
NCT03600805 (24) [back to overview] | Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52 |
NCT03600805 (24) [back to overview] | Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab |
NCT03600805 (24) [back to overview] | Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 |
NCT03600805 (24) [back to overview] | Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 |
NCT03600805 (24) [back to overview] | Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 |
NCT03600805 (24) [back to overview] | Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
NCT03600805 (24) [back to overview] | Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
NCT03600805 (24) [back to overview] | Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response |
NCT03600805 (24) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
NCT03600805 (24) [back to overview] | Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52 |
NCT03600805 (24) [back to overview] | Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population |
NCT03600805 (24) [back to overview] | Total Cumulative Corticosteroid (Including Prednisone) Dose |
NCT03600805 (24) [back to overview] | Time to First Giant Cell Arteritis Disease Flare |
NCT03600805 (24) [back to overview] | Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24 |
NCT03600805 (24) [back to overview] | Percentage of Participants Who Achieved Sustained Disease Remission at Week 52 |
NCT03600805 (24) [back to overview] | Percentage of Participants Who Achieved Sustained Disease Remission at Week 24 |
NCT03600805 (24) [back to overview] | Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set |
NCT03600805 (24) [back to overview] | Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population |
NCT03600805 (24) [back to overview] | Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set |
NCT03600805 (24) [back to overview] | Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population |
NCT03600805 (24) [back to overview] | Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set |
NCT03600805 (24) [back to overview] | Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population |
NCT03600805 (24) [back to overview] | Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set |
NCT03600818 (17) [back to overview] | Number of Participants With Absence of Disease Flare From Week 12 Through Week 52 |
NCT03600818 (17) [back to overview] | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period |
NCT03600818 (17) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
NCT03600818 (17) [back to overview] | Number of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response |
NCT03600818 (17) [back to overview] | Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function |
NCT03600818 (17) [back to overview] | Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter |
NCT03600818 (17) [back to overview] | Total Cumulative Corticosteroid Dose |
NCT03600818 (17) [back to overview] | Number of Participants Who Achieved Disease Remission up to Week 12 |
NCT03600818 (17) [back to overview] | Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab |
NCT03600818 (17) [back to overview] | Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52 |
NCT03600818 (17) [back to overview] | Number of Participants With Sustained Reduction of CRP From Week 12 Through Week 52 |
NCT03600818 (17) [back to overview] | Percentage of Participants Achieving Sustained Remission at Week 52 |
NCT03600818 (17) [back to overview] | Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24 |
NCT03600818 (17) [back to overview] | Time to First Polymyalgia Rheumatica Flare After Clinical Remission up to Week 52 |
NCT03600818 (17) [back to overview] | Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 52 |
NCT03600818 (17) [back to overview] | Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters |
NCT03600818 (17) [back to overview] | Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function |
NCT03649841 (2) [back to overview] | Rate of Undetectable Prostate Specific Antigen (PSA) (< 0.2) |
NCT03649841 (2) [back to overview] | Incidence of Adverse Events |
NCT03721965 (1) [back to overview] | Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
NCT03726749 (5) [back to overview] | Adverse Events |
NCT03726749 (5) [back to overview] | Cumulative Prednisone Dose |
NCT03726749 (5) [back to overview] | Disease Flares |
NCT03726749 (5) [back to overview] | Serious Adverse Events |
NCT03726749 (5) [back to overview] | Sustained Remission |
NCT03748641 (1) [back to overview] | Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR) |
NCT03793439 (2) [back to overview] | Number of Participants With Significantly Decreased Expression of STAT1 Mediated Genes as Determined by RNA Sequencing |
NCT03793439 (2) [back to overview] | Number of Participants With 50% Reduction in Corticosteroid Requirement |
NCT03816332 (4) [back to overview] | Duration of Overall Survival After Receiving Nivolumab, Tacrolimus, and Prednisone |
NCT03816332 (4) [back to overview] | Duration of Progression-free Survival After Receiving Nivolumab, Tacrolimus, and Prednisone |
NCT03816332 (4) [back to overview] | Rate of Allograft Loss After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone |
NCT03816332 (4) [back to overview] | Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone |
NCT03817853 (8) [back to overview] | Objective Response Rate (ORR) at the End of Induction (EOI) Therapy |
NCT03817853 (8) [back to overview] | Duration (In Minutes) of Obinutuzumab Administration by Cycle |
NCT03817853 (8) [back to overview] | Time to IRR From Infusion to Onset of the IRR During Cycle 2 |
NCT03817853 (8) [back to overview] | Percentage of Participants With Adverse Events (AEs) |
NCT03817853 (8) [back to overview] | Percentage of Grade >=3 Infusion-Related Reactions (IRRs) During Cycle 2 in Patients Who Had Previously Received Obinutuzumab at the Standard Infusion Rate During Cycle 1 Without Experiencing a Grade 3 or 4 IRR |
NCT03817853 (8) [back to overview] | Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle |
NCT03817853 (8) [back to overview] | Percentage of IRRs Regardless of Grade by Cycle |
NCT03817853 (8) [back to overview] | Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle |
NCT03827018 (10) [back to overview] | Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26 |
NCT03827018 (10) [back to overview] | Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26 |
NCT03827018 (10) [back to overview] | Time to Elevated C-Reactive Protein (CRP) by Week 26 |
NCT03827018 (10) [back to overview] | Cumulative Corticosteroid Dose at the End of the Washout Safety Follow-up Period |
NCT03827018 (10) [back to overview] | Cumulative Corticosteroid Dose at Week 26 |
NCT03827018 (10) [back to overview] | Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal CRP Level |
NCT03827018 (10) [back to overview] | Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal ESR |
NCT03827018 (10) [back to overview] | Percentage of Participants Who Completed the 26-week Corticosteroid Taper and Who Had No Signs or Symptoms of GCA Nor New or Worsening Vasculitis by Imaging by Week 26 |
NCT03827018 (10) [back to overview] | Sustained Remission Rate at Week 26 |
NCT03827018 (10) [back to overview] | Time to Flare by Week 26 |
NCT03827473 (5) [back to overview] | Prostate Specific Antigen Progression Free Survival (PSA-PFS) |
NCT03827473 (5) [back to overview] | Prostate-specific Antigen (PSA) Response |
NCT03827473 (5) [back to overview] | Change in Quality of Life - FACT-P |
NCT03827473 (5) [back to overview] | Change in Quality of Life - FACT/GOG-NTX |
NCT03827473 (5) [back to overview] | Change in Quality of Life - PROMIS Fatigue |
NCT03834506 (12) [back to overview] | Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) |
NCT03834506 (12) [back to overview] | Time to Prostate-specific Antigen (PSA) Progression |
NCT03834506 (12) [back to overview] | Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST) |
NCT03834506 (12) [back to overview] | Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE) |
NCT03834506 (12) [back to overview] | Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review |
NCT03834506 (12) [back to overview] | "Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (Worst Pain in 24 Hours) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score" |
NCT03834506 (12) [back to overview] | Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) |
NCT03834506 (12) [back to overview] | Overall Survival (OS) |
NCT03834506 (12) [back to overview] | Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review |
NCT03834506 (12) [back to overview] | Number of Participants Who Experienced an Adverse Event (AE) |
NCT03834506 (12) [back to overview] | Prostate-specific Antigen (PSA) Response Rate |
NCT03834506 (12) [back to overview] | Time to First Symptomatic Skeletal-related Event (SSRE) |
NCT03834519 (2) [back to overview] | Radiographic Progression-Free Survival (rPFS) |
NCT03834519 (2) [back to overview] | Overall Survival (OS) |
NCT03895801 (12) [back to overview] | IFX-1 Blocking Activity 10 nM |
NCT03895801 (12) [back to overview] | Vasculitis Damage Index (VDI) |
NCT03895801 (12) [back to overview] | Change From Baseline in BVASv3 Total Score |
NCT03895801 (12) [back to overview] | Plasma Concentrations of C5a |
NCT03895801 (12) [back to overview] | Physician Global Assessment (PGA) |
NCT03895801 (12) [back to overview] | IFX-1 Plasma Concentrations (Pre-dose) |
NCT03895801 (12) [back to overview] | IFX-1 Blocking Activity 2.5 nM |
NCT03895801 (12) [back to overview] | Glucocorticoid Toxicity Index (GTI) |
NCT03895801 (12) [back to overview] | Percentage of Subjects With Clinical Remission |
NCT03895801 (12) [back to overview] | Percentage of Subjects Achieving Clinical Response |
NCT03895801 (12) [back to overview] | Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE) |
NCT03895801 (12) [back to overview] | Estimated Glomerular Filtration Rate |
NCT04054375 (15) [back to overview] | Fasting Glucose |
NCT04054375 (15) [back to overview] | Fasting Lipid Profile |
NCT04054375 (15) [back to overview] | Muscle Strength Test |
NCT04054375 (15) [back to overview] | Functional Assessments - Upper Limb Strength |
NCT04054375 (15) [back to overview] | Respiratory Changes |
NCT04054375 (15) [back to overview] | Creatine Kinase |
NCT04054375 (15) [back to overview] | Brooke Scale Score |
NCT04054375 (15) [back to overview] | Bone Density |
NCT04054375 (15) [back to overview] | Vignos Scale Score |
NCT04054375 (15) [back to overview] | HbgA1c |
NCT04054375 (15) [back to overview] | 6 Minute Walk Test |
NCT04054375 (15) [back to overview] | 10 Meter Run Timed |
NCT04054375 (15) [back to overview] | Muscle Imaging |
NCT04054375 (15) [back to overview] | Lean Mass % |
NCT04054375 (15) [back to overview] | Functional Assessments - NSAD Change |
NCT04072822 (15) [back to overview] | Number of Participants With AKI (Acute Kidney Injury) |
NCT04072822 (15) [back to overview] | Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation. |
NCT04072822 (15) [back to overview] | Number of Participants Requiring Transfer to ICU for Care, Intubation for Airway Control, Need for Ventilator Support or RRT. |
NCT04072822 (15) [back to overview] | Number of Participants With Infections |
NCT04072822 (15) [back to overview] | Percentage of Participants With Renal Dysfunction |
NCT04072822 (15) [back to overview] | Survival at 90 Days |
NCT04072822 (15) [back to overview] | To Measure the Changes in Lille Score |
NCT04072822 (15) [back to overview] | Transplant Free Survival Rate |
NCT04072822 (15) [back to overview] | Changes in Liver Function |
NCT04072822 (15) [back to overview] | Number of Participants With Progression of Sepsis |
NCT04072822 (15) [back to overview] | Number of Transfers to ICU |
NCT04072822 (15) [back to overview] | Survival |
NCT04072822 (15) [back to overview] | Changes in MELD Score |
NCT04072822 (15) [back to overview] | Development of Multi-organ Failure |
NCT04072822 (15) [back to overview] | Development of SIRS (Systemic Inflammatory Response Syndrome) |
NCT04177095 (6) [back to overview] | Incidence of Acute Rejection |
NCT04177095 (6) [back to overview] | Incidence of Acute Rejection |
NCT04177095 (6) [back to overview] | Incidence of de Novo Donor Specific Antibodies |
NCT04177095 (6) [back to overview] | Increase in eGFR |
NCT04177095 (6) [back to overview] | Survival |
NCT04177095 (6) [back to overview] | Rate of New-onset Proteinuria |
NCT04542278 (7) [back to overview] | Percent Change From Baseline Mean in Autoantibody Levels |
NCT04542278 (7) [back to overview] | Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score |
NCT04542278 (7) [back to overview] | Change in Short Form Health Survey (SF-12) Physical Component Score (PCS) |
NCT04542278 (7) [back to overview] | Change in Short Form Health Survey (SF-12) Mental Component Score (MCS) |
NCT04542278 (7) [back to overview] | Thyroid Difficulty Scale Score |
NCT04542278 (7) [back to overview] | Surgical Complications: Parathyroid Hormone (PTH) Level |
NCT04542278 (7) [back to overview] | Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury |
NCT04660799 (14) [back to overview] | Observed SC and IV Rituximab Area Under the Curve (AUCsc and AUCiv) |
NCT04660799 (14) [back to overview] | Subcutaneous Serum Rituximab Trough Concentration (Ctrough SC) and Intravenous Serum Rituximab Trough Concentration (Ctrough IV) |
NCT04660799 (14) [back to overview] | Area Under the Curve (AUC) of Rituximab |
NCT04660799 (14) [back to overview] | Maximum Observed Serum Concentration (Cmax) of Rituximab |
NCT04660799 (14) [back to overview] | Number of Participants Positive for Anti-drug Antibodies (ADAs) to Rituximab |
NCT04660799 (14) [back to overview] | Number of Participants Positive for Anti-rHuPH20 Antibodies |
NCT04660799 (14) [back to overview] | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT04660799 (14) [back to overview] | Objective Response Rate (ORR), Complete Response (CR) or Partial Response (PR), as Determined by Investigator and IRC Using Lugano Response Criteria (LRC) for Malignant Lymphoma |
NCT04660799 (14) [back to overview] | Time to Cmax (Tmax) of Rituximab |
NCT04660799 (14) [back to overview] | Trough Serum Concentration (Ctrough) of Rituximab |
NCT04660799 (14) [back to overview] | Number of Participants With Rituximab Administration-related Reactions (ARRs) |
NCT04660799 (14) [back to overview] | Complete Response Rate (CRR) as Determined by the Independent Review Committee (IRC) Using Lugano Response Criteria (LRC) for Malignant Lymphoma |
NCT04660799 (14) [back to overview] | CRR, as Determined by IRC Using International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) 1999 Guidelines |
NCT04660799 (14) [back to overview] | CRR, as Determined by the Investigator Using Lugano Response Criteria for Malignant Lymphoma |
NCT04745832 (2) [back to overview] | Number of SAEs (Zandelisib When Combined With Rituximab) |
NCT04745832 (2) [back to overview] | Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab) |
NCT04766996 (2) [back to overview] | Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm |
NCT04766996 (2) [back to overview] | Total Post-operative Opioid Requirements With Non-opioid Drug Regimen |
NCT04907227 (12) [back to overview] | Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST) |
NCT04907227 (12) [back to overview] | Time to First Symptomatic Skeletal-related Event (SSRE) |
NCT04907227 (12) [back to overview] | Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) |
NCT04907227 (12) [back to overview] | Prostate-specific Antigen (PSA) Response Rate |
NCT04907227 (12) [back to overview] | Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review |
NCT04907227 (12) [back to overview] | Number of Participants Who Experienced an Adverse Event (AE) |
NCT04907227 (12) [back to overview] | Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE) |
NCT04907227 (12) [back to overview] | "Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (Worst Pain in 24 Hours) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score" |
NCT04907227 (12) [back to overview] | Overall Survival (OS) |
NCT04907227 (12) [back to overview] | Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) |
NCT04907227 (12) [back to overview] | Time to Prostate-specific Antigen (PSA) Progression |
NCT04907227 (12) [back to overview] | Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review |
Complete Remission (CR)
complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count > 1,000 x 10^6/1, a platelet count > 100,000 x 10^9/1, no circulating blasts, and < than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia. (NCT00002766)
Timeframe: 2 years
Intervention | participants (Number) |
---|
| Complete Remission | Complete Response (CR) | Failure | Failure-Progression | Relapse |
---|
All-2 | 50 | 14 | 5 | 8 | 1 |
,L-20 | 50 | 11 | 14 | 10 | 0 |
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Failure-free Survival at 5 Years
"Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years.~Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ.~Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission." (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5
Intervention | Proportion of patients (Number) |
---|
Arm A (ABVD) | 0.74 |
Arm B (Stanford V) | 0.71 |
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5-year Overall Survival
Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years. (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years
Intervention | Proportion of patients (Number) |
---|
Arm A (ABVD) | 0.88 |
Arm B (Stanford V) | 0.88 |
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Incidence of Second Cancers
Number of patients who developed second primary cancers (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years
Intervention | participants (Number) |
---|
Arm A (ABVD) | 15 |
Arm B (Stanford V) | 19 |
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Proportion of Patients With Complete or Partial Response to Treatment With MTX
We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement. (NCT00003910)
Timeframe: Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date.
Intervention | proportion of participants (Number) |
---|
Methotrexate | 0.39 |
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Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX
We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement. (NCT00003910)
Timeframe: Assessed during the first 4 months of treatment and followed until reaching full study stop date
Intervention | proportion of participants (Number) |
---|
Cyclophosphamide (Cy) | 0.64 |
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2-year Overall Survival Rates
Percentage of participants surviving 2 years post registration (NCT00004031)
Timeframe: up to 2 years post registration
Intervention | percentage of participants (Number) |
---|
CHOP/CHOP-R x 3 | 71.1 |
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant | 73.7 |
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2 Year Progression-free Survival
Percentage of participants without disease progression up to 2 years post-registration. (NCT00004031)
Timeframe: From registration until death
Intervention | percentage of participants (Number) |
---|
CHOP/CHOP-R x 3 | 55.4 |
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant | 69.1 |
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Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients
Number of patients with adverse events that are related to study drug (NCT00004124)
Timeframe: Up to 22 months from registration
Intervention | Participants (Number) |
---|
| Abdominal pain/cramping | Abscess | Alkaline phosphatase increase | Allergic reaction | Allergic rhinitis | Alopecia | Anal incontinence | Anemia | Anorexia | Anxiety/agitation | Apnea | Arrhythmia, NOS | Arthralgia | Arthritis | Ataxia (incoordination) | Bilirubin increase | Blurred vision | Bone pain | Bruising | CPK increase | Cardiac ischemia/infarction | Cardiovascular-other | Cataract | Cerebrovascular ischemia | Chest pain,not cardio or pleur | Conduction abnormality/block | Confusion | Conjunctivitis | Constipation/bowel obstruction | Cough | Creatinine increase | Cushingoid appearance | Dehydration | Depression | Diarrhea without colostomy | Dizziness/light headedness | Dry eye | Dry skin | Dysmenorrhea | Dyspepsia/heartburn | Dyspnea | Dysuria | Ear-other | Edema | Endocrine-other | Epistaxis | Erectile impotence | Eryth/rash/eruption/desq, NOS | Esophagitis/dysphagia | Eye-other | Fatigue/malaise/lethargy | Febrile neutropenia | Feminization of male | Fever without neutropenia | Fever, NOS | Flatulence | Flu-like symptoms-other | Flushing | GGT increase | GI Mucositis, NOS | GI-other | GU-other | Gastritis | Gastritis/ulcer, NOS | Glaucoma | Gynecomastia | Headache | Hematologic-other | Hematuria | Hemolysis | Hemoptysis | Hemorrhage-other | Hiccoughs | Hot flashes | Hypercalcemia | Hypercholesterolemia | Hyperglycemia | Hyperkalemia | Hypermagnesemia | Hypernatremia | Hypertension | Hypertriglyceridemia | Hypoalbuminemia | Hypocalcemia | Hypoglycemia | Hypokalemia | Hypomagnesemia | Hyponatremia | Hypotension | Hypothyroidism | Hypoxia | Incontinence | Infection w/o 3-4 neutropenia | Infection with 3-4 neutropenia | Infection, unk ANC | Inner ear-hearing loss | Insomnia | Invol. movement/restlessness | Joint,muscle,bone-other | LVEF decrease/CHF | Leukopenia | Libido loss | Local injection site reaction | Lung-other | Lymphopenia | Male infertility | Melena/ GI bleeding | Memory loss | Metabolic-other | Middle ear-hearing loss/otitis | Mood/consciousness change, NOS | Mouth dryness | Muscle weakness (not neuro) | Myalgia | Myalgia/arthralgia, NOS | Myocarditis | Nail changes | Nausea | Neuro-other | Neuropathic pain | Neutropenia/granulocytopenia | PRBC transfusion | Pain-other | Palpitations | Pelvic pain | Pericar. effusion/pericarditis | Personality/behavioral change | Phlebitis | Pigmentation changes/yellowing | Pleural effusions | Pneumonitis/infiltrates | Proctitis | Proteinuria | Pruritus | RT-GI mucositis, NOS | RT-focal dermatitis, NOS | RT-late bladder morbidity | RT-late intestinal morbidity | RT-pain | Rash/desquamation | Rectal bleeding/hematochezia | Rectal/perirectal pain | Respiratory infect w/o neutrop | Respiratory infection, unk ANC | Rigors/chills | SGOT (AST) increase | SGPT (ALT) increase | Salivary change, NOS | Second primary | Seizures | Sensory neuropathy | Sexual/reproductive-other | Sinus bradycardia | Skin-other | Speech impairment | Stomatitis/pharyngitis | Supraventricular arrhythmia | Surgery-wound infection | Sweating | Syncope | Taste disturbance | Tearing | Thrombocytopenia | Thrombosis/embolism | Tremor | Troponin T (cTnT) increase | Urinary frequency/urgency | Urinary retention | Urinary tr infect w/ neutrop | Urinary tr infect w/o neutrop | Urinary tr infection, unk ANC | Urine color change | Urticaria | Ventricular arrhythmia | Vertigo | Vision,NOS | Voice change/stridor/larynx | Vomiting | Weakness (motor neuropathy) | Weight gain | Weight loss |
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Arm I: Bicalutamide + Goserelin | 19 | 0 | 11 | 1 | 2 | 91 | 2 | 52 | 7 | 52 | 1 | 0 | 43 | 17 | 1 | 5 | 3 | 19 | 1 | 0 | 1 | 0 | 5 | 1 | 11 | 1 | 6 | 0 | 57 | 10 | 7 | 0 | 0 | 80 | 55 | 33 | 1 | 11 | 0 | 7 | 21 | 14 | 0 | 40 | 3 | 0 | 181 | 0 | 2 | 1 | 258 | 0 | 1 | 0 | 1 | 2 | 2 | 5 | 1 | 0 | 12 | 9 | 2 | 0 | 2 | 140 | 37 | 1 | 9 | 0 | 0 | 1 | 0 | 439 | 4 | 5 | 44 | 0 | 0 | 0 | 38 | 2 | 1 | 1 | 0 | 8 | 1 | 3 | 3 | 2 | 0 | 88 | 5 | 0 | 1 | 3 | 79 | 2 | 11 | 0 | 14 | 163 | 11 | 0 | 4 | 2 | 0 | 15 | 0 | 0 | 2 | 10 | 55 | 26 | 1 | 0 | 4 | 26 | 5 | 0 | 11 | 0 | 112 | 1 | 9 | 0 | 12 | 0 | 0 | 0 | 0 | 4 | 3 | 13 | 0 | 3 | 1 | 2 | 1 | 46 | 12 | 7 | 1 | 1 | 7 | 42 | 22 | 0 | 0 | 1 | 37 | 2 | 0 | 11 | 0 | 5 | 0 | 0 | 138 | 0 | 1 | 0 | 3 | 2 | 0 | 0 | 86 | 13 | 0 | 1 | 3 | 3 | 3 | 1 | 1 | 0 | 0 | 10 | 3 | 179 | 12 |
,Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | 41 | 1 | 11 | 5 | 16 | 131 | 2 | 141 | 41 | 62 | 1 | 1 | 64 | 17 | 1 | 20 | 6 | 34 | 14 | 2 | 1 | 5 | 6 | 0 | 19 | 0 | 14 | 4 | 117 | 34 | 17 | 8 | 6 | 85 | 75 | 71 | 5 | 28 | 1 | 44 | 49 | 11 | 2 | 56 | 2 | 2 | 146 | 2 | 13 | 6 | 357 | 2 | 0 | 9 | 6 | 3 | 6 | 4 | 0 | 10 | 20 | 9 | 0 | 1 | 0 | 100 | 82 | 1 | 13 | 1 | 1 | 4 | 4 | 422 | 5 | 2 | 78 | 4 | 1 | 4 | 38 | 0 | 6 | 7 | 1 | 11 | 1 | 2 | 11 | 0 | 4 | 71 | 10 | 2 | 4 | 2 | 92 | 2 | 27 | 8 | 317 | 133 | 17 | 2 | 49 | 3 | 2 | 12 | 1 | 1 | 3 | 13 | 77 | 45 | 12 | 1 | 57 | 205 | 4 | 1 | 239 | 3 | 127 | 6 | 11 | 1 | 11 | 5 | 3 | 1 | 1 | 4 | 1 | 23 | 1 | 1 | 0 | 1 | 0 | 63 | 10 | 5 | 7 | 8 | 24 | 42 | 26 | 1 | 6 | 1 | 57 | 1 | 4 | 11 | 1 | 49 | 2 | 1 | 129 | 3 | 46 | 6 | 35 | 5 | 2 | 1 | 101 | 7 | 1 | 2 | 2 | 44 | 4 | 0 | 1 | 1 | 6 | 51 | 6 | 151 | 29 |
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Overall Survival
Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact. (NCT00004124)
Timeframe: at 10 Years
Intervention | percentage of probability of survival (Number) |
---|
Arm I: Bicalutamide + Goserelin | 87 |
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | 86 |
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Disease Free Survival
Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact. (NCT00004124)
Timeframe: at 10 Years
Intervention | percentage of probability of survival (Number) |
---|
Arm I: Bicalutamide + Goserelin | 72 |
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | 72 |
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Percentage of Patients With Overall Survival as Assessed by Time to Death
Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors. (NCT00004228)
Timeframe: 5 years
Intervention | percentage of participants (Number) |
---|
A0 (Localized Disease Stg I/II) Modified CCG BFM | 96 |
A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 84 |
A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | 88 |
B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | 81 |
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | 85 |
B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | 85 |
B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | 92 |
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Event-free Survival
Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification. (NCT00004228)
Timeframe: 5 years
Intervention | percentage of particpants (Number) |
---|
A0 (Localized Disease Stg I/II) Modified CCG BFM | 88 |
A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 82 |
A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens | 80 |
B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | 63 |
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | 82 |
B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | 84 |
B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | 90 |
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Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine
PFS is defined as the time from start of treatment until disease relapse or progression, death, or last follow-up. Progression was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma and is defined as ≥50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously involved node or the appearance of any new lesion (NCT00005780)
Timeframe: Time from treatment start date until date of disease relapse or progression, death, or date last follow-up, an average of 25 months
Intervention | Months (Median) |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 25.0 |
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Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH)
Participants with an immune response against carrier molecule KLH measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer. (NCT00005780)
Timeframe: After vaccinations administered at 0, 1, 2, 3 and 5 months
Intervention | percentage of participants (Number) |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 74 |
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Percentage of Participants With an Antibody Response to Idiotype Vaccine
Participants with an immune response to idiotype vaccine measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer. (NCT00005780)
Timeframe: Weeks 12 to 32
Intervention | percentage of participants (Number) |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 30 |
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Percentage of Participants With Induction of Type 1 Cytokine T-cell Response
Participants with tumor specific T-cell responses during B-cell recovery was assessed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab and were measured by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT). A positive response required the response to be at least twice the negative controls. (NCT00005780)
Timeframe: After vaccinations administered at 0, 1, 2, 3 and 5 months
Intervention | percentage of participants (Number) |
---|
| Peripheral blood mononuclear cells (PBMC) | Granulocyte macrophage colony-stimulating factor (GM-CSF) | Tumor necrosis factor α (TNFα) | Interferon-gamma (IFN-γ) |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 87 | 65 | 52 | 74 |
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Time to Recovery of CD4 T Lymphocytes (CD4+)
Recovery of CD4+ was measured by flow cytometry. Blood samples were collected via apheresis and analyzed by multicolor flow cytometry in peripheral blood mononuclear cells (PBMCs) for cluster of differentiation 4 (CD4). Time to recovery of CD4 T lymphocytes was defined as the time required for CD4 T lymphocytes to increase above the lower limit of normal of the normal laboratory value range of 359 cells/mcL (NCT00005780)
Timeframe: After chemotherapy before vaccination, up to 6 months
Intervention | Months (Median) |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 3 |
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Overall Survival (OS)
OS was determined by the Kaplan-Meier method and is defined as the time from treatment start date until date of death or last follow-up. (NCT00005780)
Timeframe: Time from treatment start date until date of death or date last follow-up, up to 250 months
Intervention | Months (Median) |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 89.7 |
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Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0).
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00005780)
Timeframe: Up to 30 days after last intervention, up to 12.5 months or 1.04 years
Intervention | Participants (Count of Participants) |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 26 |
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Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)
Response was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma. Complete Response (CR) is a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., Lactate dehydrogenase (LDH) definitely assignable to the lymphoma. Complete Response Unconfirmed (CRu) is as per CR criteria except that if a residual node is > 1.5cm, it must have regressed by > 75% in the sum of the products of the greatest diameters (SPD). Partial Response (PR) is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Stable Disease (SD) is defined as less than a PR but not progressive disease. Progression is ≥50% increase from nadir in the SPD of any previously involved node or the appearance of any new lesion. (NCT00005780)
Timeframe: After 6 cycles of EPOCH-R therapy, an average of 18 weeks
Intervention | percentage of participants (Number) |
---|
| Complete Response | Complete Response Unconfirmed | Partial Response | Stable Disease | Progression |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 80.8 | 7.7 | 7.7 | 0 | 3.8 |
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Immune Response
Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells. (NCT00006184)
Timeframe: 105 days
Intervention | Particpants (Number) |
---|
Recipient - Chemotherapy Group | 7 |
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Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00006184)
Timeframe: 9 years
Intervention | Participants (Count of Participants) |
---|
Recipient - Chemotherapy Group | 10 |
Donor - Vaccination Generation Group | 10 |
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1 Year Overall Survival
Overall survival is time from treatment start date until date of death or date last known alive. (NCT00006436)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Arm 1-Combination Chemo and Biological Therapy | 83.7 |
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Number of Participants With at Least One Hematologic Toxicity Event of Febrile Neutropenia
Toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Febrile neutropenia is defined as a life-threatening complication requiring hospitalization and urgent broad-spectrum antibiotics. (NCT00006436)
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.
Intervention | Participants (Count of Participants) |
---|
Arm 1-Combination Chemo and Biological Therapy | 18 |
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Recovery of CD4 T Cells (CD4) Counts
Participants with human immunodeficiency virus (HIV) who undergo chemotherapy may have a delay in the recovery of their normal CD4+ T-cells. This delay could result in an increased risk of infection. Recovery of CD4 cells counts is the time from end of therapy until the time that the CD4 counts first reached above 200 cells/uL. (NCT00006436)
Timeframe: From the end of chemotherapy every 3 months for the first 2 years
Intervention | months (Median) |
---|
Arm 1-Combination Chemo and Biological Therapy | 2.5 |
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Recovery of Human Immunodeficiency Virus (HIV) Viral Load
The HIV viral load is a measure of actively replicating virus in the blood. If no anti-retroviral therapy is given, then reduction of this HIV viral load to manageable levels might risk infection. In our study, the recovery of HIV viral load was measured the time from the initiation of antiretroviral therapy until the viral load was undetectable or < 50 copies. (NCT00006436)
Timeframe: Either following or concurrently with combination chemo and biological therapy, approximately every 6 to 8 weeks after therapy was completed up to 16 months
Intervention | months (Median) |
---|
Arm 1-Combination Chemo and Biological Therapy | 2 |
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1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)
"1-year PFS is defined as participants who remain free of disease progression or death at one year from study entry. We compared the 1-year PFS of participants with negative results on interim positron emission tomography (PET) scans to those with positive results on interim PET scans.~PFS is defined as the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival." (NCT00006436)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
| Interim PET scan positive 1-year PFS | Interim PET scan negative 1 year PFS |
---|
Arm 1-Combination Chemo and Biological Therapy | 61.5 | 89.3 |
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Number of Cycles of Hematologic Toxicity
Cumulative number of cycles of hematologic toxicity. Hematologic (i.e., decrease in bone marrow and blood cells) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). (NCT00006436)
Timeframe: Up to 112 cycles (each cycle is 21 days + 7 days window)
Intervention | cycles (Number) |
---|
| Febrile neutropenia | Neutropenia with a Nadir <500 cells/mm^3 | Neutropenia with a Nadir <100 cells/mm^3 | Thrombocytopenia with a Nadir <50,000 platelets/mm^3 | Thrombocytopenia with a Nadir <25,000 platelets/mm^3 | Anemia: hemoglobin <8 g/dL |
---|
Arm 1-Combination Chemo and Biological Therapy | 25 | 112 | 77 | 40 | 6 | 36 |
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Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Non-hematologic (i.e., not begin in bone marrow or blood) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. (NCT00006436)
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.
Intervention | Participants (Count of Participants) |
---|
| Serious infection | Neurologic event | Syncope | Confusion | Motor neuropathy | Vision disturbance | Hyperglycemia | Hypophosphatemia | Hypocalcemia | Hypokalemia | Hyponatremia | Dehydration | Mucositis/Stomatitis | Liver test abnormalities | Pancreatitis | Diarrhea | Constipation | Serious hemorrhage | Fatigue | Headache | Bone pain | Nausea | Anorexia | Hypoxia | Myelodysplastic syndrome |
---|
Grade 3 | 17 | 0 | 1 | 1 | 0 | 1 | 4 | 2 | 2 | 1 | 1 | 1 | 6 | 6 | 1 | 2 | 1 | 5 | 2 | 5 | 1 | 0 | 0 | 0 | 0 |
,Grade 4 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 4 | 0 |
,Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
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Overall Response
Overall response was determined by the Cheson Response Criteria. Participants with either a complete response (CR), complete response unconfirmed or partial response were considered responders. Less than a partial response was considered a non-response to therapy (i.e., Stable Disease and/or Progressive Disease). Complete response was defined as the disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size. Complete response unconfirmed is a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. Partial response is defined as a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. (NCT00006436)
Timeframe: The participants were followed for an average of 6 months to determine response to therapy.
Intervention | Participants (Count of Participants) |
---|
| Complete Response | Complete Response Unconfirmed | Partial Response | Non-Responder - Stable Disease | Non-Responder - Progressive Disease |
---|
Arm 1-Combination Chemo and Biological Therapy | 53 | 10 | 1 | 1 | 1 |
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Percentage of Participants With Complete Response
Complete response was assessed by the Cheson Response Criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). (NCT00006436)
Timeframe: The participants were followed for an average of 6 months to determine response to therapy.
Intervention | percentage of participants (Number) |
---|
Arm 1-Combination Chemo and Biological Therapy | 95 |
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Percentage of Participants With CR/CRu Lasting 1 Year
"Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy).~Complete response unconfirmed (CRu) is when a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by > 75% in sum of the products of the greatest diameters or are < 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR." (NCT00006436)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Arm 1-Combination Chemo and Biological Therapy | 82.5 |
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Progression Free Survival at 1 Year
PFS is the time interval from start of treatment to documented evidence of disease progression. Progression is defined according to the Cheson response criteria. Disease progression as indicated by imaging scans at one year following therapy. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). (NCT00006436)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Arm 1-Combination Chemo and Biological Therapy | 79.1 |
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Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00006436)
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.
Intervention | Participants (Count of Participants) |
---|
Arm 1-Combination Chemo and Biological Therapy | 66 |
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Overall Survival at 2 Years
Measured from date of registration to date of death due to any cause (NCT00006721)
Timeframe: 0-2 years
Intervention | percentage of participants (Number) |
---|
CHOP + Rituximab | 97 |
CHOP + Tositumomab | 93 |
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Overall Survival at 5 Years
Measured from date of registration to date of death due to any cause (NCT00006721)
Timeframe: 0-5 years
Intervention | percentage of participants (Number) |
---|
CHOP + Rituximab | 92 |
CHOP + Tositumomab | 86 |
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Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00006721)
Timeframe: Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death
Intervention | participants (Number) |
---|
CHOP + Rituximab | 224 |
CHOP + Tositumomab | 223 |
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Progression-free Survival at 5 Years
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00006721)
Timeframe: 0-5 years
Intervention | percentage of participants (Number) |
---|
CHOP + Rituximab | 60 |
CHOP + Tositumomab | 66 |
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Progression-free Survival at 2 Years
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00006721)
Timeframe: 0-2 years
Intervention | percentage of participants (Number) |
---|
CHOP + Rituximab | 76 |
CHOP + Tositumomab | 80 |
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Overall Survival From Registration
Overall survival (OS) was computed using the number of months from the date of registration to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS. (NCT00024167)
Timeframe: Followed every 4 weeks from registration until death, up to 7 years.
Intervention | months (Median) |
---|
Induction Treatment + Strontium-89 | 27.9 |
Induction Treatment + No Strontium-89 | 26.6 |
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Overall Survival From Randomization
Overall survival (OS) was computed using the number of months from the date of randomization to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS. (NCT00024167)
Timeframe: Followed every 4 weeks from randomization until death, up to 7 years.
Intervention | months (Median) |
---|
Induction Treatment + Strontium-89 | 24.2 |
Induction Treatment + No Strontium-89 | 22.8 |
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Disease Response Assessed by Modified RECIST Criteria
Number of participants with complete response and very good partial response at the end of protocol therapy. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
Intervention | Number of participants (Number) |
---|
Arm I (Patients Off-therapy Before Callback-Induction Only) | 5 |
Arm II (RER With CR [ABVE-PC, IFRT]) | 370 |
Arm III (RER With CR [ABVE-PC]) | 380 |
Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 538 |
Arm V (RER With PD) | 29 |
Arm VI (SER [DECA, ABVE-PC, IFRT]) | 105 |
Arm VII (SER [ABVE-PC, IFRT]) | 100 |
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Event-free Survival
Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. (NCT00025259)
Timeframe: 5 years
Intervention | Probability of survival (Number) |
---|
Arm I (Patients Off-therapy Before Callback-Induction Only) | 0.89 |
Arm II (RER With CR [ABVE-PC, IFRT]) | 0.87 |
Arm III (RER With CR [ABVE-PC]) | 0.84 |
Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 0.87 |
Arm V (RER With PD) | 0.70 |
Arm VI (SER [DECA, ABVE-PC, IFRT]) | 0.79 |
Arm VII (SER [ABVE-PC, IFRT]) | 0.74 |
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Overall Survival
Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact. (NCT00025259)
Timeframe: 5 years
Intervention | Probability of survival (Number) |
---|
Arm I (Patients Off-therapy Before Callback-Induction Only) | 0.93 |
Arm II (RER With CR [ABVE-PC, IFRT]) | 0.98 |
Arm III (RER With CR [ABVE-PC]) | 0.98 |
Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 0.98 |
Arm VI (SER [DECA, ABVE-PC, IFRT]) | 0.96 |
Arm VII (SER [ABVE-PC, IFRT]) | 0.93 |
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Grade 3 or 4 Non-hematologic Toxicity
Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
Intervention | Number of participants (Number) |
---|
Arm I (Patients Off-therapy Before Callback-Induction Only) | 10 |
Arm II (RER With CR [ABVE-PC, IFRT]) | 153 |
Arm III (RER With CR [ABVE-PC]) | 130 |
Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 216 |
Arm V (RER With PD) | 11 |
Arm VI (SER [DECA, ABVE-PC, IFRT]) | 62 |
Arm VII (SER [ABVE-PC, IFRT]) | 45 |
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Second Hodgkin's Disease Progression
Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis. (NCT00026208)
Timeframe: 16 years
Intervention | Participants (Count of Participants) |
---|
Stanford V-C + Low-dose Radiotherapy | 3 |
Stanford V-C Only | 1 |
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Survival at 5 and 10 Years
Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints. (NCT00026208)
Timeframe: 5 and 10 years
Intervention | Participants (Count of Participants) |
---|
| 5 years | 10 years |
---|
Stanford V-C + Low-dose Radiotherapy | 67 | 41 |
,Stanford V-C Only | 3 | 3 |
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Progression-free Survival (PFS)
Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression. (NCT00026208)
Timeframe: up to 3 years
Intervention | percentage of participants (Number) |
---|
Stanford V-C + Low-dose Radiotherapy | 89.7 |
Stanford V-C Only | 50 |
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Overall Survival (OS)
Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation. (NCT00026208)
Timeframe: 16 years
Intervention | years (Median) |
---|
Stanford V-C + Low-dose Radiotherapy | 10.4 |
Stanford V-C Only | 13.2 |
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Frequency of Complete Response
"The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as complete regression of all palpable and radiographic demonstrable disease by computed tomography (CT) scan or positron emission tomography-CT (PET-CT)." (NCT00026208)
Timeframe: 5 weeks
Intervention | Participants (Count of Participants) |
---|
Stanford V-C + Low-dose Radiotherapy | 31 |
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Number of Responders
A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA. (NCT00033293)
Timeframe: Changes from baseline to 2 months, 6 months, and 1 year
Intervention | participants (Number) |
---|
Arm I (Chemotherapy, Immunoglobulin Therapy) | 21 |
Arm II (Chemotherapy, Observation) | 11 |
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Tumor Outcome in Terms of Overall Survival (OS) Rate
OS rate from time of study enrollment. (NCT00033293)
Timeframe: Up to 3 years
Intervention | 3 year OS (Number) |
---|
Arm I (Chemotherapy, Immunoglobulin Therapy) | 100 |
Arm II (Chemotherapy, Observation) | 96.0 |
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Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death
EFS rate for neuroblastoma event from time of study enrollment. (NCT00033293)
Timeframe: Up to 3 years
Intervention | 3 year EFS (Number) |
---|
Arm I (Chemotherapy, Immunoglobulin Therapy) | 92.3 |
Arm II (Chemotherapy, Observation) | 96.0 |
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Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing
"The Bayley Scales of infant development mental scale best score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline." (NCT00033293)
Timeframe: Changes from baseline to the better of 6 months or 1 year
Intervention | Change in Bayley's score (Mean) |
---|
Arm I (Chemotherapy, Immunoglobulin Therapy) | 117.5 |
Arm II (Chemotherapy, Observation) | 100.75 |
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Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)
"The best score at the two time points will be used in this analysis. For a given patient, this best score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated." (NCT00033293)
Timeframe: Changes from baseline to the better of 6 months or 1 year
Intervention | Change in VABS score (Mean) |
---|
Arm I (Chemotherapy, Immunoglobulin Therapy) | 84.53 |
Arm II (Chemotherapy, Observation) | 144.73 |
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2 Year Overall Survival
Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method. (NCT00039130)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Rituximab With High Intensity Chemotherapy | 80 |
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2 Year Event Free Survival
Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure. (NCT00039130)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Rituximab With High Intensity Chemotherapy | 78 |
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Complete Response Rate
Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease. (NCT00039130)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
Rituximab With High Intensity Chemotherapy | 83 |
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Progression Free Survival
Kaplan-Meier estimates will be used to verify the progression free survival. (NCT00039195)
Timeframe: 2 years
Intervention | percentage of patients progression free (Number) |
---|
Induction R-CHOPac Therapy | 79 |
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Overall Survival
(NCT00040937)
Timeframe: 4-7 years
Intervention | proportion surviving at 4 years (Number) |
---|
Treatment Arm | .64 |
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Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.
To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen. (NCT00040937)
Timeframe: Induction
Intervention | Participants (Number) |
---|
Induction/PBSC Mobilization | 2 |
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Early Post Transplantation Relapse
Participants who experienced recurrence or progression of disease following transplant. (NCT00043979)
Timeframe: up to 300 days
Intervention | Days (Median) |
---|
Arm 2-Recipients | 100 |
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Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant
Participants who are alive at two years following Allo-Hematopoietic Stem Cell Transplant. (NCT00043979)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
| From date of enrollment | From date of transplantation |
---|
Arm 2-Recipients | 39.1 | 34.8 |
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Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Site of radiotherapy (high energy radiation) and/or toxicity experienced by the participants post HSCT radiotherapy. Grading was preformed using the Modified Glucksberg Criteria. (NCT00043979)
Timeframe: up to 6 cycles or 168 days
Intervention | Participants (Count of Participants) |
---|
| Chest wall; G2 skin | Abdomen; G4 GI | Pancreas; G4 LFTs, G4 pancreatitis | Pleura, mediastinum; G4 LFTs, G2 mucositis | Chest wall; G4 skin, G3 mucositis | Spine, skull; G2 nausea+vomiting, G2 fatigue | Pelvis; G4 enteritis | Pulmonary (cyberknife) | Brain; B3 mucositis | Whole lung; G3 mucositis, G3 skin, G5 lung | L arm, R shoulder, B/L femur |
---|
Arm 2-Recipients | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
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Number of Participants With Acute and Chronic GVHD
Acute GVHD as by Modified Glucksberg Criteria occurring before day 100. Chronic GVHD as per Seattle criteria occurring after day 100. (NCT00043979)
Timeframe: up to 5 years or death
Intervention | participants (Number) |
---|
| acute GVHD | chronic GVHD |
---|
Recipients -Cyclosporine GVHD Prophylaxis | 12 | 12 |
,Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis | 5 | 5 |
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Cluster of Differentiation 4 (CD4) Reconstitution
The median CD4 count with a range of 85-1565 (absolute count) was used to determine recovery and were considered recovered if in this range. The CD4 count was established by flow cytometry testing. (NCT00043979)
Timeframe: Day +28-42
Intervention | mm(3) (Median) |
---|
Arm 2-Recipients | 284 |
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Number of Participants to Complete Conversion to >95% Donor Chimerism
Participants who tolerated the transplantation regimen and accepted >95% of the donors blood, marrow, and/or tissue. (NCT00043979)
Timeframe: up to 30 days
Intervention | Participants (Count of Participants) |
---|
| Day +14 | Day +28 |
---|
Arm 2-Recipients | 23 | 23 |
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Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)
Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). RECIST criteria offer a simplified, conservative, extraction of imaging data for wide application in clinical trials. They presume that linear measures are an adequate substitute for 2-D (dimensional) methods and registers four response categories: Complete response (CR) is disappearance of all target lesions. Partial response (PR) is 30% increase in the sum of the longest diameter of target lesions. Progressive disease (PD) is 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is small changes that do not meet above criteria. For the purposes of this study very good partial response ((VGPR) is >75% reduction in disease) was also employed. (NCT00043979)
Timeframe: up to 10 cycles of therapy or 280 days
Intervention | Participants (Count of Participants) |
---|
| Complete Response (CR) | Progressive Disease (PD) | Partial Response (PR) | Very Good Partial Response (VGPR) |
---|
Arm 2-Recipients | 2 | 4 | 4 | 2 |
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Toxicity
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00043979)
Timeframe: 16.5 months
Intervention | Participants (Number) |
---|
Arm 2-Recipients | 30 |
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Number of Participants With Engraftment
Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, >95% donor engraftment at day 100 in >75% of patients. (NCT00043979)
Timeframe: 100 days
Intervention | Participants (Number) |
---|
Arm 2-Recipients | 23 |
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Number of Participants Who Experienced Graft Versus Tumor Effect (GVT)
GVT is defined as tumor response after day 42 post-transplantation without cytotoxic therapy. (NCT00043979)
Timeframe: up to day 100
Intervention | Participants (Count of Participants) |
---|
Arm 2-Recipients | 0 |
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Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment
Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma (NCT00049036)
Timeframe: 60 days
Intervention | proportion (Number) |
---|
EPOCH + Concurrent Rituximab | 0.69 |
EPOCH Followed by Rituximab | 0.53 |
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Number of Recipients With a Response to Reduced-intensity Stem Cell Transplantation (RIST)
Complete remission (CR) is complete disappearance of all detectable signs and symptoms of lymphoma for a period of at least one month. Complete remission unconfirmed (CRu) is a residual lymph node mass > 1.5 cm in greatest transverse diameter will be considered CRu if it has regressed by more than 75% in the SPD, does not change over at least one month, is negative by PET or gallium, and is negative on any biopsies obtained (biopsy not required). Progressive disease (PD) is a 25% or greater increase in SPD of all measured lesions compared to the smallest previous measurements, or appearance of any new lesion(s). (NCT00051311)
Timeframe: At least 100 days after post reduced-intensity stem cell transplantation (RIST).
Intervention | Participants (Count of Participants) |
---|
| Complete Remission or Complete Remission Unconfirmed | Progressive Disease |
---|
Recipient | 15 | 16 |
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Number of Recipients Who Developed Grades I-IV Acute Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis
Here is the number of recipients who developed grades I-IV acute graft versus host disease (GVHD) following a combination of cyclosporine and a mini-dose methotrexate regimen for graft-versus-host disease (GVHD) prophylaxis. Grades I-IV acute GVHD clinical staging was assessed by the Glucksberg Criteria. Grade I-IV acute GVHD can occur in the skin, liver, and/or gut. Grade 1: rash < 25% body surface area (BSA), total bilirubin 2-3 mg/dl, and diarrhea 500-1000 ml/d. Grade 2: 25-50% BSA, total bilirubin 3-6 mg/dl, and diarrhea 1000-1500 ml/d. Grade 3: generalized erythroderma, total bilirubin 6-15 mg/dl, and diarrhea >1500 ml/d. Grade 4: desquamation and bullae, total bilirubin >15 mg/dl, and pain +/- ileus. (NCT00051311)
Timeframe: At least 100 days of follow-up post reduced-intensity stem cell transplantation (RIST)
Intervention | Participants (Count of Participants) |
---|
| Grade I GVHD | Grade II GVHD | Grade III GVHD | Grade IV GVHD |
---|
Recipient | 1 | 7 | 6 | 0 |
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Percentage of Recipients Who Achieved Donor Chimerism at Day +14
Recipients who achieved engraftment with donor chimerism. Engraftment is defined as a target peripheral blood cluster of differentiation 4 (CD4) count of 100 cells/ul after induction therapy. (NCT00051311)
Timeframe: Day+14
Intervention | percentage of recipients (Number) |
---|
Recipient | 90 |
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Number of Recipients With Non-serious Adverse Events
Here is the number of recipients with non-serious adverse events assessed by the Common Toxicity Criteria version 2.0. A non-serious adverse event is any untoward medical occurrence. (NCT00051311)
Timeframe: Date treatment consent signed to date off study, approximately 58 months and 13 days.
Intervention | Participants (Count of Participants) |
---|
Recipient | 31 |
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Number of Recipients Who Developed Chronic Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis
Here is the number of recipients who developed chronic graft versus host disease (GVHD) following a combination of cyclosporine and a mini-dose methotrexate regimen for graft-versus-host disease (GVHD) prophylaxis. Grades I-IV chronic GVHD clinical staging was assessed by the Glucksberg Criteria. Grade I-IV chronic GVHD can occur in the skin, liver, and/or gut. Grade 1: rash < 25% body surface area (BSA), total bilirubin 2-3 mg/dl, and diarrhea 500-1000 ml/d. Grade 2: 25-50% BSA, total bilirubin 3-6 mg/dl, and diarrhea 1000-1500 ml/d. Grade 3: generalized erythroderma, total bilirubin 6-15 mg/dl, and diarrhea >1500 ml/d. Grade 4: desquamation and bullae, total bilirubin >15 mg/dl, and pain +/- ileus. (NCT00051311)
Timeframe: At least 100 days of follow-up post reduced-intensity stem cell transplantation (RIST)
Intervention | Participants (Count of Participants) |
---|
Recipient | 23 |
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Number of Recipients Evaluable Who Achieved Full Donor Chimerism at Day+100
Recipients who achieved engraftment with donor chimerism. Engraftment is defined as a target peripheral blood cluster of differentiation 4 (CD4) count of 100 cells/ul after induction therapy. (NCT00051311)
Timeframe: Day+100
Intervention | Participants (Count of Participants) |
---|
Recipient | 29 |
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Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00054665)
Timeframe: 43 months
Intervention | Participants (Number) |
---|
Part A: PS-341 Alone | 23 |
Part B: PS-341 & EPOCH | 44 |
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Clinical Response Rate
Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease (NCT00054665)
Timeframe: 18 weeks
Intervention | Participants (Number) |
---|
| Partial response | Complete response |
---|
Part A: PS-341 Alone | 1 | 0 |
,Part B: PS-341 & EPOCH | 7 | 8 |
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Minimal Residual Disease
The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section). (NCT00057811)
Timeframe: Not Provided
Intervention | percentage of samples analyzed (Number) |
---|
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 22 |
Group C (Chemotherapy, Monoclonal Antibody Therapy) | 70 |
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Response Rate
Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present.. (NCT00057811)
Timeframe: Up to 5 years
Intervention | percentage of participants analyzed (Number) |
---|
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 88 |
Group C (Chemotherapy, Monoclonal Antibody Therapy) | 83 |
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Grade ≥ 3 Stomatitis
The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences (NCT00057811)
Timeframe: Up to 1 year
Intervention | participants (Number) |
---|
| Incidence of grade ≥ 3 stomatitis | No incidence of grade ≥ 3 stomatitis |
---|
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 4 | 41 |
,Group C (Chemotherapy, Monoclonal Antibody Therapy) | 6 | 34 |
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Toxic Death
Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death. (NCT00057811)
Timeframe: Up to 1 year
Intervention | participants (Number) |
---|
| Toxic death | No toxic death |
---|
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 0 | 45 |
,Group C (Chemotherapy, Monoclonal Antibody Therapy) | 2 | 38 |
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Incidence of Adverse Experiences
Determine the incidence of adverse experiences, hematologic toxicity (WBC, hemoglobin, and platelet nadirs; and transfusion requirements), cardiac toxicity (incidence of left ventricular dysfunction and cardiomyopathy by echocardiography), and the development of human antimouse antibody/human anti-chimeric antibody in patients treated with this regimen. (NCT00058422)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
R-CHOP and Ibritumomab Tiuxetan (Zevalin) | 65 |
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Event-free Survival (EFS)
Percentage of EFS patients. This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause. To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05) and the lower critical values are based on testing the alternative hypothesis at 0.005 level. (NCT00059839)
Timeframe: From first enrollment up to 3 years.
Intervention | percentage of participants (Number) |
---|
Standard (APO) With Vincristine (Arm I) | 74 |
Consolidation (Includes Vinblastine) (Arm II) | 79 |
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Objective Response to Treatment
Objective response assessed using standard myeloma response criteria. Objective response is defined as a > 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks. (NCT00060346)
Timeframe: Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry
Intervention | proportion of participants (Number) |
---|
Rituximab + CHOP | 0.938 |
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Event-free Survival
Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method. (NCT00066469)
Timeframe: 2 years
Intervention | percentage of participants analyzed (Number) |
---|
Cyclophosphamide, Prednisone, Rituximab | 71 |
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Maximum Tolerated Dose (MTD) of Alemtuzumab
MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously up to 2 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT). (NCT00069238)
Timeframe: up to 2 cycles of therapy, approximately 42 days
Intervention | mg (Number) |
---|
All Participants | 30 |
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Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00069238)
Timeframe: 67 months and 9 days
Intervention | Participants (Count of Participants) |
---|
All Participants | 31 |
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Progression-free Survival
Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. (NCT00070018)
Timeframe: at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter
Intervention | percentage of participants (Number) |
---|
CHOP + RT + Zevalin | 89 |
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Percentage of Patients With Opportunistic Infection
Participants are susceptible to opportunistic infections such as bacterial, fungal, viral, protozoan infections and more due to immune suppression from chemotherapy drugs used to treat their disease. (NCT00074490)
Timeframe: First 100 days post-transplant
Intervention | percentage of participants (Number) |
---|
Arm IVD Cohort 1 (Th2 DLI) | 0 |
Arm IVD Cohort 3 (Multiple Th2 DLI) | 11.11 |
Arm IVA (12-day Expanded Th2 DLI) | 7.50 |
Arm IVB (6-day Expanded Th2 DLI) | 9.09 |
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 11.90 |
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Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD)
GVHD of the skin, liver and gut were graded on a scale of 1, 2, 3, and 4 (e.g. the grades are not added together) using the National Institutes of Health Consensus Criteria. Grade 1 is minimal GVHD, Grade 2 is moderate GVHD, Grade 3 is severe GVHD and Grade 4 is very severe GVHD. Grade 4 is a worse outcome than Grade 1. (NCT00074490)
Timeframe: first 100 days post-transplant
Intervention | percentage of patients (Number) |
---|
Arm IVD Cohort 1 (Th2 DLI) | 0 |
Arm IVD Cohort 3 (Multiple Th2 DLI) | 11.11 |
Arm IVA (12-day Expanded Th2 DLI) | 10 |
Arm IVB (6-day Expanded Th2 DLI) | 40.91 |
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 40.48 |
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Percentage of Patients to Receive T Cell Infusion
T cells administered by intravenous infusion after patient received transplant. (NCT00074490)
Timeframe: first 100 days post-transplant
Intervention | percentage of patients (Number) |
---|
Arm IVD Cohort 1 (Th2 DLI) | 100 |
Arm IVD Cohort 3 (Multiple Th2 DLI) | 100 |
Arm IVA (12-day Expanded Th2 DLI) | 100 |
Arm IVB (6-day Expanded Th2 DLI) | 100 |
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 100 |
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Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00074490)
Timeframe: Date treatment consent signed to date off study, approximately 5 years
Intervention | Participants (Count of Participants) |
---|
Arm IVD Cohort 1 (Th2 DLI) | 1 |
Arm IVD Cohort 3 (Multiple Th2 DLI) | 27 |
Arm IVA (12-day Expanded Th2 DLI) | 40 |
Arm IVB (6-day Expanded Th2 DLI) | 44 |
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 42 |
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Correlation of Early Marrow Response Status With MRD Negative.
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: Day 29
Intervention | participants (Number) |
---|
Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 182 |
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 72 |
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 198 |
Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 188 |
Prednisone, Capizzi Methotrexate <10 Years | 195 |
Prednisone, Capezzi Methotrexate >= 10 Years | 471 |
Prednisone and High Dose Methotrexate < 10 Yrs Old | 190 |
Prednisone and High Dose Methotrexate >=10 Years | 479 |
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 208 |
Prednisone, Capezzi Methotrexate (Down's Syndrome) | 25 |
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 3 |
Prednisone and High Dose Methotrexate (Non Randomly Assigned) | 18 |
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Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
Event Free Probability. (NCT00075725)
Timeframe: 5 years
Intervention | percentage of participants (Number) |
---|
Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 83.2 |
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 81.6 |
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 69.1 |
Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 91.2 |
Prednisone, Capizzi Methotrexate <10 Years | 82.1 |
Prednisone, Capezzi Methotrexate >= 10 Years | 73.5 |
Predisone and High Dose Methotrexate < 10 Yrs Old | 80.8 |
Prenisone and High Dose Methotrexate >=10 Years | 75.8 |
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 77.0 |
Prenisone, Capezzi Methotrexate (Down's Syndrome) | 61.8 |
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 44.4 |
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Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 Years
Intervention | percentage of participants (Number) |
---|
Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 79.2 |
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 69.9 |
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 65.6 |
Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 86.2 |
Prednisone, Capizzi Methotrexate <10 Years | 93.8 |
Prednisone, Capizzi Methotrexate >= 10 Years | 63.1 |
Predisone and High Dose Methotrexate < 10 Yrs Old | 84.2 |
Prednisone and High Dose Methotrexate >=10 Years | 73.6 |
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 74.6 |
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Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years
Intervention | percentage of participants (Number) |
---|
Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 66.5 |
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 43.3 |
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 35.4 |
Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 80 |
Prednisone, Capizzi Methotrexate <10 Years | 34.7 |
Prednisone, Capizzi Methotrexate >= 10 Years | 39 |
Prednisone and High Dose Methotrexate < 10 Yrs Old | 55 |
Prednisone and High Dose Methotrexate >=10 Years | 47.8 |
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 49.4 |
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Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years
Intervention | percentage of participants (Number) |
---|
Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 95.4 |
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 92.9 |
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 87.4 |
Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 98.1 |
Prednisone, Capizzi Methotrexate <10 Years | 93.3 |
Prednisone, Capizzi Methotrexate >= 10 Years | 90.2 |
Prednisone and High Dose Methotrexate < 10 Yrs Old | 94.5 |
Prednisone and High Dose Methotrexate >=10 Years | 90.5 |
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 91.6 |
Prednisone, Capizzi Methotrexate (Down's Syndrome) | 78.3 |
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 25.0 |
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Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).
Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years
Intervention | percentage of participants (Number) |
---|
Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 86.4 |
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 93.6 |
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 80.5 |
Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 93.1 |
Prednisone, Capizzi Methotrexate <10 Years | 86.5 |
Prednisone, Capezzi Methotrexate >= 10 Years | 83.4 |
Prednisone and High Dose Methotrexate < 10 Yrs Old | 84.2 |
Prednisone and High Dose Methotrexate >=10 Years | 83.9 |
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 85.3 |
Prednisone, Capezzi Methotrexate (Down's Syndrome) | 74.4 |
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 25 |
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Correlation of Early Marrow Response Status With MRD Positive.
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: Day 29
Intervention | participants (Number) |
---|
Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 26 |
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 12 |
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 43 |
Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 14 |
Prednisone, Capizzi Methotrexate <10 Years | 16 |
Prednisone, Capezzi Methotrexate >= 10 Years | 95 |
Prednisone and High Dose Methotrexate < 10 Yrs Old | 17 |
Prednisone and High Dose Methotrexate >=10 Years | 98 |
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 39 |
Prednisone, Capezzi Methotrexate (Down's Syndrome) | 3 |
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 3 |
Prednisone and High Dose Methotrexate (Non Randomly Assigned) | 3 |
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Overall Response Rate (ORR) Lasting at Least 4 Months
The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months. (NCT00088530)
Timeframe: approximately 24 months
Intervention | participants (Number) |
---|
Experimental Group | 12 |
Comparator Group | 6 |
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Overall Survival
The time between the date of randomization and the date of death due to any cause. (NCT00088530)
Timeframe: 18 months after 6 cycles of treatment; approximately 24 months
Intervention | Months (Median) |
---|
Experimental Group | 10.2 |
Comparator Group | 7.6 |
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Progression-Free Survival (PFS)
The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause. (NCT00088530)
Timeframe: 18 months after 6 cycles of treatment; approximately 24 months
Intervention | months (Median) |
---|
Experimental Group | 5.3 |
Comparator Group | 2.6 |
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Complete Response (CR) and Complete Response Unconfirmed (CRu)
Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT) (NCT00088530)
Timeframe: EOT; approximately 6 months
Intervention | percentage of randomized patients (Number) |
---|
| END OF TREATMENT: CR/CRu, n (%) | END OF STUDY: CR/CRu, n (%) |
---|
Comparator Group | 5.7 | 7.1 |
,Experimental Group | 20.0 | 24.3 |
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Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of >50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by >50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease. (NCT00088881)
Timeframe: Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin
Intervention | proportion of participants (Number) |
---|
Treatment | 0.89 |
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Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently > 1.5 cm in greatest diameter that has decreased by > 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by > 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). (NCT00088881)
Timeframe: Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin
Intervention | proportion of participants (Number) |
---|
Treatment | 0.87 |
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3-year Overall Survival (OS) Rate
Overall survival (OS) is defined as the time from step 1 registration to death of any cause. OS is censored at the date last known alive for cases that are alive. The 3-year OS rate is defined as the probability of patients remaining alive at 3 years. (NCT00088881)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.
Intervention | probability (Number) |
---|
Treatment | 0.98 |
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3-year Time to Treatment Failure (TTF) Rate
Time to treatment failure (TTF) is defined as the time from step 1 registration to disease progression or death. TTF is censored at last documented progression free for cases without progression. The 3-year TTF rate is defined as the probability of patients remaining free from treatment failure at 3 years. (NCT00088881)
Timeframe: Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.
Intervention | probability (Number) |
---|
Treatment | 0.92 |
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Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)
Clinical and radiographic response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded or the appearance of one or more new lesions. (NCT00089609)
Timeframe: up to 34 months
Intervention | Participants (Count of Participants) |
---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) |
---|
Main Cohort - Prostate Cancer | 2 | 19 | 11 | 1 |
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Time to Progression Using Bubley Criteria
Time to disease progression was based on the Prostate-Specific Antigen (PSA) Working Group 1 Criteria (Bubley Criteria) and standard Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. Per the criteria, investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period. (NCT00089609)
Timeframe: up to 40 months
Intervention | Months (Median) |
---|
Main Cohort - Prostate Cancer | 18.3 |
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Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00089609)
Timeframe: 37 months
Intervention | Participants (Count of Participants) |
---|
Main Cohort - Prostate Cancer | 60 |
Expansion Cohort - Prostate Cancer | 13 |
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Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level
"The assay utilized has no standard curve. Categorizing patients with ≥ 75% PSA decline in one group and < PSA decline in another group, every patient is their own control with comparison of CAEC at baseline vs. 6 weeks (after two cycles of treatment). Blood is drawn from the patient and a million viable mononuclear cells are counted and then it is determined how many CAECs are in the specimen. The cell count is then compared from baseline to post 2 cycles of treatment. Thus, significant increase is dependent upon this comparison and varies between patients." (NCT00089609)
Timeframe: Baseline and at 6 weeks (after two cycles of treatment)
Intervention | Participants (Count of Participants) |
---|
Main Cohort - Particpants With ≥75% PSA Decline | 14 |
Main Cohort - Particpants With <75% PSA Decline | 0 |
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Number of Participants Who Had a Prostate-specific Antigen (PSA) Response
PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression. (NCT00089609)
Timeframe: 21.6 months
Intervention | Participants (Count of Participants) |
---|
Main Cohort - Prostate Cancer | 52 |
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Number of Participants Who Died After a Follow Up of 34 Months Following Treatment
From on study date to date of death at 34 months. (NCT00089609)
Timeframe: 34 months
Intervention | Participants (Count of Participants) |
---|
Main Cohort - Prostate Cancer | 38 |
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Hearing Improvement
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average. (NCT00097448)
Timeframe: 2 months
Intervention | dB (Mean) |
---|
Oral Steroids | 30.7 |
IT Steroids | 28.7 |
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Rate of Minimal Residual Disease (MRD) < 0.01%
Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD < 0.01%. (NCT00098839)
Timeframe: At the end of Block 1 of re-induction therapy (day 36)
Intervention | Proportion of participants (Number) |
---|
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly | .195 |
Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly | .295 |
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Remission Re-induction (CR2) Rate
The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC >1000/uL and platelet count >100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or < 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count. (NCT00098839)
Timeframe: At the end of Block 1 of re-induction therapy (day 36)
Intervention | proportion of participants (Number) |
---|
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly | .646 |
Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly | .660 |
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Event-free Survival Rate
Proportion of patients who were event free at 4 months (NCT00098839)
Timeframe: At 4 months after enrollment
Intervention | Proportion of participants (Number) |
---|
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly | .604 |
Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly | .640 |
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Pharmacokinetics
Mean trough serum concentration measured before final dose of epratuzumab. (NCT00098839)
Timeframe: Up to day 36
Intervention | ug/mL (Mean) |
---|
Twice Weekly Dosing Schedule | 501 |
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Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses
Ejection fraction ( EF) refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction. Cardiology evaluation performed before second dose of pegylated liposomal doxorubicin or before entry onto trial, re-evaluation by cardiologist obtained in asymptomatic patients after chemotherapy cycle 4 and again after completion of therapy, and more often if symptomatic. Severe cardiac toxicity considered to be both Grade 3 and 4, and are graded according to NCI common toxicity criteria, CTCAE version 3.0. (NCT00101010)
Timeframe: Up to 24 weeks (8 cycles of 21 days)
Intervention | participants (Number) |
---|
Rituximab - Combination Chemotherapy | 10 |
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Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses
Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on International Workshop Criteria (IWG) for Tumor Response Criteria assessed with CT & FDG-PET scans at 4 cycles (12 weeks). CR defined as disappearance of all target and non-target lesions in liver & spleen, & all lymph node masses regressed to normal size. PR defined as ≥50% reduction in sum of product of diameters (SPD) for measured lymph nodes, splenic & liver lesions separately compared to baseline SPD. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. (NCT00101010)
Timeframe: Evaluation after 12 weeks (4 cycles of 21 days)
Intervention | Participants (Count of Participants) |
---|
| Complete Response (CR) | Uncomfirmed Complete Response (CRu) | Partial Response (PD) |
---|
Rituximab - Combination Chemotherapy | 47 | 8 | 14 |
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Rate of Immunological Response to Vaccination
"Immunological response to vaccination, as measured by in vitro testing of peripheral blood mononuclear cells (PBMCs) for interferon gamma secretion, delayed type hypersensitivity reaction (DTH) in response to irradiated autologous tumor cells, and lymphocyte accumulation at DTH and vaccine injection sites.~DTH Skin Testing was performed within 2 weeks prior to first vaccine, and again after fourth vaccine was administered. Aliquots containing 10^6 irradiated autologous tumor cells were re-suspended in 0.2 mL of Plasma-Lyte A and injected intradermally in the forearm and marked. 48 hours later, injection site was inspected for induration and erythema.~3mm punch biopsy of DTH injection site and vaccine site was obtained 48 hours after administration of irradiated tumor cells before and after the vaccine series. Vaccine site biopsy was obtained 2-5 days after the second vaccine had been given. Granulocytic and lymphocytic accumulation at these sites was graded by a pathologist." (NCT00101101)
Timeframe: 4 months per participant
Intervention | participants (Number) |
---|
| Clinical DTH | Increase in Interferon Gamma Secretion |
---|
Vaccine and Conventional Therapy | 0 | 15 |
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Disease Remission
A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease. (NCT00104299)
Timeframe: 6 months post-randomization
Intervention | Participants (Number) |
---|
Rituximab | 63 |
Control Group | 52 |
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Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization
"The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 6 months post-randomization
Intervention | participants (Number) |
---|
Rituximab | 62 |
Control Group | 51 |
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Number of Subjects Experiencing Serious Adverse Events
Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC. (NCT00104299)
Timeframe: Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)
Intervention | participants (Number) |
---|
| # Participants with at least one SAE | Blood and Lymphatic System Disorders | Cardiac Disorders | Eye Disorders | Gastrointestinal Disorders | General Disorders and Administration Site | Immune System Disorders | Infections and Infestations | Injury, Poisoning, and Procedural Complications | Investigations | Metabolism and Nutrition Disorders | Musculoskeletal and Connective Tissue Disorders | Neoplasms Benign, Malignant, and Unspecified | Nervous System Disorders | Pregnancy, Puerperium, and Perinatal Conditions | Psychiatric Disorders | Renal and Urinary Disorders | Respiratory, Thoracic, and Mediastinal Disorders | Vascular Disorders |
---|
Control Group | 37 | 5 | 2 | 1 | 1 | 3 | 2 | 12 | 0 | 0 | 2 | 3 | 2 | 0 | 0 | 1 | 3 | 8 | 7 |
,Rituximab | 42 | 4 | 2 | 1 | 4 | 5 | 2 | 12 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 4 | 8 | 1 |
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Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident (NCT00104299)
Timeframe: Through common close-out (defined as 18 months after the last participant is enrolled in the trial)
Intervention | participants (Number) |
---|
| Death | Grade 2 or Higher Leukopenia | Grade 2 or Higher Thrombocytopenia | Grade 3 or Higher Infections | Hemorrhagic Cystitis (Grade 2 or Lower) | Malignancy | Venous Thromboembolic Event | Hospitalization Resulting from the Disease | Cerebrovascular Accident (CVA) | Infusion Reactions Leading to Infusion Disc. |
---|
Control Group | 2 | 23 | 1 | 16 | 1 | 2 | 8 | 7 | 1 | 0 |
,Rituximab | 2 | 7 | 4 | 18 | 2 | 5 | 6 | 16 | 1 | 1 |
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The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
"Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization
Intervention | Days (Number) |
---|
| 25% Quartile (95%CI) | 50% Quartile (95%CI) | 75% Quartile (95%CI) |
---|
Control Group | 230 | NA | NA |
,Rituximab | 243 | NA | NA |
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The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing. (NCT00104299)
Timeframe: 18 months post-randomization
Intervention | Days (Number) |
---|
| 25% Quartile (95%CI) | 50% Quartile (95%CI) | 75% Quartile (95%CI) |
---|
Control Group | 168 | NA | NA |
,Rituximab | 246 | NA | NA |
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Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups
"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and completing taper of glucocorticoid by 6 months post-randomization.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization
Intervention | Days (Number) |
---|
| 25% Quartile (95%CI) | 50% Quartile (95%CI) | 75% Quartile (95%CI) |
---|
Control Group | 177 | 183 | 266 |
,Rituximab | 176 | 180 | 189 |
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Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups
"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization
Intervention | Days (Number) |
---|
| 25% Quartile (95%CI) | 50% Quartile (95%CI) | 75% Quartile (95%CI) |
---|
Control Group | 29 | 43 | 112 |
,Rituximab | 30 | 57 | 119 |
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Event-free Survival
Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment. (NCT00107198)
Timeframe: At 5 years
Intervention | Probability participants (Number) |
---|
Surgery or Combination Chemotherapy, With/Without Radiotherapy | 0.85 |
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Grade 3 or 4 Toxicity
(NCT00107198)
Timeframe: Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.
Intervention | Participants (Number) |
---|
Surgery or Combination Chemotherapy, With/Without Radiotherapy | 26 |
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Cure by Surgery Alone in Stage I Resected Patients
To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone. (NCT00107198)
Timeframe: At 2 years
Intervention | Probability participants (Number) |
---|
Surgery or Combination Chemotherapy, With/Without Radiotherapy | 0.82 |
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Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients
To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy. (NCT00107198)
Timeframe: At 5 years
Intervention | Probability participants (Number) |
---|
Surgery or Combination Chemotherapy, With/Without Radiotherapy | 0.89 |
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Failure-free Survival (FFS)
The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause. (NCT00107198)
Timeframe: At 5 years
Intervention | Probability participants (Number) |
---|
Surgery or Combination Chemotherapy, With/Without Radiotherapy | 0.91 |
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Response Rate (Complete, Complete Unconfirmed, and Partial)
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00107380)
Timeframe: 6 months
Intervention | participants (Number) |
---|
| Partial Response | Confirmed Response | Unconfirmed Response | No Response |
---|
R-CHOP + I-131-tositumomab | 21 | 41 | 10 | 12 |
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Progression-free Survival (PFS) at 2 Years
Clinical responses were evaluated according to International Workshop NHL criteria (Cheson et al, 1999). Progression disease was defined as if a (CR, CRU) was not achieved at a previous assessment, a 50% increase in the SPD of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Appearance of a new lesion/site. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Death due to disease without prior documentation of progression. PFS is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00107380)
Timeframe: 0-2 years
Intervention | percentage of participants (Number) |
---|
R-CHOP + I-131-tositumomab | 69 |
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Crohn's Disease Endoscopic Index of Severity (CDEIS)
Measure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0-30. A higher score indicates more severe mucosal inflammation. (NCT00109473)
Timeframe: Baseline and 12 weeks
Intervention | Scores on a scale (Mean) |
---|
| Baseline | Week 12 |
---|
Corticosteroid (CTX) | 8 | 6 |
,Growth Hormone Plus Corticosteroid (CTX) | 9 | 3 |
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Crohn's Disease Histologic Index of Severity (CDHIS)
The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16 (NCT00109473)
Timeframe: Baseline and 12 weeks
Intervention | scores on a scale (Number) |
---|
| Baseline | Week 12 |
---|
Corticosteroid (CTX) | 8 | 8 |
,Growth Hormone Plus Corticosteroid (CTX) | 7 | 6 |
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Fecal Calprotectin
Fecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease. (NCT00109473)
Timeframe: At 24 and 64 weeks
Intervention | micrograms per gram (microg/g) (Mean) |
---|
| Baseline | Week 12 |
---|
Corticosteroid (CTX) | 904 | 656 |
,Growth Hormone Plus Corticosteroid (CTX) | 863 | 868 |
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Pediatric Crohn's Disease Activity Index (PCDAI)
The PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30. (NCT00109473)
Timeframe: Baseline, 12 and 24 weeks
Intervention | Scores on a scale (Mean) |
---|
| Baseline | Week 12 | Week 24 |
---|
Corticosteroid (CTX) | 33 | 22 | 6 |
,Growth Hormone Plus Corticosteroid (CTX) | 32 | 8 | 9 |
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Serum IGF-1 (Insulin-like Growth Factor 1)z Score
"Elevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis.~The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean." (NCT00109473)
Timeframe: Baseline, 12 weeks, 24 weeks
Intervention | Z score (Mean) |
---|
| Baseline | Week 12 | Week 24 |
---|
Corticosteroid (CTX) | -0.7 | -1 | 3.8 |
,Growth Hormone Plus Corticosteroid (CTX) | -0.4 | 1.8 | 3.3 |
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Total Corticosteroid Use
The total corticosteroid use over 12 weeks between groups, using the unpaired t test. (NCT00109473)
Timeframe: 12 weeks
Intervention | mg (Mean) |
---|
| prednisone | budesonide |
---|
Cortecosteroids Alone | 28 | 8 |
,Growth Hormone Plus Cortecosteroid | 22 | 7 |
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IMPACT III Score
Health-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life. (NCT00109473)
Timeframe: Baseline, 12 weeks, 24 weeks
Intervention | Scores on a scale (Mean) |
---|
| Baseline | Week 12 |
---|
Corticosteroid (CTX) | 132 | 136 |
,Growth Hormone Plus Corticosteroid (CTX) | 134 | 143 |
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Height Velocity
"Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height.~It is calculated by measuring height at two points of time and then dividing the change by the amount of time." (NCT00109473)
Timeframe: Baseline, week 12, 24 and 48
Intervention | cm/year (Mean) |
---|
| Baseline | Week 12 | Week 24 |
---|
Corticosteroid (CTX) | 3 | 3 | 7 |
,Growth Hormone Plus Corticosteroid (CTX) | 5 | 8 | 9 |
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Continuous Complete Remission at 1 Year
A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study. (NCT00109837)
Timeframe: After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year
Intervention | participants (Number) |
---|
Treatment | 21 |
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Toxicity
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event (NCT00109837)
Timeframe: Patients were assessed for adverse events after the induction cycle
Intervention | Participants with a given type of AE (Number) |
---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | AST, SGOT (serum glut oxaloacetic transaminase) | Albumin, serum-low (hypoalbuminemia) | Alkaline phosphatase | Anorexia | Ascites (non-malignant) | Bilirubin (hyperbilirubinemia) | Calcium, serum-low (hypocalcemia) | Cholecystitis | Cholesterol, serum-high (hypercholesterolemia) | Coagulation-Other (Specify) | Colitis, infectious (e.g., Clostridium difficile) | Constipation | DIC (disseminated intravascular coagulation) | Death not assoc with CTCAE term-Multi-organ fail | Edema: limb | Fatigue (asthenia, lethargy, malaise) | Febrile neutropenia | Fever (in the abs of neutropenia) | Fibrinogen | Glucose, serum-high (hyperglycemia) | Glucose, serum-low (hypoglycemia) | Hemoglobin | Hypertension | Hypotension | Hypoxia | Ileus, GI (functional obstruction of bowel) | Infec(doc clin or mibio) w/ Gr 3/4 neut-Anal | Infec(doc clin or mibio) w/ Gr 3/4 neut-Bladder | Infec(doc clin or mibio) w/ Gr 3/4 neut-Blood | Infec(doc clin or mibio) w/ Gr 3/4 neut-Bronchus | IInfec(doc clin or mibio) w/ Gr 3/4 neut-Catheter | Infec(doc clin or mibio) w/ Gr 3/4 neut-Eye NOS | Infec(doc clin or mibio) w/ Gr 3/4 neut-Lung | Infec(doc clin or mibio) w/ Gr 3/4 neut-Nose | Infec(doc clin or mibio) w/ Gr 3/4 neut-Pharynx | Infec(doc clin or mibio) w/ Gr 3/4 neut-Ur tract | Infec with nor ANC or Gr 1/2 neut-Lung (pneumonia) | Infection-Other (Specify) | Leukocytes (total WBC) | Lipase | Liver dysfunction/failure (clinical) | Lymphopenia | Magnesium, serum-high (hypermagnesemia) | Mucositis/stomatitis (clinical exam) - Oral cavity | Mucositis/stomatitis (funct/symp) - Oral cavity | Mucositis/stomatitis (func/symp) - Pharynx | Muscle weak,gen spec area-Whole body | Nausea | Neuropathy: motor | Neutrophils/granulocytes (ANC/AGC) | Pain - Abdomen NOS | Pain - Bone | Pain - Neck | Pancreatic endocrine: glucose intolerance | Pancreatitis | Phosphate, serum-low (hypophosphatemia) | Platelets | Potassium, serum-high (hyperkalemia) | Potassium, serum-low (hypokalemia) | Rash/desquamation | Renal failure | Sodium, serum-low (hyponatremia) | Thrombosis/thrombus/embolism | Thrombotic microangiopathy | Triglyceride, serum-high (hypertriglyceridemia) | Tumor lysis syndrome | Typhlitis (cecal inflammation) | Uric acid, serum-high (hyperuricemia) | Vomiting |
---|
Induction | 17 | 13 | 3 | 2 | 2 | 1 | 6 | 7 | 1 | 2 | 1 | 1 | 1 | 2 | 1 | 1 | 3 | 18 | 1 | 11 | 16 | 1 | 33 | 2 | 3 | 2 | 1 | 1 | 1 | 11 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 2 | 1 | 43 | 1 | 2 | 19 | 1 | 2 | 1 | 1 | 2 | 3 | 1 | 47 | 1 | 1 | 1 | 1 | 1 | 1 | 44 | 1 | 7 | 1 | 2 | 6 | 1 | 2 | 1 | 5 | 1 | 1 | 1 |
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Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline
PSA decline will be reported on all patients and will be defined as a decrease in PSA value by >= 50% for two successive evaluations at least 4 weeks apart. The reference PSA value for these declines should be measured within 2 weeks before starting therapy. (NCT00110214)
Timeframe: Duration of study (up to 5 years)
Intervention | percentage of participants (Number) |
---|
Docetaxel + Placebo | 57.9 |
Docetaxel + Bevacizumab | 69.5 |
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Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities
"The National Cancer Institute (NCI) Criteria for Adverse Events(CTCAE) Version 3.0 was used to evaluate toxicity. These events were considered at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death" (NCT00110214)
Timeframe: During treatment (up to 2 years)
Intervention | percentage of participants (Number) |
---|
Docetaxel + Placebo | 56.2 |
Docetaxel + Bevacizumab | 75.4 |
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Progression-free Survival (PFS)
"PFS was defined as the data of randomization to date of progression or death due to any cause, whichever occurs first. PFS was estimated using the Kaplan Meier method.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions" (NCT00110214)
Timeframe: Duration of study (up to 5 years)
Intervention | months (Median) |
---|
Docetaxel + Placebo | 7.5 |
Docetaxel + Bevacizumab | 9.9 |
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Overall Survival
Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method. (NCT00110214)
Timeframe: Duration of study (up to 5 years)
Intervention | months (Median) |
---|
Docetaxel + Placebo | 21.5 |
Docetaxel + Bevacizumab | 22.6 |
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Progression-Free Survival Rate at 2 and 5 Years
"Progression-free survival (PFS) is defined as the time from randomization to progression, relapse, or death from any cause, whichever occurred first. Progression (PD) or Relapse>~≥ 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders.>~Appearance of any new lesion during or after completion of therapy.>~PET+ is not a criterion for progressive disease. Patients only with PET+ findings must have evidence of progression on CT or biopsy proven.>~The PFS rate (percentage of participants who are alive and progression-free) at 2 and 5 years Kaplan Meier estimates and 95% Confidence Intervals are reported below." (NCT00118209)
Timeframe: Up to 5 years post-registration
Intervention | percentage of participants (Number) |
---|
| 2-year PFS | 5-year PFS |
---|
Arm A - R-CHOP | 75.5 | 66.0 |
,Arm B - DA-EPOCH-R | 78.9 | 68.0 |
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Overall Survival Rate at 2 and 5 Years
Overall survival is defined as the time from randomization to death due to any cause. The overall survival (OS) rate (percentage of participants who are still alive) at 2 and 5 years Kaplan Meier estimates and 95% confidence intervals are reported below. (NCT00118209)
Timeframe: Up to 5 years post-registration
Intervention | percentage of participants (Number) |
---|
| 2-year OS rate | 5-year OS rate |
---|
Arm A - R-CHOP | 85.7 | 78.5 |
,Arm B - DA-EPOCH-R | 86.5 | 77.5 |
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Response Rate
The overall response rate is defined as the percentage of participants with a response (Complete Response or Partial Response) (NCT00118209)
Timeframe: Up to 5 years post-registration
Intervention | percentage of participants (Number) |
---|
Arm B - DA-EPOCH-R | 86.7 |
Arm A - R-CHOP | 88.0 |
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OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
MMAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or 7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL. (NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Intervention | participants (Number) |
---|
| Leukocytes | Neutrophils+bands (absolute) | Lymphocytes (absolute) | Monocytes (absolute) | Basophils (absolute) | Eosinophils (absolute) |
---|
Abatacept | 18 | 6 | 32 | 0 | 0 | 3 |
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OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx. (NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Intervention | participants (Number) |
---|
| ALP | AST | ALT | GGT | Bilirubin (total) | BUN | Creatinine |
---|
Abatacept | 0 | 3 | 4 | 6 | 0 | 3 | 7 |
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OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides
MAs are laboratory measurements marked as abnormal, as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx ULN. If pre-Rx >ULN, then >2.0* pre-Rx or 2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx. (NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Intervention | participants (Number) |
---|
| Glucose (serum) (n = 110) | Glucose (fasting serum) (n = 55) | Albumin (n = 110) | Cholesterol (total) (n = 15) | Triglycerides (n = 10) | Triglycerides (fasting) (n = 9) |
---|
Abatacept | 21 | 6 | 6 | 0 | 0 | 0 |
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OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total)
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95x LLN or >1.05x ULN (if pre-RxULN. If pre-Rx >ULN, then >1.05x pre-Rx or 1.1xULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.1xpre-Rx or 1.2xULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.25x pre-Rx or NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Intervention | participants (Number) |
---|
| Sodium (serum) | Potassium (serum) | Chloride (serum) | Calcium (total) | Protein (total) |
---|
Abatacept | 0 | 7 | 0 | 1 | 4 |
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OL; Number of Participants With Significant AEs of Special Interest
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs of particular importance were associated with the use of immunomodulatory agents. Number of participants with infections, malignant Neoplasms, pre-specified autoimmune disorders, acute-infusional AEs and peri-infusional AEs were recorded. (NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Intervention | participants (Number) |
---|
| Infections | Malignant neoplasms | Pre-specified autoimmune disorders | Acute-infusional AEs | Peri-infusional AEs |
---|
Abatacept | 82 | 1 | 4 | 3 | 15 |
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OL; Number of Participants With MAs in Urinalysis
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, red blood cells (RBC), white blood cells (WBC): >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; Glomerular filtration rate (GFR): <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol. (NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Intervention | participants (Number) |
---|
| Protein (n = 110) | Glucose (n= 110) | Blood (n = 110) | Leukocyte esterase (n = 104) | WBC (n = 105) | RBC (n = 101) | GFR (n = 110) | Protein/creatinine ratio (n = 109) |
---|
Abatacept | 12 | 0 | 41 | 28 | 57 | 35 | 9 | 10 |
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OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment
MSD technology was used to detect antibodies specific for CTLA4-T and for abatacept. (NCT00119678)
Timeframe: After the first dose of open-label period
Intervention | participants (Number) |
---|
Abatacept | 30 |
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DB; Number of Participants With a New SLE Flare During the Initial 6 Months
SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29). (NCT00119678)
Timeframe: From start of corticosteroid taper to 6 months.
Intervention | Participants (Number) |
---|
Abatacept | 75 |
Placebo | 36 |
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DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment
Electrochemiluminescence (ECL) immunoassay based on Meso Scale Discovery (MSD) technology was used to detect antibodies specific for CTLA4-T and for abatacept. (NCT00119678)
Timeframe: From Day 1 to Day 365
Intervention | participants (Number) |
---|
Abatacept | 2 |
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Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare
SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved. Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29). (NCT00119678)
Timeframe: From start of corticosteroid taper to Day 365
Intervention | Participants (Number) |
---|
Abatacept | 94 |
Placebo | 47 |
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DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline
SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. (NCT00119678)
Timeframe: From start of study drug treatment to Day 365
Intervention | participants (Number) |
---|
| No change | Increased 1 | Increased >1 |
---|
Abatacept | 101 | 3 | 3 |
,Placebo | 44 | 2 | 1 |
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DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* LLN or >1.5* ULN (or, if pre-Rx value NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier
Intervention | participants (Number) |
---|
| Hemoglobin (n = 120, 58) | Hematocrit (n=120, 58) | Erythrocytes (n=120, 58) | Platelet count (n= 118, 58) |
---|
Abatacept | 1 | 1 | 1 | 3 |
,Placebo | 1 | 1 | 1 | 0 |
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DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or 7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL. (NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier
Intervention | participants (Number) |
---|
| Leukocytes (n = 120, 58) | Neutrophils+bands (absolute) (n = 120, 59) | Lymphocytes (absolute) (n = 120, 59) | Monocytes (absolute) (n = 120, 59) | Basophils (absolute) (n = 120, 59) | Eosinophils (absolute) (n = 120, 59) |
---|
Abatacept | 26 | 8 | 46 | 1 | 0 | 6 |
,Placebo | 11 | 2 | 30 | 0 | 0 | 2 |
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DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dl or >220 mg/dl; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx ULN. If pre-Rx >ULN, then >2.0* pre-Rx or 2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx. (NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier
Intervention | participants (Number) |
---|
| Glucose (serum) (n = 120, 59) | Glucose, fasting (n = 77, 37) | Albumin (n = 120, 59) | Cholesterol (total) (n = 118, 58) | Triglycerides (n = 75, 36) | Triglycerides (fasting) (n = 64, 34) |
---|
Abatacept | 27 | 5 | 4 | 0 | 0 | 0 |
,Placebo | 10 | 1 | 1 | 0 | 0 | 0 |
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DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total)
MAs are laboratory measurements marked as abnormal as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95* LLN or >1.05* ULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.05* pre-Rx or 1.1* ULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.1* pre-Rx or 1.2* ULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.25* pre-Rx or NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier
Intervention | participants (Number) |
---|
| Sodium (serum) (n = 120, 59) | Potassium (serum) (n = 120, 59) | Chloride (serum) (n = 120, 59) | Calcium (total) (n= 120, 59) | Protein (total) (n = 120, 59) |
---|
Abatacept | 1 | 1 | 0 | 0 | 1 |
,Placebo | 0 | 1 | 0 | 0 | 0 |
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DB; Number of Participants With MAs in Urinalysis
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, RBC, WBC: >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* pre-Rx, or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; GFR: <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol. (NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier
Intervention | participants (Number) |
---|
| Protein (n = 120, 58) | Glucose (n = 120, 58) | Blood (n = 120, 58) | Leukocyte esterase (n = 107, 51) | RBC (n = 107, 55) | WBC (n = 115, 54) | Protein, 24 hours (n = 89, 40) | GFR (n = 120, 59) | Protein/creatinine ratio (n = 119, 58) |
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Abatacept | 15 | 1 | 39 | 23 | 38 | 61 | 4 | 7 | 11 |
,Placebo | 9 | 2 | 18 | 8 | 16 | 26 | 1 | 4 | 4 |
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DB; Number of Participants With Significant AEs of Special Interest
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of special interest were associated with the use of immunomodulatory agents. Number of participants with infections, malignant neoplasms, pre-specified autoimmune disorders, acute infusional AEs and peri-infusional AEs were recorded. (NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier
Intervention | participants (Number) |
---|
| Infections | Malignant neoplasms | Pre-specified autoimmune disorders | Acute-infusional AEs | Peri-infusional AEs |
---|
Abatacept | 71 | 1 | 4 | 5 | 27 |
,Placebo | 38 | 0 | 2 | 5 | 13 |
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DB; Total Number of New SLE Flares Each Participant Experienced
SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29). (NCT00119678)
Timeframe: From start of corticosteroid taper to Day 365
Intervention | Participants (Number) |
---|
| None | 1 | 2 | >=3 | Inception treatment failure |
---|
Abatacept | 24 | 47 | 21 | 17 | 9 |
,Placebo | 10 | 21 | 10 | 11 | 5 |
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DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx. (NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier
Intervention | participants (Number) |
---|
| ALP (n = 120, 59) | AST (n = 120, 59) | ALT (n = 120, 59) | GGT (n = 120, 59) | Bilirubin (total) (n = 120, 59) | BUN (n = 120, 59) | Creatinine (n = 120, 59) |
---|
Abatacept | 2 | 3 | 2 | 3 | 0 | 4 | 6 |
,Placebo | 0 | 0 | 0 | 3 | 0 | 3 | 4 |
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OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count
MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* lower limit of normal (LLN) or >1.5* upper limit of normal (ULN) (or, if pre-Rx value NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period
Intervention | participants (Number) |
---|
| Hemoglobin (n = 110) | Hematocrit (n = 110) | Erythrocytes (n = 110) | Platelet count (n = 108) |
---|
Abatacept | 2 | 3 | 2 | 3 |
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Progression-free Survival at 1 Year
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00121199)
Timeframe: 0-1 year
Intervention | percentage of participants (Number) |
---|
CHOP + Rituximab + Bevacizumab | 77 |
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Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00121199)
Timeframe: After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years.
Intervention | participants (Number) |
---|
| Complete Response (CR) | Partial Response (PR) | Unconfirmed Complete Response (UCR) | Unconfirmed Partial Response (UPR) | No Response |
---|
CHOP + Rituximab + Bevacizumab | 22 | 20 | 6 | 1 | 15 |
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Progression-free Survival at 2 Year
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00121199)
Timeframe: 0-2 years
Intervention | percentage of participants (Number) |
---|
CHOP + Rituximab + Bevacizumab | 69 |
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Number of Participants With Progression-Free Survival
The primary objective of this study is to determine whether adding early chemotherapy based on docetaxel plus prednisone compared to standard of care alone reduces disease progression as evidenced by detectable PSA in high risk patients with prostate cancer who have undergone radical prostatectomy. (NCT00132301)
Timeframe: Up to 100 months (centralized follow-up)
Intervention | Participants (Count of Participants) |
---|
Arm 1: Docetaxel and Prednisone | 66 |
Arm 2: Standard of Care | 84 |
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Percentage of Participants Experiencing Grade 3-5 Toxicity
Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria). (NCT00133991)
Timeframe: Up to 2 years
Intervention | Participants (Count of Participants) |
---|
R-CVP + HiCy | 21 |
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Event-free Survival
Percentage of participants alive without relapse at 1 year and 3 years. (NCT00133991)
Timeframe: 1 year and 3 years
Intervention | percentage of participants (Number) |
---|
| 1 year | 3 years |
---|
R-CVP + HiCy | 52 | 52 |
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Overall Response Rate
Number of participants who have a complete or partial remission (2007 International Working Group criteria). (NCT00133991)
Timeframe: Up to 3 months
Intervention | Participants (Count of Participants) |
---|
| Complete remission | Partial remission |
---|
R-CVP + HiCy | 11 | 2 |
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Overall Survival
Percentage of participants alive at 1 year and at 3 years. (NCT00133991)
Timeframe: 1 year and 3 years
Intervention | percentage of participants (Number) |
---|
| 1 year | 3 years |
---|
R-CVP + HiCy | 57 | 57 |
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Relapse Pattern
Percentage of participants experiencing central nervous system (CNS) and systemic relapse. (NCT00133991)
Timeframe: Up to 6 months
Intervention | Participants (Count of Participants) |
---|
| Systemic relapse only | Systemic and CNS relapse |
---|
R-CVP + HiCy | 3 | 2 |
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Compare Qualitative and Quantitative Toxicity Between the Two Study Arms
Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT00134056)
Timeframe: Assessed every 3 weeks up to 52 weeks
Intervention | Participants (Number) |
---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | AST, SGOT | Adult respiratory distress syndrome (ARDS) | Albumin, serum-low (hypoalbuminemia) | Alkaline phosphatase | Allergic reaction/hypersensitivity | Allergy/Immunology-Other (Specify) | Amylase | Anorexia | Arthritis (non-septic) | Aspiration | Auditory/Ear-Other (Specify) | Bilirubin (hyperbilirubinemia) | Blood/Bone Marrow-Other (Specify) | CNS cerebrovascular ischemia | CPK (creatine phosphokinase) | Calcium, serum-low (hypocalcemia) | Cardiac Arrhythmia-Other (Specify) | Cardiac General-Other (Specify) | Cardiac troponin I (cTnI) | Cardiac troponin T (cTnT) | Cardiac-ischemia/infarction | Conduction abnormality NOS | Confusion | Constipation | Cough | Creatinine | Dehydration | Diarrhea | Dizziness | Dry mouth/salivary gland (xerostomia) | Dysphagia (difficulty swallowing) | Dyspnea (shortness of breath) | Edema: head and neck | Edema: limb | Edema: trunk/genital | Erectile dysfunction | Esophagitis | Fatigue (asthenia, lethargy, malaise) | Febrile neutropenia | Fever in absence of neutropenia, ANC lt1.0x10e9/L | Fracture | Glucose, serum-high (hyperglycemia) | Glucose, serum-low (hypoglycemia) | Heartburn/dyspepsia | Hemoglobin | Hemolysis | Hemorrhage, Respiratory tract NOS | Hemorrhage, GI - Rectum | Hemorrhage, GI - Stomach | Hemorrhage, GI - Upper GI NOS | Hemorrhage, GU - Bladder | Hemorrhage/Bleeding-Other (Specify) | Hemorrhoids | Hot flashes/flushes | Hypertension | Hypotension | Hypoxia | INR (of prothrombin time) | Induration/fibrosis (skin and subcutaneous tissue) | Inf (clin/microbio) w/Gr 3-4 neuts - Bladder | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus | Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | Inf (clin/microbio) w/Gr 3-4 neuts - Nerve-periph | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | Inf w/normal ANC or Gr 1-2 neutrophils - Blood | Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus | Inf w/normal ANC or Gr 1-2 neutrophils - Colon | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | Inf w/normal ANC or Gr 1-2 neutrophils - Muscle | Inf w/normal ANC or Gr 1-2 neutrophils - Scrotum | Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | Inf w/normal ANC or Gr 1-2 neutrophils - Stomach | Inf w/normal ANC or Gr 1-2 neutrophils - Trachea | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | Inf w/normal ANC or Gr 1-2 neutrophils - Ungual | Inf w/unknown ANC - Middle ear (otitis media) | Inf w/unknown ANC - Upper aerodigestive NOS | Infection with unknown ANC - Blood | Infection with unknown ANC - Lung (pneumonia) | Infection with unknown ANC - Upper airway NOS | Infection with unknown ANC - Urinary tract NOS | Infection-Other (Specify) | Insomnia | Left ventricular diastolic dysfunction | Left ventricular systolic dysfunction | Leukocytes (total WBC) | Lipase | Lymphopenia | Magnesium, serum-high (hypermagnesemia) | Metabolic/Laboratory-Other (Specify) | Mood alteration - agitation | Mood alteration - depression | Mucositis/stomatitis (clinical exam) - Oral cavity | Mucositis/stomatitis (clinical exam) - Pharynx | Mucositis/stomatitis (clinical exam) - Stomach | Mucositis/stomatitis (functional/symp) - Esophagus | Mucositis/stomatitis (functional/symp) - Oral cav | Mucositis/stomatitis (functional/symp) - Pharynx | Mucositis/stomatitis (functional/symp) - Rectum | Muscle weakness, not d/t neuropathy - Extrem-lower | Muscle weakness, not d/t neuropathy - body/general | Myocarditis | Nail changes | Nasal cavity/paranasal sinus reactions | Nausea | Neuropathy: motor | Neuropathy: sensory | Neutrophils/granulocytes (ANC/AGC) | Opportunistic inf associated w/gt=Gr 2 lymphopenia | PTT (Partial thromboplastin time) | Pain - Abdomen NOS | Pain - Back | Pain - Bone | Pain - Chest wall | Pain - Chest/thorax NOS | Pain - Extremity-limb | Pain - Joint | Pain - Muscle | Pain - Neuralgia/peripheral nerve | Pain - Pelvis | Pain-Other (Specify) | Phosphate, serum-low (hypophosphatemia) | Platelets | Pneumonitis/pulmonary infiltrates | Pneumothorax | Potassium, serum-high (hyperkalemia) | Potassium, serum-low (hypokalemia) | Pulmonary/Upper Respiratory-Other (Specify) | Rash: hand-foot skin reaction | Renal failure | Renal/Genitourinary-Other (Specify) | Right ventricular dysfunction (cor pulmonale) | SVT and nodal arrhythmia - Atrial fibrillation | SVT and nodal arrhythmia - Atrial flutter | SVT and nodal arrhythmia - Sinus tachycardia | Sodium, serum-low (hyponatremia) | Somnolence/depressed level of consciousness | Speech impairment (e.g., dysphasia or aphasia) | Sudden death | Syncope (fainting) | Thrombosis/embolism (vascular access-related) | Thrombosis/thrombus/embolism | Vasovagal episode | Vomiting | Watery eye (epiphora, tearing) | Weight gain |
---|
Arm I: Placebo | 2 | 2 | 3 | 3 | 4 | 5 | 0 | 0 | 5 | 1 | 0 | 1 | 0 | 2 | 0 | 2 | 7 | 2 | 1 | 2 | 1 | 2 | 1 | 1 | 3 | 1 | 4 | 9 | 10 | 3 | 1 | 1 | 38 | 0 | 16 | 1 | 2 | 0 | 60 | 8 | 1 | 1 | 20 | 1 | 1 | 47 | 1 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 2 | 2 | 9 | 10 | 3 | 1 | 1 | 2 | 0 | 0 | 11 | 1 | 1 | 1 | 4 | 0 | 2 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 4 | 1 | 1 | 3 | 101 | 0 | 30 | 1 | 0 | 1 | 1 | 2 | 1 | 1 | 0 | 3 | 0 | 0 | 2 | 11 | 1 | 0 | 2 | 11 | 7 | 10 | 140 | 1 | 1 | 4 | 1 | 5 | 0 | 1 | 1 | 2 | 8 | 1 | 0 | 0 | 3 | 7 | 7 | 1 | 2 | 11 | 0 | 1 | 4 | 1 | 0 | 3 | 1 | 0 | 8 | 1 | 0 | 2 | 3 | 0 | 9 | 0 | 8 | 0 | 0 |
,Arm II: Atrasentan | 2 | 4 | 0 | 0 | 6 | 6 | 1 | 1 | 5 | 0 | 1 | 0 | 1 | 2 | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 4 | 2 | 1 | 8 | 7 | 1 | 0 | 1 | 17 | 1 | 2 | 0 | 0 | 1 | 40 | 20 | 2 | 0 | 24 | 0 | 1 | 22 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 2 | 1 | 2 | 3 | 3 | 1 | 0 | 2 | 0 | 1 | 1 | 6 | 0 | 2 | 0 | 3 | 2 | 1 | 1 | 0 | 5 | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 3 | 1 | 0 | 2 | 98 | 1 | 32 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 1 | 3 | 1 | 1 | 1 | 8 | 0 | 1 | 0 | 5 | 6 | 11 | 154 | 1 | 0 | 0 | 2 | 8 | 1 | 0 | 1 | 2 | 3 | 1 | 1 | 1 | 0 | 4 | 0 | 0 | 1 | 2 | 1 | 0 | 2 | 0 | 1 | 2 | 1 | 1 | 3 | 0 | 1 | 0 | 1 | 1 | 11 | 2 | 7 | 1 | 1 |
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Number of Patients With a Change in Functional Status
Functional status will be measured with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index. The FACT-P also addresses four general domains of QOL (physical, functional, emotional, and social well-being subscales) as well as symptom concerns associated with prostate cancer and its treatment. (NCT00134056)
Timeframe: up to 18 months study period
Intervention | Participants (Count of Participants) |
---|
Arm I: Placebo | 118 |
Arm II: Atrasentan Hydrochloride | 139 |
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Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)
"Pain palliation is the proportion of patients showing a two-point reduction in the Worst Pain score (WPS) maintained for two consecutive assessments with no increase in analgesic use. Increase in analgesic use is defined as an increase in Analgesic code Level to 2 (weak opioid) or 3 (strong opioid). Patients will be classified as pain palliated or not palliated. Patients with a WPS of 0 will be defined as stable if their WPS remains 0 for Weeks 7 and 10 with no increase in analgesic use, but they will not be categorized as responders. Pain palliation response is measured by BPI short form that has the following: yes/no question about pain today; 4 pain rating questions (worst pain, least pain, average pain, and current pain); pain medications and pain relief; 7 items addressing effect of pain on functioning. For patients who continue to receive treatment beyond 12 treatment cycles, the Worst Pain item is measured by Pain Medication Log and Pain Assessment" (NCT00134056)
Timeframe: up to 18 months study period
Intervention | Participants (Count of Participants) |
---|
Arm I: Placebo | 75 |
Arm II: Atrasentan | 83 |
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Compare Pain Progression Between the Two Study Arms.
Pain progression is defined as patients reporting an increase of at least two Worst Pain points, maintained for at least two consecutive assessments, increase to Level 3 (strong opioid) on the Pain Medication Log Analgesic Code for patients receiving Level 2 (weak opioid) analgesics at randomization, or an increase to Level 2 or 3 analgesics for patients receiving Level 0 or 1 analgesics at randomization. (NCT00134056)
Timeframe: Up to 52 weeks
Intervention | Participants (Count of Participants) |
---|
Arm I: Placebo | 59 |
Arm II: Atrasentan | 41 |
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Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.
Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients without progression are censored at date of last contact. Disease progression is defined by confirmed bone disease progression, soft tissue or pain progression. (NCT00134056)
Timeframe: Up to 7 years after study opens
Intervention | months (Median) |
---|
Arm I: Placebo | 9.1 |
Arm II: Atrasentan | 9.2 |
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Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.
PSA Partial Response: Greater than or equal to 50% reduction in baseline PSA. There must be no evidence of soft tissue progression, or confirmed none disease progression, or pain progression. (NCT00134056)
Timeframe: Up to 7 years after study opens
Intervention | Participants (Count of Participants) |
---|
Arm I: Placebo | 243 |
Arm II: Atrasentan | 249 |
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Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.
Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact. (NCT00134056)
Timeframe: Up to 7 years after study opens
Intervention | months (Median) |
---|
Arm I: Placebo | 17.6 |
Arm II: Atrasentan | 17.8 |
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Number of Participants Who Qualify for Random Assignment
(NCT00135694)
Timeframe: One to two years post-transplantation
Intervention | participants (Number) |
---|
All Enrolled | 95 |
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Total Immunosuppression From Month 21 to Month 24 Post-randomization
Daily immunosuppression score in units per day averaged over the 3-month period from Month 21 to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.) (NCT00135694)
Timeframe: Month 21 to Month 24 post-randomization
Intervention | units per day (Mean) |
---|
Randomized to Immunosuppression Withdrawal | 2.8 |
Randomized to Immunosuppression Maintenance | 3.7 |
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Immunosuppression-free Duration
Time (in days) from withdrawing off of all immunosuppressive drugs to re-starting immunosuppression or study termination/completion. (NCT00135694)
Timeframe: Discontinuation of all immunosuppression to end of trial participation or to time of restarting immunosuppression, whichever came first, assessed up to two years
Intervention | Days (Mean) |
---|
Randomized to Immunosuppression Withdrawal | 555.2 |
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Number of Participants Experiencing Graft Loss or Death
Number of participants with graft loss or death. Graft loss is defined as subject death or re-transplantation. (NCT00135694)
Timeframe: Randomization to 2 years post-randomization.
Intervention | participants (Number) |
---|
Randomized to Immunosuppression Withdrawal | 1 |
Randomized to Immunosuppression Maintenance | 0 |
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Total Burden of Immunosuppression From Random Assignment to Month 24
Total immunosuppression score in units taken as the sum of units per day over the 2-year period from randomization to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.). (NCT00135694)
Timeframe: Randomization to Month 24 post-randomization
Intervention | units (Mean) |
---|
Randomized to Immunosuppression Withdrawal | 2198.5 |
Randomized to Immunosuppression Maintenance | 2708.4 |
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Number of Participants With Clinical Complications Usually Attributed to Immunosuppression
This is a composite endpoint comprising clinical complications related to immunosuppression and is defined as the occurrence of any of the following: death or graft loss, grade 4 secondary malignancy (graded by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), grade 4 opportunistic infection (graded by CTCAE version 3.0), stage 3 or higher fibrosis, or decrease in renal function. Decrease in renal function is defined as: a) the estimated glomerular filtration rate (eGFR) using creatinine obtained prior to and closest to randomization will be considered the baseline and will be compared to the eGFR using creatinine obtained at 24 months +/- 3 months after randomization; b) for those with a baseline eGFR 30-90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR; c) for those with a baseline eGFR greater than 90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR and a decrease in eGFR to less than 90 ml per min per 1.73 meter-squared. (NCT00135694)
Timeframe: Randomization to 2 years post-randomization
Intervention | participants (Number) |
---|
Randomized to Immunosuppression Withdrawal | 12 |
Randomized to Immunosuppression Maintenance | 4 |
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Number of Participants Who Successfully Stop Taking Immunosuppression for at Least 6 Months
(NCT00135694)
Timeframe: Randomization until study completion or participant termination (up to six years post-transplant)
Intervention | participants (Number) |
---|
Randomized to Immunosuppression Withdrawal | 12 |
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Relationship of Inhibition of DNA Synthesis and Clinical Response
Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis. (NCT00136084)
Timeframe: Measurements were assessed in Induction I chemotherapy
Intervention | Percent inhibition of DNA Synthesis (Mean) |
---|
Overall | 66.7 |
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To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy
Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment. (NCT00136084)
Timeframe: Measurements were assessed in Induction I chemotherapy
Intervention | Percent Inhibition of DNA Synthesis (Mean) |
---|
Arm 1: (HDAC) | 60.6 |
Arm 2:(LDAC) | 72.8 |
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To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy
Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up (NCT00136084)
Timeframe: Five Year
Intervention | Percentage of Participants (Number) |
---|
Overall | 62.4 |
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Minimal Residual Disease (MRD).
Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (>=0.1%). (NCT00136084)
Timeframe: Day 22 MRD measurement
Intervention | participants (Number) |
---|
| MRD Positive | MRD Negative |
---|
Arm 1: (HDAC) | 31 | 68 |
,Arm 2:(LDAC) | 43 | 63 |
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Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)
To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO) (NCT00136084)
Timeframe: Consolidation I
Intervention | Participants (Number) |
---|
| Negative | Positive |
---|
Overall | 11 | 4 |
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Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO
To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy. (NCT00136084)
Timeframe: Induction II
Intervention | Participants (Number) |
---|
| Decrease | Increase or no change |
---|
Overall | 27 | 2 |
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Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.
To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy (NCT00136084)
Timeframe: Induction II
Intervention | Participants (Number) |
---|
| Experienced Grade 3 or 4 toxicities | Did not experience Grade 3 or 4 toxicities |
---|
Overall | 27 | 3 |
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Overall Event-free Survival (EFS)
EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate. (NCT00137111)
Timeframe: Median follow-up time (range) 5.6 (1.3 to 8.9) years
Intervention | Percentage of Participants (Number) |
---|
Total Therapy | 87.3 |
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Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).
Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells. (NCT00137111)
Timeframe: 42 hours after start of high dose methotrexate infusion (HDMTX)
Intervention | pmol/1,000,000,000 cells (Mean) |
---|
4 hr | 1688 |
24 hr | 2521 |
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Continuous Complete Remission Since Week 56 Therapy.
CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate. (NCT00137111)
Timeframe: Median follow up time (range) 4.5 (1 to 7.8) years
Intervention | Percentage of participants (Number) |
---|
Patients With High Risk of CNS Relapse | 92.2 |
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Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)
"White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count~Measurement: Percentage change of leukemia cells from baseline" (NCT00137111)
Timeframe: Immediately before the methotrexate infusion and three days after subsequent infusion
Intervention | Percent change (Mean) |
---|
4 hr | -44 |
24 hr | -50 |
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Minimal Residual Disease (MRD)
Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (>=0.01%). (NCT00137111)
Timeframe: End of Induction (Day 46 MRD measurement)
Intervention | participants (Number) |
---|
| Negative <0.01% | Positive >= 0.01% |
---|
Total Therapy | 390 | 102 |
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Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)
Assesses health related quality of life and advanced prostate cancer specific symptoms. FACT-General (FACT-G) assesses 4 domains: physical, social and family, emotional, and functional well-being. The prostate cancer subscale assesses prostate cancer symptoms focusing on pain, urination problems, and sexual functions. Individual scores range from 0 (not at all) to 4 (very much). Scores for some of the individual questions are reverse-coded in order for higher scores to correspond to better health status. FACT-P overall score range is 0 to 156; higher scores indicate better health status. (NCT00137436)
Timeframe: Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)
Intervention | scores on a scale (Mean) |
---|
| Bsl mean C1.D1 (n=47) | Change from Bsl - C2.D1 (n=42) | Change from Bsl - C3.D1 (n=31) | Change from Bsl - C4.D1 (n=30) | Change from Bsl - C5.D1 (n=33) | Change from Bsl - C6.D1 (n=31) | Change from Bsl - C7.D1 (n=29) | Change from Bsl - C8.D1 (n=25) | Change from Bsl - C9.D1 (n=24) | Change from Bsl - C10.D1 (n=22) | Change from Bsl - C11.D1 (n=21) | Change from Bsl - C12.D1 (n=18) | Change from Bsl - C13.D1 (n=16) | Change from Bsl - C14.D1 (n=17) | Change from Bsl - C15.D1 (n=12) | Change from Bsl - C16.D1 (n=12) | Change from Bsl - EOT (n=36) |
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SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg | 112.0 | 6.4 | 7.2 | 6.6 | 4.9 | 8.2 | 4.4 | 3.6 | 0.2 | 2.0 | 3.1 | 4.1 | 5.6 | 7.9 | 4.1 | 6.2 | 0.6 |
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Duration of PSA Response (DPR)
Defined as time from first documentation of PSA response (≥50% decrease in PSA from baseline that is subsequently confirmed) to first documentation of PSA progression (defined for patients with a PSA response as a 50% increase over nadir [lowest] and increase in absolute-value PSA level by at least 5 ng/mL [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir / lowest] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value). Calculated as (end date for DPR - first PSA response + 1)/7. (NCT00137436)
Timeframe: Baseline to first documentation of PSA progression up to 28 days after date of last dose
Intervention | weeks (Median) |
---|
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg | 39.1 |
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Percentage of Participants With Objective Response Rate (ORR)
Defined as confirmed complete response (CR: disappearance of all target lesions) or confirmed partial response (PR: ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. (NCT00137436)
Timeframe: Baseline to first documentation of PSA progression up to 28 days after date of last dose
Intervention | percentage of participants (Number) |
---|
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg | 42.4 |
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Time to PSA Progression
Defined as the time from start of study treatment to first documentation of PSA progression using the PSA Working Group criteria calculated as (first event date - first dose date + 1)/7. PSA progression is defined for patients with a PSA response, as a 50% increase over nadir (lowest) and increase in absolute-value PSA level by at least 5 nanograms per milliliter (ng/mL) [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir (lowest)] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value. (NCT00137436)
Timeframe: Baseline to first documentation of PSA progression up to 28 days after date of last dose
Intervention | weeks (Median) |
---|
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg | 42.1 |
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Percentage of Participants With Prostate Specific Antigen (PSA) Response
PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed. (NCT00137436)
Timeframe: Baseline, Day 1 of each 21-day cycle
Intervention | percentage of participants (Median) |
---|
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg | 56.4 |
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Time to First Moderate or Severe Flare
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. A severe flare = participants had BILAG A score(s) present in one or more domains or BILAG B scores present in three or more domains at the same visit following a visit of inactive disease state defined above. A moderate flare = participants had only BILAG B scores present in two domains at the same visit following a visit of inactive disease state. (NCT00137969)
Timeframe: 52 weeks
Intervention | days (Median) |
---|
Rituximab 1000 mg + Prednisone | 112.0 |
Placebo + Prednisone | 126.0 |
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Number of Participants Who Achieved an MCR in The ITT Population
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. (NCT00137969)
Timeframe: From Weeks 24 to 52
Intervention | participants (Number) |
---|
Rituximab 1000 mg + Prednisone | 14 |
Placebo + Prednisone | 9 |
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Number of Participants Who Achieved an MCR (Excluding PCR)
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. (NCT00137969)
Timeframe: From baseline to 52 weeks
Intervention | participants (Number) |
---|
Rituximab 1000 mg + Prednisone | 21 |
Placebo + Prednisone | 14 |
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Number of Participants Who Achieved a BILAG C or Better in All Domains
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. (NCT00137969)
Timeframe: 24 weeks
Intervention | participants (Number) |
---|
Rituximab 1000 mg + Prednisone | 42 |
Placebo + Prednisone | 24 |
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Change in SLE Expanded Health Survey Physical Function Score From Baseline
Short Form (36) with additional questions specific to lupus (scale = 0-100; with 100 representing the highest level of functioning possible) to measure the ability of rituximab to improve quality of life. A positive value for this outcome measure indicates that symptoms have improved. (NCT00137969)
Timeframe: From baseline to 52 weeks
Intervention | score on a scale (Mean) |
---|
Rituximab 1000 mg + Prednisone | 8.2 |
Placebo + Prednisone | 4.1 |
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Number of Participants Who Achieved a PCR (Including MCR)
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. MCR = participants who achieved BILAG C or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. (NCT00137969)
Timeframe: From baseline to 52 Weeks
Intervention | participants (Number) |
---|
Rituximab 1000 mg + Prednisone | 50 |
Placebo + Prednisone | 25 |
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Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks was calculated as: 1. Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks. 2. Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study. 3. Minus the Time-Adjusted AUC by the baseline BILAG global score (NCT00137969)
Timeframe: From baseline to 52 weeks
Intervention | BILAG score unit (Mean) |
---|
Rituximab 1000 mg + Prednisone | -5.8 |
Placebo + Prednisone | -5.9 |
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Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period
The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. (NCT00137969)
Timeframe: From baseline to 52 weeks
Intervention | Participants (Number) |
---|
| MCR (excluding PCR) | PCR | Nonclinical Response (NCR) |
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Placebo + Prednisone | 14 | 11 | 63 |
,Rituximab 1000 mg + Prednisone | 21 | 29 | 119 |
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Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation
"Biopsy-proven acute renal (kidney) rejection [1, 2].~Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection[2]~Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999" (NCT00141037)
Timeframe: Up to one year post kidney transplantation procedure
Intervention | Rejection Events (Number) |
---|
Steroid-Free Immunosuppression | 18 |
Steroid-Based Immunosuppression | 19 |
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The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation
Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free (NCT00141037)
Timeframe: One year post kidney transplantation procedure
Intervention | Standard Deviation Score (SDS) (Mean) |
---|
Steroid-Free Immunosuppression | 0.37 |
Steroid-Based Immunosuppression | 0.35 |
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Relative Change From Baseline in Quality of Sleep at Week 12
Participants assessed quality of sleep on a 100 mm VAS, where 0 mm = very good, 100 mm = very bad. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12
Intervention | percent change (Mean) |
---|
MR Prednisone | 4.63 |
IR Prednisone | 0.13 |
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Relative Change From Baseline in Pain Intensity at Week 12
Participants assessed pain intensity on a 100 millimeter (mm) visual analog scale (VAS), where 0 mm = no pain, 100 mm = worst pain. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12
Intervention | percent change (Mean) |
---|
MR Prednisone | -8.57 |
IR Prednisone | -6.53 |
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Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12
Intervention | percent change (Mean) |
---|
MR Prednisone | 0.07 |
IR Prednisone | -4.7 |
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Relative Change From Baseline in Duration of Morning Stiffness at Week 12
Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12
Intervention | percent change (Mean) |
---|
MR Prednisone | -22.7 |
IR Prednisone | -0.4 |
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Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total DAS28 score range from 0 to approximately 10. DAS28 less than or equal to (≤) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity, and DAS28 >5.1 = severe disease activity. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12
Intervention | percent change (Mean) |
---|
MR Prednisone | -9.03 |
IR Prednisone | -12.30 |
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Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12
Intervention | percent change (Mean) |
---|
MR Prednisone | 19.43 |
IR Prednisone | 21.0 |
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Percentage of Participants With Recurrence of Joint Stiffness at Week 12
Participants recorded the status of recurrence of joint stiffness (Yes/No) in diary data. Percentage of participants who selected Yes for recurrence of joint stiffness, are reported. (NCT00146640)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
MR Prednisone | 47 |
IR Prednisone | 43 |
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Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.
A BPAR is defined when the investigator had a suspicion of an acute rejection, where the final clinical diagnosis confirmed the occurrence of an acute rejection, where a biopsy was performed that confirmed the presence of an acute rejection, and where anti-rejection treatment intervention was initiated. The efficacy measured the first rejections (clinically and biopsy proven rejections) at 3 months. (NCT00149994)
Timeframe: Month 3
Intervention | Percentage of Participants (Number) |
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Cyclosporine A | 33.3 |
Tacrolimus | 32.9 |
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Overall Survival and Progression Free Survival
measured by overall Response Rate (ORR), which includes Complete response and partial response. (NCT00151281)
Timeframe: 38 months
Intervention | percentage of patients (Number) |
---|
Study Treatment Arm | 73 |
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Asses the Toxicity Profiles
Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0. (NCT00151281)
Timeframe: 38 months
Intervention | Participants (Count of Participants) |
---|
| Grade 3 or 4 neutropenia | Anemia | Thrombocytopenia | Fatigue | Constipation | Cough | Nausea | Neuropathy | Dyspnea | Rash |
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RT-PEPC Drug Therapy | 14 | 1 | 4 | 22 | 14 | 14 | 13 | 13 | 11 | 10 |
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The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment
"QoL assessments were obtained with version 3 of the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). Users of the FACT-G are able to generate an overall score and four subscale scores with ranges and distributions that are sample-specific. All questions in the FACT-G use a 5-point rating scale (0 = Not at all to 4 = Very much) A higher number indicates a better Quality of Life, and has a possible range of 0-108 points.~ANOVA was used to compare the difference in the means of total score among the different time points (baseline, every 2M until 6M, and every 6M until PD). The mean of the total FACT-G scores at baseline and mean of total score at all timepoints (using ANOVA) are reported below." (NCT00151281)
Timeframe: baseline, every 2 months until Month 6, and every 6 months until disease progression
Intervention | FACT-G score (Mean) |
---|
| Mean FACT-G Score at baseline | Mean Total FACT-G Score between all time points |
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RT-PEPC Drug Therapy | 83.3 | 89.4 |
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Dynamic Levels of Plasma VEGF
Stromal angiogenesis was assessed using blood vascular and perivascular markers, including VEGFR-1, VEGFR-2, CD34, and a-SMA, as well as lymphatic vascular markers ofVEGFR-3, podoplanin, and Lyve-1. (NCT00151281)
Timeframe: 38 months
Intervention | pg/mL (Median) |
---|
RT-PEPC Drug Therapy | 109.5 |
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Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up
Renal biopsies were collected for all cases of suspected acute rejection. For these cases, regardless of initiation of anti-rejection treatment, a graft core biopsy had been performed within 48 hours. These biopsies were listed on the Kidney Allograft Biopsy eCRF and the results used for patient management for BPAR. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. BPAR, graft loss, death, or loss to follow-up was analyzed by means of frequency tables. (NCT00154284)
Timeframe: Month 12
Intervention | Participants (Number) |
---|
| Biopsy-proven Acute Rejection (BPAR) | Graft Loss | Death | Loss to Follow-up |
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Everolimus (Certican) With Cyclosporine (Neoral) Continuation | 10 | 0 | 0 | 0 |
,Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal | 10 | 0 | 0 | 0 |
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Calculated Creatinine Clearance at 6 Month and 12 Month
"Creatinine clearance calculated by Cockcroft-Gault formula and summarized by mean, and standard deviation. Cockcroft-Gault formula to calculate Creatinine Clearance (CrCl[mL/min]) is shown below:~CrCl[mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female." (NCT00154284)
Timeframe: 6 month and 12 months
Intervention | mL/min (Mean) |
---|
| 6 Month | 12 Month |
---|
Everolimus (Certican) With Cyclosporine (Neoral) Continuation | 63.6 | 65.6 |
,Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal | 72.9 | 72.3 |
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Serum Creatinine at Month 6 and 12
serum creatinine summarized by mean and standard deviation (NCT00154284)
Timeframe: 6 month and 12 months
Intervention | µmol/L (Mean) |
---|
| 6 Month | 12 Month |
---|
Everolimus (Certican) With Cyclosporine (Neoral) Continuation | 139.1 | 135.6 |
,Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal | 120.1 | 123.0 |
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Mean Cases of Acute Rejection (MCAR) Per Patient
"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection." (NCT00157014)
Timeframe: 52 Weeks
Intervention | MCAR per patient (Mean) |
---|
Tacrolimus - Adult | 0.15 |
Cyclosporine - Adult | 0.17 |
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The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)
"The markers assessed were p-ERK ½, p-JNK and p-p38 MAPK.~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment." (NCT00157014)
Timeframe: 2 Weeks and 52 Weeks
Intervention | Densitometry / Densitometry of GAPDH (Mean) |
---|
| p-ERK ½ - Week 2 | p-ERK ½ - Week 52 | p-ERK ½ - Change from Week 2 | p-JNK - Week 2 | p-JNK - Week 52 | p-JNK - Change from Week 2 | p-p38 MAPK - Week 2 | p-p38 MAPK - Week 52 | p-p38 MAPK - Change from Week 2 |
---|
Cyclosporine - Pediatric | 1.67 | 1.22 | -0.27 | 0.91 | 0.82 | 0.04 | 0.43 | 0.58 | 0.34 |
,Tacrolimus - Pediatric | 1.74 | 0.93 | -0.09 | 1.17 | 0.57 | -0.21 | 0.83 | 0.24 | -0.04 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C
Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | mg/L (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 1.29 | 1.48 | 0.27 |
,Tacrolimus - Adult | 1.21 | 1.29 | 0.06 |
[back to top]
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin
Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | ng/mL (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 98.96 | 80.93 | -19.16 |
,Tacrolimus - Adult | 90.40 | 68.60 | -18.58 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes
Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | pg/mL (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 53.94 | 50.44 | -3.43 |
,Tacrolimus - Adult | 52.03 | 30.08 | -13.29 |
[back to top]
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen
Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | g/L (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 4.4 | 3.8 | -0.5 |
,Tacrolimus - Adult | 4.4 | 3.4 | -1.1 |
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Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)
Severe Acute Rejection was defined as rejection with ISHLT Grade 4. (NCT00157014)
Timeframe: 52 Weeks
Intervention | Patients (Number) |
---|
Tacrolimus - Pediatric | 0 |
Cyclosporine - Pediatric | 0 |
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Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection
Severe Acute Rejection is defined as rejection with ISHLT Grade 4. (NCT00157014)
Timeframe: 52 Weeks
Intervention | Patients (Number) |
---|
Tacrolimus - Adult | 0 |
Cyclosporine - Adult | 0 |
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Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)
A summary of rejection episodes requiring treatment regardless of biopsy grade or presence of hemodynamic compromise. (NCT00157014)
Timeframe: 52 Weeks
Intervention | Rejection Episodes (Number) |
---|
Tacrolimus - Pediatric | 3 |
Cyclosporine - Pediatric | 3 |
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Number of Cardiac Rejection Episodes Requiring Treatment
The number of rejection episodes requiring treatment (medications started/ stopped, non-medication treatment, or both) regardless of biopsy grade or presence of hemodynamic compromise. (NCT00157014)
Timeframe: 52 Weeks
Intervention | Rejection Episodes (Number) |
---|
Tacrolimus - Adult | 12 |
Cyclosporine - Adult | 11 |
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Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)
"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection." (NCT00157014)
Timeframe: 52 Weeks
Intervention | MCAR per patient (Mean) |
---|
Tacrolimus - Pediatric | 0.60 |
Cyclosporine - Pediatric | 0.50 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM
"Change is defined as Week 52 assessment - Pre-Transplant assessment.~s-ICAM= soluble-intracellular adhesion molecule" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | ng/mL (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 674.46 | 503.71 | -183.96 |
,Tacrolimus - Adult | 766.58 | 590.30 | -227.58 |
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Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)
A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26. (NCT00157014)
Timeframe: 26 Weeks and 52 Weeks
Intervention | Patients (Number) |
---|
| Week 26 | Week 52 |
---|
Cyclosporine - Pediatric | 3 | 1 |
,Tacrolimus - Pediatric | 2 | 1 |
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Time to First Acute Rejection Episode Following de Novo Cardiac Transplant
"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant." (NCT00157014)
Timeframe: 52 Weeks
Intervention | Days (Mean) |
---|
Tacrolimus - Adult | 55.0 |
Cyclosporine - Adult | 35.60 |
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Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)
"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant." (NCT00157014)
Timeframe: 52 Weeks
Intervention | Days (Mean) |
---|
Tacrolimus - Pediatric | 56.3 |
Cyclosporine - Pediatric | 49.0 |
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Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)
Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | mg/L (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Pediatric | 0.77 | 0.84 | -0.01 |
,Tacrolimus - Pediatric | 0.86 | 0.87 | -0.11 |
[back to top]
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine
Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | nM (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 482.43 | 368.95 | -99.79 |
,Tacrolimus - Adult | 422.63 | 451.88 | 71.44 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1
"Change is defined as Week 52 assessment - Pre-Transplant assessment.~MCP-1= monocyte chemoattractant protein-1" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | pg/mL (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 193.63 | 180.90 | -16.49 |
,Tacrolimus - Adult | 233.05 | 229.96 | 42.92 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG
"Change is defined as Week 52 assessment - Pre-Transplant assessment.~GSH/GSSG= ratio of reduced to oxidised glutathione" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | Ratio (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 58.83 | 53.72 | -5.55 |
,Tacrolimus - Adult | 55.07 | 51.69 | -2.07 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6
"Change is defined as Week 52 assessment - Pre-Transplant assessment.~IL= Interleukin" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | pg/mL (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 2.54 | 0.90 | -1.56 |
,Tacrolimus - Adult | 3.36 | 0.98 | -2.84 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18
Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | pg/mL (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 496.2 | 427.2 | -71.0 |
,Tacrolimus - Adult | 574.0 | 534.6 | 5.2 |
[back to top]
Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)
Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | pg/mL (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Pediatric | 104.68 | 66.48 | -30.07 |
,Tacrolimus - Pediatric | 106.06 | 69.71 | -38.31 |
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Number of Patients With Treatment Failure and Crossover for Treatment Failure
"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant." (NCT00157014)
Timeframe: 52 Weeks
Intervention | Patients (Number) |
---|
| Treatment Failures | Crossover for Treatment Failures |
---|
Cyclosporine - Adult | 11 | 8 |
,Tacrolimus - Adult | 6 | 2 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP
"Change is defined as Week 52 assessment - Pre-Transplant assessment.~hsCRP= high-sensitivity C Reactive Protein" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | mg/L (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 21.83 | 3.95 | -18.69 |
,Tacrolimus - Adult | 32.85 | 3.01 | -34.32 |
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Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)
"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant." (NCT00157014)
Timeframe: 52 Weeks
Intervention | Patients (Number) |
---|
| Treatment Failures | Crossover for Treatment Failures |
---|
Cyclosporine - Pediatric | 3 | 3 |
,Tacrolimus - Pediatric | 1 | 0 |
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The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies
"The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase).~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment." (NCT00157014)
Timeframe: 2 Weeks and 52 Weeks
Intervention | Densitometry / Densitometry of GAPDH (Mean) |
---|
| p-ERK ½ - Week 2 | p-ERK ½ - Week 52 | p-ERK ½ - Change from Week 2 | p-JNK - Week 2 | p-JNK - Week 52 | p-JNK - Change from Week 2 | p-p38 MAPK - Week 2 | p-p38 MAPK - Week 52 | p-p38 MAPK - Change from Week 2 |
---|
Cyclosporine - Adult | 0.90 | 0.79 | -0.05 | 1.23 | 1.46 | 0.22 | 0.54 | 0.77 | 0.23 |
,Tacrolimus - Adult | 0.70 | 0.87 | 0.05 | 1.10 | 1.33 | 0.03 | 0.48 | 0.63 | 0.14 |
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Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52
A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26. (NCT00157014)
Timeframe: 26 Weeks and 52 Weeks
Intervention | Patients (Number) |
---|
| Week 26 | Week 52 |
---|
Cyclosporine - Adult | 16 | 29 |
,Tacrolimus - Adult | 22 | 33 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine
Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | μmol/L (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 15.9 | 15.8 | 0.7 |
,Tacrolimus - Adult | 14.2 | 13.5 | 0.3 |
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Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)
Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | mg/L (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Pediatric | 12.08 | 2.43 | -13.94 |
,Tacrolimus - Pediatric | 30.46 | 26.31 | -7.85 |
[back to top]
Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)
Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | nM (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Pediatric | 12701.21 | 41147.62 | 21514.62 |
,Tacrolimus - Pediatric | 233.08 | 5462.99 | 5148.42 |
[back to top]
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP
"Change is defined as Week 52 assessment - Pre-Transplant assessment.~BNP= Brain Natriuretic Peptide" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | ng/L (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 4240.8 | 1856.8 | -1446.7 |
,Tacrolimus - Adult | 4314.8 | 670.1 | -4018.4 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin
Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | ng/mL (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 11.14 | 10.49 | 0.20 |
,Tacrolimus - Adult | 11.88 | 8.77 | -2.22 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T
Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | ug/L (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 0.28 | 0.04 | -0.27 |
,Tacrolimus - Adult | 0.30 | 0.03 | -0.32 |
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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars
"Change is defined as Week 52 assessment - Pre-Transplant assessment.~T-bars = thiobarbituric acid reactive substances" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks
Intervention | nmol/mL (Mean) |
---|
| Pre-Transplant | Week 52 | Change from Pre-Transplant at Week 52 |
---|
Cyclosporine - Adult | 3.91 | 3.14 | -0.77 |
,Tacrolimus - Adult | 3.78 | 3.25 | -0.64 |
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Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria
"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one acute rejection." (NCT00157014)
Timeframe: 52 Weeks
Intervention | Rejection Episodes (Number) |
---|
| Total Acute Rejection Episodes | Acute Rejection Episodes with ISHLT Grade ≥3A | Acute Rejection Episodes w/ Hemodynamic Compromise |
---|
Cyclosporine - Adult | 8 | 7 | 2 |
,Tacrolimus - Adult | 8 | 3 | 6 |
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Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)
"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one rejection episode." (NCT00157014)
Timeframe: 52 Weeks
Intervention | Rejection Episodes (Number) |
---|
| Total Acute Rejection Episodes | Acute Rejection Episodes with ISHLT Grade ≥3A | Acute Rejection Episodes w/ Hemodynamic Compromise |
---|
Cyclosporine - Pediatric | 3 | 3 | 0 |
,Tacrolimus - Pediatric | 3 | 3 | 0 |
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Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability
Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom. (NCT00184002)
Timeframe: At end of every cycle
Intervention | Participants (Count of Participants) |
---|
DR-COP | 35 |
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Percentage of Patients With Complete Response to the Combination Chemotherapy
"Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study.~Response to the study treatment will be determined according to the criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al (23)." (NCT00184002)
Timeframe: At completion of cycle 4, 6, and 8
Intervention | Percentage of participants (Number) |
---|
| Complete Response | Partial Response |
---|
DR-COP | 75.0 | 23.0 |
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Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00193479)
Timeframe: 18 Months
Intervention | percentage of patients (Number) |
---|
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab | 81 |
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Number of Newborns With a Birth Platelet Count > 50,000/uL
this uses the birth platelet count of the fetuses from the study when they are born (NCT00194987)
Timeframe: 32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40
Intervention | number of newborns with >50,000 pets (Number) |
---|
IVIG 1g/kg Twice Per Week | 48 |
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day | 47 |
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Number of Fetal Platelet Counts > 50,000/uL
Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined (NCT00194987)
Timeframe: 32 +/- 2 weeks
Intervention | number newborns with >50,000 pats (Number) |
---|
IVIG 1g/kg Twice Per Week | 44 |
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day | 43 |
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Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study
number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation (NCT00194987)
Timeframe: time of ICH (range 20-40 wks)
Intervention | number of newborns with ICH (Number) |
---|
IVIG 1g/kg Twice Per Week | 0 |
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day | 0 |
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Creatinine Clearance Rate
Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. (NCT00195429)
Timeframe: 12 months
Intervention | ml/min (Mean) |
---|
Sirolimus + Tacrolimus | 60 |
Sirolimus + Prednisone | 63.4 |
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Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies). (NCT00195429)
Timeframe: 12 months
Intervention | participants (Number) |
---|
| Subjects with Acute Rejection | Subjects without Acute Rejection |
---|
Sirolimus + Prednisone | 3 | 20 |
,Sirolimus + Tacrolimus | 3 | 21 |
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Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions
"Results represent the database as of January 29, 2009.~The difference in hypointense brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. Hypointense lesions display as dark areas on the MRI image, and represent areas of permanent axonal damage." (NCT00203047)
Timeframe: Day 0, Month 36 or early termination visit
Intervention | cm^3 (Mean) |
---|
GA + Placebo | 0.43 |
GA + Prednisone | 0.17 |
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Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method
"Results represent the database as of January 29, 2009. Brain volume was measured at baseline and at months 24, 36 and at early termination visits by magnetic resonance imaging (MRI). Brain atrophy was measured by comparing the change in brain volume from baseline to the latest scan at the three during study timeframes. SIENA is a fully automated method of analyzing longitudinal brain change.~Adjusted (least square) mean values are presented." (NCT00203047)
Timeframe: Day 0, latest scan at month 24, 36 or early termination visit
Intervention | percent change of baseline brain volume (Least Squares Mean) |
---|
GA + Placebo | -0.46 |
GA + Prednisone | -0.43 |
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Cumulative Number of Enhancing Lesions at Months 12, 24 and 36
"Results represent the database as of January 29, 2009.~Enhancing lesions are lesions that show inflammation on an MRI and are assumed to be new lesions. The sum of enhancing lesions observed in MRIs taken at months 12, 24 and 36 are offered." (NCT00203047)
Timeframe: Months 12, 24, and 36
Intervention | lesions (Mean) |
---|
GA + Placebo | 0.69 |
GA + Prednisone | 0.76 |
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Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions
"Results represent the database as of January 29, 2009.~The difference in T2 brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. T2 lesions are hyperintense lesions meaning that they appear as bright spots on the MRI image. These tend to show the total number of lesions and disease burden." (NCT00203047)
Timeframe: Day 0, Month 36 or the early termination visit
Intervention | cm^3 (Mean) |
---|
GA + Placebo | 0.07 |
GA + Prednisone | 0.09 |
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Change in Salivary Cortisol (First 6 Participants)
(NCT00204737)
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeks
Intervention | ug/dl (Mean) |
---|
| Baseline | 6 Weeks | 12 Weeks |
---|
Placebo | 0.08 | 0.09 | 0.07 |
,Prednisone | 0.13 | 0.10 | 0.10 |
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Number of Other Adverse Events
The Systematic Assessment for Treatment Emergent Events-General Inquiry (SAFTEE-GI) was used to collect and analyze data about potential medication related side effects. Each of 12 subjects was queried using the SAFTEE-GI at 3 time points (1, 2 and 3 weeks) for a possible of 36 adverse event reports. (NCT00204737)
Timeframe: up to 3 weeks
Intervention | incidence of adverse events (Number) |
---|
| Musculoskeletal | Sleeplessness | Reduced Blood Sugar | Decreased Energy | Upper Respiratory Infection | Increased Mood | Mild Urinary Hesitancy |
---|
Placebo | 1 | 0 | 0 | 1 | 1 | 0 | 1 |
,Prednisone | 2 | 3 | 2 | 0 | 1 | 1 | 0 |
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Number of Participants Achieving CAPS Response
CAPS response defined as a 30% reduction in CAPS score from baseline. (NCT00204737)
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeks
Intervention | Participants (Count of Participants) |
---|
| baseline to 2 weeks | baseline to 6 weeks | baseline to 12 weeks |
---|
Placebo | 0 | 0 | 0 |
,Prednisone | 4 | 3 | 1 |
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Change in Clinical Global Impression Severity (CGI-S) Score
CGI-S is scored by a clinician. It is a 7 point scale where 1 = normal, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. (NCT00204737)
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeks
Intervention | score on a scale (Mean) |
---|
| Baseline | 2 Weeks | 6 Weeks | 12 Weeks |
---|
Placebo | 5.5 | 5.5 | 5.2 | 5.5 |
,Prednisone | 5.5 | 4.7 | 4.8 | 4.5 |
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Change in Clinician-Administered PTSD Scale (CAPS)
This measure tests the hypothesis that there will be a 30% or greater improvement in the Clinician-Administered PTSD (Post Traumatic Stress Disorder) Scale over the course of the study. CAPS is a 30-item survey with a total possible range of scores from 0-120 where the higher the score, the more severe the symptoms. (NCT00204737)
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeks
Intervention | score on a scale (Mean) |
---|
| Baseline | 2 Weeks | 6 Weeks | 12 Weeks |
---|
Placebo | 90.7 | 86.2 | 81.5 | 82.5 |
,Prednisone | 96.0 | 66.3 | 72.8 | 75.2 |
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Change in Dehydroepiandrosterone Sulfate (DHEA-S)
DHEA-S measured at baseline, 2 weeks, 6 weeks, and 12 weeks (NCT00204737)
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeks
Intervention | mcg/dl (Mean) |
---|
| Baseline | 2 Weeks | 6 Weeks | 12 Weeks |
---|
Placebo | 201.2 | 148.7 | 156.8 | 157.8 |
,Prednisone | 123.8 | 87.7 | 123.5 | 112.3 |
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Change in Hamilton Depression Rating Scale (HAM-D)
HAM-D is a 21-item survey where scoring is based on the first 17-items. It has a total possible range of scores 0-50 where higher scores indicate more severe depression. (NCT00204737)
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeks
Intervention | score on a scale (Mean) |
---|
| Baseline | 2 Weeks | 6 Weeks | 12 Weeks |
---|
Placebo | 16.8 | 14.8 | 14.5 | 15.7 |
,Prednisone | 19.2 | 13.2 | 11.7 | 12.3 |
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Change in PCL-PTSD Score
PCL-PTSD is a 17-item survey with a total possible range of scores 17-85 where higher scores indicate more severe symptoms. (NCT00204737)
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeks
Intervention | score on a scale (Mean) |
---|
| Baseline | 2 Weeks | 6 Weeks | 12 Weeks |
---|
Placebo | 64.2 | 59.8 | 60.3 | 64.2 |
,Prednisone | 68.7 | 58.8 | 56.0 | 58.2 |
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Change in Salivary Cortisol (Last 6 Participants)
Participants provided saliva samples at 16:00, 24:00, and 08:00. After these samples are collected, participants take 0.5mg dexamethasone orally at 23:00, and a fourth sample is collected at 08:00 post dexamethasone. Post-dexamethasone data is reported here. (NCT00204737)
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeks
Intervention | ug/dl (Mean) |
---|
| Baseline | 6 Weeks | 12 Weeks |
---|
Placebo | 0.138 | 0.157 | 0.183 |
,Prednisone | 0.1 | 0.103 | 0.112 |
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Progression-Free Survival
PFS was defined as the period of time from treatment start to the first documentation of PD, recurrence, or death. PD was defined as a greater than or equal to 50% increase from baseline in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or non-responders, or the appearance of any new lesions during or at the end of therapy. PFS was censored at the last date for which the response assessment resulted in the absence of PD for participants who did not demonstrate objective progression or recurrence. Participants who withdrew prior to evidence of disease progression or recurrence, PFS was censored at the last date assessment showed an absence of PD. (NCT00211185)
Timeframe: From the date of first dose of study drug until date of first documentation of PD, recurrence, or death from any cause, assessed up to 5 years 9 months
Intervention | Weeks (Mean) |
---|
Denileukin Diftitox in Combination With CHOP | 12.4 |
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Percentage of Participants With Overall Survival
Overall Survival (OS) was defined as the time from the date of registration to the date of the participant's death. OS was determined by reviewing all participant's records every 6 months until the study was administratively closed or all participants died, whichever occurred first. Participants who were lost to follow-up but were still alive at the date of last contact were censored at the date of last contact. Participants who did not have a recorded date of death were censored for OS at the last date at which they were known to be alive. (NCT00211185)
Timeframe: From date of randomization until death, or administrative close of study, whichever came first, assessed up to 5 years 9 months
Intervention | Percentage of participants (Number) |
---|
Denileukin Diftitox in Combination With CHOP | 63.3 |
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Duration of Response
Duration of response was defined as the length of time from the first date at which the response criteria were met (taking the earliest date at which a PR, CRu, or the confirmed CR occurred) until the date that recurrent or PD or death was accurately documented, per the criteria defined for progression-free survival (PFS). All participants within the EA population who achieved a response per the criteria defined were included in the duration of the response analysis. Participants lost to follow-up prior to PD or death were censored at the date they were last known to still be responding to treatment. Duration of response was estimated using the Kaplan-Meier method with the median duration of response summarized. (NCT00211185)
Timeframe: From the date of the first documented CR (confirmed or unconfirmed) or PR until the date of first documentation of recurrent or PD or death, assessed up to 5 years 9 months
Intervention | Months (Median) |
---|
Denileukin Diftitox in Combination With CHOP | 29.7 |
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Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants
An adverse event (AE) was any medical occurrence in a participant who was administered denileukin diftitox and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and did not necessarily have a causal relationship with this treatment. An AE included any side effect, injury, toxicity, sensitivity reaction, or any undesirable clinical or laboratory event that was not normally observed in the participant. Safety was assessed for all participants who received at least one dose of study medication and was monitored throughout the study. Safety evaluations were based on the incidence, intensity, and type of AE, and clinically significant changes in the participant's medical history, physical examination findings, vital signs, and clinical laboratory results. Participants also notified the study staff of any problems that occurred between visits by telephone, and if necessary, were evaluated by the investigator or study staff at an unscheduled interim visit. (NCT00211185)
Timeframe: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months
Intervention | Percentage of participants (Number) |
---|
| Fatigue | Nausea | Hemoglobin | Neuropathy-sensory | Alanine transaminase | Hyperglycemia | Hypoalbuminemia | Leukocytes | Fever | Hypocalcemia | Lymphopenia | Aspartate transaminase | Dyspnea | Platelets | Alopecia | Neutrophils | Constipation | Edema-limb | Hyponatremia |
---|
Denileukin Diftitox in Combination With CHOP | 63.3 | 46.9 | 40.8 | 40.8 | 34.7 | 34.7 | 34.7 | 34.7 | 32.7 | 30.6 | 30.6 | 28.6 | 28.6 | 28.6 | 26.5 | 26.5 | 24.5 | 20.4 | 20.4 |
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Overall Response in the Intent To Treat (ITT) Population
Response rate was defined as the percentage of the ITT population who achieved a Complete Response (CR), Unconfirmed Complete Response (CRu), or Partial Response (PR). The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease. (NCT00211185)
Timeframe: From the start of the treatment to the date of participant's death assessed up to 5 years 9 months
Intervention | Percentage of participants (Number) |
---|
| Confirmed complete response | Unconfirmed complete response | Partial response | Stable disease | Disease progression | Early death | Inadequate assessment |
---|
Denileukin Diftitox in Combination With CHOP | 51.0 | 4.1 | 10.2 | 6.1 | 4.1 | 4.1 | 20.4 |
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Overall Response in the Efficacy Analyzable (EA) Population
Response rate was defined as the percentage of the EA population who achieved a CR, CRu, or PR. The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease. (NCT00211185)
Timeframe: From the start of the treatment to the date of the participant's death assessed up to 5 years 9 months
Intervention | Percentage of participants (Number) |
---|
| Confirmed complete response | Unconfirmed complete response | Partial response | Stable disease | Disease progression | Early death | Inadequate assessment |
---|
Denileukin Diftitox in Combination With CHOP | 67.6 | 5.4 | 13.5 | 8.1 | 5.4 | 0.0 | 0.0 |
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3-Year Overall Survival
3-year overall survival is defined as the probability of patients surviving at 3 years from study entry. (NCT00217425)
Timeframe: Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.
Intervention | probability (Number) |
---|
Treatment (A-CHOP Followed by MA) | 0.39 |
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12-Month Progression-Free Survival (PFS)
12-month progression-free survival is defined as the probability of patients remaining alive and progression-free at 12 months from study entry. (NCT00217425)
Timeframe: Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.
Intervention | probability (Number) |
---|
Treatment (A-CHOP Followed by MA) | 0.44 |
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Overall Response Rate
Overall response rate is defined as proportion of patients who achieve complete remission [CR, unconfirmed CR (CRu) or Functional CR] or partial remission. Response is assessed using the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Chesen, 1999). (NCT00217425)
Timeframe: Assessed after cycle 3, cycle 6, and cycle 8 (if given).
Intervention | proportion (Number) |
---|
Treatment (A-CHOP Followed by MA) | 0.90 |
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Overall Response Rate
"Response was evaluated for Anemia and Spleen:~Major anemia response: hemoglobin increase to within normal limits in the absence of transfusion. Minor anemia response: hemoglobin improvement of at least 2 grams per deciliter independent of transfusion support, or achievement of transfusion independence in transfusion-dependent patients. Major spleen response: normalization of spleen size to the range of 12-14 centimeters by ultrasound. Minor spleen response: a 50% or more decrease in excess spleen size by ultrasound. Complete remission (CR): complete resolution of disease-related symptoms, splenomegaly, normalization of peripheral blood count, white cell differential and smear, and normalization of bone marrow histology. Partial remission (PR): a major or minor response in anemia or splenomegaly. Overall Response (OR)=CR + PR, assessed among eligible, treated patients." (NCT00227591)
Timeframe: Assessed at the end of cycle 3
Intervention | Proportion of participants (Number) |
---|
Lenalidomide | 0.26 |
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5-year Overall Survival
5-year overall survival is defined as the probability of patients who remain alive at 5 years from study entry. The method of Kaplan and Meier (1958) was used to estimate overall survival. (NCT00274924)
Timeframe: Every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.
Intervention | probability (Number) |
---|
Group I (PET Negative) | 0.77 |
Group II (PET Positive) | 0.69 |
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2-year Progression-Free Survival (PFS)
2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS. (NCT00274924)
Timeframe: Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.
Intervention | probability (Number) |
---|
Group I (PET Negative) | 0.76 |
Group II (PET Positive) | 0.42 |
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6-month Cumulative Rejection Incidence (Either CMR, AMR or Both)
Biopsy shows evidence of either AMR or CMR or evidence both. (NCT00275509)
Timeframe: Up to 6 months
Intervention | Participants (Count of Participants) |
---|
Tymoglobulin | 21 |
Daclizumab | 23 |
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6-month Acute Antibody-mediated Rejection Rate (AMR)
A diagnosis of AMR was based on the 2013 international Banff Classification Criteria and is defined as the presence of circulating donor-specific antibody (DSA) and either: 1) peritubular capillary staining of C4d and at least one of the following: peritubular capillaritis (ptc) score>0, glomerulitis (g) score>0, acute thrombotic microangiopathy (TMA) in the absence of any other cause, or other features consistent with AMR (endothelial injury, fibrin thrombi, microinfarctions, interstitial hemorrhage), or 2) absence of capillary staining of C4d and the presence of ptc>0 and g>0 or ptc>0 or g>0 and acute TMA, in the absence of any other cause of TMA. (NCT00275509)
Timeframe: Up to 6 months
Intervention | Participants (Count of Participants) |
---|
Tymoglobulin | 17 |
Daclizumab | 16 |
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Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52
A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5. (NCT00282347)
Timeframe: Week 24 to Week 52
Intervention | Percentage of participants (Number) |
---|
Rituximab | 1.4 |
Placebo | 6.9 |
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Change From Baseline in Anti-double-stranded DNA at Week 52
(NCT00282347)
Timeframe: Baseline to Week 52
Intervention | IU/mL (Mean) |
---|
Rituximab | 0.45 |
Placebo | 1.06 |
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British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks
The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score. (NCT00282347)
Timeframe: Baseline to Week 52
Intervention | Units on a scale (Mean) |
---|
Rituximab | -8.49 |
Placebo | -8.58 |
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Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52
A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) < 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of < 1.0 or if the Baseline UP to CR was > 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR. (NCT00282347)
Timeframe: Week 52
Intervention | Percentage of participants (Number) |
---|
| CRR | PRR | NRR |
---|
Placebo | 30.6 | 15.3 | 54.2 |
,Rituximab | 26.4 | 30.6 | 43.1 |
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Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52
The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement. (NCT00282347)
Timeframe: Baseline to Week 52
Intervention | Units on a scale (Mean) |
---|
Rituximab | 4.8 |
Placebo | 5.7 |
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Change From Baseline in C3 and C4 Complement Levels at Week 52
(NCT00282347)
Timeframe: Baseline to Week 52
Intervention | mg/dL (Mean) |
---|
| C3 Complement | C4 Complement |
---|
Placebo | 25.9 | 6.6 |
,Rituximab | 37.5 | 9.9 |
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Time to Achieve a Complete Renal Response
(NCT00282347)
Timeframe: Baseline to Week 52
Intervention | Weeks (Median) |
---|
Rituximab | 11.99 |
Placebo | 12.12 |
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Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52
(NCT00282347)
Timeframe: Baseline to Week 52
Intervention | Percentage of participants (Number) |
---|
Rituximab | 47.4 |
Placebo | 53.7 |
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Percentage of Participants Who Achieved a Complete Renal Response at Week 52
A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5. (NCT00282347)
Timeframe: Week 52
Intervention | Percentage of participants (Number) |
---|
Rituximab | 26.4 |
Placebo | 30.6 |
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Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)
Change in estimated glomerular filtration rate from baseline to Month 3 calculated by using abbreviated MDRD formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1. (NCT00284934)
Timeframe: Baseline and 3 months
Intervention | mL/min/1.73m^2 (Mean) |
---|
| Baseline (n= 47, 45) | Month 3 (n= 44, 43) | Change from Baseline to Month 3 (n= 44, 43) |
---|
High EC-MPS | 46.4 | 48.6 | 2.1 |
,Standard Dose EC-MPS | 45.3 | 44.6 | -0.4 |
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Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months
A biopsy-proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB, or III based on the Banff 1997 classification.The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss. (NCT00284934)
Timeframe: 6 months
Intervention | Participants (Number) |
---|
| Biopsy proven acute rejection | Treated acute rejection | Graft loss | Death |
---|
High EC-MPS | 0 | 0 | 0 | 0 |
,Standard Dose EC-MPS | 0 | 0 | 0 | 0 |
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Number of Participants With Graft and Patient Survivals at 6 Months
Graft survival was defined as the number of patients with no graft loss. The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss. Patient survival was defined as the number of patients alive with or without a functioning graft. (NCT00284934)
Timeframe: 6 months
Intervention | Participants (Number) |
---|
| Graft survival | Patient survival |
---|
High EC-MPS | 45 | 45 |
,Standard Dose EC-MPS | 47 | 47 |
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Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)
Change in estimated glomerular filtration rate from baseline to Month 6 calculated by using abbreviated Modification of Diet in Renal Disease (MDRD) formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1. (NCT00284934)
Timeframe: Baseline and Month 6
Intervention | mL/min/1.73m^2 (Mean) |
---|
| Baseline (n= 47, 45) | Month 6 (n= 45, 43) | Change from Baseline - Month 6 (n= 45, 43) |
---|
High EC-MPS | 56.4 | 49.1 | 2.4 |
,Standard Dose EC-MPS | 45.3 | 44.7 | -0.4 |
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Incidence of Adverse Events
Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted. (NCT00288080)
Timeframe: From start of treatment until the end of follow-up
Intervention | percentage of participants (Number) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
---|
Androgen Suppression + Radiation Therapy | 14.9 | 48.4 | 26.0 | 4.3 | 1.4 |
,Androgen Suppression + Radiation Therapy + Chemotherapy | 2.1 | 25.9 | 40.1 | 28.4 | 0.7 |
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Overall Survival
Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (NCT00288080)
Timeframe: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Intervention | percentage of participants (Number) |
---|
Androgen Suppression + Radiation Therapy | 88.7 |
Androgen Suppression + Radiation Therapy + Chemotherapy | 93.3 |
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Local Control
Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method. (NCT00288080)
Timeframe: From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Intervention | percentage of participants (Number) |
---|
Androgen Suppression + Radiation Therapy | 99.2 |
Androgen Suppression + Radiation Therapy + Chemotherapy | 99.5 |
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Disease-free Survival
A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method. (NCT00288080)
Timeframe: From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Intervention | percentage of participants (Number) |
---|
Androgen Suppression + Radiation Therapy | 73.0 |
Androgen Suppression + Radiation Therapy + Chemotherapy | 78.5 |
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Biochemical Control
Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. (NCT00288080)
Timeframe: From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Intervention | percentage of participants (Number) |
---|
Androgen Suppression + Radiation Therapy | 82.0 |
Androgen Suppression + Radiation Therapy + Chemotherapy | 84.1 |
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Percent of Participants Who Experienced All-Cause Morbidity Within 12 Months of Post-HCT
Morbidity is the occurrence of NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 adverse event grade 3 or higher. (NCT00288626)
Timeframe: From the time of Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT) to 1 year after HCT.
Intervention | Percentage of Participants (Number) |
---|
HDIT and HCT | 95.8 |
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Percent of Participants Who Experienced All-Cause Morbidity
Morbidity is the occurrence of NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 adverse event grade 3 or higher. (NCT00288626)
Timeframe: From the time of enrollment until completion of the 5-year follow-up, an average of 6 years.
Intervention | percentage of participants (Number) |
---|
HDIT and HCT | 100 |
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Overall Survival
The probability that a participant did not experienced a death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood's formula for standard error was used to calculate 90% confidence intervals. Participants that did not die were censored at the time of last follow-up. (NCT00288626)
Timeframe: From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years
Intervention | Probability (Number) |
---|
| 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | 1.0 | 1.0 | 0.957 | 0.911 | 0.863 |
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Event-Free Survival Probability During the 5 Years After Transplant
Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error. (NCT00288626)
Timeframe: 5 years
Intervention | Probability (Number) |
---|
HDIT and HCT | 0.692 |
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Number of New T2-Weighted Lesions From Baseline
A T2-weighted magnetic resonance imaging (MRI) scan was used to determine the number of new T2 lesions in the brain relative to Baseline. A value of 0 means that the participant didn't worsen. Values greater than 0 indicate an increase in disease activity from baseline. (NCT00288626)
Timeframe: 6 Months to 5 years after HCT
Intervention | Lesions per scan (Mean) |
---|
| 6 Months Post Transplant | 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | 0.2 | 0.2 | 0.2 | 0.1 | 0.4 | 0.1 |
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Event-Free Survival Probability During the 3 Years After Transplant
Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error. (NCT00288626)
Timeframe: 3 years
Intervention | Probability (Number) |
---|
HDIT and HCT | 0.784 |
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Percent Change From Screening in Brain Volume
Magnetic resonance imaging (MRI) scan techniques measured ventricular volumes and grey and white matter brain volumes. Change from screening was computed as the value at the time point minus the screening value. (NCT00288626)
Timeframe: 8 weeks to 5 years after HCT
Intervention | Percent Change (Mean) |
---|
| 8 Weeks Post Transplant | 6 Months Post Transplant | 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | -0.8 | -1.1 | -1.2 | -1.6 | -2.2 | -2.0 | -2.3 |
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MS Relapse-Free Survival Probability After Transplant
"MS clinical relapse is defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit or disability, and lasting over 48 hours. Clinical relapse was determined by the participant's neurologist and was measured as days from transplant to new or worsening neurological symptom relative to baseline.~Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error." (NCT00288626)
Timeframe: 1 to 5 years after HCT
Intervention | Probability (Number) |
---|
| 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | 0.958 | 0.915 | 0.869 | 0.869 | 0.869 |
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MS Progression-Free Survival Probability After Transplant
"MS progression is measured as number of days from transplant to first Kurtzke's Expanded Disability Status Scale (EDSS) increase of more than 0.5 relative to the baseline measurement. EDSS assesses disability in Multiple Sclerosis patients. Eight functional systems are evaluated: visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and ambulation. The overall score ranges from 0 (normal neurological exam) to 10 (death due to MS).~Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood's formula for standard error." (NCT00288626)
Timeframe: 1 to 5 years after HCT
Intervention | Probability (Number) |
---|
| 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | 1.0 | 0.913 | 0.913 | 0.913 | 0.913 |
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MRI Activity-Free Survival Probability After Transplant
MS disease activity is measured as days from transplant to first occurrence of >= 2 new MS lesions on Magnetic resonance imaging (MRI) relative to baseline. Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood's formula for standard error. (NCT00288626)
Timeframe: 1 to 5 years after HCT
Intervention | Probability (Number) |
---|
| 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | 0.958 | 0.958 | 0.958 | 0.910 | 0.863 |
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Event-Free Survival Probability After Transplant
Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood's formula for standard error. (NCT00288626)
Timeframe: 1, 2, and 4 years after HCT
Intervention | Probability (Number) |
---|
| 1 Year Post Transplant | 2 Years Post Transplant | 4 Years Post Transplant |
---|
HDIT and HCT | 0.958 | 0.828 | 0.738 |
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Disease-Modifying Therapy Survival Probability After Transplant
Treatment with disease-modifying therapy was measured by the number of days from transplant to the first treatment with an additional disease-modifying therapy. Examples of therapy include interferon beta-1a, glatiramer acetate, natalizumab, alemtuzumab, other immunosuppressive medications, or experimental therapies directed against MS activity. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error. (NCT00288626)
Timeframe: 1 to 5 years after HCT
Intervention | Probability (Number) |
---|
| 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | 1.0 | 1.0 | 1.0 | 1.0 | 0.950 |
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Change From Baseline in T2-Weighted Lesion Volume
A T2-weighted magnetic resonance imaging (MRI) scan was used to assess the volume of T2 lesions in the brain. Change from baseline was computed as the value at the time point minus the baseline value. (NCT00288626)
Timeframe: 8 weeks to 5 years after HCT
Intervention | milliliters (Mean) |
---|
| 8 Weeks Post Transplant | 6 Months Post Transplant | 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | -0.8 | -0.7 | -1.0 | -1.6 | -1.9 | -1.9 | -2.3 |
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Change From Baseline in T1-Weighted Lesion Volume
A T1-weighted magnetic resonance imaging (MRI) scan was used to assess the volume of T1 lesions in the brain. Change from baseline was computed as the value at the time point minus the baseline value. (NCT00288626)
Timeframe: 8 weeks to 5 years after HCT
Intervention | milliliter (Mean) |
---|
| 8 Weeks Post Transplant | 6 Months Post Transplant | 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | -0.1 | 0.0 | 0.2 | 0.3 | 0.4 | 0.4 | 0.3 |
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Change From Baseline in Number of Gadolinium-Enhanced Lesions
Multiple sclerosis disease-related lesions were assessed by gadolinium-enhanced magnetic resonance imaging (MRI). Change from baseline was computed as the value at the time point minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. (NCT00288626)
Timeframe: 8 weeks to 5 years after HCT
Intervention | Lesions per scan (Mean) |
---|
| 8 Weeks Post Transplant | 6 Months Post Transplant | 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | -2.1 | -2.3 | -2.5 | -2.5 | -1.3 | -2.2 | -2.7 |
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Change From Baseline in Extended Disability Status Scale (EDSS)
Kurtzke's Expanded Disability Status Scale (EDSS) assesses disability in Multiple Sclerosis patients. Eight functional systems are evaluated: visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and ambulation. The overall score ranges from 0 (normal neurological exam) to 10 (death due to MS). Change from baseline was computed as the value at the time point minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. A change of > 0.5 in EDSS was a treatment-failure criterion. (NCT00288626)
Timeframe: 6 months to 5 years after HCT
Intervention | units on a scale (Mean) |
---|
| 6 Months Post Transplant | 1 Year Post Transplant | 2 Years Post Transplant | 3 Years Post Transplant | 4 Years Post Transplant | 5 Years Post Transplant |
---|
HDIT and HCT | -0.3 | -0.7 | -0.8 | -0.8 | -0.6 | -0.9 |
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Time to Neutrophil Engraftment
Neutrophil engraftment, or neutrophil count recovery, is defined as an Absolute Neutrophil Count (ANC) > 500/ μL for 2 consecutive measurements on different days. Normal range is 1500 to 8000/μL. Reference: http://www.medicinenet.com (NCT00288626)
Timeframe: From time of graft infusion to time of engraftment, up to 6 years
Intervention | Days (Mean) |
---|
HDIT and HCT | 10.8 |
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Time to Platelet Engraftment
Platelet engraftment, or platelet count recovery, is defined as Platelets > 20,000/μL for two consecutive measurements on different days with no platelet transfusions in the preceding 7 days. Normal range is 150,000-450,000/μL. Reference: http://www.hopkinsmedicine.org/heart_vascular_institute/clinical_services/centers_excellence/womens_cardiovascular_health_center/patient_information/health_topics/platelets.html. (NCT00288626)
Timeframe: From time of graft infusion to time of engraftment, up to 6 years
Intervention | Days (Mean) |
---|
HDIT and HCT | 18.5 |
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Response Rate R-HCVAD vs. R-CHOP
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00290498)
Timeframe: 3 years
Intervention | Participants (Count of Participants) |
---|
| Complete Remission | Inevaluable | Progressive Disease | Partial Remission | Complete Remission Unconfirmed |
---|
R-CHOP | 7 | 1 | 1 | 0 | 1 |
,R-HCVAD | 40 | 2 | 1 | 4 | 2 |
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Progression Free Survival (Rate)
Progression free survival (PFS) for three years following therapy with Rituxan-HCVAD alternating with Rituximab with high -dose methotrexate/ara-C and standard R-CHOP in patients with newly diagnosed B-cell aggressive non-Hodgkin's lymphomas younger than 60 years old and with adjusted IPI 2 or higher adverse prognostic features. (NCT00290498)
Timeframe: 3 years post-therapy
Intervention | Participants (Count of Participants) |
---|
R-HCVAD/MA | 35 |
R-CHOP | 7 |
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Time-Weighted Average MG Activity of Daily Living (MG-ADL)
MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life. (NCT00294658)
Timeframe: baseline, month 4, 6 and every 3 months through 36 months
Intervention | units on a scale (Mean) |
---|
Thymectomy Plus Prednisone | 2.24 |
Prednisone Alone | 3.41 |
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Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years
Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. (NCT00294658)
Timeframe: baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months
Intervention | mg (Mean) |
---|
Thymectomy Plus Prednisone | 32 |
Prednisone Alone | 54 |
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Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)
For each participant who took azathioprine, we penalized them by taking the prednisone dose at the time azathioprine commenced. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months. (NCT00294658)
Timeframe: baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months
Intervention | mg (Mean) |
---|
Thymectomy Plus Prednisone | 33.3 |
Prednisone Alone | 57.9 |
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Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)
For each participant who took azathioprine, we penalized them by taking the maximum dose of prednisone before azathioprine was added. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months
Intervention | mg (Mean) |
---|
Thymectomy Plus Prednisone | 34.4 |
Prednisone Alone | 64.4 |
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Number of Serious Adverse Events
Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60) (NCT00294658)
Timeframe: baseline to 3 years
Intervention | events (Number) |
---|
Thymectomy Plus Prednisone | 48 |
Prednisone Alone | 93 |
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Number of Patients With at Least One Serious Adverse Events
Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60) (NCT00294658)
Timeframe: baseline to 3 years
Intervention | participants (Number) |
---|
Thymectomy Plus Prednisone | 25 |
Prednisone Alone | 33 |
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Intravenous Immunoglobulin Use
(NCT00294658)
Timeframe: baseline to 3 years
Intervention | participants (Number) |
---|
Thymectomy Plus Prednisone | 11 |
Prednisone Alone | 23 |
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Cumulative Number of Hospital Days
Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60) (NCT00294658)
Timeframe: baseline to 3 years
Intervention | days (Mean) |
---|
Thymectomy Plus Prednisone | 8.4 |
Prednisone Alone | 19.2 |
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Cumulative Days in Hospital for Myasthenia Gravis Exacerbation
Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60) (NCT00294658)
Timeframe: baseline to 2 years
Intervention | days (Mean) |
---|
Thymectomy Plus Prednisone | 5.5 |
Prednisone Alone | 26.4 |
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Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment
Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months
Intervention | mg (Mean) |
---|
| Not prednisone naïve | Prednisone naïve |
---|
Prednisone Alone | 56 | 45 |
,Thymectomy Plus Prednisone | 35 | 25 |
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Azathioprine Use
(NCT00294658)
Timeframe: baseline to 3 years
Intervention | participants (Number) |
---|
Thymectomy Plus Prednisone | 11 |
Prednisone Alone | 28 |
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Treatment Associated Symptoms (TAS)
Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit. (NCT00294658)
Timeframe: Month 0, 1, 2, 3, 4 then every 3 months through Month 36
Intervention | Participants (Count of Participants) |
---|
| Month 0 | Month 1 | Month 2 | Month 3 | Month 4 | Month 6 | Month 9 | Month 12 | Month 15 | Month 18 | Month 21 | Mpnth 24 | Mpnth 27 | Month 30 | Month 33 | Month 36 |
---|
Prednisone Alone | 53 | 52 | 53 | 54 | 54 | 53 | 50 | 52 | 51 | 51 | 50 | 51 | 50 | 50 | 48 | 47 |
,Thymectomy Plus Prednisone | 63 | 55 | 61 | 60 | 59 | 60 | 59 | 56 | 56 | 52 | 52 | 52 | 50 | 49 | 51 | 49 |
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Hospitalization for Exacerbation of Myasthenia Gravis
(NCT00294658)
Timeframe: baseline to 2 years and baseline to 3 years
Intervention | participants (Number) |
---|
| Months 0-24 | Months 0-36 |
---|
Prednisone Alone | 17 | 22 |
,Thymectomy Plus Prednisone | 6 | 6 |
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Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset
Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months
Intervention | units on a scale (Mean) |
---|
| Age (years) at Disease Onset < 40 | Age (years) at Disease Onset ≥ 40 |
---|
Prednisone Alone | 9.60 | 7.85 |
,Thymectomy Plus Prednisone | 6.50 | 5.33 |
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Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset
Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months
Intervention | mg (Mean) |
---|
| Age (Years) at Disease Onset < 40 | Age (Years) at Disease Onset ≥ 40 |
---|
Prednisone Alone | 55 | 49 |
,Thymectomy Plus Prednisone | 35 | 27 |
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Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex
Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months
Intervention | mg (Mean) |
---|
| Female | Male |
---|
Prednisone Alone | 54 | 55 |
,Thymectomy Plus Prednisone | 33 | 31 |
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Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex
Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months
Intervention | units on a scale (Mean) |
---|
| Female | Male |
---|
Prednisone Alone | 9.73 | 7.45 |
,Thymectomy Plus Prednisone | 6.47 | 5.23 |
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Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term
Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60) (NCT00294658)
Timeframe: baseline to 3 years
Intervention | events (Number) |
---|
| Gastrointestinal disorder | Hepatobiliary disorder | Infection or infestation | Injury, poisoning, or procedure complication | Metabolism or nutrition disorder | Nervous system disorder | Respiratory, thoracic, or mediastinal disorder | Surgical or medical procedure | Vascular disorder |
---|
Prednisone Alone | 2 | 1 | 7 | 0 | 0 | 22 | 2 | 7 | 1 |
,Thymectomy Plus Prednisone | 2 | 0 | 4 | 2 | 1 | 8 | 1 | 0 | 0 |
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Minimal Manifestation (MM) Status at Month 12, 24 and 36
Number of participants who were in minimal manifestation status at month 12, 24 and 36. (NCT00294658)
Timeframe: Month 12, 24 and 36
Intervention | participants (Number) |
---|
| Month 12 | Month 24 | Month 36 |
---|
Prednisone Alone | 20 | 20 | 24 |
,Thymectomy Plus Prednisone | 41 | 39 | 39 |
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Classification of Serious Adverse Events
(NCT00294658)
Timeframe: baseline to 3 years
Intervention | participants (Number) |
---|
| Life-threatening | Disability or incapacity | Medical or surgical intervention | Death | Complication due to thytmectomy | Hospitalization |
---|
Prednisone Alone | 7 | 2 | 5 | 1 | 0 | 31 |
,Thymectomy Plus Prednisone | 1 | 8 | 9 | 0 | 1 | 15 |
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Plasma Exchange Use
(NCT00294658)
Timeframe: baseline to 3 years
Intervention | participants (Number) |
---|
Thymectomy Plus Prednisone | 10 |
Prednisone Alone | 9 |
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Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years
Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. The time weighted average is a calculation that provides an integrated measure of the outcome over the time of followup. The denominator that was used to compute the time-weighted average for the Quantitative Myasthenia Gravis (QMG) score and the prednisone dose was the number of days from randomization to the last visit. Computations used the trapezoidal method where in the QMG score is multiplied by the number of days at this level from one visit to the next and added up over the entire followup experience and divided by the total number of days from randomization. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months
Intervention | units on a scale (Mean) |
---|
Thymectomy Plus Prednisone | 6.15 |
Prednisone Alone | 8.99 |
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Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)
Physicians reported prescribed alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prescribed prednisone dosages had been weighted over the days of reporting period. (NCT00294658)
Timeframe: baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months
Intervention | mg (Mean) |
---|
Thymectomy Plus Prednisone | 34.3 |
Prednisone Alone | 55.6 |
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Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36
MG Activity of Daily Living total scores range from 0 to 24 by visit, with the lower scores indicating better daily living quality of life. (NCT00294658)
Timeframe: Month 12, 24, and 36
Intervention | units on a scale (Mean) |
---|
| Month 12 | Month 24 | Month 36 |
---|
Prednisone Alone | 3.33 | 3.11 | 2.69 |
,Thymectomy Plus Prednisone | 1.92 | 2.02 | 2.14 |
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Cumulative Days in Hospital for Myasthenia Gravis Exacerbation
Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60) (NCT00294658)
Timeframe: baseline to 3 years
Intervention | days (Mean) |
---|
Thymectomy Plus Prednisone | 8.7 |
Prednisone Alone | 22.5 |
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Treatment Associated Complications (TAC)
Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit. (NCT00294658)
Timeframe: Month 0, 1, 2, 3, 4 then every 3 months through Month 36
Intervention | Participants (Count of Participants) |
---|
| Month 0 | Month 1 | Month 2 | Month 3 | Month 4 | Month 6 | Month 9 | Month 12 | Month 15 | Month 18 | Month 21 | Mpnth 24 | Mpnth 27 | Month 30 | Month 33 | Month 36 |
---|
Prednisone Alone | 17 | 15 | 20 | 16 | 23 | 22 | 26 | 28 | 24 | 24 | 20 | 23 | 17 | 19 | 23 | 23 |
,Thymectomy Plus Prednisone | 22 | 15 | 22 | 21 | 23 | 21 | 37 | 35 | 29 | 28 | 22 | 28 | 25 | 23 | 24 | 23 |
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Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment
Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months
Intervention | units on a scale (Mean) |
---|
| Not prednisone naïve | Prednisone naïve |
---|
Prednisone Alone | 9.10 | 8.84 |
,Thymectomy Plus Prednisone | 6.30 | 5.66 |
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Maximum Tolerated Dose
Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants (NCT00295932)
Timeframe: 2 years
Intervention | mg/m^2 of Bortezomib (Number) |
---|
| Weekly Bortezomib | Twice-Weekly Bortezomib |
---|
Arm I | 1.8 | 1.5 |
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Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma
Toxicity assessed using NCI-CTC v. 3.0 (NCT00295932)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 4 |
1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 6 |
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 3 |
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 4 |
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 2 |
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 18 |
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham | 3 |
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami | 4 |
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham | 10 |
Weekly Bortezomib Dosing Schedule | 12 |
Twice-weekly Bortezomib Dosing Schedule | 13 |
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New-onset Diabetes Mellitus (NODM) as Secondary Outcome
The incidence of new-onset Diabetes mellitus (NODM, based on percentage of previously non-diabetic patients who developed DM post-transplantation, was similar between the 2 groups. (NCT00296244)
Timeframe: 6 months
Intervention | Percentage of participants (Number) |
---|
Control Group | 40 |
Study Group | 42 |
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Infection as an Adverse Effect of Steroids
Incidence of bacterial infection was similar in the control group as well as study group, 4 patients in both groups had infection (NCT00296244)
Timeframe: 3 months post-transplant
Intervention | Percentage of participants (Number) |
---|
Control Group | 20 |
Study Group | 21 |
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Incidence and Severity of HCV Recurrence Post-OLT
The incidence and severity of HCV recurrence based on Hepatitis C PCR levels and protocol liver biopsy findings were found to be similar between the 2 groups. (NCT00296244)
Timeframe: 6 months post-transplant
Intervention | Percentage of participants (Number) |
---|
Control Group | 27 |
Study Group | 29 |
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Patient Survival Rate
Percentage of recipients who are still alive at the end of 1 and 2 years. (NCT00296244)
Timeframe: 1 and 2 years
Intervention | Percentage of participants (Number) |
---|
| 1-year patient survival rate | 2-year patient survival rate |
---|
Control Group | 100 | 90 |
,Study Group | 94.7 | 84 |
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Graft Survival Rate
Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years. (NCT00296244)
Timeframe: 1 and 2 years
Intervention | percentage of participants (Number) |
---|
| 1-year graft survival rate | 2-year graft survival rate |
---|
Control Group | 100 | 90 |
,Study Group | 94.7 | 84 |
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Acute Rejection Rate
Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive (NCT00296244)
Timeframe: 6 months post-transplant
Intervention | Percentage of participants (Number) |
---|
Control Group | 5 |
Study Group | 5 |
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Progression-free Survival (PFS)
Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance. (NCT00301821)
Timeframe: the time from study entry to 36 months
Intervention | percentage of participants (Number) |
---|
| Progression Free Survival at 12 months | Progression Free Survival at 24 months | Progression Free Survival at 36 months |
---|
Epratuzumab + Rituximab + CHOP | 85 | 77 | 76 |
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Overall Survival
Percentage of participants alive at different time points (NCT00301821)
Timeframe: time from study entry to 36 months
Intervention | percentage of Participants (Number) |
---|
| Overall Survival at 12 months | Overall Survival at 24 months | Overall Survival at 36 months |
---|
Epratuzumab + Rituximab + CHOP | 89 | 81 | 80 |
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Overall Response Rate (ORR)
Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance. (NCT00301821)
Timeframe: Baseline to first 6 cycles of treatment
Intervention | percentage of participants (Number) |
---|
Epratuzumab + Rituximab + CHOP | 95 |
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Event-free Survival After 12 Months
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12). (NCT00301821)
Timeframe: From Baseline to 12 months
Intervention | percentage of participants (Number) |
---|
Epratuzumab + Rituximab + CHOP | 78 |
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Intensive Therapy Free Survival (ITFS).
Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy. (NCT00302003)
Timeframe: At 60 months
Intervention | Probability of survival (Number) |
---|
Group 1 | 0.89 |
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Event Free Survival (EFS)
Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS). (NCT00302003)
Timeframe: At 60 months
Intervention | Probability of survival (Number) |
---|
Group 1 | 0.79 |
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Overall Survival
Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact. (NCT00302003)
Timeframe: At 60 months
Intervention | Probability of survival (Number) |
---|
Group 1 | 0.99 |
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Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT). (NCT00302003)
Timeframe: At 60 months
Intervention | Probability of survival (Number) |
---|
Group 1 | 0.49 |
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To Evaluate the Total Number of Circulating Lymphocytes and Lymphocyte Phenotypes and to Correlate With the Effectiveness of Rituximab and Oral Cyclophosphamide to Achieve and Preserve Complete Eradication of the Refractory Autoantibody.
the 2 recruited patients did not eradicate their inhibitors with 3 weeks of corticosteroids and did not progress in clinical trial since funding was eliminated and study terminated (NCT00306670)
Timeframe: When 25 patients have completed the study.
Intervention | Participants (Count of Participants) |
---|
Oral Cyclophosphamide | 0 |
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Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant
HbA1C, change = value at month x post-transplant - pre-conversion baseline. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | percentage of glucose (Mean) |
---|
| Change at 12 Months post-transplant (n=23,26) | Change at 24 Months post-transplant (n=17,25) | Change at 36 Months post-transplant (n=14,16) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 0.008 | 0.009 | 0.012 |
,Tacrolimus With Mycophenolate/Prednisone | 0.001 | 0.006 | -0.001 |
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Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.
hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | mg/L (Mean) |
---|
| Change at 12 Months post-transplant (n=23,33) | Change at 24 Months post-transplant (n=18,31) | Change at 36 Months post-transplant (n=15,22) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 1.611 | -0.563 | 0.336 |
,Tacrolimus With Mycophenolate/Prednisone | 1.379 | 1.723 | 3.164 |
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Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant
Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | micromole/liter (µmol/L) (Mean) |
---|
| Change at 12 Months post-transplant (n=23,33) | Change at 24 Months post-transplant (n=19,31) | Change at 36 Months post-transplant (n=15,22) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 1.278 | 1.316 | 1.087 |
,Tacrolimus With Mycophenolate/Prednisone | 0.530 | 2.158 | 2.459 |
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Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant
Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | picomole/liter (pmol/L) (Mean) |
---|
| Change at 12 Months post-transplant (n=16,23) | Change at 24 Months post-transplant (n=13,23) | Change at 36 Months post-transplant (n=10,14) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | -4.549 | -6.120 | -22.759 |
,Tacrolimus With Mycophenolate/Prednisone | 17.953 | 32.180 | -2.731 |
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Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant
IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | pg/mL (Mean) |
---|
| Change at 12 Months post-transplant (n=23,32) | Change at 24 Months post-transplant (n=18,29) | Change at 36 Months post-transplant (n=15,22) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | -0.239 | 0.128 | -0.800 |
,Tacrolimus With Mycophenolate/Prednisone | 0.463 | 0.783 | 0.164 |
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Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant
Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | milligram per deciliter (mg/dL) (Mean) |
---|
| Change at 12 Months post-transplant (n=23,30) | Change at 24 Months post-transplant (n=18,26) | Change at 36 Months post-transplant (n=13,17) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 13.496 | 12.517 | 11.885 |
,Tacrolimus With Mycophenolate/Prednisone | -11.680 | 6.073 | 6.547 |
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Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant
TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | pg/mL (Mean) |
---|
| Change at 12 Months post-transplant (n=23,32) | Change at 24 Months post-transplant (n=18,30) | Change at 36 Months post-transplant (n=15,22) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 0.991 | -0.367 | -0.441 |
,Tacrolimus With Mycophenolate/Prednisone | 0.000 | 1.894 | 0.000 |
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Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant
Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | µmol/L (Mean) |
---|
| Change at 12 Months post-transplant (n=23,33) | Change at 24 Months post-transplant (n=19,31) | Change at 36 Months post-transplant (n=15,22) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | -51.53 | -29.02 | -19.03 |
,Tacrolimus With Mycophenolate/Prednisone | 11.10 | 3.89 | -0.58 |
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Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant
Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | pmol/L (Mean) |
---|
| Change at 12 Months post-transplant (n=21,33) | Change at 24 Months post-transplant (n=19,29) | Change at 36 Months post-transplant (n=14,21) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | -10.21 | -36.23 | -40.00 |
,Tacrolimus With Mycophenolate/Prednisone | -11.38 | -27.46 | -46.39 |
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Number of Participants Who Used Anti-hypertensive Medications
"Participants who reported yes for taking anti-hypertensive medications as concomitant medication." (NCT00311311)
Timeframe: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Intervention | participants (Number) |
---|
| From consent to conversion | From conversion to Month 12 | From Months 12 to Month 24 | From Months 24 to Month 36 |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 19 | 21 | 21 | 18 |
,Tacrolimus With Mycophenolate/Prednisone | 30 | 30 | 30 | 28 |
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Number of Participants Who Used Lipid Lowering Therapies
"Participants who reported yes for taking lipid lowering therapies as concomitant medication." (NCT00311311)
Timeframe: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Intervention | participants (Number) |
---|
| From consent to conversion | From conversion to Month 12 | From Months 12 to Month 24 | From Months 24 to Month 36 |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 13 | 22 | 23 | 18 |
,Tacrolimus With Mycophenolate/Prednisone | 24 | 29 | 28 | 27 |
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Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant
Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries. (NCT00311311)
Timeframe: Pre-conversion baseline and 12 months post-transplant
Intervention | millimeter cube/year (mmˆ3/year) (Mean) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | -49.31 |
Tacrolimus With Mycophenolate/Prednisone | 0.66 |
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CIMT at Pre-conversion Baseline
Mean CIMT=average of left CIMT and right CIMT. (NCT00311311)
Timeframe: Pre-conversion baseline
Intervention | mm (Mean) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 0.735 |
Tacrolimus With Mycophenolate/Prednisone | 0.773 |
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TPV at Pre-conversion Baseline
TPV is the sum of the assessment in left and right distal common carotid arteries. (NCT00311311)
Timeframe: Pre-conversion baseline
Intervention | mmˆ3 (Mean) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 68.68 |
Tacrolimus With Mycophenolate/Prednisone | 48.57 |
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Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant
Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit - CIMT at Conversion Baseline) / Imaging interval in years. (NCT00311311)
Timeframe: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
Intervention | millimeter/year (mm/year) (Mean) |
---|
| Annual Change Rate at 12 months (n=16,28) | Annual Change Rate at 18 months (n=15,26) | Annual Change Rate at 24 months (n=15,23) | Annual Change Rate at 36 months (n=8,13) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 0.048 | 0.041 | 0.023 | 0.028 |
,Tacrolimus With Mycophenolate/Prednisone | 0.012 | -0.0002 | 0.015 | -0.007 |
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Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant
Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries. (NCT00311311)
Timeframe: Pre-conversion baseline, and 18, 24 and 36 months post-transplant
Intervention | mmˆ3/year (Mean) |
---|
| Month 18 post-transplant (n=12,12) | Month 24 post-transplant (n=11,14) | Month 36 post-transplant (n=7,11) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 17.15 | 25.28 | 6.62 |
,Tacrolimus With Mycophenolate/Prednisone | 19.71 | 9.10 | 8.98 |
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Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant
Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | microgram per milliliter (µg/mL) (Mean) |
---|
| Change at 12 Months post-transplant (n=23,33) | Change at 24 Months post-transplant (n=18,31) | Change at 36 Months post-transplant (n=15,22) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 5.352 | 2.244 | 1.487 |
,Tacrolimus With Mycophenolate/Prednisone | -2.205 | -0.267 | -1.413 |
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Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant
Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | pg/mL (Mean) |
---|
| Change at 12 Months post-transplant (n=22,30) | Change at 24 Months post-transplant (n=18,30) | Change at 36 Months post-transplant (n=14,22) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 0.294 | 0.426 | 0.411 |
,Tacrolimus With Mycophenolate/Prednisone | 0.028 | 0.138 | -0.104 |
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Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant
Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline. (NCT00311311)
Timeframe: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
Intervention | millimole/liter (mmol/L) (Mean) |
---|
| Change in TC 12 Months post-transplant (n=23,30) | Change in LDL 12 Months post-transplant (n=21,30) | Change in HDL 12 Months post-transplant (n=23,30) | Change in Tg 12 Months post-transplant (n=23,30) | Change in TC 18 Months post-transplant (n=21,29) | Change in LDL 18 Months post-transplant (n=20,29) | Change in HDL 18 Months post-transplant (n=21,29) | Change in Tg 18 Months post-transplant (n=21,29) | Change in TC 24 Months post-transplant (n=19,27) | Change in LDL 24 Months post-transplant (n=16,27) | Change in HDL 24 Months post-transplant (n=19,27) | Change in Tg 24 Months post-transplant (n=19,27) | Change in TC 36 Months post-transplant (n=15,21) | Change in LDL 36 Months post-transplant (n=13,21) | Change in HDL 36 Months post-transplant (n=15,21) | Change in Tg 36 Months post-transplant (n=15,21) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 0.510 | 0.277 | 0.059 | 0.617 | 0.361 | 0.222 | 0.106 | 0.359 | 0.240 | 0.067 | 0.067 | 0.547 | 0.386 | 0.027 | 0.098 | 0.527 |
,Tacrolimus With Mycophenolate/Prednisone | -0.164 | -0.056 | -0.053 | -0.117 | 0.082 | 0.138 | -0.030 | -0.057 | -0.008 | 0.054 | -0.019 | -0.088 | -0.323 | -0.257 | 0.111 | -0.385 |
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Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant
Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | gram per liter (g/L) (Mean) |
---|
| Change at 12 Months post-transplant (n=22,31) | Change at 24 Months post-transplant (n=19,29) | Change at 36 Months post-transplant (n=14,20) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 0.62 | 0.45 | 0.40 |
,Tacrolimus With Mycophenolate/Prednisone | 0.20 | 0.33 | 0.21 |
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Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant
Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Intervention | mmol/L (Mean) |
---|
| Change at 12 Months post-transplant (n=23,33) | Change at 24 Months post-transplant (n=19,31) | Change at 36 Months post-transplant (n=14,22) |
---|
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | 0.606 | 0.832 | 0.686 |
,Tacrolimus With Mycophenolate/Prednisone | -0.083 | -0.076 | -0.214 |
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Total Number of Circulation Tumor Cells (CTCs)
Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining. (NCT00313781)
Timeframe: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)
Intervention | Number of CTCs/7.5 mL (Mean) |
---|
| Baseline (Cycle 1 Day 1) (n=46, 39) | Cycle 3 Day1 (n=28, 29) | Cycle 5 Day 1 (n=25, 23) |
---|
CP-751,871+Docetaxel+Prednisone | 105.17 | 6.39 | 15.20 |
,Docetaxel+Prednisone | 213.23 | 12.21 | 17.78 |
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Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)
Levels of HAHA in serum were detected at baseline. (NCT00313781)
Timeframe: Baseline (Day 1 of Cycle 1)
Intervention | mg/deciliter (dl) (Mean) |
---|
CP-751,871+Docetaxel+Prednisone | 1130.3 |
Docetaxel+Prednisone | 1338.1 |
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Human Anti-human Antibody (HAHA) at the Last Follow-up Visit
Levels of HAHA in serum were detected at the last follow-up visit. (NCT00313781)
Timeframe: The last follow-up visit (150 days post last dose)
Intervention | mg/dl (Mean) |
---|
CP-751,871+Docetaxel+Prednisone | 944.81 |
Docetaxel+Prednisone | 819.00 |
Docetaxel+Prednisone+CP-751,871 Crossover | 970.86 |
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Percentage of Participants With Prostate Specific Antigen (PSA) Best Response
Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as >= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. (NCT00313781)
Timeframe: Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)
Intervention | Percentage of participants (Mean) |
---|
CP-751,871+Docetaxel+Prednisone | 51.7 |
Docetaxel+Prednisone | 60.2 |
Docetaxel+Prednisone+CP-751,871 Crossover | 28.1 |
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Progression Free Survival (PFS)
PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3. (NCT00313781)
Timeframe: Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)
Intervention | Months (Median) |
---|
CP-751,871+Docetaxel+Prednisone | 4.9 |
Docetaxel+Prednisone | 7.7 |
Docetaxel+Prednisone+CP-751,871 Crossover | 4.0 |
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Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs
Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive CTCs. (NCT00313781)
Timeframe: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)
Intervention | Number of IGF-1R positive CTCs/7.5 mL (Mean) |
---|
| Baseline (Cycle 1 Day 1) (n=22, 18) | Cycle 3 Day1 (n=12, 15) | Cycle 5 Day 1 (n=11, 10) |
---|
CP-751,871+Docetaxel+Prednisone | 24.73 | 2.33 | 2.00 |
,Docetaxel+Prednisone | 54.94 | 4.93 | 3.90 |
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Proportion Responding to Treatment With of the Combination of Ixabepilone and Mitoxantrone Hydrochloride With Prednisone in Hormone Refractory Prostate Cancer Patients Who Have Had Prior Taxane Chemotherapy Based Upon a PSA Decline of > 50% (Phase II)
"Descriptive statistics will be calculated to characterize the disease and treatment factors including the proportion responding with a 95% confidence interval. If accrual is completed and more than 15 of 58 patients show > 50% Prostate Specific Antigen (PSA) declines after 3 courses, then the null hypothesis of a 20% response proportion will be rejected. PSA declines for individual patients will be plotted in the form of a waterfall diagram of maximal PSA declines.~58 patients were enrolled for phase II, two were ineligible so 56 patients were analyzed." (NCT00331344)
Timeframe: Every 3 courses until cancer progression/excessive toxicity or death
Intervention | Participants (Count of Participants) |
---|
Treatment (Combination Chemotherapy) | 25 |
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Time to Progression (Phase II)
Measured from the start of protocol therapy until RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.0 progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00331344)
Timeframe: Every 3 months until cancer progression/excessive toxicity or death
Intervention | months (Median) |
---|
Treatment (Combination Chemotherapy) | 4.4 |
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Number of Patients That Achieved a Complete Response (CR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00337987)
Timeframe: After 4 years
Intervention | participants (Number) |
---|
Denileukin Diftitox/CHOP Administration | 27 |
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Number of Patients That Achieved a Complete Response or a Partial Response (PR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00337987)
Timeframe: After 4 years
Intervention | participants (Number) |
---|
Denileukin Diftitox/CHOP Administration | 32 |
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Percent Change in Flare at Resolution
(NCT00345046)
Timeframe: 2 months
Intervention | Percent change in flare (Mean) |
---|
Pred Forte 1% | 64.8 |
Econo Pred Plus 1% | 68.3 |
Predisolone Acetate 1% | 65.7 |
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Progression-free Survival Based on PSA Progression
Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up. (NCT00348816)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
Docetaxel (Single Arm) | 12 |
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Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero.. (NCT00348816)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
Docetaxel (Single Arm) | 12 |
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Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial
Participants that decreased total daily corticosteroids ≤ 0.25mg/kg one year after rituximab infusion began (NCT00350545)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Rituximab + Prednisone Arm | 14 |
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Overall Survival
Overall survival at 6 and 12 months (NCT00350545)
Timeframe: 6 and 12 months
Intervention | Participants (Count of Participants) |
---|
| 6 month overall survival | 12 month overall survival |
---|
Rituximab + Prednisone Arm | 33 | 30 |
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Number of Participants With Complete and/or Partial GVHD Response
To have physician documentation of clinical GVHD response using organ staging and scoring scale- NIH clinical GVHD consensus response criteria applied 6 months after rituximab infusion began (NCT00350545)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
| Complete response | Partial response |
---|
Rituximab + Prednisone Arm | 12 | 15 |
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Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation
Failure-free survival (FFS) was defined as participants who are surviving with no relapse and second line of cGVHD treatment. (NCT00350545)
Timeframe: 6 and 12 Months
Intervention | Participants (Count of Participants) |
---|
| 6 month FFS | 12 month FFS |
---|
Rituximab + Prednisone Arm | 28 | 21 |
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Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose.
Participants that have successfully tapered prednisone to a dose of 0.25 mg/kg/Day by 6 Months without clinical relapse. (NCT00350545)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Rituximab + Prednisone Arm | 14 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -2.31 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -1.35 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -1.46 |
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3-year Overall Survival (OS) Probability
Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3-years
Intervention | probability (Number) |
---|
HOD05 Participants | 1.00 |
HOD99 Participants | 0.978 |
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3-year Local Failure-free Survival Probability
Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3 years
Intervention | probability (Number) |
---|
HOD05 Participants | 0.887 |
HOD99 Participants | 0.932 |
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3-year Event-Free Survival Probability
The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame. (NCT00352027)
Timeframe: 3 years
Intervention | probability (Number) |
---|
Stanford V Chemotherapy | 0.887 |
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Patient Quality of Life (QoL), Symptom Distress Scale
"The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.~Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 17.3 |
Week 8 | 19.6 |
Week 12 | 18.1 |
After Radiation | 15.1 |
Off-therapy | 14.3 |
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Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 90.9 |
Week 8 | 88.6 |
Week 12 | 88.0 |
After Radiation | 90.1 |
Off-therapy | 91.1 |
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Patient Quality of Life (QoL), PedsQL v.4.0: Total Score
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 80.9 |
Week 8 | 74.4 |
Week 12 | 75.3 |
After Radiation | 83.1 |
Off-therapy | 84.5 |
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Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 73.1 |
Week 8 | 69.5 |
Week 12 | 72.6 |
After Radiation | 78.4 |
Off-therapy | 81.3 |
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Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 79.3 |
Week 8 | 77.6 |
Week 12 | 78.6 |
After Radiation | 84.3 |
Off-therapy | 84.3 |
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Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 83.2 |
Week 8 | 68.4 |
Week 12 | 69.1 |
After Radiation | 80.8 |
Off-therapy | 85.2 |
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Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 72.6 |
Week 8 | 75.3 |
Week 12 | 75.7 |
After Radiation | 84.5 |
Off-therapy | 81.6 |
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Patient Quality of Life (QoL), PedsQL v.3.0: Worry
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 71.2 |
Week 12 | 72.2 |
After Radiation | 74.5 |
Off-therapy | 76.0 |
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Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 89.2 |
Week 12 | 82 |
After Radiation | 89.4 |
Off-therapy | 87.3 |
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Patient Quality of Life (QoL), PedsQL v.3.0: Total Score
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 74.1 |
Week 12 | 74.2 |
After Radiation | 81.7 |
Off-therapy | 83.5 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -2.52 |
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Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 71.8 |
Week 12 | 70.9 |
After Radiation | 68.1 |
Off-therapy | 80.1 |
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Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 77.6 |
Week 12 | 81.3 |
After Radiation | 81.4 |
Off-therapy | 84.7 |
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Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 63.9 |
Week 12 | 71.5 |
After Radiation | 79.9 |
Off-therapy | 88.0 |
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Patient Quality of Life (QoL), PedsQL v.3.0: Nausea
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 62.7 |
Week 12 | 60.1 |
After Radiation | 76.7 |
Off-therapy | 81.6 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -1.41 |
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Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 79.1 |
Week 12 | 78.2 |
After Radiation | 87.0 |
Off-therapy | 82.0 |
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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 77.6 |
Week 8 | 69.1 |
Week 12 | 72.3 |
After Radiation | 77.8 |
Off-therapy | 83.5 |
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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 86.1 |
Week 8 | 83.0 |
Week 12 | 80.7 |
After Radiation | 85.1 |
Off-therapy | 89.1 |
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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 74.4 |
Week 8 | 62.8 |
Week 12 | 70.8 |
After Radiation | 75.6 |
Off-therapy | 78.9 |
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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 76.2 |
Week 8 | 71.0 |
Week 12 | 74.1 |
After Radiation | 79.0 |
Off-therapy | 88.0 |
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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 79.8 |
Week 8 | 65.3 |
Week 12 | 67.3 |
After Radiation | 73.6 |
Off-therapy | 84.6 |
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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Pre-therapy | 67.7 |
Week 8 | 65.4 |
Week 12 | 68.1 |
After Radiation | 73.0 |
Off-therapy | 82.0 |
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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 70 |
Week 12 | 69.2 |
After Radiation | 71.9 |
Off-therapy | 78.7 |
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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 81.9 |
Week 12 | 72.6 |
After Radiation | 78.5 |
Off-therapy | 81.8 |
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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 71.7 |
Week 12 | 69.3 |
After Radiation | 74.5 |
Off-therapy | 80.0 |
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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 70.0 |
Week 12 | 60.0 |
After Radiation | 63.1 |
Off-therapy | 73.8 |
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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 74.9 |
Week 12 | 72.2 |
After Radiation | 73.7 |
Off-therapy | 76.3 |
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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 61.2 |
Week 12 | 61.8 |
After Radiation | 73.1 |
Off-therapy | 82.7 |
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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 61.2 |
Week 12 | 57.4 |
After Radiation | 72.2 |
Off-therapy | 83.2 |
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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 79.2 |
Week 12 | 80.4 |
After Radiation | 80.3 |
Off-therapy | 84.3 |
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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 77.6 |
Week 12 | 79.5 |
After Radiation | 78.6 |
Off-therapy | 79.9 |
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Disease Failure Rate Within Radiation Fields
Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). (NCT00352027)
Timeframe: 3 years
Intervention | proportion of participants (Number) |
---|
Stanford V Chemotherapy | 0.1125 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Pre-therapy | -2.9 |
Parent and Patient Scores at Week 8 | -4.8 |
Parent and Patient Scores at Week 12 | -4.8 |
Parent and Patient Scores at After Radiation | -5 |
Parent and Patient Scores at Off-therapy | -2.9 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Pre-therapy | -5.3 |
Parent and Patient Scores at Week 8 | -5.7 |
Parent and Patient Scores at Week 12 | -7.4 |
Parent and Patient Scores at After Radiation | -5.0 |
Parent and Patient Scores at Off-therapy | -3.3 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Pre-therapy | 1.3 |
Parent and Patient Scores at Week 8 | -5.3 |
Parent and Patient Scores at Week 12 | -4.1 |
Parent and Patient Scores at After Radiation | -3.4 |
Parent and Patient Scores at Off-therapy | -4.3 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Pre-therapy | -2.8 |
Parent and Patient Scores at Week 8 | -6.4 |
Parent and Patient Scores at Week 12 | -6.3 |
Parent and Patient Scores at After Radiation | -5.6 |
Parent and Patient Scores at Off-therapy | -3.3 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Pre-therapy | -2.9 |
Parent and Patient Scores at Week 8 | -2.3 |
Parent and Patient Scores at Week 12 | -1.9 |
Parent and Patient Scores at After Radiation | -5.4 |
Parent and Patient Scores at Off-therapy | -2 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Pre-therapy | -4.9 |
Parent and Patient Scores at Week 8 | -9.4 |
Parent and Patient Scores at Week 12 | -8.0 |
Parent and Patient Scores at After Radiation | -10.8 |
Parent and Patient Scores at Off-therapy | -1.7 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Week 8 | -0.7 |
Parent and Patient Scores at Week 12 | -3.9 |
Parent and Patient Scores at After Radiation | -2.7 |
Parent and Patient Scores at Off-therapy | -0.5 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Week 8 | -6.1 |
Parent and Patient Scores at Week 12 | -8.8 |
Parent and Patient Scores at After Radiation | -7.9 |
Parent and Patient Scores at Off-therapy | -6.6 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Week 8 | -1.5 |
Parent and Patient Scores at Week 12 | -5.2 |
Parent and Patient Scores at After Radiation | -4.5 |
Parent and Patient Scores at Off-therapy | -5 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -1.20 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Week 8 | -0.2 |
Parent and Patient Scores at Week 12 | -9.3 |
Parent and Patient Scores at After Radiation | -2.2 |
Parent and Patient Scores at Off-therapy | -8.7 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Week 8 | -2.5 |
Parent and Patient Scores at Week 12 | -9.5 |
Parent and Patient Scores at After Radiation | -5.9 |
Parent and Patient Scores at Off-therapy | -9.3 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -0.87 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Week 8 | -2.0 |
Parent and Patient Scores at Week 12 | -9.5 |
Parent and Patient Scores at After Radiation | -5.6 |
Parent and Patient Scores at Off-therapy | -5.4 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Week 8 | -1.2 |
Parent and Patient Scores at Week 12 | -3.4 |
Parent and Patient Scores at After Radiation | -3.0 |
Parent and Patient Scores at Off-therapy | -1.1 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Week 8 | -0.3 |
Parent and Patient Scores at Week 12 | -3.6 |
Parent and Patient Scores at After Radiation | -7.4 |
Parent and Patient Scores at Off-therapy | -6.3 |
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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Parent and Patient Scores at Week 8 | -1.0 |
Parent and Patient Scores at Week 12 | 0.14 |
Parent and Patient Scores at After Radiation | -8.0 |
Parent and Patient Scores at Off-therapy | -4.0 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -1.46 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -0.79 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -1.21 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -0.92 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -1.9 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -1.56 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -1.06 |
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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
Intervention | beta coefficient (Number) |
---|
QoL Participants | -0.96 |
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Patient Quality of Life (QoL), PedsQL v.3.0: Communication
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Intervention | units on a scale (Mean) |
---|
Week 8 | 80.7 |
Week 12 | 83.0 |
After Radiation | 87.2 |
Off-therapy | 89.0 |
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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)
For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy
Intervention | Participants (Count of Participants) |
---|
| Normal | Hypothyroid | Hyperthyroid | Thyroid Nodule |
---|
Year 1 Off Therapy | 60 | 8 | 2 | 0 |
,Year 10 Off Therapy | 20 | 3 | 0 | 0 |
,Year 2 Off Therapy | 54 | 11 | 1 | 0 |
,Year 5 Off Therapy | 37 | 8 | 1 | 0 |
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3-year Event-free Survival (EFS) Probability
Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3 years
Intervention | probability (Number) |
---|
HOD05 Participants | 0.887 |
HOD99 Participants | 0.844 |
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Toxicities With Grade >1
Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. (NCT00352027)
Timeframe: 3 years
Intervention | adverse events (Number) |
---|
| Alanine transaminase (ALT) | Aspartate transaminase (AST) | Allergic reaction/hypersensitivity | Constipation | Febrile neutropenia | Fever (in the absence of neutropenia) | Glucose | GGT (gamma-Glutamyltranspeptidase) | Hemoglobin | Hypoxia | Ileus, GI (functional obstruction of bowel) | Infection with Grade 3 or 4 neutrophils | Infection - Other | Infection with normal ANC or Grade 1-2 neutrophils | Infection with unknown ANC | Insomnia | Leukocytes (total WBC) | Lymphopenia | Mucositis/stomatitis (functional/symptomatic) | Nausea | Neuropathy: motor | Neuropathy: sensory | Neutrophils/granulocytes (ANC/AGC) | Pain | Phosphate | Platelets | Potassium | Sodium | Syndromes - Other | Thrombosis/embolism (vascular access-related) | Thrombosis/thrombus/embolism | Vomiting |
---|
HOD05 - Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,HOD05 - Grade 3 | 1 | 1 | 4 | 0 | 7 | 2 | 0 | 1 | 26 | 1 | 1 | 2 | 1 | 3 | 0 | 1 | 41 | 22 | 0 | 1 | 0 | 1 | 24 | 5 | 1 | 0 | 2 | 1 | 1 | 2 | 0 | 2 |
,HOD05 - Grade 4 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 7 | 0 | 0 | 0 | 0 | 32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
,HOD05 - Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,HOD99 - Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
,HOD99 - Grade 3 | 0 | 0 | 0 | 1 | 5 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 1 | 1 | 0 | 19 | 0 | 1 | 2 | 1 | 1 | 9 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 4 |
,HOD99 - Grade 4 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 30 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,HOD99 - Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Prognostic Factors for Treatment Failure: Stage
Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage NCT00352027)
Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
Intervention | events (Number) |
---|
| Stage Stage ≥III | |
---|
Stanford V Chemotherapy | 8 | 3 |
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Prognostic Factors for Treatment Failure: Histology
Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. (NCT00352027)
Timeframe: 3 years follow-up
Intervention | events (Number) |
---|
| Classical, Nodular Sclerosing | Other |
---|
Stanford V Chemotherapy | 10 | 1 |
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Prognostic Factors for Treatment Failure: Gender
Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. (NCT00352027)
Timeframe: 3 years follow-up
Intervention | events (Number) |
---|
| Male | Female |
---|
Stanford V Chemotherapy | 5 | 6 |
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Local and Distant Failure for Children Treated With Tailored-field Radiation
The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field. (NCT00352027)
Timeframe: from first enrollment date up to 3 years follow-up
Intervention | probability that the event occurs (Number) |
---|
| Cumulative incidence of distant failure at 3 years | Cumulative incidence of local failure at 3 years |
---|
Stanford V Chemotherapy | 0.0375 | 0.1127 |
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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)
Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy
Intervention | Participants (Count of Participants) |
---|
| Normal | Abnormal |
---|
Year 1 Off Therapy | 46 | 20 |
,Year 10 Off Therapy | 9 | 1 |
,Year 2 Off Therapy | 41 | 20 |
,Year 5 Off Therapy | 25 | 11 |
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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)
Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy
Intervention | Participants (Count of Participants) |
---|
| Normal | Abnormal |
---|
Year 1 Off Therapy | 51 | 5 |
,Year 10 Off Therapy | 10 | 6 |
,Year 2 Off Therapy | 44 | 8 |
,Year 5 Off Therapy | 24 | 4 |
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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)
Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy
Intervention | Participants (Count of Participants) |
---|
| Normal | Abnormal |
---|
Year 1 Off Therapy | 68 | 0 |
,Year 10 Off Therapy | 15 | 1 |
,Year 2 Off Therapy | 57 | 1 |
,Year 5 Off Therapy | 36 | 2 |
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Prognostic Factors for Treatment Failure: Age
Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. (NCT00352027)
Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
Intervention | events (Number) |
---|
Stanford V Chemotherapy | 11 |
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Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement)
Time to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death. (NCT00352794)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Lenalidomide + Prednisone | 14 |
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Objective Response Rate (ORR)
Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed. (NCT00365274)
Timeframe: Up to 5 years
Intervention | percentage of participants (Number) |
---|
| Complete Response | Partial Response |
---|
SGN-30 + Combination Chemotherapy | 83 | 17 |
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Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis)
This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation. (NCT00371826)
Timeframe: Month 12
Intervention | Participants (Number) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 34 |
CNI+MPA+ Steroid | 31 |
Steroid Withdrawal | 13 |
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Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis)
Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria. (NCT00371826)
Timeframe: At Month 12
Intervention | mg/mg (Mean) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 0.2 |
CNI+MPA+ Steroid | 0.1 |
Steroid Withdrawal | 0.1 |
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Mean Serum Creatinine (12 Months Analysis)
(NCT00371826)
Timeframe: At Month 12
Intervention | umol/L (Mean) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 118.9 |
CNI+MPA+ Steroid | 161.0 |
Steroid Withdrawal | 148.6 |
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Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis)
The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. (NCT00371826)
Timeframe: At Month 12
Intervention | mL/min per 1.73 m^2 (Mean) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 65.2 |
CNI+MPA+ Steroid | 69.3 |
Steroid Withdrawal | 66.9 |
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Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis)
(NCT00371826)
Timeframe: At Month 12, 24 and 36
Intervention | Participants (Number) |
---|
| At Month 12 | At Month 24 | At Month 36 |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 1 | 1 | 1 |
,CNI+MPA+ Steroid | 0 | 0 | 2 |
,Steroid Withdrawal | 0 | 0 | 0 |
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Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis)
Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria. (NCT00371826)
Timeframe: At Month 12, 18, 24 and 36
Intervention | mg/mmol (Mean) |
---|
| At 12 Month (n = 18, 32, 2) | At 18 Month (n= 17, 31, 2) | At 24 Month ( n= 16, 29, 1) | At 36 Month ( n= 15, 25, 0) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 23.5 | 28.2 | 30.0 | 30.6 |
,CNI+MPA+ Steroid | 8.1 | 8.1 | 6.6 | 23.4 |
,Steroid Withdrawal | 4.8 | 5.3 | 7.0 | NA |
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Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis)
The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. (NCT00371826)
Timeframe: At Month 24 and 36
Intervention | mL/min per 1.73 m^2 (Mean) |
---|
| Month 24 (n= 23, 36, 4) | Month 36 (n= 19, 35, 3) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 69.5 | 71.6 |
,CNI+MPA+ Steroid | 71.8 | 69.1 |
,Steroid Withdrawal | 67.0 | 61.0 |
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Number of Participants With Erythropoietin Usage (36 Months Analysis)
(NCT00371826)
Timeframe: Month 36
Intervention | participants (Number) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 5 |
CNI+MPA+ Steroid | 7 |
Steroid Withdrawal | 2 |
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Number of Participants With Erythropoietin Usage (12 Months Analysis)
(NCT00371826)
Timeframe: Month 12
Intervention | participants (Number) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 20 |
CNI+MPA+ Steroid | 10 |
Steroid Withdrawal | 8 |
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Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis)
"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.~The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss." (NCT00371826)
Timeframe: Month 12
Intervention | Participants (Number) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 16 |
CNI+MPA+ Steroid | 8 |
Steroid Withdrawal | 11 |
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Number of Participants With Any Wound Problems (36 Months Analysis)
Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis. (NCT00371826)
Timeframe: At Month 12, 24 and 36
Intervention | Participants (Number) |
---|
| At Month 12 | At Month 24 | At Month 36 |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 6 | 9 | 10 |
,CNI+MPA+ Steroid | 11 | 13 | 13 |
,Steroid Withdrawal | 2 | 2 | 2 |
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Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis)
The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded criteria Donor (ECD) organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status. (NCT00371826)
Timeframe: At Month 12
Intervention | Participants (Number) |
---|
| Age < 55 years | Age > = 55 years | ECD Organ | NO ECD Organ | Male | Female | Living donor | Deceased donor | BMI < 18.5 | BMI 18.5 - <25 | BMI 25 - <30 | BMI >= 30 | Years on dialysis before transplantation: None | < 1 Year on dialysis before transplantation | 1 - 5 Years on dialysis before transplantation | > 5 Years on dialysis before transplantation | Diabetes mellitus: No | Diabetes mellitus: Yes | Hypertension: No | Hypertension: Yes | Cardiovascular disease : No | Cardiovascular disease: Yes | Nephrosclerosis: No | Nephrosclerosis: Yes | Glomerulonephritis/glomerular disease : No | Glomerulonephritis/glomerular disease: Yes | Cytomegalovirus : Negative | Cytomegalovirus : Positive |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 11 | 4 | 3 | 12 | 11 | 4 | 9 | 6 | 0 | 5 | 8 | 2 | 1 | 3 | 8 | 3 | 10 | 5 | 2 | 13 | 4 | 11 | 15 | 0 | 8 | 7 | 2 | 13 |
,CNI+MPA+ Steroid | 5 | 1 | 0 | 6 | 6 | 0 | 6 | 0 | 1 | 2 | 3 | 0 | 0 | 3 | 1 | 2 | 4 | 2 | 1 | 5 | 3 | 3 | 6 | 0 | 5 | 1 | 2 | 4 |
,Steroid Withdrawal | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 0 | 3 | 1 | 1 | 0 | 1 | 2 | 2 | 4 | 1 | 0 | 5 | 2 | 3 | 4 | 1 | 3 | 2 | 0 | 5 |
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Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis)
The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded Criteria Donor [ECD] organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status. (NCT00371826)
Timeframe: At Month 36
Intervention | Participants (Number) |
---|
| Age < 55 years | Age > = 55 years | ECD Organ | NO ECD Organ | Male | Female | Living donor | Deceased donor | BMI < 18.5 | BMI 18.5 - <25 | BMI 25 - <30 | BMI >= 30 | Years on dialysis before transplantation: None | < 1 Year on dialysis before transplantation | 1 - 5 Years on dialysis before transplantation | > 5 Years on dialysis before transplantation | Diabetes mellitus: No | Diabetes mellitus: Yes | Hypertension: No | Hypertension: Yes | Cardiovascular disease : No | Cardiovascular disease: Yes | Nephrosclerosis: No | Nephrosclerosis: Yes | Glomerulonephritis/glomerular disease : No | Glomerulonephritis/glomerular disease: Yes | Cytomegalovirus : Negative | Cytomegalovirus : Positive |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 6 | 0 | 0 | 6 | 4 | 2 | 5 | 1 | 1 | 1 | 4 | 0 | 0 | 3 | 2 | 1 | 3 | 3 | 1 | 5 | 3 | 3 | 6 | 0 | 4 | 2 | 1 | 5 |
,CNI+MPA+ Steroid | 7 | 1 | 0 | 8 | 7 | 1 | 6 | 2 | 0 | 3 | 4 | 1 | 1 | 4 | 2 | 1 | 6 | 2 | 1 | 7 | 5 | 3 | 7 | 1 | 7 | 1 | 4 | 4 |
,Steroid Withdrawal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis)
"Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.~Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done." (NCT00371826)
Timeframe: At Month 36
Intervention | Participants (Number) |
---|
| YES | NO | Not Done |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 2 | 8 | 8 |
,CNI+MPA+ Steroid | 1 | 16 | 14 |
,Steroid Withdrawal | 1 | 1 | 1 |
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Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis)
"A per-protocol biopsy was performed at Baseline and Month 12 and read by an independent blinded pathologist in order to assess chronic allograft nephropathy. Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.~Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done." (NCT00371826)
Timeframe: At Month 12
Intervention | Participants (Number) |
---|
| YES | NO | Not Done |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 8 | 15 | 7 |
,CNI+MPA+ Steroid | 6 | 26 | 8 |
,Steroid Withdrawal | 2 | 5 | 3 |
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Number of Participants With Employment Status (36 Months Analysis)
"The various employment status reported are:~Employed/self employed full time~Employed part time~Unemployed~Homemaker~Volunteer~Permanently disabled~Non-permanently disable~Retired~Other" (NCT00371826)
Timeframe: At screening (at day 0 +/- 7 days ), At Month 36
Intervention | Participants (Number) |
---|
| Screening visit: Employed/self employed full time | Month 36: Employed/self employed full time | Screening visit: Employed part time | Month 36: Employed part time | Screening visit: Unemployed | Month 36: Unemployed | Screening visit: Homemaker | Month 36 : Homemaker | Screening visit: Permanently disabled | Month 36: Permanently disabled | Screening visit: Non-permanently disabled | Month 36: Non-permanently disabled | Screening visit: Retired | Month 36: Retired | Screening visit: Other | Month 36: Other |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 5 | 4 | 4 | 3 | 5 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
,CNI+MPA+ Steroid | 10 | 10 | 7 | 4 | 7 | 6 | 3 | 3 | 1 | 1 | 1 | 1 | 2 | 2 | 0 | 0 |
,Steroid Withdrawal | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis)
A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification. (NCT00371826)
Timeframe: At Month 12, 24 and 36
Intervention | Participants (Number) |
---|
| At Month 12 | At Month 24 | At Month 36 |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 4 | 5 | 6 |
,CNI+MPA+ Steroid | 4 | 5 | 8 |
,Steroid Withdrawal | 0 | 0 | 0 |
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Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis)
"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.~The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss." (NCT00371826)
Timeframe: At Month 12, 24 and 36
Intervention | Participants (Number) |
---|
| At Month 12 | At Month 24 | At Month 36 |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 4 | 6 | 7 |
,CNI+MPA+ Steroid | 4 | 6 | 10 |
,Steroid Withdrawal | 0 | 0 | 0 |
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Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)
"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L~Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L" (NCT00371826)
Timeframe: Overall Post Baseline up to month 36
Intervention | Participants (Number) |
---|
| Total Cholesterol: High | Triglycerides : High |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 6 | 0 |
,CNI+MPA+ Steroid | 0 | 1 |
,Steroid Withdrawal | 1 | 0 |
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Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis)
"The symptoms of post transplant diabetes mellitus (PTDM) and impaired fasting glucose are defined as any of the following conditions:~Patients receiving glucose lowering treatment~Fasting plasma glucose (FPG) >= 126 mg/dL on 2 separate occasions~Hemoglobin subtype A1c (HbA1c) > 6.5%~Diabetes reported as treatment emergent AE with end date > Day 15" (NCT00371826)
Timeframe: At Month 12
Intervention | Participants (Number) |
---|
| Glucose lowering treatment | FPG >= 126 mg/dL on 2 separate occasions | HbA1c > 6.5% | Diabetes as treatment emergent AE | Any of the above symptoms |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 10 | 6 | 12 | 8 | 19 |
,CNI+MPA+ Steroid | 9 | 0 | 3 | 2 | 10 |
,Steroid Withdrawal | 5 | 5 | 5 | 3 | 8 |
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Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis)
"Based on Banff 97 criteria, sub clinical acute rejection can be:~GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).~GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).~GRADE III - Cases with transmural arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).~Borderline' category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)." (NCT00371826)
Timeframe: At Month 36
Intervention | Participants (Number) |
---|
| Month 36: NO | Month 36: Borderline | Month 36: Grade IA | Month 36: Grade IB | Month 36: Grade IIA | Month 36: Grade IIB | Month 36: Grade III | Month 36: Not Done |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 9 | 1 | 0 | 0 | 0 | 0 | 0 | 8 |
,CNI+MPA+ Steroid | 15 | 1 | 1 | 0 | 0 | 0 | 0 | 14 |
,Steroid Withdrawal | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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Number of Participants With Wound Problems(12 Months Analysis)
Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis. (NCT00371826)
Timeframe: At Month 12
Intervention | Participants (Number) |
---|
| Any wound healing problem | Infection related to kidney surgery | Dehiscence | Lymphocele | Hernia | Seroma | Hematoma | Ureteral anastomotic complication | Other |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 16 | 2 | 3 | 3 | 3 | 4 | 4 | 2 | 3 |
,CNI+MPA+ Steroid | 15 | 4 | 2 | 4 | 2 | 9 | 0 | 1 | 1 |
,Steroid Withdrawal | 9 | 3 | 2 | 3 | 1 | 3 | 2 | 1 | 0 |
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Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis)
Measurements of bone mineral density (BMD) by Dual Energy X-ray Absorptiometry (DEXA) were done at Week 2 and Month 24. Change in BMD between week 2 and Month 24 were done for neck of femur and lumbar spine. (NCT00371826)
Timeframe: Week 2, Month 24
Intervention | g/cm^2 (Mean) |
---|
| Neck of Femur (Month 24- Week 2) | Lumbar Spine (Month 24 - Week 2) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 0.2 | -0.0 |
,CNI+MPA+ Steroid | -0.1 | -0.1 |
,Steroid Withdrawal | -0.1 | -0.0 |
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Mean Serum Creatinine (36 Months Analysis)
(NCT00371826)
Timeframe: At Month 12, 18, 24 and 36
Intervention | umol/L (Mean) |
---|
| At Month 12 (n= 23, 39, 4) | At Month 18 (n= 22, 36, 4) | At Month 24 (n = 23, 36, 4) | At Month 36 (n= 19, 35, 3) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 112.7 | 113.6 | 119.9 | 119.4 |
,CNI+MPA+ Steroid | 123.0 | 121.4 | 123.7 | 131.8 |
,Steroid Withdrawal | 146.8 | 146.3 | 146.5 | 176.0 |
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Number of Patient Survival and Graft Survival (12 Months Analysis)
(NCT00371826)
Timeframe: At Month 12
Intervention | Participants (Number) |
---|
| Patient Survival | Graft Survival |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 49 | 49 |
,CNI+MPA+ Steroid | 46 | 45 |
,Steroid Withdrawal | 30 | 30 |
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Number of Patient Survival and Graft Survival (36 Months Analysis)
(NCT00371826)
Timeframe: At Month 12, 24 and 36
Intervention | Participants (Number) |
---|
| Month 12: Patient Survival | Month 12: Graft Survival | Month 24: Patient Survival | Month 24: Graft Survival | Month 36: Patient Survival | Month 36: Graft Survival |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 23 | 23 | 23 | 23 | 23 | 23 |
,CNI+MPA+ Steroid | 39 | 39 | 39 | 39 | 39 | 39 |
,Steroid Withdrawal | 4 | 4 | 4 | 4 | 4 | 4 |
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Number of Participants With Employment Status (12 Months Analysis)
"The various employment status reported are:~Employed/self employed full time~Employed part time~Unemployed~Homemaker~Volunteer~Permanently disabled~Non-permanently disable~Retired~Other" (NCT00371826)
Timeframe: At screening (at day 0 +/- 7 days ), At Month 12
Intervention | Participants (Number) |
---|
| Screening visit: Employed/self employed full time | Month 12: Employed/self employed full time | Screening visit: Employed part time | Month 12: Employed part time | Screening visit: Unemployed | Month 12: Unemployed | Screening visit: Homemaker | Month 12 : Homemaker | Screening visit: Volunteer | Month 12: Volunteer | Screening visit: Permanently disabled | Month 12: Permanently disabled | Screening visit: Non-permanently disabled | Month 12: Non-permanently disabled | Screening visit: Retired | Month 12: Retired | Screening visit: Other | Month 12: Other |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 18 | 6 | 9 | 3 | 10 | 6 | 3 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 4 | 1 | 1 | 1 |
,CNI+MPA+ Steroid | 21 | 14 | 7 | 5 | 8 | 1 | 5 | 5 | 0 | 0 | 2 | 2 | 2 | 0 | 2 | 2 | 0 | 0 |
,Steroid Withdrawal | 9 | 2 | 4 | 0 | 10 | 6 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
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Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)
"Notable abnormal systolic blood pressure is defined as :~Either an increase of >=30 that results in >=180 or >200 (mm/Hg)~OR a decrease of >=30 that results in <=90 or <75 (mm/Hg) from baseline~Notable abnormal diastolic blood pressure is defined as :~Either an increase of >=20 that results in >=105 or >115 (mm/Hg)~OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline" (NCT00371826)
Timeframe: Baseline, Overall post baseline up to Month 36
Intervention | Participants (Number) |
---|
| SBP: >=180 mm/Hg or 200 mm/Hg | SBP: < = 90 mm/Hg or < 200 mm/Hg | DBP : >=105 mm/Hg or >115 mm/Hg | DBP: <=50 mm/Hg or <40 mm/Hg |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 3 | 1 | 2 | 1 |
,CNI+MPA+ Steroid | 4 | 0 | 5 | 4 |
,Steroid Withdrawal | 1 | 0 | 1 | 0 |
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Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis)
This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation. (NCT00371826)
Timeframe: Month 36
Intervention | Participants (Number) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 16 |
CNI+MPA+ Steroid | 30 |
Steroid Withdrawal | 1 |
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Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis)
(NCT00371826)
Timeframe: At Month 12
Intervention | Participants (Number) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 5 |
CNI+MPA+ Steroid | 2 |
Steroid Withdrawal | 2 |
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Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis)
A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification. (NCT00371826)
Timeframe: At Month 12
Intervention | Participants (Number) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 15 |
CNI+MPA+ Steroid | 6 |
Steroid Withdrawal | 5 |
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Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis)
"Based on Banff 97 criteria, sub clinical acute rejection can be:~GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).~GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).~GRADE III - Cases with transmural arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).~Borderline category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)." (NCT00371826)
Timeframe: At Month 12
Intervention | Participants (Number) |
---|
| NO | Borderline | Grade IA | Grade IB | Grade IIA | Grade IIB | Grade III | Not Done |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 20 | 2 | 1 | 0 | 0 | 0 | 0 | 7 |
,CNI+MPA+ Steroid | 29 | 2 | 0 | 1 | 0 | 0 | 0 | 8 |
,Steroid Withdrawal | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 3 |
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Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis)
"The symptoms of new onset diabetes mellitus after transplantation (NODAT) and impaired fasting glucose are defined as any of the following conditions:~Patients receiving glucose lowering treatment~2 fasting plasma glucose (FPG) values >= 126 mg/dL or 2 random plasma glucose (RPG) values >= 200 mg/dL or FPG value >= 126 mg/dL and 1 RPG value >= 200 mg/dL~Diabetes reported as treatment emergent AE with end date > Day 15" (NCT00371826)
Timeframe: At Month 36
Intervention | Participants (Number) |
---|
| Glucose lowering treatment | FPG or RPG | Diabetes as treatment emergent AE | Any of the above symptoms |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 5 | 3 | 5 | 6 |
,CNI+MPA+ Steroid | 10 | 2 | 4 | 11 |
,Steroid Withdrawal | 2 | 1 | 2 | 2 |
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Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)
"Notable abnormal systolic blood pressure is defined as :~Either an increase of >=30 that results in >=180 or >200 (mm/Hg)~OR a decrease of >=30 that results in <=90 or <75 (mm/Hg)from baseline~Notable abnormal diastolic blood pressure is defined as :~Either an increase of >=20 that results in >=105 or >115 (mm/Hg)~OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline" (NCT00371826)
Timeframe: Baseline, Overall post-baseline up to 12 month
Intervention | Participants (Number) |
---|
| SBP: >=180 mm/Hg or 200 mm/Hg | SBP: < = 90 mm/Hg or < 200 mm/Hg | DBP : >=105 mm/Hg or >115 mm/Hg | DBP: <=50 mm/Hg or <40 mm/Hg |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 5 | 1 | 3 | 1 |
,CNI+MPA+ Steroid | 5 | 0 | 6 | 4 |
,Steroid Withdrawal | 7 | 0 | 5 | 0 |
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Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)
"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L~Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L" (NCT00371826)
Timeframe: Overall post baseline up to month 12
Intervention | Participants (Number) |
---|
| Total Cholesterol: High (n = 48, 47,30) | Triglycerides : High (n= 48, 46, 30) |
---|
Calcineurin Inhibitor (CNI) Withdrawal | 6 | 1 |
,CNI+MPA+ Steroid | 0 | 0 |
,Steroid Withdrawal | 3 | 0 |
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Patient Survival.
(NCT00374231)
Timeframe: 12 months
Intervention | participants (Number) |
---|
Corticosteroid Withdrawal | 39 |
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Time Post Transplant Corticosteroid Withdrawal
The mean days from post transplant corticosteroid withdrawal. (NCT00374231)
Timeframe: 12 months
Intervention | days (Mean) |
---|
Corticosteroid Withdrawal | 257 |
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Incidence of Biopsy Confirmed Acute Rejection at 12 Months.
(NCT00374231)
Timeframe: 12 months
Intervention | participants (Number) |
---|
Corticosteroid Withdrawa. | 5 |
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Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00376961)
Timeframe: At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment
Intervention | participants (Number) |
---|
| Complete Response | Partial Response | Unconfirmed Complete Response | Unconfirmed Partial Response | No Response | Assessment Inadequate |
---|
R-CHOP-V Followed by VM | 17 | 16 | 13 | 1 | 4 | 14 |
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2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause. (NCT00376961)
Timeframe: 0-2 years
Intervention | percentage of participants (Number) |
---|
R-CHOP-V Followed by VM | 62 |
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2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
Measured from date of registration to date of death due to any cause or last contact (NCT00376961)
Timeframe: 0-2 years
Intervention | percentage of participants (Number) |
---|
R-CHOP-V Followed by VM | 85 |
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Event Free Survival. EFS
Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT). (NCT00381680)
Timeframe: 3 years after enrollment
Intervention | percentage of participants EFS at 3 yrs3 (Number) |
---|
Regimen A: Standard Vincristine Dosing | 66.0 |
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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1 (NCT00381680)
Timeframe: End of Block 1 (35 days) of Induction therapy
Intervention | percentage of participants (Number) |
---|
Regimen A | 50.8 |
Regimen B | 41.5 |
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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3. (NCT00381680)
Timeframe: End of Block 3 (105 days) of Induction therapy
Intervention | percentage of participants (Number) |
---|
Regimen A | 81.4 |
Regimen B | 88.9 |
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Adjusted Event Free Survival
Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT). (NCT00381680)
Timeframe: 3 years
Intervention | adjusted percentage of participants (Number) |
---|
| Received SCT | Did not receive SCT |
---|
Regimen A: Standard Vincristine Dosing | 82.2 | 64.2 |
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Frequency and Severity of Adverse Effects
Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy. (NCT00381680)
Timeframe: Up to 107 weeks
Intervention | percentage of participants (Number) |
---|
| CC or CT genotype | High-risk CEP72 genotype (TT at rs924607) |
---|
All Patients | 17.3 | 44.4 |
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Event Free Survival (EFS)
Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months. (NCT00381680)
Timeframe: 3 years
Intervention | percentage of participants (Number) |
---|
| MRD < 0.01% BL1 | MRD >= 0.01% BL1 | MRD < 0.01% BL3 | MRD >= 0.01% BL3 |
---|
Regimen A | 88.5 | 60.0 | 83.8 | 61.5 |
,Regimen B | 77.3 | 46.2 | 83.3 | 33.3 |
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Part 2: Progression Free Survival (PFS)
The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first. (NCT00385827)
Timeframe: Randomization, Week 12, then every 9 weeks until 1 month after last dose administration, then every 3 months until disease progression or death, up to 2 years
Intervention | days (Median) |
---|
Part 2: Mitoxantrone + Prednisone | 228.0 |
Part 2: Mitoxantrone + Prednisone + Siltuximab | 97.0 |
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Number of Participants With Prostate Specific Antigen (PSA) Response
The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response. (NCT00385827)
Timeframe: Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until disease progression, up to 2 years
Intervention | participants (Number) |
---|
Part 1: Mitoxantrone + Prednisone + Siltuximab | 4 |
Part 2: Mitoxantrone + Prednisone | 12 |
Part 2: Mitoxantrone + Prednisone + Siltuximab | 7 |
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Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT00385827)
Timeframe: Baseline up to 12 weeks after last dose administration
Intervention | participants (Number) |
---|
| AEs | SAEs |
---|
Part 1: Mitoxantrone + Prednisone + Siltuximab | 9 | 5 |
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Time to Clinical Deterioration (TtCD)
The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier. (NCT00385827)
Timeframe: Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until clinical deterioration or death, up to 2 years
Intervention | days (Median) |
---|
Part 1: Mitoxantrone + Prednisone + Siltuximab | 199.0 |
Part 2: Mitoxantrone + Prednisone | 298.0 |
Part 2: Mitoxantrone + Prednisone + Siltuximab | 183.0 |
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Overall Survival (OS)
The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date. (NCT00385827)
Timeframe: Start of treatment (Part 1)/Randomization (Part 2) until death, up to 2 years
Intervention | days (Median) |
---|
Part 1: Mitoxantrone + Prednisone + Siltuximab | 368.0 |
Part 2: Mitoxantrone + Prednisone | 394.0 |
Part 2: Mitoxantrone + Prednisone + Siltuximab | 311.0 |
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Clinical Activity
Determined by discontinuation of immunosuppression with resolution of all reversible CGVHD manifestations. Evaluated at 2 years after enrollment (NCT00388362)
Timeframe: 3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus
Intervention | participants (Number) |
---|
| Complete Remission | Partial Remission |
---|
Sirolimus Therapy | 4 | 4 |
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Overall Survival
Administration of Sirolimus and Prednisone (NCT00388362)
Timeframe: 3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus
Intervention | participants (Number) |
---|
Sirolimus Therapy | 21 |
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Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .
(NCT00389818)
Timeframe: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Intervention | proportion of patients (Number) |
---|
DR-COP | 0.475 |
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Serious Adverse Events
Serious Adverse Events (NCT00393367)
Timeframe: 0-5 days
Intervention | participants (Number) |
---|
| Return within 5 days with hosptial admission | Increased level of care |
---|
Budesonide Inhalation Suspension (BIS) | 2 | 1 |
,Placebo (Saline) | 2 | 0 |
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Number of Participants With Adverse Events (Non-serious).
(NCT00393367)
Timeframe: within 30 days of the ED visit
Intervention | Participants (Number) |
---|
| Rhinorrhea | Headache | Diarrhea | Sore throat | Cough | Hyperglycemia |
---|
Budesonide Inhalation Suspension (BIS) | 6 | 5 | 3 | 4 | 2 | 2 |
,Placebo (Normal Saline) | 11 | 9 | 7 | 3 | 3 | 0 |
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Relapse / Readmission Numbers.
Participants admitted to the hospital within 5 days of the ED visit (NCT00393367)
Timeframe: within 5 days of ED visit
Intervention | Participants (Number) |
---|
Budesonide Inhalation Suspension (BIS) | 2 |
Placebo (Normal Saline) | 2 |
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Oxygen Saturation.
Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment. (NCT00393367)
Timeframe: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator
Intervention | Percent Hemoglobin Saturation (Mean) |
---|
Budesonide Inhalation Suspension (BIS) | 1.0 |
Placebo (Normal Saline) | 1.0 |
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Number of Subjects Remaining in the Severe Asthma Category
Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Intervention | Participants (Number) |
---|
Budesonide Inhalation Suspension (BIS) | 4 |
Placebo (Normal Saline) | 4 |
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Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category
Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Intervention | Participants (Number) |
---|
Budesonide Inhalation Suspension (BIS) | 22 |
Placebo (Normal Saline) | 11 |
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Number of Subjects Moving From the Severe Asthma to Mild Asthma Category
Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Intervention | Participants (Number) |
---|
Budesonide Inhalation Suspension (BIS) | 8 |
Placebo (Normal Saline) | 10 |
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Number of Patients Hospitalized
The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician. (NCT00393367)
Timeframe: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo
Intervention | Participants (Number) |
---|
Budesonide Inhalation Suspension (BIS) | 56 |
Placebo (Saline) | 55 |
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Mean Change in Respiratory Rate.
Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator. (NCT00393367)
Timeframe: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator
Intervention | Breaths per minute (Mean) |
---|
Budesonide Inhalation Suspension (BIS) | -6 |
Placebo (Normal Saline) | -6 |
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Mean Change in Asthma Score at 2 Hours
The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. (NCT00393367)
Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
Intervention | Units on a scale (Mean) |
---|
Budesonide Inhalation Suspension (BIS) | -2.9 |
Placebo (Normal Saline) | -3.0 |
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Change in Mean Heart Rate
Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol (NCT00393367)
Timeframe: From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Intervention | Beats per minute (Mean) |
---|
Budesonide Inhalation Suspension (BIS) | 12 |
Placebo (Normal Saline) | 13 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=117,126,126) | Cycle 7 - approximately Month 7 (n=100,110,110) | Cycle 10 - approximately Month 10 (n=86,93,96) | Cycle 13 - approximately Month 13 (n=73,73,81) | Cycle 16 - approximately Month 16 (n=62,53,62) |
---|
MPp+p | -0.0 | 2.1 | 3.8 | -0.0 | 1.6 |
,MPR+p | -6.4 | -8.5 | -4.3 | -2.3 | -6.3 |
,MPR+R | -2.6 | -1.7 | -4.3 | -5.0 | -3.2 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=115,125,124) | Cycle 7 - approximately Month 7 (n=98,109,112) | Cycle 10 - approximately Month 10 (n=87,92,95) | Cycle 13 - approximately Month 13 (n=73,73,80) | Cycle 16 - approximately Month 16 (n=63,52,61) |
---|
MPp+p | 3.2 | 0.9 | -0.0 | 0.8 | 0.5 |
,MPR+p | 1.9 | -1.2 | 1.4 | -1.4 | 1.3 |
,MPR+R | 2.3 | 3.4 | 1.1 | 5.5 | 10.6 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=114,124,128) | Cycle 7 - approximately Month 7 (n=96,111,112) | Cycle 10 - approximately Month 10 (n=86,93,97) | Cycle 13 - approximately Month 13 (n=73,73,81) | Cycle 16 - approximately Month 16 (n=63,51,62) |
---|
MPp+p | -4.9 | -2.7 | -1.7 | -3.3 | -2.2 |
,MPR+p | 4.8 | 0.6 | -1.1 | -2.7 | -5.2 |
,MPR+R | -1.8 | -3.5 | -5.0 | -5.0 | -1.6 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=115,125,128) | Cycle 7 - approximately Month 7 (n=98,111,113) | Cycle 10 - approximately Month 10 (n=87,92,97) | Cycle 13 - approximately Month 13 (n=73,73,83) | Cycle 16 - approximately Month 16 (n=63,52,63) |
---|
MPp+p | 1.3 | 0.7 | -2.7 | -1.4 | -4.0 |
,MPR+p | -2.0 | 0.1 | -4.4 | -3.0 | -3.5 |
,MPR+R | 0.3 | 2.9 | 1.0 | -0.0 | 0.3 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=119,125,130) | Cycle 7 - approximately Month 7 (n=99,111,111) | Cycle 10 - approximately Month 10 (n=87,93,96) | Cycle 13 - approximately Month 13 (n=75,72,83) | Cycle 16 - approximately Month 16 (n=64,52,63) |
---|
MPp+p | -5.6 | -5.7 | -8.0 | -4.8 | -6.4 |
,MPR+p | 1.9 | -5.7 | -5.4 | -8.8 | -16.0 |
,MPR+R | 1.7 | -3.7 | -5.0 | -6.2 | -7.8 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale
Data as of 11 May 2010 cutoff. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=114,121,125) | Cycle 7 - approximately Month 7 (n=96,108,110) | Cycle 10 - approximately Month 10 (n=84,86,96) | Cycle 13 - approximately Month 13 (n=70,70,82) | Cycle 16 - approximately Month 16 (n=61,50,62) |
---|
MPp+p | 6.1 | 4.2 | 6.2 | 5.4 | 8.1 |
,MPR+p | 5.6 | 8.1 | 8.8 | 8.8 | 7.2 |
,MPR+R | 2.3 | 8.0 | 12.4 | 7.6 | 10.7 |
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Time to First Response
Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria. (NCT00405756)
Timeframe: Up to 66 weeks
Intervention | weeks (Mean) |
---|
MPR+R | 10.0 |
MPR+p | 9.3 |
MPp+p | 16.2 |
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Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)
"Data as of 11 May 2010 cutoff. TTP was the time between randomization and disease progression as determined by the CAC. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: up to 165 weeks
Intervention | weeks (Median) |
---|
MPR+R | 148.1 |
MPR+p | 62.7 |
MPp+p | 61.3 |
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Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)
"Data as of 11 May 2010 cutoff. PFS calculated from the start of the Maintenance period to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause.~PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: Approximately week 37 (start of cycle 10) to week 165
Intervention | weeks (Median) |
---|
MPR+R | 112.0 |
MPR+p | 32.3 |
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Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)
"Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: up to 165 weeks
Intervention | weeks (Median) |
---|
MPR+R | 136.1 |
MPR+p | 62.1 |
MPp+p | 56.1 |
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Kaplan Meier Estimates of Overall Survival (OS)
Data as of 11 May 2010 cutoff. Overall survival (OS) was defined as the time between randomization and death. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who were lost to follow-up prior to the end of the trial, or who were withdrawn from the trial, were censored at the time of last contact. Participants who were still being treated were censored at the last available date available, or clinical cut-off date, if it was earlier. (NCT00405756)
Timeframe: up to 177 weeks
Intervention | weeks (Median) |
---|
MPR+R | NA |
MPR+p | NA |
MPp+p | NA |
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Kaplan Meier Estimates for Time to Next Antimyeloma Therapy
Data as of 11 May 2010 cutoff. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy. (NCT00405756)
Timeframe: Up to 168 weeks
Intervention | weeks (Median) |
---|
MPR+R | 128.9 |
MPR+p | 66.1 |
MPp+p | 66.3 |
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Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)
"Data as of 11 May 2010 cutoff. Duration of myeloma response was defined as the time from the initial response date to the earlier of progressive disease (PD) as determined by the CAC or death on study. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: Up to 149 weeks
Intervention | weeks (Median) |
---|
MPR+R | 121.6 |
MPR+p | 56.1 |
MPp+p | 55.4 |
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Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period
Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption. (NCT00405756)
Timeframe: Up to 169 weeks (Double-blind therapy period plus 4 weeks)
Intervention | participants (Number) |
---|
| >=1 adverse event (AE) | >=1 CTCAE grade 3-4 AE | >=1 CTCAE grade 5 AE | >=1 serious AE (SAE) | >=1 AE related to Lenaldomide/Placebo | >=1 AE related to Melphalan | >=1AE related to Prednisone | >=1 Grade 3-4 AE related to Lenaldomide/Placebo | >=1 Grade 3-4 AE related to Melphalan | >=1 Grade 3-4 AE related to Prednisone | >=1 Grade 5 AE related to Lenalidomide/Placebo | >=1 Grade 5 AE related to Melphalan | >=1 Grade 5 AE related to Prednisone | >=1 SAE related to Lenalidomide/Placebo | >=1 SAE related to Melphalan | >=1 SAE related to Prednisone | >=1 AE leading to Lenalidomide/Placebo withdrawal | >=1 AE leading to Melphalan withdrawal | >=1 AE leading to Prednisone withdrawal | >=1 AE leading to Lenalidomide/Plac dose reduction | >=1 AE leading to Melphalan dose reduction | >=1 AE leading to Prednisone dose reduction | >=1 AE leading to Lenalidomide/Plac dose interrupt | >=1 AE leading to Melphalan dose interruption | >=1 AE leading to Prednisone dose interruption |
---|
MPp+p | 153 | 107 | 7 | 56 | 131 | 126 | 93 | 68 | 62 | 22 | 2 | 3 | 1 | 11 | 11 | 5 | 14 | 10 | 10 | 26 | 21 | 5 | 51 | 0 | 15 |
,MPR+p | 151 | 129 | 6 | 62 | 145 | 134 | 94 | 117 | 110 | 29 | 2 | 1 | 1 | 32 | 24 | 16 | 24 | 19 | 19 | 70 | 58 | 7 | 82 | 1 | 39 |
,MPR+R | 150 | 137 | 7 | 66 | 148 | 140 | 87 | 128 | 118 | 32 | 3 | 3 | 1 | 38 | 27 | 19 | 26 | 20 | 20 | 71 | 47 | 15 | 92 | 5 | 28 |
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Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period
Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE). (NCT00405756)
Timeframe: Up to 165 weeks
Intervention | participants (Number) |
---|
| Complete response (CR) | Partial response (PR) | Stable disease (SD) | Progressive disease (PD) | Response not evaluable (NE) |
---|
MPp+p | 5 | 72 | 70 | 0 | 7 |
,MPR+p | 5 | 99 | 40 | 2 | 7 |
,MPR+R | 15 | 102 | 28 | 0 | 7 |
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Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=113,120,125) | Cycle 7 - approximately Month 7 (n=95,108,111) | Cycle 10 - approximately Month 10 (n=85,89,94) | Cycle 13 - approximately Month 13 (n=72,72,81) | Cycle 16 - approximately Month 16 (n=62,50,61) |
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MPp+p | 0.6 | 1.8 | 0.3 | 0.3 | -0.9 |
,MPR+p | 0.1 | -1.7 | 0.0 | -1.0 | -2.9 |
,MPR+R | 1.3 | 0.4 | -1.6 | -3.8 | -2.1 |
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Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=112,121,124) | Cycle 7 - approximately Month 7 (n=93,108,112) | Cycle 10 - approximately Month 10 (n=83,88,97) | Cycle 13 - approximately Month 13 (n=71,73,81) | Cycle 16 - approximately Month 16 (n=62,52,62) |
---|
MPp+p | 7.6 | 9.8 | 14.5 | 11.9 | 14.4 |
,MPR+p | 4.3 | 7.7 | 6.6 | 6.3 | 7.7 |
,MPR+R | 4.7 | 14.6 | 17.3 | 17.3 | 18.5 |
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Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=110,117,119) | Cycle 7 - approximately Month 7 (n=88,104,108) | Cycle 10 - approximately Month 10 (n=79,83,94) | Cycle 13 - approximately Month 13 (n=68,72,79) | Cycle 16 - approximately Month 16 (n=59,52,61) |
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MPp+p | 4.5 | 5.2 | 3.9 | 5.1 | 2.7 |
,MPR+p | -0.3 | 2.6 | -4.0 | -0.5 | 6.4 |
,MPR+R | 2.1 | 3.8 | 7.6 | 1.0 | 3.4 |
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Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=113,121,127) | Cycle 7 - approximately Month 7 (n=96,109,112) | Cycle 10 - approximately Month 10 (n=85,91,95) | Cycle 13 - approximately Month 13 (n=72,73,82) | Cycle 16 - approximately Month 16 (n=62,51,62) |
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MPp+p | -5.4 | -6.0 | -5.4 | -6.3 | -3.3 |
,MPR+p | -8.7 | -9.7 | -7.1 | -8.8 | -5.9 |
,MPR+R | -8.9 | -9.0 | -7.9 | -7.2 | -10.5 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=115,125,127) | Cycle 7 - approximately Month 7 (n=98,111,112) | Cycle 10 - approximately Month 10 (n=87,92,97) | Cycle 13 - approximately Month 13 (n=72,73,83) | Cycle 16 - approximately Month 16 (n=63,52,63) |
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MPp+p | 6.0 | 6.1 | 4.1 | 6.2 | 9.8 |
,MPR+p | 0.3 | 4.4 | 4.5 | 7.5 | 6.1 |
,MPR+R | 5.1 | 8.3 | 10.9 | 11.8 | 13.2 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=119,127,130) | Cycle 7 - approximately Month 7 (n=99,112,113) | Cycle 10 - approximately Month 10 (n=86,95,95) | Cycle 13 - approximately Month 13 (n=74,74,82) | Cycle 16 - approximately Month 16 (n=64,53,63) |
---|
MPp+p | 7.4 | 6.9 | 5.6 | 5.7 | 7.1 |
,MPR+p | 3.0 | 8.0 | 7.5 | 11.7 | 8.5 |
,MPR+R | 1.8 | 5.7 | 9.3 | 9.7 | 12.2 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=120,127,130) | Cycle 7 - approximately Month 7 (n=100,112,112) | Cycle 10 - approximately Month 10 (n=88,95,96) | Cycle 13 - approximately Month 13 (n=75,74,83) | Cycle 16 - approximately Month 16 (n=64,53,63) |
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MPp+p | 4.5 | 2.7 | 5.1 | 3.3 | 1.1 |
,MPR+p | 3.3 | 8.1 | 8.5 | 9.7 | 7.6 |
,MPR+R | 1.9 | 8.2 | 8.9 | 8.6 | 10.0 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=120,127,129) | Cycle 7 - approximately Month 7 (n=100,112,113) | Cycle 10 - approximately Month 10 (n=88,95,97) | Cycle 13 - approximately Month 13 (n=74,74,83) | Cycle 16 - approximately Month 16 (n=64,53,63) |
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MPp+p | -13.4 | -11.5 | -9.8 | -12.1 | -12.2 |
,MPR+p | -13.8 | -16.5 | -15.6 | -14.9 | -11.0 |
,MPR+R | -14.4 | -17.8 | -17.2 | -13.7 | -20.3 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=120,127,130) | Cycle 7 - approximately Month 7 (n=99,112,112) | Cycle 10 - approximately Month 10 (n=87,95,97) | Cycle 13 - approximately Month 13 (n=75,72,83) | Cycle 16 - approximately Month 16 (n=64,52,62) |
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MPp+p | -0.0 | 0.7 | 0.3 | -0.4 | -1.3 |
,MPR+p | -1.3 | -0.7 | -1.4 | -3.0 | -4.2 |
,MPR+R | 3.3 | 0.5 | 1.9 | 0.7 | 1.0 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=118,124,128) | Cycle 7 - approximately Month 7 (n=100,109,111) | Cycle 10 - approximately Month 10 (n=87,94,96) | Cycle 13 - approximately Month 13 (n=75,73,83) | Cycle 16 - approximately Month 16 (n=64,53,63) |
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MPp+p | -5.0 | -5.7 | -1.7 | -6.8 | -3.7 |
,MPR+p | -1.6 | -6.4 | -2.5 | 0.9 | -0.6 |
,MPR+R | 2.0 | -1.0 | -5.0 | -4.9 | -4.7 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=111,123,125) | Cycle 7 - approximately Month 7 (n=94,111,112) | Cycle 10 - approximately Month 10 (n=84,92,97) | Cycle 13 - approximately Month 13 (n=70,72,83) | Cycle 16 - approximately Month 16 (n=61,52,63) |
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MPp+p | -2.9 | -2.1 | -1.7 | -4.0 | -5.3 |
,MPR+p | -1.1 | -0.6 | 0.7 | -0.5 | -0.6 |
,MPR+R | 2.4 | 2.1 | 6.0 | 4.8 | 1.6 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=120,127,129) | Cycle 7 - approximately Month 7 (n=100,112,110) | Cycle 10 - approximately Month 10 (n=87,95,95) | Cycle 13 - approximately Month 13 (n=74,74,82) | Cycle 16 - approximately Month 16 (n=64,53,62) |
---|
MPp+p | -5.1 | -5.7 | -6.9 | -7.5 | -4.1 |
,MPR+p | -5.5 | -9.5 | -7.5 | -10.7 | -9.7 |
,MPR+R | -3.0 | -7.6 | -7.5 | -7.1 | -10.0 |
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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) |
---|
| Cycle 4 - approximately Month 4 (n=115,125,128) | Cycle 7 - approximately Month 7 (n=98,111,112) | Cycle 10 - approximately Month 10 (n=86,92,97) | Cycle 13 - approximately Month 13 (n=73,73,83) | Cycle 16 - approximately Month 16 (n=63,52,63) |
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MPp+p | 6.8 | 5.0 | 4.7 | 6.6 | 6.9 |
,MPR+p | 2.7 | 4.2 | 1.6 | 1.1 | -0.2 |
,MPR+R | 4.8 | 8.8 | 9.0 | 8.2 | 9.9 |
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Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from end of induction
Intervention | percent probability (Number) |
---|
| High Risk | Induction Failure |
---|
ARM II (Combination Chemotherapy) | 85.0 | 100 |
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Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
Intervention | percent probability (Number) |
---|
ARM I and ARM II (Combination Chemotherapy) | 91.45 |
ARM III and ARM IV (Combination Chemotherapy) | 85.78 |
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Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
Disease-free survival defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, remission death) or date of last contact for those who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
Intervention | percent probability (Number) |
---|
ARM I (Combination Chemotherapy) | 91.76 |
ARM II (Combination Chemotherapy) | 90.53 |
ARM III (Combination Chemotherapy) | 86.06 |
ARM IV (Combination Chemotherapy) | 84.89 |
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Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from end of induction
Intervention | percent probability (Number) |
---|
| Standard Risk | High Risk |
---|
ARM I (Combination Chemotherapy) | 87.4 | 85.1 |
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Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
Intervention | percent probability (Number) |
---|
ARM I and ARM III (Combination Chemotherapy) | 82.96 |
ARM II and ARM IV (Combination Chemotherapy) | 88.30 |
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Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
Intervention | percent probability (Number) |
---|
ARM I (Combination Chemotherapy) | 89.01 |
ARM II (Combination Chemotherapy) | 90.53 |
ARM III (Combination Chemotherapy) | 78.07 |
ARM IV (Combination Chemotherapy) | 86.46 |
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Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
Intervention | percent probability (Number) |
---|
| Intermediate Risk | High Risk |
---|
ARM II (Combination Chemotherapy) | 1.08 | 0 |
,ARM IV (Combination Chemotherapy) | 0.85 | 3.45 |
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Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
Intervention | percent probability (Number) |
---|
| Low Risk | Intermediate Risk | High Risk |
---|
ARM I (Combination Chemotherapy) | 1.85 | 1.16 | 3.64 |
,ARM III (Combination Chemotherapy) | 1.92 | 9.1 | 6.52 |
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Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis. (NCT00413920)
Timeframe: Month 3
Intervention | Number of participants (Number) |
---|
| Treatment Failure | Biopsy Proven Acute Rejection | Graft Loss | Death | Loss to Follow-up | Acute Rejection | Treated Acute Rejection |
---|
With Steroids | 8 | 5 | 1 | 2 | 0 | 19 | 16 |
,Without Steroids | 17 | 10 | 5 | 2 | 0 | 32 | 31 |
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Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status
"The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status.~Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.~Slow graft function is defined as a serum creatinine value > 250 µmol/L at day 5." (NCT00413920)
Timeframe: Month 3
Intervention | Number of participants (Number) |
---|
| Delayed Graft Function [N= 25,24] | Slow Graft Function [N= 36,23] | Immediate Graft Function [N= 51,63] |
---|
With Steroids | 4 | 1 | 3 |
,Without Steroids | 8 | 6 | 3 |
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Number of Participants With Subclinical Histological Rejections
The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies. (NCT00413920)
Timeframe: Month 3
Intervention | Number of participants (Number) |
---|
| Sample quality inadequate | Subclinical rejection | Borderline lesions | BPAR |
---|
With Steroids | 6 | 17 | 5 | 12 |
,Without Steroids | 7 | 12 | 2 | 10 |
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Number of Participants Requiring Steroids in Non-steroid Treatment Group
(NCT00413920)
Timeframe: Months 3 and 6
Intervention | Number of participants (Number) |
---|
| 3 Months | 6 Months |
---|
Without Steroids | 25 | 20 |
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Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation
Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis. (NCT00413920)
Timeframe: 6 months post transplantation
Intervention | Number of participants (Number) |
---|
Without Steroids | 20 |
With Steroids | 16 |
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The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months
If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. (NCT00413920)
Timeframe: Month 6
Intervention | Number of participants (Number) |
---|
| Biopsy Proven Acute Rejection | Graft Loss | Death | Loss to Follow-up | Acute Rejection | Treated Acute Rejection |
---|
With Steroids | 8 | 3 | 5 | 0 | 21 | 19 |
,Without Steroids | 13 | 5 | 2 | 0 | 37 | 36 |
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Time to Pain Progression
"Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score & noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.~Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)" (NCT00417079)
Timeframe: from baseline up to 104 weeks (study cut-off)
Intervention | Months (Median) |
---|
Mitoxantrone + Prednisone | NA |
Cabazitaxel + Prednisone | 11.1 |
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Time to Progression Free Survival (PFS)
Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)
Intervention | Months (Median) |
---|
Mitoxantrone + Prednisone | 1.4 |
Cabazitaxel + Prednisone | 2.8 |
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Time to Prostatic Specific Antigen (PSA) Progression
"In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.~In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later." (NCT00417079)
Timeframe: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)
Intervention | Months (Median) |
---|
Mitoxantrone + Prednisone | 3.1 |
Cabazitaxel + Prednisone | 6.4 |
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Time to Tumor Progression
Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST) (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)
Intervention | Months (Median) |
---|
Mitoxantrone + Prednisone | 5.4 |
Cabazitaxel + Prednisone | 8.8 |
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Pain Response
Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks. (NCT00417079)
Timeframe: from baseline up to 104 weeks (study cut-off)
Intervention | Percentage of participants (Number) |
---|
Mitoxantrone + Prednisone | 7.7 |
Cabazitaxel + Prednisone | 9.2 |
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Overall Survival
"Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.~In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first." (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)
Intervention | Months (Median) |
---|
Mitoxantrone + Prednisone | 12.7 |
Cabazitaxel + Prednisone | 15.1 |
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Overall Tumor Response
"Tumor Overall Response Rate (ORR) (only in patients with measurable disease):~Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.~Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.~Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response." (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)
Intervention | percentage of participants (Number) |
---|
Mitoxantrone + Prednisone | 4.4 |
Cabazitaxel + Prednisone | 14.4 |
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PSA (Prostate-Specific Antigen) Response
PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later. (NCT00417079)
Timeframe: from baseline up to 104 weeks (study cut-off)
Intervention | Percentage of participants (Number) |
---|
Mitoxantrone + Prednisone | 17.8 |
Cabazitaxel + Prednisone | 39.2 |
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Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit
The Modification of Diet in Renal Disease (MDRD) formula was used to calculate the GFR. Serum creatinine levels, age, sex and race were used to estimate the GFR levels in mL/min/1.73m^2. (NCT00419926)
Timeframe: at 21 days, 84 days and 180 days
Intervention | (mL/min/1.73m^2) (Mean) |
---|
| At 21 days | At 84 days | At 180 days |
---|
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen | 47.3 | 52.1 | 53.5 |
,Standard Mycophenolate Sodium (Myfortic) Dosing Regimen | 46.8 | 51.8 | 51.3 |
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Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death
To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection [BPAR], graft loss [GFL] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.) (NCT00419926)
Timeframe: 6 months
Intervention | number of participants (Number) |
---|
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen | 33 |
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen | 36 |
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen | 26 |
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen | 35 |
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Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death
The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.) (NCT00419926)
Timeframe: 21 and 84 days
Intervention | number of participants (Number) |
---|
| Day 84 | Day 21 |
---|
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen | 20 | 33 | 14 | 26 |
,Standard Mycophenolate Sodium (Myfortic) Dosing Regimen | 21 | 34 | 20 | 33 |
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Number of Patients With Complete Remission
Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value. (NCT00423098)
Timeframe: 12 Weeks
Intervention | participants (Number) |
---|
| Yes | No |
---|
Low Dose | 5 | 34 |
,Standard Dose | 9 | 33 |
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Number of Patients With Complete Remission
Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab. (NCT00423098)
Timeframe: 24 Weeks
Intervention | Participants (Number) |
---|
| Yes | No |
---|
Low Dose | 8 | 31 |
,Standard Dose | 8 | 34 |
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Number of Patients With Adverse Events and Infections
Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. (NCT00423098)
Timeframe: 24 weeks
Intervention | participants (Number) |
---|
| At least one adverse event | Any severe adverse event | Any drug related adverse event | Any serious adverse event | Any infection | Any severe infection | Any drug related infection | Any serious infection |
---|
Low Dose | 30 | 3 | 16 | 4 | 17 | 1 | 6 | 1 |
,Standard Dose | 35 | 7 | 18 | 8 | 25 | 3 | 10 | 4 |
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Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)
Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks. (NCT00423098)
Timeframe: 12 Weeks and 24 Weeks
Intervention | mg/kg (Mean) |
---|
| Week 12 | Week 24 |
---|
Low Dose | 68.2 | 73.0 |
,Standard Dose | 106.1 | 114.2 |
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Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)
SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common. (NCT00423098)
Timeframe: From Baseline to week 4, week 12 and week 24
Intervention | Units on a scale (Mean) |
---|
| Change from Baseline to Week 4: (N= 39, 37) | Change from Baseline to Week 12: (N= 41, 35) | Change from Baseline to Week 24: (N= 39, 34) |
---|
Low Dose | -7.7 | -10.3 | -9.8 |
,Standard Dose | -7.4 | -9.7 | -10.3 |
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Number of Patients With Partial Remission
Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved. (NCT00423098)
Timeframe: Baseline to 12 and 24 weeks
Intervention | Participants (Number) |
---|
| At 12 weeks - Yes | At 12 weeks - No | At 24 weeks - Yes | At 24 weeks - No |
---|
Low Dose | 11 | 28 | 14 | 25 |
,Standard Dose | 16 | 26 | 20 | 22 |
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Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)
BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72]. (NCT00423098)
Timeframe: From Baseline to week 4, week 12 and week 24
Intervention | Units on a scale (Mean) |
---|
| Change from baseline Week 4: (N= 40, 37) | Change from baseline Week 12: (N= 41, 35) | Change from baseline Week 24: (N= 40, 34) |
---|
Low Dose | -5.5 | -8.7 | -9.4 |
,Standard Dose | -4.8 | -8.6 | -8.6 |
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Duration of Exposure to Study Medication
The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1. (NCT00423098)
Timeframe: 24 weeks
Intervention | days (Mean) |
---|
Standard Dose | 164.5 |
Low Dose | 157.7 |
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Number of Patients With Moderate to Severe Flares
A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72) (NCT00423098)
Timeframe: 12 and 24 weeks
Intervention | participants (Number) |
---|
| At week 12 - Yes | At week 12 - No | At week 24 - Yes | At week 24 - No |
---|
Low Dose | 0 | 39 | 0 | 39 |
,Standard Dose | 0 | 42 | 1 | 41 |
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Number of Patients With Treatment Failure
Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission. (NCT00423098)
Timeframe: 12 Weeks and 24 Weeks
Intervention | participants (Number) |
---|
| At 12 weeks - Yes | At 12 weeks - No | At 24 weeks - Yes | At 24 weeks - No |
---|
Low Dose | 25 | 14 | 22 | 17 |
,Standard Dose | 23 | 19 | 21 | 21 |
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Participants With Remission of Renal Disease Activity at 3 Months
Remission of renal disease activity was indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever smaller) (NCT00424749)
Timeframe: 3 months after beginning of remission induction regimen
Intervention | participants (Number) |
---|
Rituximab | 3 |
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Participants With Normalization of Eosinophil Count at 6 Months
Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L. (NCT00424749)
Timeframe: 6 months after beginning of remission induction regimen
Intervention | participants (Number) |
---|
Rituximab | 2 |
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Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period
CRR defined as meeting all of 5 criteria. RF: (Glomerular filtration rate [GFR] calculated using MDRD equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. (NCT00430677)
Timeframe: At Month 12 from Day 1
Intervention | Participants (Number) |
---|
Abatacept 30/10 mg/kg | 38 |
Abatacept 10/10 mg/kg | 37 |
Placebo | 31 |
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Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)
RI is defined as meeting all of the following criteria. Renal function: If MDRD is abnormal at screening, within 10% of the MDRD at screening; if MDRD is 60-89 at screening, greater than or equal to 50% improvement based on the screening value or 90% or greater of MDRD at screening; if MDRD is 15-59 at screening, if MDRD is normal at screening-within 10% of the MDRD at screening. Proteinuria: improvement greater than or equal to 50% from screening. Hematuria: red blood cell (RBC)count within normal limit of central laboratory. Pyuria: white blood cell (WBC) count within normal limit of central laboratory. Cylindruria: No RBC or WBC casts. (NCT00430677)
Timeframe: Day 1 (randomization) to 12 months.
Intervention | Days (Median) |
---|
Abatacept 30/10 mg/kg | 141 |
Abatacept 10/10 mg/kg | 136 |
Placebo | 144 |
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Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period
Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. (NCT00430677)
Timeframe: Day 1 (randomization) to 12 months.
Intervention | days (Number) |
---|
Abatacept 30/10 mg/kg | NA |
Abatacept 10/10 mg/kg | NA |
Placebo | NA |
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Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period
SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. (NCT00430677)
Timeframe: Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose)
Intervention | Units on a scale (Mean) |
---|
| Baseline (n=68, 67, 70) | Post Baseline Mean (n=68, 67, 70) |
---|
Abatacept 10/10 mg/kg | 0.27 | 0.40 |
,Abatacept 30/10 mg/kg | 0.34 | 0.53 |
,Placebo | 0.29 | 0.44 |
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Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period
The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365
Intervention | Units on a scale (Mean) |
---|
| Baseline (Day 1) for Day 85 (n=90, 94, 95) | Baseline (Day 1) for Day 169 (n=92, 94, 97) | Baseline (Day 1) for Day 253 ( n=92, 94, 97) | Baseline (Day 1) for Day 365 ( n=92, 94, 97) |
---|
Abatacept 10/10 mg/kg | 39.14 | 39.14 | 39.14 | 39.14 |
,Abatacept 30/10 mg/kg | 40.60 | 40.41 | 40.41 | 40.41 |
,Placebo | 39.64 | 39.59 | 39.59 | 39.59 |
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Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period
A visual analogue scale (VAS) is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured. The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365
Intervention | Units on a scale (Mean) |
---|
| Baseline (Day 1) for Day 85 (n=90, 94, 95) | Baseline (Day 1) for Day 169 (n=92, 94, 97) | Baseline (Day 1) for Day 253 (n=92, 94, 97) | Baseline (Day 1) for Day 365 (n=92, 94, 97) |
---|
Abatacept 10/10 mg/kg | 41.95 | 41.95 | 41.95 | 41.95 |
,Abatacept 30/10 mg/kg | 48.86 | 48.80 | 48.80 | 48.80 |
,Placebo | 48.93 | 48.25 | 48.25 | 48.25 |
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Baseline Mental Component Summary of the Short SF-36 During Short-term Period
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365
Intervention | Units on a scale (Mean) |
---|
| Baseline (Day 1) for Day 85 ( n=89, 91, 93) | Baseline (Day 1) for Day 169 (n=92,94,96) | Baseline (Day 1) for Day 253 ( n=92,94,96) | Baseline (Day 1) for Day 365 ( n=92,94,96) |
---|
Abatacept 10/10 mg/kg | 43.80 | 41.84 | 41.84 | 41.84 |
,Abatacept 30/10 mg/kg | 42.18 | 44.08 | 44.08 | 44.08 |
,Placebo | 42.68 | 42.59 | 42.59 | 42.59 |
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Baseline Quantitative Immunoglobulins During the Short-term Period
A quantitative immunoglobulins (Igs) test is used to detect abnormal levels of the three major classes of Igs (IgG, IgA, and IgM). Abnormal test results typically indicate that there is something affecting the immune system which requires further testing. (NCT00430677)
Timeframe: Baseline (Day 1)
Intervention | mg/dL (Mean) |
---|
| Immunoglobulin IgA | Immunoglobulin IgG | Immunoglobulin IgM |
---|
Abatacept 10/10 mg/kg | 218.04 | 864.12 | 97.10 |
,Abatacept 30/10 mg/kg | 246.28 | 939.80 | 100.96 |
,Placebo | 230.23 | 1013.17 | 98.49 |
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Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period
Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. (NCT00430677)
Timeframe: Day 1 to 12 months
Intervention | Participants (Number) |
---|
Abatacept 30/10 mg/kg | 22 |
Abatacept 10/10 mg/kg | 27 |
Placebo | 20 |
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Baseline Renal Function Over Time During Short-term Period
Baseline (BL) renal function, as estimated by calculation of the MDRD (Modification of Diet in Renal Disease) equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A negative value indicates worsening. (NCT00430677)
Timeframe: Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365
Intervention | milliliters per minute (mL/min)/1.73 m^2 (Mean) |
---|
| Baseline (Day 1) for Day 15 (n=98,94,98) | Baseline (Day 1) for Day 29 (n=98,95,98) | Baseline (Day 1) for Day 57 (n=94, 89, 96) | Baseline (Day 1) for Day 85 (n=90, 91, 93) | Baseline (Day 1) for Day 113 (n=91, 83, 91) | Baseline (Day 1) for Day 141 (n=89, 83, 90) | Baseline (Day 1) for Day 169 (n=83, 82, 85) | Baseline (Day 1) for Day 197 (n=84, 81, 87) | Baseline (Day 1) for Day 225 (n=84, 81, 84) | Baseline (Day 1) for Day 253 (n=81, 76, 81) | Baseline (Day 1) for Day 281 (n=78, 77, 80) | Baseline (Day 1) for Day 309 (n=77, 76, 78) | Baseline (Day 1) for Day 337 (n=74, 75, 79) | Baseline (Day 1) for Day 365 (n=75, 73, 78) |
---|
Abatacept 10/10 mg/kg | 99.09 | 98.56 | 98.76 | 100.22 | 101.23 | 101.05 | 101.95 | 101.85 | 101.64 | 101.25 | 102.64 | 100.64 | 101.00 | 101.30 |
,Abatacept 30/10 mg/kg | 92.57 | 93.08 | 91.54 | 94.53 | 94.43 | 93.62 | 94.83 | 94.55 | 94.87 | 94.89 | 94.17 | 94.74 | 95.51 | 95.04 |
,Placebo | 91.01 | 91.23 | 91.58 | 92.76 | 92.41 | 92.83 | 92.56 | 92.69 | 93.25 | 93.38 | 93.13 | 92.71 | 92.90 | 93.03 |
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Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365
Intervention | Units on a scale (Mean) |
---|
| Day 85 (n=89, 91, 93) | Day 169 (n=92, 94, 96) | Day 253 (n=92, 94, 96) | Day 365 (n=92, 94, 96) |
---|
Abatacept 10/10 mg/kg | 2.61 | 4.07 | 4.80 | 5.00 |
,Abatacept 30/10 mg/kg | 4.17 | 4.18 | 4.23 | 4.24 |
,Placebo | 2.86 | 3.39 | 3.45 | 3.77 |
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Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period
The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365
Intervention | Units on a scale (Least Squares Mean) |
---|
| Day 85 (n=90, 94, 95) | Day 169 (n=92, 94, 97) | Day 253 ( n=92, 94, 97) | Day 365 ( n=92, 94, 97) |
---|
Abatacept 10/10 mg/kg | -1.40 | -1.69 | -2.95 | -3.21 |
,Abatacept 30/10 mg/kg | -1.54 | -2.68 | -3.54 | -4.20 |
,Placebo | -0.67 | -1.08 | -3.06 | -4.79 |
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Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period
"A visual analogue scale is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured.~The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue." (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365
Intervention | Units on a scale (Mean) |
---|
| Day 85 (n=90, 94, 95) | Day 169 (n=92, 94, 97) | Day 253 (n=92, 94, 97) | Day 365 (n=92, 94, 97) |
---|
Abatacept 10/10 mg/kg | -4.94 | -9.52 | -11.90 | -12.32 |
,Abatacept 30/10 mg/kg | -9.18 | -7.18 | -8.78 | -12.21 |
,Placebo | -6.20 | -4.71 | -7.35 | -11.07 |
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Change in Quantitative Immunoglobulin From Baseline During Short-term Period
"A quantitative immunoglobulin (Ig) test is used to detect abnormal levels of the 3 major classes of Ig (IgG, IgA, and IgM). Abnormal test results typically indicate that something is affecting the immune system and further testing is required.~Please refer to Outcome 31 for the respective baseline values" (NCT00430677)
Timeframe: Day 365
Intervention | mg/dL (Mean) |
---|
| Ig A (n=76, 73, 78) | IgG (n=76, 73, 78) | IgM (n=76, 73, 78) |
---|
Abatacept 10/10 mg/kg | -34.48 | 27.21 | -19.38 |
,Abatacept 30/10 mg/kg | -32.83 | 41.41 | -17.76 |
,Placebo | -26.51 | 23.42 | -20.62 |
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Change in Renal Function From Baseline Over Time During Short-term Period
Mean change from baseline in renal function, as estimated by calculation of the MDRD equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A positive value indicates improvement. Change from baseline=Post-baseline-baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365
Intervention | milliliters per minute (mL/min)/1.73 m^2 (Mean) |
---|
| Day 15; (n=98,94,98) | Day 29 (n=98, 95, 98) | Day 57 (n=94 89 96) | Day 85 (n=90, 91, 93) | Day 113 (n=91, 83, 91) | Day 141 (n=89, 83, 90) | Day 169 (n=83, 82, 85) | Day 197 (n=84, 81, 87) | Day 225 (n=84, 81, 84) | Day 253 (n=81, 76, 81) | Day 281 (n=78, 77, 80) | Day 309 (n=77, 76, 78) | Day 337 (n=74, 75, 79) | Day 365 (n=75, 73, 78) |
---|
Abatacept 10/10 mg/kg | 1.15 | 4.51 | 7.28 | 6.20 | 10.23 | 7.90 | 10.55 | 10.67 | 7.72 | 7.22 | 6.81 | 9.53 | 10.15 | 11.03 |
,Abatacept 30/10 mg/kg | -0.24 | 2.26 | 5.96 | 8.56 | 5.31 | 8.33 | 8.12 | 7.71 | 7.32 | 4.70 | 5.68 | 6.34 | 5.34 | 5.17 |
,Placebo | 0.62 | 1.70 | 2.38 | 2.89 | 4.12 | 3.62 | 7.34 | 6.79 | 7.19 | 5.86 | 5.38 | 6.00 | 4.39 | 5.68 |
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Mean Change From Baseline in SLICC/ACR Damage Index
SLICC=Systemic Lupus International Collaborating Clinics; ACR=American College of Rheumatology. The SLICC/ACR Damage Index measures organ damage (nonreversible change, unrelated to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months unless otherwise stated. The index assesses 47 items in 12 systems: Ocular, Neuropsychiatric, Renal, Pulmonary, Cardiovascular, Gastrointestinal, Peripheral Vascular, Musculoskeletal, Skin, Premature Gonadal Failure, Diabetes, Malignancy. Scores range from 0 to 2, and the same lesion cannot be scored twice. If damage is noted for a particular item, it is scored 1. No damage is scored 0. Some items may score 2 points if they occur more than once, so that the maximum possible score is 47. Scores can only increase with time, but scores rarely reach over 12. It is usually completed (or updated) yearly. (NCT00430677)
Timeframe: Day 365 to termination of the long-term extension phase
Intervention | Units on a scale (Mean) |
---|
| Day 365 (n=69, 65, 74) | Day 729 (n=66, 65, 69) | Day 1093 (n=41, 38, 44) |
---|
Abatacept 10/10 mg/kg | -0.17 | -0.28 | -0.16 |
,Abatacept 30/10 mg/kg | -0.12 | -0.21 | -.27 |
,Placebo | -0.08 | -0.10 | 0.02 |
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Number of Participants Achieving Complete Response by ACCESS Definition
The Abatacept and Cyclophosphamide Combination Efficacy and Safety Study (ACCESS) defines complete response as a response meeting all of the following criteria: serum creatinine ≤upper limit of normal as defined by the central laboratory or ≤125% of the higher value at either screening or baseline; urine protein/creatinine ratio <50 mg/mmoL; and prednisone or prednisone-equivalent dose tapered to 10 mg per day. (NCT00430677)
Timeframe: End of short-term period (Day 365) to termination of the long-term extension period
Intervention | participants (Number) |
---|
| Day 365 | Day 645 (n=55, 56, 61) |
---|
Abatacept 10/10 mg/kg | 30 | 28 |
,Abatacept 30/10 mg/kg | 29 | 27 |
,Placebo | 25 | 25 |
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Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis
Patient response=complete, partial, or no response. Complete response=serum creatinine (SCr) normal, inactive urinary sediment, no cellular casts, urinary protein/creatinine (UPCR) ratio<56.5 mg/mmol. Partial response=SCr normal or ≤25% above baseline value, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the baseline ratio. No response=Not achieving complete or partial response criteria. (NCT00430677)
Timeframe: At Day 365 (end of Short-term Period) and Day 645
Intervention | Participants (Number) |
---|
| Day 365 | Day 645 (n=59, 59, and 62) |
---|
Abatacept 10/10 mg/kg | 39 | 29 |
,Abatacept 30/10 mg/kg | 43 | 45 |
,Placebo | 42 | 36 |
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Number of Participants Achieving Renal Response
Renal response=serum creatinine level ≤25% above baseline value and greater than or equal to 50% improvement in the urine protein/creatinine ratio with 1 of the following: urine protein/creatinine ratio (UPCR) <113 mg/mmol, if the baseline ratio was <= 339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio >339 mg/mmol. (NCT00430677)
Timeframe: At Day 365 (end of short-term period) and Day 645
Intervention | participants (Number) |
---|
| Day 365 | Day 645 (n=59, 59, 62) |
---|
Abatacept 10/10 mg/kg | 66 | 59 |
,Abatacept 30/10 mg/kg | 46 | 47 |
,Placebo | 74 | 62 |
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Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period
preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Hemoglobin (g/dL): >3g/dL decrease from preRX value. Hematocrit(%): <0.75*preRX. Erythrocytes (*10^6 c/uL): <0.75*preRX. Platelet count (*10^9 c/L): <0.67*LLN, or >1.5*ULN, or if preRX 1.25*ULN, or if preRX ULN; if preRX>ULN, use >1.2*preRX or 7.50*10^3 c/uL. Monocytes (absolute) (*10^3 c/uL): If value >2000/mm^3. Basophils (absolute)(*10^3 c/uL): If value >.750*10^3 c/uL. Eosinophils (absolute) (*10^3 c/uL): If value >.750*10^3 c/uL. ALP (U/L): >2*ULN, or if preRX>ULN, use >3* preRX. AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. GGT (U/L):>2*ULN, or if preRX >ULN, use >3*preRX. Bilirubin, total (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX. BUN (mg/dL): >1.5*preRX. (NCT00430677)
Timeframe: From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period
Intervention | Participants (Number) |
---|
| Hemoglobin (low) | Hemoglobin (high) | Hematocrit (n=210) (low) | Hematocrit (n=210) (high) | Erythrocytes (low) | Erythrocytes (high) | Platelet count (n=210) (low) | Platelet count (n=210) (high) | Leukocytes (low) | Leukocytes (high) | Neutrophils + Bands (absolute) (low) | Neutrophils + Bands (absolute) (high) | Lymphocytes (absolute) (low) | Lymphocytes (absolute) (high) | Monocytes (absolute) (low) | Monocytes (absolute) (high) | Basophils (absolute) (low) | Basophils (absolute) (high) | Eosinophils (absolute) (low) | Eosinophils (absolute) (high) | Alkaline phosphatase (ALP) (low) | ALP (high) | Aspartate aminotransferase (AST) (low) | AST (high) | Alanine aminotransferase (ALT) (low) | ALT (high) | G-glutamyl transferase (GGT) (low) | GGT (high) | Bilirubin, total (low) | Bilirubin, total (high) | Blood urea nitrogen (BUN) (low) | BUN (high) | Creatinine (low) | Creatinine (high) |
---|
Abatacept 10 mg/kg | 13 | NA | 11 | NA | 10 | NA | 1 | 0 | 40 | 9 | 4 | NA | 59 | 0 | NA | 0 | NA | 0 | NA | 8 | NA | 3 | NA | 3 | NA | 5 | NA | 14 | NA | 0 | NA | 9 | NA | 16 |
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Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRXULN if preRX>ULN, use >1.05*preRX or 1.1*ULN, or if preRX ULN if preRX>ULN, use >1.1*preRX or 1.1*ULN, or if preRXULN. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRXULN if preRX>ULN, use >1.25*preRX or 220 mg/dL. Glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRX ULN if preRX>ULN, use >2.0*preRX or 2*preRX. Triglycerides (mg/dL): >=2.5*ULN, or if preRX>ULN, use >=2.5*preRX. Triglycerides, fasting (mg/dL): >=2*ULN, or if preRX>ULN, use >2.0*preRX. (NCT00430677)
Timeframe: From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period
Intervention | Participants (Number) |
---|
| Sodium, serum (low) | Sodium, serum (high) | Potassium, serum (n=210) (low) | Potassium, serum (n=210) (high) | Chloride, serum (low) | Chloride, serum (high) | Calcium, total (n=210) (low) | Calcium, total (n=210) (high) | Glucose, serum (low) | Glucose, serum (high) | Glucose, fasting serum (low) (n=143) | Glucose, fasting serum (high) (n=143) | Protein, total (low) | Protein, total (high) | Albumin (low) | Albumin (high) | Cholesterol, total (low) (n=32) | Cholesterol, total (high) (n=32) | Triglycerides (low) (n=20) | Triglycerides (high) (n=20) | Triglycerides, fasting (low) (n=18) | Triglycerides, fasting (high) (n=18) | Protein, urine (low) | Protein, urine (high) | Glucose, urine (low) | Glucose, urine (high) | Blood, urine (low) | Blood, urine (high) | Leukocyte esterase, urine (low) (n=185) | Leukocyte esterase, urine (high) (n=185) |
---|
Abatacept 10 mg/kg | 1 | 2 | 11 | 3 | 0 | 0 | 1 | 2 | 23 | 2 | 2 | 2 | 19 | 0 | 12 | NA | 32 | NA | 20 | NA | 18 | NA | NA | 9 | NA | 1 | NA | 35 | NA | 27 |
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Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)
preRX=pretreatment. Protein, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 OR 3 then use >=4. Glucose, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Blood, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Leukocyte esterase, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. (NCT00430677)
Timeframe: From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period
Intervention | Participants (Number) |
---|
| Protein, urine (low) | Protein, urine (high) | Glucose, urine (low) | Glucose, urine (high) | Blood, urine (low) | Blood, urine (high) | Leukocyte esterase, urine (low) (n=185) | Leukocyte esterase, urine (high) (n=185) |
---|
Abatacept 10 mg/kg | NA | 9 | NA | 1 | NA | 35 | NA | 27 |
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Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period
A validated, sensitive electrochemiluminescence (ECL) immunoassay based on Meso-Scale Discovery instrumentation was used to evaluate immunogenicity. The ECL assay differentiated between two antibody specificities: (1) the 'Ig and/or Junction (Jn) Region' and (2) 'CLTA4 and possibly Ig'. A sample was considered positive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept with or without CTLA4-T. (NCT00430677)
Timeframe: Day 169, Day 365
Intervention | Participants (Number) |
---|
| CTLA4 and possibly Ig; Day 169 (n=90) | CTLA4 and possibly Ig; Day 365 (n=74) | CTLA4 and possibly Ig;Overall on TRT visits (n=90) | CTLA4 and possibly Ig; Overall Post visits (n=20) | CTLA4 and possibly Ig; Overall (n=96) | Ig/Jn region; Day 169 (n=90) | Ig/Jn region; Day 365 (n=78) | Ig/Jn region; Overall on TRT visits (n=90) | Ig/Jn region; Overall on Post visits (n=20) | Ig/Jn region; Overall (n=95) |
---|
Abatacept 10/10 mg/kg | 1 | 0 | 1 | 5 | 6 | 0 | 0 | 0 | 1 | 1 |
,Abatacept 30/10 mg/kg | 2 | 1 | 3 | 7 | 9 | 0 | 1 | 1 | 0 | 1 |
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Vital Signs Summary During the Short-term Period: Heart Rate
(NCT00430677)
Timeframe: 0 - 12 Months
Intervention | beats per minute (Mean) |
---|
| Day 1: before infusion; n=99,98,100 | Day 1: 1hour after infusion; n=98,98,98 | Day 1: 2.5 hours after infusion; n=97,96,96 | Day 15: before infusion; n=97,93,99 | Day 15: 1hour after infusion; n=96,94,98 | Day 15: 2.5 hours after infusion; n=93,92,95 | Day 29: before infusion; n=94,93,99 | Day 29: 1hour after infusion; n=93,92,99 | Day 29: 2.5 hours after infusion; n=92,90,97 | Day 57: before infusion; n=93,88,84 | Day 57: 1hour after infusion; n=93,84,94 | Day 57: 2.5 hours after infusion; n=91,84,91 | Day 85: before infusion; n=89,86,91 | Day 85: 1hour after infusion; n=88,84,89 | Day 113: before infusion; n=88,82,92 | Day 113: 1hour after infusion; n=87,80,91 | Day 141: before infusion; n=84,82,89 | Day 141: 1hour after infusion; n=84,81,86 | Day 169: before infusion; n=85,82,86 | Day 169: 1hour after infusion; n=84,82,85 | Day 197: before infusion; n=83,82,84 | Day 197: 1hour after infusion; n=82,82,85 | Day 225: before infusion; n=83,76,81 | Day 225: 1hour after infusion; n=83,76,81 | Day 253: before infusion; n=78,77,81 | Day 253: 1hour after infusion; n=78,77,81 | Day 281: before infusion; n=75,76,77 | Day 281: 1hour after infusion; n=74,76,76 | Day 309: before infusion; n=76,75,77 | Day 309: 1hour after infusion; n=76,74,77 | Day 337: before infusion; n=73,75,80 | Day 337: 1hour after infusion; n=73,73,79 |
---|
Abatacept 10/10 mg/kg | 79.2 | 79.6 | 82.2 | 81.0 | 80.1 | 81.7 | 80.8 | 79.9 | 82.1 | 82.2 | 81.6 | 83.4 | 82.3 | 80.4 | 80.4 | 80.2 | 79.3 | 79.1 | 78.0 | 78.8 | 78.1 | 78.7 | 77.6 | 78.0 | 79.1 | 79.3 | 78.3 | 77.6 | 76.5 | 77.4 | 76.4 | 77.4 |
,Abatacept 30/10 mg/kg | 82.4 | 81.3 | 81.8 | 83.1 | 81.3 | 81.5 | 83.7 | 81.7 | 81.3 | 83.4 | 81.0 | 82.5 | 84.8 | 83.3 | 82.1 | 81.8 | 82.8 | 81.4 | 80.1 | 79.5 | 81.7 | 79.8 | 80.1 | 79.1 | 81.4 | 78.8 | 80.1 | 78.0 | 79.8 | 77.9 | 78.5 | 77.6 |
,Placebo | 82.6 | 81.9 | 83.8 | 83.7 | 82.6 | 84.7 | 83.0 | 81.7 | 84.7 | 82.8 | 81.8 | 83.8 | 82.5 | 83.5 | 83.0 | 82.6 | 82.6 | 81.3 | 79.1 | 81.4 | 79.3 | 79.6 | 78.9 | 80.2 | 81.5 | 79.5 | 79.3 | 78.7 | 78.2 | 78.4 | 78.9 | 78.3 |
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Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP)
(NCT00430677)
Timeframe: 0 - 12 Months
Intervention | mmHg (Mean) |
---|
| Day 1: SBP-before infusion; n=76,81,73 | Day 1: SBP-1hour after infusion; n=69,78,70 | Day 1: SBP-2.5 hours after infusion; n=79,81,76 | Day 15: SBP-before infusion; n=78,78,74 | Day 15: SBP- 1hour after infusion; n=72,75,71 | Day 15: SBP-2.5 hours after infusion; n=80,78,78 | Day 29: SBP-before infusion; n=77,79,75 | Day 29: SBP-1hour after infusion; n=72,75,74 | Day 29: SBP-2.5 hours after infusion; n=80,79,82 | Day 57: SBP-before infusion; n=74,76,70 | Day 57: SBP-1hour after infusion; n=74,69,68 | Day 57: SBP-2.5 hours after infusion; n=81,73,73 | Day 85: SBP- before infusion; n=73,71,67 | Day 85: SBP-1hour after infusion; n=73,69,72 | Day 113: SBP-before infusion; n=72,70,70 | Day 113: SBP-1hour after infusion; n=75,70,75 | Day 141: SBP-before infusion; n=66,70,66 | Day 141: SBP-1hour after infusion; n=72,71,70 | Day 169: SBP-before infusion; n=70,70,66 | Day 169: SBP-1hour after infusion; n=75,71,71 | Day 197: SBP-before infusion; n=68,70,64 | Day 197: SBP-1hour after infusion; n=72,73,70 | Day 225: SBP-before infusion; n=70,64,63 | Day 225: SBP-1hour after infusion; n=72,65,68 | Day 253: SBP-before infusion; n=63,66,63 | Day 253: SBP-1hour after infusion; n=69,67,67 | Day 281: SBP-before infusion; n=63,66,58 | Day 281: SBP-1hour after infusion; n=66,65,64 | Day 309: SBP-before infusion; n=63,63,59 | Day 309: SBP-1hour after infusion; n=67,66,64 | Day 337: SBP-before infusion; n=63,64,61 | Day 337: SBP-1hour after infusion; n=68,65,67 |
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Abatacept 10/10 mg/kg | 127.8 | 126.7 | 127.8 | 125.5 | 125.9 | 124.9 | 126.2 | 125.9 | 126.4 | 124.8 | 122.1 | 123.6 | 118.7 | 119.6 | 121.7 | 121.0 | 119.2 | 117.9 | 117.6 | 118.2 | 118.9 | 117.4 | 118.8 | 119.5 | 120.2 | 117.1 | 116.5 | 119.4 | 116.3 | 114.1 | 117.3 | 117.7 |
,Abatacept 30/10 mg/kg | 128.2 | 127.7 | 127.1 | 127.6 | 126.9 | 130.1 | 125.6 | 126.2 | 126.3 | 126.4 | 124.6 | 127.0 | 122.0 | 121.8 | 122.6 | 121.5 | 121.4 | 120.9 | 118.5 | 120.3 | 119.0 | 117.7 | 118.2 | 116.6 | 120.6 | 118.1 | 120.7 | 119.5 | 119.4 | 119.6 | 119.9 | 120.4 |
,Placebo | 126.2 | 126.0 | 126.2 | 129.2 | 128.2 | 131.2 | 126.9 | 128.6 | 127.6 | 123.0 | 124.4 | 126.1 | 122.2 | 122.0 | 119.9 | 120.1 | 118.8 | 120.4 | 118.6 | 118.9 | 118.7 | 120.4 | 119.5 | 118.8 | 120.9 | 119.7 | 120.3 | 121.0 | 120.5 | 119.2 | 119.3 | 119.3 |
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Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug. (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Intervention | Participants (Number) |
---|
| Deaths | SAEs | Related SAEs | AEs | Related AEs | Discontinued due to AEs |
---|
Abatacept 10/10 mg/kg | 2 | 28 | 19 | 89 | 53 | 13 |
,Abatacept 30/10 mg/kg | 5 | 33 | 20 | 93 | 61 | 14 |
,Placebo | 7 | 31 | 15 | 94 | 55 | 9 |
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Participants With AEs of Special Interest During the Short-term Period
AEs of special interest were prospectively identified to be those that may be associated with the use of immunomodulatory agents. They are a subset of all AEs and may be either serious or non-serious. (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Intervention | Participants (Number) |
---|
| Infections and Infestations | Malignancies | Autoimmune Disorders | Acute Infusional AEs | Peri-infusional AEs |
---|
Abatacept 10/10 mg/kg | 70 | 1 | 5 | 18 | 18 |
,Abatacept 30/10 mg/kg | 75 | 0 | 4 | 23 | 23 |
,Placebo | 75 | 1 | 3 | 17 | 17 |
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Participants With Marked Abnormalities Urinalysis During the Short-term Period
PTV=pretreatment value. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase , if missing PTV then use >=2+ (or, if value >=4, or if PTV=0 or 0.5, >=2 or if PTV=1, >=3, or if PTV=2 or 3, >=4). (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Intervention | Participants (Number) |
---|
| Urine Protein (n=99,98,99) | Urine Glucose (n=99,98,99) | Urine Blood (n=99,98,99) | Urine Leukocyte esterase (n=85,91,90) |
---|
Abatacept 10/10 mg/kg | 3 | 3 | 19 | 8 |
,Abatacept 30/10 mg/kg | 6 | 1 | 16 | 10 |
,Placebo | 8 | 0 | 17 | 8 |
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Participants With Marked Hematology Abnormalities During the Short-term Period
LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. Low(↓)Hemoglobin:>3g/dL decrease from PTV; ↓Hematocrit:<0.75xPTV;↓Erythrocyte count:<0.75xPTV; high(↑)Platelet count:>1.5xULN;↓Platelet count:<0.67xLLN;↓Leukocyte count:<0.75X LLN;↑Leukocyte count:>1.25xULN;↓Absolute(AB)Neutrophils+Bands:<1.00x10^3c/uL;↑AB Lymphocyte count:>7.50x10^3 c/uL; ↓AB lymphocyte count:<0.750x10^3 c/uL;↑AB monocyte count:>2000/mm^3;↑AB basophil count:>400/mm^3;↑AB eosinophil count:>0.750x10^3 c/uL. (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Intervention | Participants (Number) |
---|
| Low Hemoglobin (n=98, 98, 99) | Low Hematocrit (n=97, 98, 99) | Low Erythrocyte Count (n=98, 98, 99) | High Platelet Count (n=98, 98, 98) | Low Platelet Count (n=98, 98, 98) | High Leukocyte Count (n=98, 98, 99) | Low Leukocyte Count (n=98,98,99) | Low Absolute Neutrophils + Bands (n=98,98,99) | High Absolute Lymphocyte Count (n=98,98,99) | Low Absolute Lymphocyte Count (n=98, 98, 99) | High Absolute Monocyte Count (n=98, 98, 99) | High Absolute Basophil Count (n=98, 98, 99) | High Absolute Eosinophil Count (n=98, 98, 99) |
---|
Abatacept 10/10 mg/kg | 3 | 1 | 1 | 0 | 3 | 10 | 18 | 2 | 2 | 32 | 1 | 0 | 3 |
,Abatacept 30/10 mg/kg | 6 | 5 | 4 | 1 | 1 | 15 | 13 | 1 | 0 | 47 | 1 | 0 | 0 |
,Placebo | 9 | 7 | 7 | 1 | 1 | 11 | 16 | 7 | 0 | 53 | 1 | 0 | 0 |
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Participants With Marked Laboratory Abnormalities During the Short-term Period
LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. ↑Serum Sodium:>1.05x ULN;↓Serum Potassium:<0.9x LLN;↑Serum Potassium:>1.1x ULN;↓Total Calcium:<0.8X LLN;↑Total Calcium:>1.2x ULN; ↓Serum Glucose(SG):<65 mg/dL;↑SG:>220 mg/dL;↓Fasting SG:<0.8x LLN;↑Fasting SG:>1.5x ULN;↓Total Protein:<0.9x LLN;↓Albumin:<0.9x LLN;↑Total Cholesterol:>2x PTV;↑Triglycerides:>=2.5x ULN;↑Fasting Triglycerides:>=2x ULN (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Intervention | Participants (Number) |
---|
| High Serum Sodium (n=98, 98, 99) | Low Serum Potassium (n=98, 98, 99) | High Serum Potassium (n=98, 98, 99) | Low Total Calcium (n=98, 98, 99) | High Total Calcium (n=98, 98, 99) | Low Serum Glucose (n=98, 98, 99) | High Serum Glucose (n=98, 98, 99) | Low Fasting Serum Glucose (n=72, 73, 68) | High Fasting Serum Glucose (n=72, 73, 68) | Low Total Protein (n=98, 98, 99) | Low Albumin (n=98, 98, 99) | High Total Cholesterol (n=93,93,96) | High Triglycerides (n=71, 79, 75) | High Fasting Triglycerides (n=65, 64, 63) |
---|
Abatacept 10/10 mg/kg | 2 | 14 | 0 | 1 | 2 | 16 | 2 | 2 | 1 | 18 | 6 | 0 | 0 | 0 |
,Abatacept 30/10 mg/kg | 1 | 12 | 4 | 0 | 1 | 12 | 2 | 3 | 1 | 18 | 10 | 2 | 2 | 3 |
,Placebo | 0 | 15 | 2 | 1 | 1 | 18 | 2 | 0 | 0 | 25 | 4 | 1 | 0 | 0 |
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Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period
"ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age.~Alkaline Phosphatase:>2x ULN; ↑Aspartate Aminotransferase: >3x ULN; ↑Alanine Aminotransferase : >3x ULN; G-Glutamyl Transferase : >2x ULN; ↑Total Bilirubin : >2x ULN or if PTV > ULN then > 4x PTV; ↑Blood Urea Nitrogen >2x PTV; ↑Creatinine >1.5x PTV." (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Intervention | Participants (Number) |
---|
| High Alkaline Phosphatase | High Aspartate Aminotransferase | High Alanine Aminotransferase | High G-Glutamyl Transferase | High Total Bilirubin | High Blood Urea Nitrogen | High Creatinine |
---|
Abatacept 10/10 mg/kg | 1 | 0 | 4 | 7 | 0 | 1 | 6 |
,Abatacept 30/10 mg/kg | 1 | 2 | 7 | 7 | 0 | 5 | 16 |
,Placebo | 1 | 0 | 1 | 5 | 0 | 6 | 12 |
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Vital Signs Summary During the Short-term Period: Temperature
(NCT00430677)
Timeframe: 0 - 12 Months
Intervention | degree celcius (Mean) |
---|
| Day 1: before infusion; n=99,98,99 | Day 1: 1hour after infusion; n=98,96,97 | Day 1: 2.5 hours after infusion; n=97,93,97 | Day 15: before infusion; n=97,94,99 | Day 15: 1hour after infusion; n=96,91,98 | Day 15: 2.5 hours after infusion; n=93,91,95 | Day 29: before infusion; n=94,93,99 | Day 29: 1hour after infusion; n=93,91,98 | Day 29: 2.5 hours after infusion; n=92,90,97 | Day 57: before infusion; n=93,88,93 | Day 57: 1hour after infusion; n=93,83,94 | Day 57: 2.5 hours after infusion; n=90,84,90 | Day 85: before infusion; n=89,86,91 | Day 85: 1hour after infusion; n=87,84,89 | Day 113: before infusion; n=88,82,92 | Day 113: 1hour after infusion; n=87,79,91 | Day 141: before infusion; n=84,81,89 | Day 141: 1hour after infusion; n=84,80,86 | Day 169: before infusion; n=85,81,86 | Day 169: 1hour after infusion; n=84,80,84 | Day 197: before infusion; n=83,82,85 | Day 197: 1hour after infusion; n=82,81,84 | Day 225: before infusion; n=83,76,81 | Day 225: 1hour after infusion; n=83,75,81 | Day 253: before infusion; n=78,77,80 | Day 253: 1hour after infusion; n=78,77,81 | Day 281: before infusion; n=75,76,77 | Day 281: 1hour after infusion; n=74,76,76 | Day 309: before infusion; n=76,75,77 | Day 309: 1hour after infusion; n=75,73,77 | Day 337: before infusion; n=73,75,79 | Day 337: 1hour after infusion; n=73,72,79 |
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Abatacept 10/10 mg/kg | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.4 | 36.5 | 36.5 | 36.4 | 36.4 | 36.5 | 36.4 | 36.4 | 36.4 | 36.4 | 36.4 | 36.4 | 36.4 | 36.4 | 36.3 | 36.3 | 36.4 | 36.4 | 36.4 | 36.4 | 36.4 | 36.4 | 36.3 | 36.4 | 36.4 | 36.4 |
,Abatacept 30/10 mg/kg | 36.6 | 36.6 | 36.6 | 36.5 | 36.6 | 36.6 | 36.5 | 36.5 | 36.5 | 36.5 | 36.1 | 36.5 | 36.4 | 36.4 | 36.5 | 36.4 | 36.5 | 36.5 | 36.5 | 36.4 | 36.5 | 36.4 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 |
,Placebo | 36.5 | 36.6 | 36.6 | 36.5 | 36.5 | 36.6 | 36.5 | 36.5 | 36.5 | 36.5 | 36.6 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.4 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 | 36.5 |
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Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period
"PR is either CRR, Partial Renal Response(PRR),or no Response(NR).~CRR= Serum creatinine(SC)is normal, Inactive urinary sediment, No cellular casts, Urinary protein/creatinine (UPCR) ratio <56.5 mg/mmoL; PRR= SC is normal OR SC not >25% above BL, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the BL ratio; NR= Not achieving either a CRR or a PRR. Participants achieved response if criteria at both months 11 and 12 (Days 337 and 365) were met. Participants who Early discontinuations were categorized as NR." (NCT00430677)
Timeframe: Month 12
Intervention | Participants (Number) |
---|
| No Renal Response | Partial Renal Response | Complete Renal Response |
---|
Abatacept 10/10 mg/kg | 69 | 9 | 21 |
,Abatacept 30/10 mg/kg | 61 | 14 | 24 |
,Placebo | 66 | 14 | 20 |
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Change in SLICC/ACR Damage Index From Baseline During Short-term Period
SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. Change from baseline=Postbaseline - baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose)
Intervention | Units on a scale (Mean) |
---|
Abatacept 30/10 mg/kg | 0.17 |
Abatacept 10/10 mg/kg | 0.11 |
Placebo | 0.13 |
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Number of Months CRR Was Maintained During Short-term Period
Durability of CRR, defined as the number of months (number of consecutive planned visits beyond Day 15) a participant met the definition of CRR during the double-blind treatment period. Refer to outcome 1 for description of CRR. (NCT00430677)
Timeframe: Day 1 (randomization) to 12 Months
Intervention | Months (Median) |
---|
Abatacept 30/10 mg/kg | 0 |
Abatacept 10/10 mg/kg | 0 |
Placebo | 0 |
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Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period
RR is defined as meeting BOTH of the following criteria:RENAL FUNCTION: Less than or equal to 25% increase from baseline;PROTEINURIA: Greater than or equal to 50% improvement in the urine protein/creatinine ratio with one of the following - urine protein/creatinine ratio (UPCR) <113 mg/mmol,, if the baseline ratio was <=339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio > 339 mg/mmol. A participant was considered as achieving RR if response criteria at both months 11 and 12 (Days 337 and 365, respectively) were met. For 95% CI within each group, normal approximation is used if n>=5. (NCT00430677)
Timeframe: Month 12
Intervention | Participants (Number) |
---|
Abatacept 30/10 mg/kg | 45 |
Abatacept 10/10 mg/kg | 39 |
Placebo | 33 |
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Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period
Collected in at least 1 sample. Assessment includes immunogenicity (detection of serum antibodies which bind to CTLA4-Ig in the in vitro assays) and exposure to corticosteroids (NCT00430677)
Timeframe: Day 365 to end of long-term extension period
Intervention | Participants (Number) |
---|
Abatacept 10 mg/kg | 17 |
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Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365
Intervention | Units on a scale (Mean) |
---|
| Day 85 (n=89, 91, 93) | Day 169 (n=92, 94, 96) | Day 253 (n=92, 94, 96) | Day 365 (n=92, 94, 96) |
---|
Abatacept 10/10 mg/kg | 3.10 | 5.08 | 4.83 | 4.23 |
,Abatacept 30/10 mg/kg | 1.07 | 2.90 | 2.45 | 2.62 |
,Placebo | 1.87 | 3.69 | 2.99 | 2.84 |
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Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period
Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. (NCT00430677)
Timeframe: At Month 12 from Day 1
Intervention | Participants (Number) |
---|
Abatacept 30/10 mg/kg | 9 |
Abatacept 10/10 mg/kg | 11 |
Placebo | 8 |
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Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP)
(NCT00430677)
Timeframe: 0 - 12 Months
Intervention | mm Hg (Mean) |
---|
| Day 1: DBP-before infusion; n=76,81,73 | Day 1: DBP-1hour after infusion; n=69,78,70 | Day 1: DBP-2.5 hours after infusion; n=79,81,76 | Day 15: DBP-before infusion; n=78,78,74 | Day 15: DBP- 1hour after infusion; n=72,75,71 | Day 15: DBP-2.5 hours after infusion; n=80,78,78 | Day 29: DBP-before infusion; n=77,79,75 | Day 29: DBP-1hour after infusion; n=72,75,74 | Day 29: DBP-2.5 hours after infusion; n=80,79,82 | Day 57: DBP-before infusion; n=74,76,70 | Day 57: DBP-1hour after infusion; n=74,69,68 | Day 57: DBP-2.5 hours after infusion; n=81,73,73 | Day 85: DBP- before infusion; n=73,71,67 | Day 85: DBP-1hour after infusion; n=73,69,72 | Day 113: DBP-before infusion; n=72,70,70 | Day 113: DBP-1hour after infusion; n=75,70,75 | Day 141: DBP-before infusion; n=66,70,66 | Day 141: DBP-1hour after infusion; n=72,71,70 | Day 169: DBP-before infusion; n=70,70,66 | Day 169: DBP-1hour after infusion; n=75,71,71 | Day 197: DBP-before infusion; n=68,70,64 | Day 197: DBP-1hour after infusion; n=72,73,70 | Day 225: DBP-before infusion; n=70,64,63 | Day 225: DBP-1hour after infusion; n=72,65,68 | Day 253: DBP-before infusion; n=63,66,63 | Day 253: DBP-1hour after infusion; n=69,67,67 | Day 281: DBP-before infusion; n=63,66,58 | Day 281: DBP-1hour after infusion; n=66,65,64 | Day 309: DBP-before infusion; n=63,63,59 | Day 309: DBP-1hour after infusion; n=67,66,64 | Day 337: DBP-before infusion; n=63,64,61 | Day 337: DBP-1hour after infusion; n=68,65,67 |
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Abatacept 10/10 mg/kg | 80.6 | 79.6 | 79.0 | 80.0 | 78.7 | 78.0 | 78.8 | 78.0 | 78.2 | 78.7 | 75.3 | 76.1 | 75.2 | 75.6 | 77.0 | 76.3 | 74.0 | 74.7 | 74.1 | 74.4 | 75.8 | 74.5 | 73.6 | 74.5 | 75.9 | 74.9 | 73.3 | 74.5 | 72.9 | 72.9 | 73.4 | 73.3 |
,Abatacept 30/10 mg/kg | 80.8 | 79.6 | 79.3 | 81.1 | 79.6 | 81.4 | 79.6 | 79.9 | 78.5 | 80.0 | 78.9 | 79.5 | 79.7 | 78.1 | 78.5 | 76.1 | 78.8 | 77.8 | 75.5 | 76.5 | 76.8 | 76.1 | 74.5 | 75.0 | 76.1 | 74.5 | 77.6 | 75.9 | 78.1 | 76.4 | 78.0 | 78.1 |
,Placebo | 80.4 | 80.1 | 80.9 | 82.6 | 80.4 | 82.8 | 81.3 | 80.8 | 79.5 | 78.7 | 78.7 | 80.2 | 78.7 | 78.1 | 76.7 | 76.9 | 76.5 | 76.1 | 77.0 | 76.4 | 75.8 | 75.4 | 75.7 | 76.0 | 77.1 | 75.7 | 76.6 | 76.6 | 77.4 | 76.6 | 76.2 | 76.1 |
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Percent Probability of Participants With 6-month Progression-free Survival (PFS)
PFS is the proportion of subjects who progress or die by 6 months after the start of the combined therapy. PFS is determined by prostatic specific antigen (PSA) consensus criteria and the Response Evaluation Criteria in Solid Tumors (RECIST). PSA consensus criteria is defined as PSA decline of >/= 50% or PSA progression. RECIST is defined as the following: Complete response (CR) is disappearance of all target lesions; partial response (PR) is at least a 30% decline in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease ((PD) at least a 20% increase in the sum of the LD of target lesions, or the appearance of one or more lesions), taking as reference the smallest sum LD since the treatment started. Data is estimated and the probability of PFS as a function of time was determined using the Kaplan-Meier method. (NCT00436956)
Timeframe: 6 months
Intervention | percent probability (Number) |
---|
All Participants - AZD2171 & Prednisone | 43.9 |
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Number of Grade 3 Toxicities
Here is the number of Grade 3 (severe) toxicities. (NCT00436956)
Timeframe: 61.5 months
Intervention | toxicities (Number) |
---|
| Hypertension | Fatigue | Anorexia | Weight loss | Hypothyroidism | Dehydration | Prolonged QTc | Nausea | Diarrhea | Hypoalbuminemia | Proteinuria | Elevated alkaline phosphatase | Aspartate transaminase | Vomiting | Hyperbilirubinemia | Muscle weakness |
---|
20 mg AZD2171 + 10mg Prednisone Daily | 0 | 2 | 1 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
,20 mg AZD2171 Daily | 0 | 4 | 1 | 2 | 0 | 3 | 1 | 1 | 0 | 0 | 0 | 5 | 2 | 1 | 1 | 3 |
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Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)
Response was evaluated by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. (NCT00436956)
Timeframe: Every 2 cycles (approximately 56 days)
Intervention | Participants (Count of Participants) |
---|
| Complete Response | Confirmed Partial Response | Unconfirmed Partial Response | Not Evaluable |
---|
All Participants - AZD2171 & Prednisone | 0 | 6 | 1 | 1 |
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Number of Grade 2 Toxicities
Here is the number of Grade 2 (moderate) toxicities. (NCT00436956)
Timeframe: 61.5 months
Intervention | toxicities (Number) |
---|
| Hypertension | Fatigue | Anorexia | Weight loss | Hypothyroidism | Dehydration | Prolonged QTc | Nausea | Diarrhea | Hypoalbuminemia | Proteinuria | Elevated alkaline phosphatase | Aspartate transaminase | Vomiting | Hyperbilirubinemia | Muscle weakness |
---|
20 mg AZD2171 + 10mg Prednisone Daily | 8 | 4 | 6 | 4 | 6 | 2 | 2 | 3 | 0 | 3 | 3 | 2 | 3 | 2 | 1 | 1 |
,20 mg AZD2171 Daily | 17 | 15 | 12 | 11 | 7 | 8 | 8 | 7 | 8 | 5 | 5 | 4 | 3 | 4 | 4 | 2 |
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Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00436956)
Timeframe: Date treatment consent signed to date off study, approximately 61.5 months
Intervention | Participants (Count of Participants) |
---|
All Participants- AZD2171 & Prednisone | 59 |
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Clinical Remission on Medication
6 months of clinical inactive disease (NCT00443430)
Timeframe: 12 months or end of study
Intervention | participants (Number) |
---|
Methotrexate Arm | 3 |
Methotrexate-Prednisolone-Etanercept Arm | 9 |
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Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events
(NCT00443430)
Timeframe: Over 12 months maximum study participation per subject
Intervention | events (Number) |
---|
Methotrexate Arm | 1 |
Methotrexate-Prednisolone-Etanercept Arm | 2 |
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Proportion of Participants Who Attain Inactive Disease by 6 Months
(NCT00443430)
Timeframe: 6 months after initiation of study intervention
Intervention | participants (Number) |
---|
Methotrexate Arm | 10 |
Methotrexate-Prednisolone-Etanercept Arm | 17 |
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Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies.
Number of participants from whom paraffin-embedded DLBCL tissue samples were collected for future studies. (NCT00450385)
Timeframe: Baseline
Intervention | Participants (Count of Participants) |
---|
R-CHOP | 57 |
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PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS
Reported is PFS of participants (pts) with high or low biomarker expression levels. PFS: time from randomization to first date of PD/death from any cause. PD assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new/increased lymph node/masses and reappearance of bone marrow infiltrate. For pts who had subsequent anticancer therapy, PFS censored at date of last assessment prior to subsequent therapy. Biomarkers and number of pts censored: EIF4EBP1 Cytoplasm (C) 4,3,7,3; EIF4EBP1 Nucleus (N) 0,2,11,4; EIF4E C 5,2,6,4; EIF4E N 0,0,11,6; HDAC2 N 5,1,5,5; PCREB N 5,3,6,4; PEIF3746 C 4,2,7,4; PEIF3746 N 5,2,6,4; PEIFS209 C 5,2,5,4; PEIFS65 N 7,2,4,4; PEIFT70 C 5,2,6,4; PEIFT70 N 6,4,5,2; P GSK3B C 7,3,4,3; PKCb2 C 4,3,7,3; PS6 C 9,4,1,1; PTEN C 5,2,6,4; PTEN N 3,0,8,6. Correlation of biomarkers with PFS (statistical analyses) reported if high expression groups combined and low expression groups combined each had ≥10 pts. (NCT00451178)
Timeframe: Randomization to measured PD or death from any cause (up to 55 months)]
Intervention | months (Median) |
---|
| Marker: EIF4EBP1 Cytoplasm | Marker: EIF4EBP1 Nucleus | Marker: EIF4E Cytoplasm | Marker: EIF4E Nucleus | Marker: HDAC2 Nucleus | Marker: PCREB Nucleus | Marker: PEIF3746 Cytoplasm | Marker: PEIF3746 Nucleus | Marker: PEIFS209 Cytoplasm | Marker: PEIFS65 Nucleus | Marker: PEIFT70 Cytoplasm | Marker: PEIFT70 Nucleus | Marker: P GSK3B Cytoplasm | Marker: PKCb2 Cytoplasm | Marker: PS6 Cytoplasm | Marker: PTEN Cytoplasm | Marker: PTEN Nucleus |
---|
High Biomarker Expression (R-CHOP) | 9.49 | NA | 21.42 | 4.50 | 10.55 | 10.55 | 20.90 | NA | 9.20 | NA | NA | 32.30 | 21.42 | 10.55 | 10.02 | 21.42 | 6.34 |
,Low Biomarker Expression (R-CHOP and Enzastaurin) | 27.96 | NA | 27.96 | NA | NA | NA | NA | NA | 27.96 | 27.96 | 27.96 | 27.96 | NA | NA | 16.57 | NA | NA |
,Low Biomarker Expression (R-CHOP) | 32.30 | 10.55 | NA | 32.30 | NA | NA | NA | 32.30 | NA | 32.30 | 10.55 | NA | 9.49 | 20.90 | NA | 9.49 | 32.30 |
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Percentage of Participants With Complete Response (CR and CRu) and Objective Response [CR, CRu, and Partial Response (PR)] (Overall Response Rate)
CR, CRu, and PR were defined using International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. PR is a 50% decrease in the sum of the products of diameters for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. The percentage of participants with complete response (CR/CRu) and objective response (Cr/CRu/PR)=(Number of participants whose best overall response was CR/CRu or Cr/CRu/PR)/(Number of participants treated)*100. (NCT00451178)
Timeframe: Baseline through long-term follow-up (up to 2 years post last dose)
Intervention | percentage of participants (Number) |
---|
| Complete Response | Objective Response |
---|
R-CHOP | 42.9 | 85.7 |
,R-CHOP and Enzastaurin | 51.8 | 83.9 |
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Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died (Evaluate Toxicity and Tolerability of R-CHOP Plus Enzastaurin)
Data presented are the number of participants who experienced at least 1 TEAE, Grade 3 or 4 Common Terminology Criteria for Adverse Events (CTCAE), serious adverse event (SAE), as well as the number of participants who discontinued due to an adverse event (AE) or SAE, who died on therapy, died within 30 days post treatment or within 60 days of first dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. (NCT00451178)
Timeframe: First dose through 30 days post study treatment discontinuation (up to 56 months)
Intervention | Participants (Count of Participants) |
---|
| At Least 1 TEAE | At Least 1 Grade 3/4 CTCAE | At Least 1 SAE | Discontinued due to AE | Discontinued due to SAE | Died on Therapy (all causes) | Died within 30 days post treatment discontinuation | Died within 60 days of first dose |
---|
R-CHOP | 43 | 30 | 18 | 6 | 3 | 3 | 3 | 2 |
,R-CHOP and Enzastaurin | 56 | 50 | 35 | 10 | 4 | 5 | 6 | 3 |
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Progression-Free Survival (PFS) Time
PFS time is the elapsed time from the date of randomization to the first date of objectively-determined PD or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (other than enzastaurin maintenance therapy) prior to objectively determined disease progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the date of subsequent therapy. (NCT00451178)
Timeframe: Randomization to measured PD or death from any cause (up to 55 months)
Intervention | months (Median) |
---|
R-CHOP and Enzastaurin | 36.2 |
R-CHOP | 22.6 |
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Percentage of Participants With a PET-Negative Scan (PET-Negative Rate)
The percentage of participants with a PET-negative scan=(Number of participants who had a PET-negative scan at Cycle 6)/(Number of participants who had a PET-positive scan at baseline)*100. (NCT00451178)
Timeframe: Cycle 6 (21 days/cycle)
Intervention | percentage of participants (Number) |
---|
R-CHOP and Enzastaurin | 44.6 |
R-CHOP | 41.0 |
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Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate)
PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. Percentage of participants alive progression-free at Year 2=(Number of participants alive progression free at Year 2)/(Number of participants assessed)*100. (NCT00451178)
Timeframe: Randomization to measured PD (up to Year 2)
Intervention | percentage of participants (Number) |
---|
R-CHOP and Enzastaurin | 59 |
R-CHOP | 49 |
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Overall Survival (OS)
OS is the elapsed time from the date of study enrollment (baseline) to the date of death from any cause. For participants not known to have died as of the data cutoff date, OS was censored at the last contact date or last date known to be alive, whichever was later. (NCT00451178)
Timeframe: Baseline to death from any cause (up to 55 months)
Intervention | months (Median) |
---|
R-CHOP and Enzastaurin | NA |
R-CHOP | NA |
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Event-Free Survival (EFS)
EFS is the elapsed time from the date of randomization to the first date of objectively-determined PD, institution of a new anticancer treatment (other than maintenance therapy), or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date, who did not have objectively determined disease progression, and who were not treated with a new anticancer treatment, EFS was censored at the date of the last objectively determined disease-free assessment. (NCT00451178)
Timeframe: Randomization to measured PD, start of new therapy, or death from any cause (up to 55 months)
Intervention | months (Median) |
---|
R-CHOP and Enzastaurin | 36.2 |
R-CHOP | 22.6 |
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Duration of Complete Response (CR or CRu)
Duration of response (DOR) either CR or CRu: Elapsed time from date CR or CRu criteria met to first objectively-determined PD. For responding participants (pts) who died without PD and pts not known to have died as of data cut-off date, who did not have PD, DOR censored at date of last objective progression-free disease assessment. For responding pts who received subsequent systemic anticancer therapy (other than enzastaurin maintenance therapy) prior to PD, DOR was censored at date of last objective progression-free disease assessment prior to subsequent therapy. CR and CRu defined using International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. (NCT00451178)
Timeframe: Time of response to PD (up to 55 months)
Intervention | days (Median) |
---|
R-CHOP and Enzastaurin | NA |
R-CHOP | NA |
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Percentage of Participants With Complete Response (CR/CRu) and/or Post-Baseline PET-Negative Scan (Concordance Between Response and PET Scan)
Lesion response was assessed according to International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. Percentage of participants with CR/CRu and/or PET-negative scan=(Number of participants with complete response and/or PET-negative scan at Cycle 6)/(Number of participants with a PET-positive scan at baseline)*100. (NCT00451178)
Timeframe: Cycle 6 (21 days/cycle)
Intervention | percentage of participants (Number) |
---|
| CR/CRu and PET-Negative Post-Baseline | CR/CRu or PET-Negative Post-Baseline |
---|
R-CHOP | 25.6 | 43.6 |
,R-CHOP and Enzastaurin | 26.8 | 53.6 |
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PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS
Reported is PFS of participants (pts) with high or low biomarker expression levels. PFS: time from randomization to first date of PD/death from any cause. PD assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new/increased lymph node/masses and reappearance of bone marrow infiltrate. For pts who had subsequent anticancer therapy, PFS censored at date of last assessment prior to subsequent therapy. Biomarkers and number of pts censored: EIF4EBP1 Cytoplasm (C) 4,3,7,3; EIF4EBP1 Nucleus (N) 0,2,11,4; EIF4E C 5,2,6,4; EIF4E N 0,0,11,6; HDAC2 N 5,1,5,5; PCREB N 5,3,6,4; PEIF3746 C 4,2,7,4; PEIF3746 N 5,2,6,4; PEIFS209 C 5,2,5,4; PEIFS65 N 7,2,4,4; PEIFT70 C 5,2,6,4; PEIFT70 N 6,4,5,2; P GSK3B C 7,3,4,3; PKCb2 C 4,3,7,3; PS6 C 9,4,1,1; PTEN C 5,2,6,4; PTEN N 3,0,8,6. Correlation of biomarkers with PFS (statistical analyses) reported if high expression groups combined and low expression groups combined each had ≥10 pts. (NCT00451178)
Timeframe: Randomization to measured PD or death from any cause (up to 55 months)]
Intervention | months (Median) |
---|
| Marker: EIF4EBP1 Cytoplasm | Marker: EIF4E Cytoplasm | Marker: HDAC2 Nucleus | Marker: PCREB Nucleus | Marker: PEIF3746 Cytoplasm | Marker: PEIF3746 Nucleus | Marker: PEIFS209 Cytoplasm | Marker: PEIFS65 Nucleus | Marker: PEIFT70 Cytoplasm | Marker: PEIFT70 Nucleus | Marker: P GSK3B Cytoplasm | Marker: PKCb2 Cytoplasm | Marker: PS6 Cytoplasm | Marker: PTEN Cytoplasm | Marker: PTEN Nucleus |
---|
High Biomarker Expression (R-CHOP and Enzastaurin) | NA | NA | 27.96 | 24.10 | 27.96 | NA | NA | NA | NA | NA | 27.96 | 27.96 | NA | 27.96 | 27.96 |
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Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging
The test of association assesses the null hypothesis that the frequency of PSA response is the same for patients with and without a favorable imaging response. PSA response required a 50% reduction of the baseline PSA result that was confirmed three weeks later. Favorable imaging response is defined as stable disease, partial response, or complete response per RECIST guidelines. The Fisher's exact test was used to test this hypothesis. (NCT00452387)
Timeframe: PSA was evaluated on day 1 of every cycle (approximately every 3 weeks) during study treatment. Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.
Intervention | Participants (Number) |
---|
| PSA response (> 50% reduction) | PSA response (< or = 50% reduction) |
---|
Imaging Response (Favorable) | 3 | 6 |
,Imaging Response (Unfavorable) | 0 | 13 |
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Quality of Life (QoL)
The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The scores for the 6 categories are combined and normalized, and used to describe overall quality of life. Because normalized scores are created using a look-up index, there is no clearly defined maximum value. In practice, the maximum value for the combined scale is 73.5. (NCT00452387)
Timeframe: The Patient Care Monitor questionnaire was administered on day 1 of every cycle (approximately every 3 weeks) during study treatment.
Intervention | units on a scale (Mean) |
---|
| Baseline | Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | Cycle 6 | Cycle 7 | Cycle 8 | Cycle 9 | Cycle 10 | Cycle 11 | Cycle 12 | Cycle 13 | End of Study (at treatment discontinuation) |
---|
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib | 50.21 | 49.71 | 51.06 | 51.20 | 51.66 | 51.22 | 49.73 | 49.50 | 48.20 | 54.34 | 55.88 | 54.95 | 54.02 | 54.65 | 45.13 |
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Percentage of Participants Reaching Overall Survival
Overall survival from diagnosis (NCT00458848)
Timeframe: At 60 months
Intervention | percentage of patients (Number) |
---|
Philadelphia Positive, Imatinib Only in Induction Therapy | 48.8 |
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Number of Patients Reaching Complete Hematological Response After Induction Therapy
(NCT00458848)
Timeframe: At the end of induction, day +50
Intervention | participants (Number) |
---|
Philadelphia Positive, Imatinib Only in Induction Therapy | 49 |
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Percentage of Participants Reaching Disease Free Survival
(NCT00458848)
Timeframe: At 60 months
Intervention | percentage of participants (Number) |
---|
Philadelphia Positive, Imatinib Only in Induction Therapy | 45.8 |
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Response Based on PET Scan
Patients were scanned using Positron Emission Tomography (PET) before and after receiving single agent RAD001. Patients were classified as having partial metabolic response, stable metabolic disease, or progressive metabolic disease based on changes in PET imaging from baseline to post-treatment. A positive FDG-PET for the purposes of this study consisted of a visualized area of abnormal increased FDG uptake that matched the anatomic location of an abnormality seen on bone scan or CT. Metabolic response was assessed for percent change in SUVmax according to the criteria of the European Organization for Research and Treatment of Cancer (EORTC) : partial metabolic response (PMR) ≤ -25%; stable metabolic disease (SMD) -25% + 25%; progressive metabolic disease (PMD) > 25%. (NCT00459186)
Timeframe: 10 to 14 days after study entry
Intervention | percentage of participants (Number) |
---|
| Partial Metabolic Response | Stable Metabolic Disease | Progressive Metabolic Disease |
---|
RAD001 Followed by RAD001 + Docetaxel | 22 | 67 | 11 |
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Number of Patients Free of Dose Limiting Toxicity
"A dose limiting toxicity was defined as an adverse event or laboratory abnormality that occurs to patients on the Phase I portion of the trial, during the first 21 days following the first dose of RAD001/docetaxel during cycle 1, judged to be related to RAD001/docetaxel and meeting any of the following criteria:~Hematologic Toxicity:~CTCAE grade 4 neutropenia > 7 days or any Grade 3 or 4 neutropenia with fever Or CTCAE grade 3 or 4 thrombocytopenia > 7 days~Non-hematologic toxicity:~The occurrence of non-hematologic CTCAE grade 3 or 4 adverse events will be considered dose limiting, except for the following:~CTCAE grade 3 nausea or grade 3 or 4 vomiting CTCAE grade 3 or 4 vomiting will only be considered dose limiting if it occurs despite the use of standard anti-emetics.~CTCAE grade 3 or 4 fever identified with a source (i.e. infection, tumor)~CTCAE grade 3 or 4 alkaline phosphatase." (NCT00459186)
Timeframe: 21 days
Intervention | participants (Number) |
---|
RAD001 Followed by RAD001 + Docetaxel | 14 |
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Number of Participants With Adverse Events (AEs)
"A serious AE (SAE) was defined as any AE which resulted in death or was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or constituted an important medical event (events that may have jeopardized the patient or required intervention to prevent one of the outcomes listed above).~The severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) or according to the following scale:~Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Death.~The Investigator determined the relationship between study drug and the occurrence of an AE as Not Related or Related (since the study was double-blinded, a patient receiving only prednisone could have an AE that was judged as related to pomalidomide, and vice-versa)." (NCT00463385)
Timeframe: From date of the first dose of the study drug until discontinuation or the data cut-off date (up to approximately 45 months).
Intervention | participants (Number) |
---|
| At least one AE | At least one AE related to pomalidomide | At least one AE related to prednisone | At least one Grade 3-4 AE | At least one Grade 3-4 AE related to pomalidomide | At least one Grade 3-4 AE related to prednisone | At least one SAE | At least one SAE related to pomalidomide | At least one SAE related to prednisone | AE leading to discontinuation of pomalidomide | AE leading to discontinuation of prednisone | AE leading to a dose reduction of pomalidomide | AE leading to a dose interruption of pomalidomide | AE leading to a dose interruption of prednisone |
---|
Pomalidomide 0.5 mg + Prednisone | 21 | 15 | 5 | 15 | 6 | 3 | 8 | 3 | 3 | 6 | 1 | 1 | 7 | 3 |
,Pomalidomide 2 mg | 21 | 17 | 10 | 14 | 7 | 2 | 10 | 6 | 3 | 11 | 7 | 2 | 9 | 8 |
,Pomalidomide 2 mg + Prednisone | 18 | 16 | 11 | 13 | 11 | 6 | 11 | 8 | 5 | 5 | 2 | 1 | 9 | 6 |
,Prednisone | 20 | 15 | 10 | 10 | 6 | 5 | 6 | 4 | 4 | 7 | 5 | 0 | 5 | 2 |
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Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment
"A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.~Participants who discontinued the study early without achieving clinical response were counted as non-responders." (NCT00463385)
Timeframe: Up to 168 days
Intervention | percentage of participants (Number) |
---|
Prednisone | 55.0 |
Pomalidomide 2 mg | 23.5 |
Pomalidomide 2 mg + Prednisone | 21.1 |
Pomalidomide 0.5 mg + Prednisone | 47.6 |
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Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment
"A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.~Participants who discontinued the study early without achieving clinical response were counted as non-responders." (NCT00463385)
Timeframe: Up to 336 days
Intervention | percentage of participants (Number) |
---|
Prednisone | 50.0 |
Pomalidomide 2 mg | 18.2 |
Pomalidomide 2 mg + Prednisone | 18.2 |
Pomalidomide 0.5 mg + Prednisone | 45.5 |
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Duration of First Clinical Response
"For RBC-transfusion-dependent patients, duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the date of the first RBC-transfusion administrated at or more than 56 days after the response started. For patients who did not receive a subsequent transfusion after the response started, the end date of response was censored at the day of last hemoglobin assessment.~For RBC-transfusion-independent patients, the duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the earlier of the date of a hemoglobin increase of < 2.0 g/dL and the date of a RBC transfusion at ≥ 56 days after the response started. For patients whose hemoglobin measurements were always ≥ 2.0 g/dL and never received a RBC transfusion after response started, the end date of the response was censored at the date of last hemoglobin measurement.~Kaplan-Meier methodology was used." (NCT00463385)
Timeframe: Up to 40 months
Intervention | months (Median) |
---|
Prednisone | 3.7 |
Pomalidomide 2 mg | NA |
Pomalidomide 2 mg + Prednisone | 6.0 |
Pomalidomide 0.5 mg + Prednisone | 10.6 |
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Change From Baseline in Hemoglobin Concentration for Responders
Change from Baseline in hemoglobin for participants with a clinical response within the first 6 cycles of treatment. (NCT00463385)
Timeframe: Baseline, Cycle 6 (168 days)
Intervention | g/dL (Median) |
---|
Prednisone | 1.4 |
Pomalidomide 2 mg | 2.0 |
Pomalidomide 0.5 mg + Prednisone | -0.1 |
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Change From Baseline in Hemoglobin Concentration for Non-Responders
Change from Baseline in hemoglobin for participants without a clinical response within the first 6 cycles of treatment. (NCT00463385)
Timeframe: Baseline, Cycle 6 (168 days)
Intervention | g/dL (Median) |
---|
Prednisone | 1.2 |
Pomalidomide 2 mg | 0.1 |
Pomalidomide 2 mg + Prednisone | -0.8 |
Pomalidomide 0.5 mg + Prednisone | 0.5 |
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Change From Baseline in Likert Abdominal Pain Scale
Participants rated abdominal discomfort or pain over the previous week on a scale from zero to ten, where zero is no discomfort or pain and ten is the worst pain imaginable. (NCT00463385)
Timeframe: Baseline and Cycle 6 (168 days)
Intervention | units on a scale (Mean) |
---|
Prednisone | 0.3 |
Pomalidomide 2 mg | -1.0 |
Pomalidomide 2 mg + Prednisone | 0.3 |
Pomalidomide 0.5 mg + Prednisone | -0.1 |
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Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores
"The FACT-An comprises the four subscales of the 27-item FACT-General Scale (FACT-G), Physical Well-being, Social/Family Well-being, Emotion Well-being, Functional Well-Being, and the Additional Concerns Anemia subscale. Questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life.~Physical Well-being consists of 7 questions, the subscale score ranges from 0-28;~Social/Family Well-being consists of 7 questions, the subscale score ranges from 0-28;~Emotion Well-being consists of 6 questions, the subscale score ranges from 0-24;~Functional Well-Being consists of 7 questions, the subscale score ranges from 0-28;~Anemia subscale consists of 20 questions, the subscale score ranges from 0-80;~Total FACT-An score ranges from 0-188." (NCT00463385)
Timeframe: Baseline and Cycle 6 (168 days).
Intervention | units on a scale (Mean) |
---|
| Physical Well-Being subscale | Social/Family Well-Being subscale | Emotional Well-Being subscale | Functional Well-Being subscale | Anemia subscale | Total FACT-An score |
---|
Pomalidomide 0.5 mg + Prednisone | 2.3 | 0.9 | 1.7 | 2.5 | 5.8 | 11.4 |
,Pomalidomide 2 mg | 0.4 | -1.9 | 0.0 | -2.1 | 2.3 | 1.6 |
,Pomalidomide 2 mg + Prednisone | 5.3 | 1.7 | -0.3 | 2.7 | 19.3 | 27.3 |
,Prednisone | 0.6 | 1.9 | 1.3 | 0.9 | 1.2 | 2.3 |
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Time to the First Clinical Response
"The time to the first clinical response achieved within 168 days after the first study drug dosing date was calculated for participants who achieved a clinical response as:~Start date of the first clinical response - the first study drug date +1.~A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable." (NCT00463385)
Timeframe: Up to 168 days
Intervention | weeks (Median) |
---|
Prednisone | 0.3 |
Pomalidomide 2 mg | 8.0 |
Pomalidomide 2 mg + Prednisone | 10.1 |
Pomalidomide 0.5 mg + Prednisone | 1.2 |
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Percentage of Participants With Clinical Response by Baseline JAK2 Assessment
Percentage of participants who achieved a clinical response, presented by participants with positive and negative janus kinase 2 (JAK2) V617F mutation results at Baseline. (NCT00463385)
Timeframe: Up to 336 days
Intervention | percentage of participants (Number) |
---|
Prednisone, Positive JAK2 | 46.2 |
Pomalidomide 2 mg, PositiveJAK2 | 27.3 |
Pomalidomide 2 mg + Prednisone, Positive JAK2 | 30.0 |
Pomalidomide 0.5 mg + Prednisone, Positive JAK2 | 66.7 |
Prednisone, Negative JAK2 | 50.0 |
Pomalidomide 2 mg, Negative JAK2 | 28.6 |
Pomalidomide 2 mg + Prednisone, Negative JAK2 | 12.5 |
Pomalidomide 0.5 mg + Prednisone, Negative JAK2 | 25.0 |
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Part 2: Progression Free Survival (PFS)
PFS was defined as the time from the date of study enrollment to the first date of objectively determined progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). PD is ≥20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died and who did not have PD, PFS was censored at the date of the last progression-free assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. No participant completed a full cycle of therapy and thus no formal analysis was performed. (NCT00466440)
Timeframe: Baseline to measured PD (up to 487 days)
Intervention | Days (Median) |
---|
Part 2: Docetaxel + Prednisone + Enzastaurin | 229 |
Part 2: Docetaxel + Prednisone + Placebo | 213 |
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Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Docetaxel
AUC(0-∞) was calculated using concentration versus time data of docetaxel. Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). (NCT00466440)
Timeframe: Part 1: Cycle 1, Day 1 - predose 0.5, 1, 1.5, 2, 3, 4, 8, and 24 hours postdose; Cycle 2, Day 1 - predose, 0.5, 1, 1.5, 2, 3, 4, 8, and 24 hours postdose
Intervention | ng*h/mL (Geometric Mean) |
---|
Docetaxel 75 mg/m^2 Alone | 2350 |
Enzastaurin 500 mg QD + Docetaxel 75 mg/m^2 + Prednisone | 1750 |
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Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Docetaxel
Cmax was calculated using concentration versus time data of docetaxel. Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). (NCT00466440)
Timeframe: Part 1: Cycle 1, Day 1 - predose 0.5, 1, 1.5, 2, 3, 4, 8, and 24 hours postdose; Cycle 2, Day 1 - predose, 0.5, 1, 1.5, 2, 3, 4, 8, and 24 hours postdose
Intervention | nanograms per millimeter (ng/mL) (Geometric Mean) |
---|
Docetaxel 75 mg/m^2 Alone | 2230 |
Enzastaurin 500 mg QD + Docetaxel 75 mg/m^2 + Prednisone | 1840 |
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Prostate-Specific Androgen (PSA) Velocity at 2 Months
PSA is a protein produced by the cells of the prostate gland. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate cancer and in other prostate disorders. A blood test to measure PSA is considered the most effective test currently available for the early detection of prostate cancer. PSA velocity is computed for each participant by means of linear regression on the logarithm of PSA. The linear regression fits a line through the logarithm of the PSA value on the y-axis, and the time from baseline on the x-axis with the baseline PSA value at time zero. The resulting slope is PSA velocity. (NCT00466440)
Timeframe: Baseline up to 2 months
Intervention | microgram per liter (ug/L) per month (Mean) |
---|
Part 1: Docetaxel + Prednisone + Enzastaurin | -0.56 |
Part 2: Docetaxel + Prednisone + Enzastaurin | -0.29 |
Part 2: Docetaxel + Prednisone + Placebo | -0.55 |
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Prostate-Specific Androgen (PSA) Velocity at 3 Months
PSA is a protein produced by the cells of the prostate gland. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate cancer and in other prostate disorders. A blood test to measure PSA is considered the most effective test currently available for the early detection of prostate cancer. PSA velocity is computed for each participant by means of linear regression on the logarithm of PSA. The linear regression fits a line through the logarithm of the PSA value on the y-axis, and the time from baseline on the x-axis with the baseline PSA value at time zero. The resulting slope is PSA velocity. (NCT00466440)
Timeframe: Baseline up to 3 months
Intervention | ug/L per month (Mean) |
---|
Part 1: Docetaxel + Prednisone + Enzastaurin | -0.45 |
Part 2: Docetaxel + Prednisone + Enzastaurin | -0.30 |
Part 2: Docetaxel + Prednisone + Placebo | -0.45 |
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Part I: Pharmacokinetic (PK) Parameter: Maximum Observed Drug Concentration During a Dosing Interval at Steady State (Cmax,ss) of Enzastaurin, LSN326020, and Total Analyte (Enzastaurin + LSN326020)
Cmax,ss was calculated using concentration versus time data of enzastaurin, LSN326020, and total analyte (enzastaurin + LSN326020). Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). (NCT00466440)
Timeframe: Part 1: Cycle 1, Day 21 - predose 2, 4, 6, 8, and 24 hours postdose; Cycle 2, Day 1 - predose, 2, 3, 4, 8, and 24 hours postdose
Intervention | nanomole per liter (nmol/L) (Geometric Mean) |
---|
| Enzastaurin | LSN326020 | Total Analyte |
---|
Enzastaurin 500 mg QD + Docetaxel 75 mg/m^2 + Prednisone | 778 | 667 | 1450 |
,Enzastaurin 500 mg QD Alone | 870 | 664 | 1540 |
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Percentage of Participants Exhibiting a Decline in Prostate-Specific Androgen (PSA) From Baseline ≥30% Within First 3 Months of Treatment
PSA is a protein produced by the cells of the prostate gland. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate cancer and in other prostate disorders. A blood test to measure PSA is considered the most effective test currently available for the early detection of prostate cancer. Decline in PSA of ≥30% from baseline within the first 3 months of treatment was calculated. (NCT00466440)
Timeframe: Baseline up to 3 months
Intervention | percentage of participants (Number) |
---|
Part 1: Docetaxel + Prednisone + Enzastaurin | 69.2 |
Part 2: Docetaxel + Prednisone + Enzastaurin | 60.9 |
Part 2: Docetaxel + Prednisone + Placebo | 72.5 |
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Pharmacokinetic (PK) Parameter: Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin, LSN326020, and Total Analyte (Enzastaurin + LSN326020)
AUCτ,ss was calculated using concentration versus time data of enzastaurin, LSN326020, and total analyte (enzastaurin + LSN326020). Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). (NCT00466440)
Timeframe: Part 1: Cycle 1, Day 21 - predose 2, 4, 6, 8, and 24 hours postdose; Cycle 2, Day 1 - predose, 2, 3, 4, 8, and 24 hours postdose; Part 2: Cycle 2, Day 1 - predose, 1-3, and 4-9 hours postdose
Intervention | nanomole*hour per liter (nmol*hr/L) (Geometric Mean) |
---|
| Enzastaurin | LSN326020 | Total Analyte |
---|
Enzastaurin 500 mg QD Alone | 12900 | 15200 | 28700 |
,Enzastaurin 500 mg QD+Docetaxel 75 mg/m^2+Prednisone (Part 1) | 13100 | 15700 | 29000 |
,Enzastaurin 500 mg QD+Docetaxel 75 mg/m^2+Prednisone (Part 2) | 20800 | 24800 | 47800 |
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Part 2: Duration of Response
Duration of response is defined as the time from date of objective response to progressive disease (PD) or death or prostate-specific androgen (PSA) returning to at least 50% from original baseline value. (NCT00466440)
Timeframe: First objective response to PD/death/PSA returning to 50% or more than the original baseline value (up to 616 days)
Intervention | days (Median) |
---|
Part 2: Docetaxel + Prednisone + Enzastaurin | 231 |
Part 2: Docetaxel + Prednisone + Placebo | 201 |
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Part 2: Overall Survival (OS)
Overall survival (OS) time is defined as the time from the date of diagnosis to the date of death from any cause. For participants who are still alive at the time of analysis, survival time will be censored at the last contact date. (NCT00466440)
Timeframe: Baseline to death (up to 642 days)
Intervention | days (Median) |
---|
Part 2: Docetaxel + Prednisone + Enzastaurin | 462 |
Part 2: Docetaxel + Prednisone + Placebo | 448 |
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Part 2: Percentage of Participants With Objective Tumor Response (Response Rate)
Response using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants qualified for efficacy analysis *100, where objective responders are those participants who have met criteria either for CR or PR. (NCT00466440)
Timeframe: Baseline up to 3 years
Intervention | percentage of participants (Number) |
---|
Part 2: Docetaxel + Prednisone + Enzastaurin | 15.2 |
Part 2: Docetaxel + Prednisone + Placebo | 15.0 |
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Number of Participants With Adverse Events (AEs)
A listing of serious AEs (SAEs) and all other non-serious AEs is included in the Reported Adverse Event Module. (NCT00466440)
Timeframe: Baseline through 3 years
Intervention | Participants (Count of Participants) |
---|
| SAEs | Other Non-Serious AEs |
---|
Part 1: Docetaxel + Prednisone + Enzastaurin | 8 | 14 |
,Part 2: Docetaxel + Prednisone + Enzastaurin | 16 | 47 |
,Part 2: Docetaxel + Prednisone + Placebo | 14 | 41 |
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Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24.
Measurement of total body surface area affected by bullous pemphigoid active skin disease(active erosions, blisters, and/or lesions) was measured at Day 0 (prior to treatment with Omalizumab) and at 24 weeks (24 weeks is end of study). (NCT00472030)
Timeframe: Up to 24 weeks
Intervention | percentage of active skin disease (Number) |
---|
Omalizumab Treatment Arm | 22.5 |
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Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16
(NCT00472030)
Timeframe: Up to 24 weeks
Intervention | units per milliliter (Number) |
---|
Omalizumab Treatment Arm | 62.6 |
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Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab.
Anti-BP180 IgG levels were completed using an Elisa assay. Anti-BP180 IgG levels were obtained prior to baseline and at week 16 (NCT00472030)
Timeframe: Up to 24 weeks
Intervention | units per milliliter (Number) |
---|
Omalizumab Treatment Arm | 92.06 |
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Decrease in Eosinophil Levels Following Treatment With Omalizumab.
The subject's eosinophil count measured at baseline was compared to the eosinophil count at week 8. A normal eosinophil count at the University of Iowa Hospital lab is 0-0.4 cells per microliter (NCT00472030)
Timeframe: Baseline, 24 weeks.
Intervention | cells/microliter (Number) |
---|
Omalizumab Treatment Arm | 2.16 |
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Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
Intervention | liter per hour (l/hr) (Mean) |
---|
| Fasted | Fed |
---|
Phase I Dose Escalation (1000mg) | 2649.954 | 231.383 |
,Phase I Dose Escalation (250mg) | 4288.456 | 529.606 |
,Phase I Dose Escalation (500mg) | 5440.949 | 391.046 |
,Phase I Dose Escalation (750mg) | 1518.748 | 246.643 |
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Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate
The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects. (NCT00473746)
Timeframe: Up to Cycle 12
Intervention | mg/day (Number) |
---|
Phase I Dose Escalation | NA |
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Phase 2: Duration of Objective Response
Duration of objective response was assessed only in participants who achieved a CR or PR, and measured from the first documented date of response to the first documented date of disease progression according to the RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
Intervention | days (Median) |
---|
Phase II Dose Treatment | NA |
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Phase 2: Duration of PSA Response
Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date as defined by the PSAWG criteria. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
Intervention | days (Median) |
---|
Phase II Dose Treatment | 477 |
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Phase 2: Overall Survival
Overall survival is the time interval from the date of first dose (cycle 1 day 1) of abiraterone acetate therapy to the date of death from any cause. (NCT00473746)
Timeframe: Up to Month 60
Intervention | days (Median) |
---|
Phase II Dose Treatment | NA |
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Phase 2: PSA Progression Free Survival (PSA-PFS)
PSA-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or the PSA progression as defined by the Prostate Specific Antigen Working Group (PSAWG) criteria. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
Intervention | days (Median) |
---|
Phase II Dose Treatment | 473 |
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Phase 2: Time to PSA Progression
The time interval from the date of first dose of abiraterone acetate therapy to the date of the PSA progression as defined by the PSAWG criteria. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
Intervention | days (Median) |
---|
Phase II Dose Treatment | 497 |
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Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
Intervention | hr*nmol/L (Mean) |
---|
| Fasted | Fed |
---|
Phase I Dose Escalation (1000mg) | 3478.385 | 14404.387 |
,Phase I Dose Escalation (250mg) | 1411.268 | 1386.939 |
,Phase I Dose Escalation (500mg) | 1781.374 | 3839.804 |
,Phase I Dose Escalation (750mg) | 1665.454 | 9358.743 |
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Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
Intervention | hr*nmol/L (Mean) |
---|
| Fasted | Fed |
---|
Phase I Dose Escalation (1000mg) | 3039.937 | 13695.482 |
,Phase I Dose Escalation (250mg) | 1329.178 | 1310.715 |
,Phase I Dose Escalation (500mg) | 1625.059 | 3624.781 |
,Phase I Dose Escalation (750mg) | 1565.659 | 8920.790 |
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Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Volume of distribution is normally calculated by using equation volume of distribution =dose/initial concentration. Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
Intervention | Liter (L) (Mean) |
---|
| Fasted | Fed |
---|
Phase I Dose Escalation (1000mg) | 25494.398 | 4068.885 |
,Phase I Dose Escalation (250mg) | 653.745 | 3940.400 |
,Phase I Dose Escalation (500mg) | 10252.077 | 3418.280 |
,Phase I Dose Escalation (750mg) | 13688.367 | 2739.655 |
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Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)
Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
Intervention | participants (Number) |
---|
| Confirmed | Not Confirmed | Total |
---|
Phase II Dose Treatment | 26 | 2 | 28 |
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Phase 2: Radiographic Progression Free Survival (RAD-PFS)
RAD-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or radiographic disease progression according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
Intervention | days (Median) |
---|
Phase II Dose Treatment | NA |
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Phase 2: Radiographic Objective Response Rate (RAD-ORR)
The objective response rate is defined as the proportion of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
Intervention | participants (Number) |
---|
| Confirmed | Not Confirmed |
---|
Phase II Dose Treatment | 9 | 1 |
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Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3.
Intervention | nanomoles per liter (nmol/L) (Mean) |
---|
| Fasted | Fed |
---|
Phase I Dose Escalation (1000mg) | 509.500 | 2194.250 |
,Phase I Dose Escalation (250mg) | 283.000 | 421.000 |
,Phase I Dose Escalation (500mg) | 330.633 | 676.000 |
,Phase I Dose Escalation (750mg) | 289.533 | 1552.000 |
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Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
Intervention | hour (hr) (Mean) |
---|
| Fasted | Fed |
---|
Phase I Dose Escalation (1000mg) | 14.361 | 12.454 |
,Phase I Dose Escalation (250mg) | 5.284 | 5.125 |
,Phase I Dose Escalation (500mg) | 10.591 | 6.913 |
,Phase I Dose Escalation (750mg) | 7.066 | 7.939 |
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Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose) (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
Intervention | hour (hr) (Mean) |
---|
| Fasted | Fed |
---|
Phase I Dose Escalation (1000mg) | 1.833 | 4.000 |
,Phase I Dose Escalation (250mg) | 2.000 | 2.044 |
,Phase I Dose Escalation (500mg) | 1.500 | 2.667 |
,Phase I Dose Escalation (750mg) | 2.033 | 2.000 |
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Patients With Overall Confirmed Response
"Response that was confirmed on 2 consecutive evaluations.>~Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and <=5% plasma cells in bone marrow>~Very Good Partial Response (VGPR): >=90% reduction in serum M-spike, Urine M-spike <100mg per 24 hours>~Partial Response (PR): >=50% reduction in serum M-spike, Urine M-spike >=90% reduction or < 200mg per 24 hours, or >=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells" (NCT00477750)
Timeframe: Every cycle during treatment
Intervention | participants (Number) |
---|
| CR | VGPR | PR |
---|
Treatment (Lenalidomide, Melphalan, Prednisone) | 3 | 5 | 10 |
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Progression-free Survival
"Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)" (NCT00477750)
Timeframe: registration to progressive disease (up to 3 years)
Intervention | months (Median) |
---|
Treatment (Lenalidomide, Melphalan, Prednisone) | 21.4 |
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Percentage of Participants With Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3)
The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. (NCT00477750)
Timeframe: Every cycle during treatment up to 3 years
Intervention | percentage of patients (Number) |
---|
| Grade 3 | Grade 4 | Grade 5 |
---|
Treatment (Lenalidomide, Melphalan, Prednisone) | 33 | 67 | 0 |
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Duration of Response (DOR)
Duration of response was calculated from documentation of first response to date of progression in the subset of patients who responded. Patients without progression were censored at the date of last tumor evaluation. (NCT00477750)
Timeframe: from first response to progression or death (up to 3 years)
Intervention | months (Median) |
---|
Treatment (Lenalidomide, Melphalan, Prednisone) | 16.3 |
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Overall Survival (OS) at 3 Years
OS was defined as the time from registration to death due to any cause. Patients who were alive were censored at date of last follow-up. The overall survival at 3 years (a percentage) is reported below. (NCT00477750)
Timeframe: registration to death (up to 3 years)
Intervention | percentage of patients (Number) |
---|
Treatment (Lenalidomide, Melphalan, Prednisone) | 58 |
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Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)
The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation. (NCT00485303)
Timeframe: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months
Intervention | days (Median) |
---|
Abiraterone | 141 |
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Time to Radiographic Progression
Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
Intervention | days (Median) |
---|
Abiraterone | 88 |
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Time to PSA Progression
The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation. (NCT00485303)
Timeframe: Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)
Intervention | days (Median) |
---|
Abiraterone | 169 |
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Radiographic Progression Free Survival (PFS)
The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
Intervention | days (Median) |
---|
Abiraterone | 126 |
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Percentage of Participants With Clinical Benefit
Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
Intervention | percentage of participants (Number) |
---|
| Disease Stabilization | Change in participant ECOG score |
---|
Abiraterone | 12 | 16 |
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Percentage of Participants With Prostate Specific Antigen (PSA) Response
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response. (NCT00485303)
Timeframe: Day 1 of each cycle (of 28 days each) up to Cycle 12
Intervention | percentage of participants (Number) |
---|
Abiraterone | 37.9 |
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Overall Survival (OS)
Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death. (NCT00485303)
Timeframe: Every 3 months until death or up to 60 months
Intervention | days (Median) |
---|
Abiraterone | 492 |
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Percentage of Participants With Objective Radiographic Response
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
Intervention | percentage of participants (Number) |
---|
| Complete response (CR) | Partial Response (PR) |
---|
Abiraterone | 0 | 6.3 |
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Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33
HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA. (NCT00494780)
Timeframe: Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)
Intervention | participants (Number) |
---|
| Visit 1, n=29, 29 | Visit 28, n=18, 21 | Visit 33, n=16, 16 |
---|
1000 mg Ofatumumab + CHOP | 0 | 0 | 0 |
,500 mg Ofatumumab + CHOP | 0 | 0 | 0 |
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Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)
Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions). (NCT00494780)
Timeframe: Maximum of 23 months after the start of treatment
Intervention | participants (Number) |
---|
| Responder, CR | Responder, CRu | Responder, PR | Non-Responder, SD | Non-Responder, PD |
---|
1000 mg Ofatumumab + CHOP | 9 | 7 | 13 | 0 | 0 |
,500 mg Ofatumumab + CHOP | 6 | 10 | 10 | 2 | 1 |
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Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)
The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment. (NCT00494780)
Timeframe: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)
Intervention | Percent change in cell counts (Median) |
---|
| CD19+ | CD20+ |
---|
1000 mg Ofatumumab + CHOP | 307.9 | 307.9 |
,500 mg Ofatumumab + CHOP | 154.1 | 154.1 |
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CL After the Sixth Infusion (Week 15, Visit 22)
CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time. (NCT00494780)
Timeframe: Week 15 (Visit 22)
Intervention | Milliliters per hour (mL/h) (Geometric Mean) |
---|
500 mg Ofatumumab + CHOP | 6.29 |
1000 mg Ofatumumab + CHOP | 5.92 |
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AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)
AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity. (NCT00494780)
Timeframe: Week 15 (Visit 22)
Intervention | Milligrams * hours/liter (mg.h/L) (Geometric Mean) |
---|
| AUC(0-inf), n=20, 28 | AUC(0-504), n=24, 28 |
---|
1000 mg Ofatumumab + CHOP | 399676 | 168866 |
,500 mg Ofatumumab + CHOP | 177133 | 79500 |
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Duration of Response
The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death. (NCT00494780)
Timeframe: Followed up to 5 years
Intervention | months (Median) |
---|
500 mg Ofatumumab + CHOP | 21.0 |
1000 mg Ofatumumab + CHOP | 25.0 |
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Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)
Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. (NCT00494780)
Timeframe: Week 15 (Visit 22)
Intervention | hours (Geometric Mean) |
---|
500 mg Ofatumumab + CHOP | 652 |
1000 mg Ofatumumab + CHOP | 644 |
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Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section. (NCT00494780)
Timeframe: Up to 22 months after study start
Intervention | participants (Number) |
---|
500 mg Ofatumumab + CHOP | 29 |
1000 mg Ofatumumab + CHOP | 29 |
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Number of Participants With Complete Remission (CR) at Visit 26
Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease. (NCT00494780)
Timeframe: Maximum of 23 months after the start of treatment
Intervention | participants (Number) |
---|
500 mg Ofatumumab + CHOP | 6 |
1000 mg Ofatumumab + CHOP | 9 |
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Progression-Free Survival (PFS)
PFS is defined as the time from randomization until progression or death. (NCT00494780)
Timeframe: Followed up to 5 years
Intervention | months (Median) |
---|
500 mg Ofatumumab + CHOP | 27.6 |
1000 mg Ofatumumab + CHOP | NA |
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Time to New Anti-follicular Lymphoma (FL) Therapy
Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed. (NCT00494780)
Timeframe: Followed up to 5 years
Intervention | months (Median) |
---|
500 mg Ofatumumab + CHOP | 47.2 |
1000 mg Ofatumumab + CHOP | NA |
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Vss at the Sixth Infusion (Week 15, Visit 22)
Vss is defined as the volume of distribution at steady state of ofatumumab. (NCT00494780)
Timeframe: Week 15 (Visit 22)
Intervention | Liters (Geometric Mean) |
---|
500 mg Ofatumumab + CHOP | 5.15 |
1000 mg Ofatumumab + CHOP | 5.32 |
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Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)
Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]). (NCT00494780)
Timeframe: Week 15 (Visit 22)
Intervention | milligrams per liter (mg/L) (Geometric Mean) |
---|
| Cmax | Ctrough |
---|
1000 mg Ofatumumab + CHOP | 497 | 188 |
,500 mg Ofatumumab + CHOP | 232 | 78.5 |
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Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)
Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer. (NCT00503984)
Timeframe: Up to 1.5 years
Intervention | mg (Number) |
---|
| Initial RPTD Prednisone (mg) | Reduced RPTD Prednisone (mg) |
---|
Phase 1 - Aza + Doc | 5 | 5 |
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Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)
Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer. (NCT00503984)
Timeframe: Up to 1.5 years
Intervention | mg/m2 (Number) |
---|
| Initial RPTD Azacitidine (mg/m2) | Initial RPTD Docetaxel (mg/m2) | Reduced RPTD Azacitidine (mg/m2) | Reduced RPTD Docetaxel (mg/m2) |
---|
Phase 1 - Aza + Doc | 150 | 75 | 75 | 75 |
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Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.
"Number of participants achieving Complete Response (CR) or Partial Response to protocol therapy according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 Criteria. Per RECIST 1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; " (NCT00503984)
Timeframe: Up to 4.5 years
Intervention | participants (Number) |
---|
| Complete Response (CR) | Partial Response (PR) |
---|
Phase 1: Level 1 - 75 Aza + 60 Doc | 0 | 0 |
,Phase 1: Level 3 - 100 Aza + 75 Doc | 1 | 0 |
,Phase 1: Level 4 - 150 Aza + 75 Doc | 0 | 1 |
,Phase 2 - Aza + Doc Initial RPTD | 0 | 1 |
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Progression-Free Survival (PFS)
The time from the date of start of treatment until the first documented or confirmed disease progression, or death related to prostate cancer, whichever is earlier. (NCT00503984)
Timeframe: Up to 4.5 years
Intervention | months (Median) |
---|
All Study Participants | 4.9 |
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Overall Survival (OS)
The time from the date of initiation of study treatment until date of death from any cause. (NCT00503984)
Timeframe: Up to 4.5 years.
Intervention | months (Median) |
---|
All Study Participants | 19.5 |
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Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.
(NCT00503984)
Timeframe: Up to 4.5 years
Intervention | participants (Number) |
---|
Level 1 - 75 Aza + 60 Doc | 3 |
Level 2 - 75 Aza + 75 Doc | 4 |
Level 3 - 100 Aza + 75 Doc | 3 |
Level 4 - 150 Aza + 75 Doc | 12 |
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Number of Participants Achieving Prostate-specific Antigen (PSA) Response.
Number of participants achieving prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks. (NCT00503984)
Timeframe: Up to 4.5 years.
Intervention | participants (Number) |
---|
Phase 1: Level 1 - 75 Aza + 60 Doc | 0 |
Phase 1: Level 2 - 75 Aza + 75 Doc | 1 |
Phase 1: Level 3 - 100 Aza + 75 Doc | 2 |
Phase 1: Level 4 - 150 Aza + 75 Doc | 4 |
Phase 2 - Aza + Doc Initial RPTD | 3 |
Phase 2 - Aza + Doc Reduced RPTD | 0 |
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Duration of Response
Length of time from the date of first observation of complete response (CR) or partial response (PR) to the date of first observation of disease progression, according to prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks. (NCT00503984)
Timeframe: Up to 4.5 years.
Intervention | weeks (Median) |
---|
All Study Participants Achieving PSA Response | 20.5 |
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Duration of Response
Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response. (NCT00507416)
Timeframe: From first documented response until disease progression. Median follow-up time was 43 months.
Intervention | months (Median) |
---|
Bortezomib and Dexamethasone | 18.3 |
Bortezomib, Thalidomide, and Dexamethasone | 22.4 |
Bortezomib, Melphalan and Prednisone | 19.8 |
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Overall Survival
Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact. (NCT00507416)
Timeframe: From randomization until death. Median follow-up time was 43 months.
Intervention | months (Median) |
---|
Bortezomib and Dexamethasone | 49.8 |
Bortezomib, Thalidomide, and Dexamethasone | 51.5 |
Bortezomib, Melphalan and Prednisone | 53.1 |
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Percentage of Participants With a Complete Response
Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria. (NCT00507416)
Timeframe: Response assessed every other cycle, for up to 13 cycles (49 weeks).
Intervention | percentage of participants (Number) |
---|
Bortezomib and Dexamethasone | 3 |
Bortezomib, Thalidomide, and Dexamethasone | 4 |
Bortezomib, Melphalan and Prednisone | 4 |
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Percentage of Participants With a Complete Response or a Very Good Partial Response
"Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.~Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.~Response was assessed by the Investigator using the IMWG uniform response criteria." (NCT00507416)
Timeframe: Response assessed every other cycle for up to 13 cycles (49 weeks).
Intervention | percentage of participants (Number) |
---|
Bortezomib and Dexamethasone | 37 |
Bortezomib, Thalidomide, and Dexamethasone | 51 |
Bortezomib, Melphalan and Prednisone | 41 |
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Percentage of Participants With an Overall Response
"Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria.~CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h).~PR requires 1 of the following:~≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or~If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or~If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.~If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required." (NCT00507416)
Timeframe: Response assessed every other cycle for up to 13 cycles (49 weeks).
Intervention | percentage of participants (Number) |
---|
Bortezomib and Dexamethasone | 73 |
Bortezomib, Thalidomide, and Dexamethasone | 80 |
Bortezomib, Melphalan and Prednisone | 70 |
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Progression Free Survival (PFS)
"PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease" (NCT00507416)
Timeframe: From randomization until disease progression. Median follow-up time was 43 months.
Intervention | months (Median) |
---|
Bortezomib and Dexamethasone | 14.7 |
Bortezomib, Thalidomide, and Dexamethasone | 15.4 |
Bortezomib, Melphalan and Prednisone | 17.3 |
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Time to Alternative Therapy
Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact. (NCT00507416)
Timeframe: From randomization until alternative therapy. Median follow-up time was 43 months.
Intervention | months (Median) |
---|
Bortezomib and Dexamethasone | 19.7 |
Bortezomib, Thalidomide, and Dexamethasone | 24.5 |
Bortezomib, Melphalan and Prednisone | 19.0 |
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Change From Baseline in EORTC QLQ-C30 - Global Health Status
"The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement." (NCT00507416)
Timeframe: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13
Intervention | units on a scale (Mean) |
---|
| Cycle 3, Day 1 (n=129, 115, 125) | Cycle 5, Day 1 (n=114, 98, 107) | Cycle 7, Day 1 (n=89, 79, 84) | Cycle 9, Day 1 (n=87, 66, 67) | Cycle 11, Day 1 (n=71, 61, 65) | Cycle 13, Day 1 (n=67, 52, 61) |
---|
Bortezomib and Dexamethasone | 1.3 | -4.9 | -3.3 | -4.2 | -11.6 | -10.2 |
,Bortezomib, Melphalan and Prednisone | 2.0 | -0.4 | -4.7 | -1.0 | 2.8 | 1.0 |
,Bortezomib, Thalidomide, and Dexamethasone | -4.4 | -6.1 | -8.6 | -8.1 | -7.9 | -8.5 |
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Tumor Response Rate in Participants With Measurable Disease
Tumor response was defined as either a Complete Response (disappearance of all target lesions) or a Partial Response (≥30% decrease from baseline in target lesions) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST)version 1.0. (NCT00519285)
Timeframe: Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first
Intervention | percentage of participants (Number) |
---|
Placebo | 28.1 |
Aflibercept | 38.7 |
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Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept
"Serum for detection of anti-drug antibodies (ADA) was collected in patients treated in selected centers only. Samples were analyzed using a titer-based, bridging immunoassay developed and validated to detect ADAs in human serum.~Samples with positive antibody levels were further analyzed using a validated, non-quantitative ligand binding assay to detect neutralizing antibodies Ab).~A participant was considered to have positive antibody levels if antibodies were detected above the quantification limits." (NCT00519285)
Timeframe: Pre-dose of cycle 1 (baseline), pre-dose of each every other cycle, then 30 and 90 days after the last administration of the study drug
Intervention | participants (Number) |
---|
| At baseline | At any time post-baseline | - Neutralizing Ab | - Not neutralizing Ab | - Neutralizing potential not evaluated |
---|
Aflibercept | 2 | 9 | 2 | 5 | 2 |
,Placebo | 0 | 4 | 0 | 2 | 2 |
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Number of Participants With Adverse Events as a Measure of Safety
"Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome or illness observed by the investigator or reported by the participant during the study.~AE were collected at regular intervals throughout the study then graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.3.0)." (NCT00519285)
Timeframe: From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days
Intervention | participants (Number) |
---|
| Any Adverse Event | - Grade 3-4 AE | - Serious AE | - AE leading to death | --- Related AE leading to death | - AE leading to permanent discontinuation | - AE leading to premature discontinuation |
---|
Aflibercept | 607 | 470 | 331 | 46 | 19 | 268 | 116 |
,Placebo | 585 | 290 | 184 | 23 | 8 | 125 | 73 |
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Overall Survival Time
"Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause.~The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)
Intervention | months (Median) |
---|
Placebo | 21.22 |
Aflibercept | 22.14 |
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Pain Progression-free Survival Time
"Pain progression was defined as either ≥1-point increase in Present Pain Intensity (PPI) score or ≥25% increase in Analgesics Score (AS) confirmed at least 3 weeks later, or requirement for palliative radiotherapy. PPI scale is a self-report 0-5 scale to assess pain intensity - a score 0 reflects no pain, a score 5 reflects excruciating pain. AS is a scoring method to assess analgesics consumption. Each analgesic is scored 1 or 4 depending on the analgesic type and dose. AS is the sum of the analgesic scores.~Pain progression-free survival (PFS) time was measured as the time from the date of randomization up to the date of first pain progression or death due to any cause, whichever occurred first.~The median pain-PFS and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of event, the participant was censored at the the date of last assessment without evidence of pain progression or the study cut-off date, whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)
Intervention | months (Median) |
---|
Placebo | 9.72 |
Aflibercept | 9.20 |
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Pain Response Rate
Pain response was defined as either a ≥2-point decrease from baseline in Present Pain Intensity (PPI) score without increase in Analgesics Score (AS), or a ≥50% decrease from baseline in AS without increase in the PPI score confirmed at least 3 weeks later. Increases in PPI or AS during the first 12 weeks were ignored in determining pain response. (NCT00519285)
Timeframe: Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first
Intervention | percentage of participants (Number) |
---|
Placebo | 46.3 |
Aflibercept | 35.8 |
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Progression Free Survival Time
"Disease progression was defined as a composite of: Radiological tumor progression (≥20% increase in target lesions, or appearance of at least 2 new bone lesions); PSA progression (≥25% increase in PSA level confirmed 3 weeks later); Pain progression (increase in pain intensity or in analgesic consumption for cancer related pain confirmed 3 weeks later); Radiotherapy for cancer related symptoms; Occurence of Skeletal related events (SRE).~Progression Free survival (PFS) time was measured as the time from the date of randomization up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.~The median PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of disease progression, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)
Intervention | months (Median) |
---|
Placebo | 6.24 |
Aflibercept | 6.90 |
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Prostate Specific Antigen Progression-free Survival Time
"Prostate specific antigen (PSA) progression was defined as ≥25% increase in PSA level confirmed 3 weeks later, above the nadir in participants who had achieved a PSA response, or above the baseline in participants who hadn't achieved a PSA response.~PSA progression-free survival (PFS) time was defined as the time from the date of randomization up to the date of the first documented PSA progression or death due to any cause, whichever occurred first.~The median PSA-PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of PSA progression or death, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)
Intervention | months (Median) |
---|
Placebo | 8.11 |
Aflibercept | 8.25 |
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Prostate Specific Antigen Response Rate
Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. (NCT00519285)
Timeframe: Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first
Intervention | percentage of participants (Number) |
---|
Placebo | 63.5 |
Aflibercept | 68.6 |
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Number of Participants With Response
Periodic bone marrow samples (every 3-6 months) to check cells related to disease before/during/after study. Response classifications categorized by the International Working Group Response Criteria for Myelodysplastic Syndrome (MDS) as: Complete Remission, Partial Response, Hematologic Improvement or No Response. (NCT00520468)
Timeframe: Response evaluation within first 3 months from start of therapy, then every 3 to 6 months
Intervention | participants (Number) |
---|
| Complete Remission | Partial Response | Hematologic Improvement | No Response |
---|
Cytokine-Immunotherapy | 2 | 2 | 4 | 6 |
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6-month Progression-free Survival (PFS) Proportion
The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free (NCT00527124)
Timeframe: Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months
Intervention | percentage of patients (Number) |
---|
Arm I | 60 |
Arm II | 54 |
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Time to Progression
Analyzed with standard K-M methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of TTP. These point and CI estimates will be reported for all patients combined, and separately for each treatment arm. (NCT00527124)
Timeframe: The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks
Intervention | months (Median) |
---|
Arm I | 8.0 |
Arm II | 6.4 |
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Overall Response Rate Evaluated by the RECIST Criteria
"The overall response is determined by combining the patient's status on target lesions, PSA, non-target lesions, and new disease as defined in the following table.~Target Lesions CR CR PR SD PD Any Any Any~PSA Response CR PR PR Non-PD Any Any PD Any~Non-Target Lesions CR Non-CR/Non-PD Non-PD Non-PD Any PD Any Any~New Lesions No No No No Yes or No Yes or No Yes or No Yes~Overall Response CR PR PR SD PD PD PD PD" (NCT00527124)
Timeframe: Up to 52 weeks
Intervention | proportion of evaluable patients (Number) |
---|
| SD | PD |
---|
Arm I | .92 | .08 |
,Arm II | .92 | .08 |
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Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group
PSA < 4.0 ng/ml. is a CR. A 50% decline or better in PSA is a PR. Less than a 50% decline in PSA and less than a 25% increase in PSA is SD. A 25% or greater increase in PSA level by at least 5 ng/mL is PD by PSA only. The point estimate and 95% Wilson CI estimates of the proportion for the Prostate-specific antigen (PSA) response will be computed . (NCT00527124)
Timeframe: Up to 52 weeks
Intervention | proportion of evaluable patients (Number) |
---|
| CR | PR | SD | PD |
---|
Arm I | .35 | .27 | .35 | .04 |
,Arm II | .12 | .54 | .31 | .04 |
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Overall Survival
Analyzed with standard K-M methodology. A 12 month survival rate will be calculated since median survival was not reached by the end of the study period. (NCT00527124)
Timeframe: The time from registration date until death from any cause, assessed up to 52 weeks
Intervention | percentage of patients (Number) |
---|
Arm I | 71 |
Arm II | 76 |
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Number of Participants With Prostate Specific Antigen (PSA) Response
The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later). (NCT00537381)
Timeframe: Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days
Intervention | Participants (Number) |
---|
Docetaxel + Prednisone + Placebo | 43 |
Docetaxel + Prednisone + Intetumumab | 27 |
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Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. (NCT00537381)
Timeframe: Baseline, Week 6, 7, 10 and 13
Intervention | Percent change (Mean) |
---|
| Percent Change at Week 6 (n = 10, 48) | Percent Change at Week 7 (n = 10, 54) | Percent Change at Week 10 (n = 11, 51) | Percent Change at Week 13 (n = 11, 41) |
---|
Docetaxel + Prednisone + Intetumumab | -9.64 | 11.69 | 32.11 | 20.19 |
,Docetaxel + Prednisone + Placebo | -10.00 | -3.10 | 3.96 | 8.22 |
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Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. (NCT00537381)
Timeframe: Baseline, Week 6, 7, 10 and 13
Intervention | Percent change (Mean) |
---|
| Percent Change at Week 6 (n = 10, 48) | Percent Change at Week 7 (n = 10, 54) | Percent Change at Week 10 (n = 11, 51) | Percent Change at Week 13 (n = 11, 40) |
---|
Docetaxel + Prednisone + Intetumumab | -21.37 | -23.44 | -21.71 | -36.47 |
,Docetaxel + Prednisone + Placebo | -0.77 | 1.58 | 2.55 | -3.87 |
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Overall Survival
Overall Survival is defined as the time from the date of randomization to death due to any cause. For participants who were alive at the time of analysis, overall survival was censored at the last contact date. (NCT00537381)
Timeframe: Baseline until death (up to 887 days)
Intervention | Days (Median) |
---|
Docetaxel + Prednisone + Placebo | 626.0 |
Docetaxel + Prednisone + Intetumumab | 522.0 |
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Number of Participants With Best Overall Response (OR)
Number of participants with best OR is based on assessment of confirmed complete response (CR) or confirmed partial response (PR). Confirmed CR is defined as disappearance of all target lesions. Confirmed PR is defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. (NCT00537381)
Timeframe: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Intervention | Participants (Number) |
---|
| Complete Response | Partial Response |
---|
Docetaxel + Prednisone + Intetumumab | 0 | 8 |
,Docetaxel + Prednisone + Placebo | 1 | 9 |
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Progression-Free Survival (PFS)
The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. (NCT00537381)
Timeframe: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Intervention | Days (Median) |
---|
Docetaxel + Prednisone + Placebo | 336.0 |
Docetaxel + Prednisone + Intetumumab | 232.0 |
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Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. (NCT00537381)
Timeframe: Baseline, Week 6, 7, 10 and 13
Intervention | Percent change (Mean) |
---|
| Percent Change at Week 6 (n = 10, 48) | Percent Change at Week 7 (n = 10, 54) | Percent Change at Week 10 (n = 11, 51) | Percent Change at Week 13 (n = 11, 41) |
---|
Docetaxel + Prednisone + Intetumumab | -30.81 | -39.78 | -25.48 | -44.89 |
,Docetaxel + Prednisone + Placebo | 1.45 | -11.58 | 2.39 | 5.22 |
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Quality of Life Using the FACT-G Data
"Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.~Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome" (NCT00540644)
Timeframe: baseline and after last cycle (up to 6 cycles)
Intervention | scores on a scale (Mean) |
---|
| Physical Well-Being Change from Baseline | Social/Family Well-Being Change from Baseline | Emotional Well-Beling Change from Baseline | Functional Well-Being Change from Baseline | FACT-G Change from Baseline |
---|
Extension - Revlimid, Cyclophosphamide, Prednisone | -2.81 | -0.23 | 0.60 | -1.17 | -3.61 |
,Original Study - Revlimid, Cyclophosphamide, Prednisone | 1.57 | -0.03 | 2.52 | 3.38 | 7.44 |
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Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)
(NCT00544440)
Timeframe: Baseline (predose Week 1 Day 1) and Week 8
Intervention | Number of Participants (Number) |
---|
| Baseline (predose Week 1 Day 1) (n=49) | Week 8 (n=44) |
---|
Abiraterone Acetate | 0 | 0 |
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Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)
(NCT00544440)
Timeframe: Baseline (predose Week 1 Day 1) and Week 8
Intervention | Number of Participants (Number) |
---|
| Baseline (predose Week 1 Day 1) (n=49) | Week 8 (n=44) |
---|
Abiraterone Acetate | 2 | 2 |
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Probability of CNS Relapse
To assess whether intensification of CNS-directed intrathecal and systemic chemotherapy will improve outcome in patients at high-risk of CNS relapse. (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
Intervention | Percentage of participants (Number) |
---|
TOTXVI PEG 3500 | 0.8 |
TOTXVI PEG 2500 | 1.8 |
TOTXVI Not Randomized | 2.7 |
All Eligible Patients in TOTXV | 5.7 |
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Probability of Event-free Survival
"To estimate the event-free survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV (NCT00137111).~EFS will be measured from the date of complete response to the date of initial failure for patients who fail. Failure includes the traditional endpoints of failure to achieve a complete remission, relapse in any site, secondary malignancy, and death during induction or remission. EFS time will be measured to the date of last contact for patients who are failure free at the time of analysis. The EFS time is defined to be zero (0) for patients who die during induction therapy or fail to achieve a complete remission." (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
Intervention | Percentage of participants (Number) |
---|
TOTXVI PEG 3500 | 92.4 |
TOTXVI PEG 2500 | 91.1 |
TOTXVI Not Randomized | 86.3 |
All Eligible Patients in TOTXV | 87.1 |
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Probability of Overall Survival
To estimate the overall survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV. (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
Intervention | Percentage of participants (Number) |
---|
TOTXVI PEG 3500 | 97.5 |
TOTXVI PEG 2500 | 95.6 |
TOTVI Not Randomized | 90.8 |
All Eligible Patients in TOTXV | 93.5 |
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Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.
"The primary objective of this study is to compare the distributions of continuous complete remission of patients randomized on the first day of the continuation phase to receive a higher dose of PEG-asparaginase or to receive the conventional dose (2,500 units/m2).~The randomization will occur on the starting day of the continuation phase, at which time all information necessary for performing the randomization should be available. In the rare case that immunophenotype and/or Day-15 MRD is not available, we will make the following assumptions: If immunophenotype is unknown at the time the randomization is to be executed, then it will be assumed B-lineage. If Day-15 MRD is unknown at the time of randomization, then it will be assumed negative (<0.01%). Past experience indicate that few patients will fall into these unknown categories." (NCT00549848)
Timeframe: 3.5 years after the last enrollment up to 12.5 years
Intervention | Percentage of participants (Number) |
---|
PEG 3500 Units/m^2 | 91.6 |
PEG 2500 Units/m^2 | 90.7 |
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Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5%
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol. (NCT00549848)
Timeframe: Middle of remission induction, Day 15 in Total XVI and Day 19 in Total XV
Intervention | Participants (Count of Participants) |
---|
TOTXVI PEG 3500 | 22 |
TOTXVI PEG 2500 | 26 |
TOTXVI Not Randomized | 31 |
All Eligible Patients in TOTXV | 55 |
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Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01%
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol. (NCT00549848)
Timeframe: End of remission induction; day 42 in Total XVI and day 46 in Total XV
Intervention | Participants (Count of Participants) |
---|
TOTXVI PEG 3500 | 7 |
TOTXVI PEG 2500 | 12 |
TOTXVI Not Randomized | 20 |
All Eligible Patients in TOTXV | 44 |
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Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS
The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 (best) to 18 (worst). (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS
Intervention | Units on a Scale (Mean) |
---|
SCH 697243 | 3.71 |
Placebo | 4.91 |
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Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0 (no use of rescue medication) to 36 (maximum use of rescue medication). A lower medication score indicated less impact on symptoms and was suggestive of less use of rescue medication. (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS
Intervention | Units on a Scale (Mean) |
---|
SCH 697243 | 0.91 |
Placebo | 1.33 |
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Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication. (NCT00550550)
Timeframe: From the Start of the GPS to the End of the GPS
Intervention | Units on a Scale (Mean) |
---|
SCH 697243 | 4.62 |
Placebo | 6.25 |
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Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS
The RQLQ has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0 (best) to 6 (worst), with a higher score indicating more significant impairment. (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS
Intervention | Units on a Scale (Mean) |
---|
SCH 697243 | 1.45 |
Placebo | 1.77 |
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Mean Number of Blood Transfusions Per Visit
(NCT00551291)
Timeframe: Up to approximately 2 years
Intervention | transfusions/visit (Mean) |
---|
| Baseline (n=8) | Week 12 (n=6) | Week 18 (n=5) | End of Study (n=3) |
---|
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta | 4.13 | 5.83 | 2.80 | 2.33 |
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Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement
International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) <11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment. (NCT00551291)
Timeframe: Up to approximately 2 years
Intervention | percentage of participants (Number) |
---|
| Week 12 (n=4) | Week 18 (n=7) | End of study (n=3) |
---|
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta | 50.00 | 71.43 | 100.00 |
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Percentage of Participants With at Least One Adverse Event (AE)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. (NCT00551291)
Timeframe: Up to approximately 2 years
Intervention | percentage of participants (Number) |
---|
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta | 90.00 |
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Response of Hemangioma (IH) to Treatment
"Response of IH not confined to the dermis will be coded using the following criteria: Progressive disease: >40% increase in volume by MRI, Partial response: >65% reduction in volume by MRI, Complete response: no visual or radiographic evidence of disease, Stable disease: none of the above or <40% increase or <65% decrease in volume by MRI.~Response of superficial IH will be coded using the following criteria (based on RECIST): Progressive disease: >30% increase in IH size, Partial response: >30% reduction in size, Complete response: no evidence of disease, Stable disease: none of the above.~Our first 3 patients showed limits to using MRI volume to measure IH size/response to therapy. Unlike other solid tumors, the superficial distribution of some IH made getting volume by MRI difficult, resulting in smaller tumor estimation compared to clinical assessment. Based on these observations, we amended the protocol to report response based on RECIST criteria instead of change in IH volume." (NCT00555464)
Timeframe: 6 weeks
Intervention | participants (Number) |
---|
| Progressive Disease | Partial Response | Complete Response | Stable Disease |
---|
Oral Steroid Treatment Group | 1 | 0 | 0 | 2 |
,Vincristine Treatment Group | 0 | 2 | 0 | 2 |
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Toxicity to Medications
"Adverse events were closely monitored and recorded at weekly visits during treatment period and for two years after treatment ceased. Laboratory values were taken every other week during the treatment period.~Please see Adverse Events module for more details." (NCT00555464)
Timeframe: Initial visit, 2, 4, 6, 10 and 12 weeks of therapy
Intervention | participants (Number) |
---|
| Patients with Serious Adverse Events | Patients with Other Adverse Events |
---|
Oral Steroid Treatment Group | 0 | 0 |
,Vincristine Treatment Group | 0 | 3 |
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Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in available Arm C relapse samples (NCT00557193)
Timeframe: At relapse (up to 3 years)
Intervention | qPCR fold expression ratio (Mean) |
---|
Arm C (Safety/Efficacy Dose Level 2) | 5.73 |
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Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
Described via mean and standard deviation by group. (NCT00557193)
Timeframe: Sampled at the start of induction
Intervention | qPCR fold expression ratio (Mean) |
---|
Arm A (Standard Risk MLL-G) | 1.25 |
Arm B (IR/HR MLL-R Chemotherapy) | 7.85 |
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 5.83 |
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Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in samples which have acquired resistance to lestaurtinib (NCT00557193)
Timeframe: At relapse (up to 3 years)
Intervention | Proportion of cells that are viable (Mean) |
---|
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 0.69 |
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Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in samples which have primary resistance to lestaurtinib (NCT00557193)
Timeframe: Sampled at the start of induction
Intervention | Proportion of cells that are viable (Median) |
---|
Arm A (Standard Risk MLL-G) | 0.75 |
Arm B (IR/HR MLL-R Chemotherapy) | 0.48 |
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 0.47 |
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Percent Probability for Event-free Survival (EFS) for Patients on Arm A
EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years
Intervention | percentage probability (Number) |
---|
Arm A (Standard Risk MLL-G) | 86.67 |
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Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years
Intervention | percentage probability (Number) |
---|
Arm C (Safety/Efficacy Dose Level 2) | 35.82 |
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Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years.
Intervention | percent probability (Number) |
---|
Arm B (IR/HR MLL-R Chemotherapy) | 38.89 |
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 35.82 |
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Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status. (NCT00557193)
Timeframe: 3 Years from end of Induction)
Intervention | percent probability (Number) |
---|
Arm A (MRD Negative) | 86.05 |
Arm A (MRD Positive) | 87.5 |
Arm B (MRD Negative) | 47.37 |
Arm B (MRD Positive) | 22.73 |
Arm C (MRD Negative) | 51.85 |
Arm C (MRD Positive) | 27.03 |
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Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
Summarized with mean and standard deviation for those with available data in Arm C (NCT00557193)
Timeframe: Sampled between weeks 6-12 from start of induction
Intervention | Activity percentage (Mean) |
---|
Arm C (Safety/Efficacy Dose Level 2) | 69.00 |
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Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0-54, with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0-18, with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0-36, with a lower score indicating less use of rescue medication. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS
Intervention | Units on a Scale (Mean) |
---|
SCH 697243 | 5.08 |
Placebo | 6.39 |
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Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS
The RQLQ(s) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS
Intervention | Units on a Scale (Mean) |
---|
SCH 697243 | 1.30 |
Placebo | 1.57 |
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Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS
The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 to 18. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS
Intervention | Units on a Scale (Mean) |
---|
SCH 697243 | 3.83 |
Placebo | 4.69 |
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Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0-36. A lower medication score indicated less impact on symptomology and was suggestive of less use of rescue medication. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS
Intervention | Units on a Scale (Mean) |
---|
SCH 697243 | 1.25 |
Placebo | 1.70 |
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Percentage of Participants With Objective Response (OR)
OR was based on assessment of complete response(CR),unconfirmed CR(Cru),partial response(PR) as per International Response Criteria for Non-Hodgkin's Lymphoma.Confirmed response=response persists on repeat imaging at least 4 weeks after initial response.CR=complete disappearance of all detectable clinical/radiographic evidence of disease,lymph nodes regressed to normal size [at least 1.5 centimeter(cm) or less],spleen regressed,not palpable on physical examination,bone marrow infiltrate cleared on repeat aspiration/biopsy.PR=at least 50 percent (%) decrease in sum of product diameters of 6 greatest dominant nodes,no increase in other nodes,liver/spleen,no new sites of disease. CRu=residual lymph node greater than 1.5 cm in transverse diameter that has regressed more than 75% in product diameter.Individual nodes previously confluent,regressed more than 75% in product diameters.Indeterminate bone marrow (increased number/size of lymph aggregates without cytologic/architectural atypia). (NCT00562965)
Timeframe: Baseline, every 6 to 12 weeks during treatment period, end of treatment (EOT) (42 days after last dose), every 12 weeks during follow-up for up to 1 year after the last dose of study drug
Intervention | percentage of participants (Number) |
---|
Rituximab + Inotuzumab Ozogamicin | 93.3 |
Control Regimens R-CVP + R-FND | 64.3 |
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Progression-Free Survival (PFS)
PFS was defined as the time from randomization to disease progression or death due to any cause, whichever occurred first, censored at the last tumor evaluation date. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.44. (NCT00562965)
Timeframe: Baseline until disease progression or death or up to 1 year after last dose of study drug
Intervention | months (Median) |
---|
Rituximab + Inotuzumab Ozogamicin | NA |
Control Regimens R-CVP + R-FND | 16.4 |
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Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings
Criteria for laboratory test abnormality: Blood Chemistry (alkaline phosphatase [greater than{>}5*upper limit of normal {ULN}, calcium [less than {<}1.75 millimole per liter {mmol/L}, creatinine [>3*ULN], glucose [>13.9 mmol/L], phosphorous [<0.6 mmol/L], potassium [<3 mmol/L], aspartate transaminase [>5.0*ULN], total bilirubin [>3*ULN]), Coagulation (international normalized ratio [>2*ULN]), Hematology (hemoglobin [<80 grams/Liter], lymphocytes [<0.5*10^9/L], absolute neutrophil count [<1*10^9/L], platelet count [<50*10^9/L], WBC [<2.0*10^9/L]). (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)
Intervention | participants (Number) |
---|
| Baseline up to 42 days post-treatment | Disease follow up |
---|
Control Regimens R-CVP + R-FND | 12 | 7 |
,Rituximab + Inotuzumab Ozogamicin | 11 | 8 |
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Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings
Assessments of QT interval was performed only in rituximab + inotuzumab ozogamicinin group. QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) was analyzed as per common terminology criteria for adverse events (CTCAE) version 3.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening or disabling AE, Grade 5 = death related to AE. Number of participants with change in CTCAE grading at post-baseline time point compared to the baseline were presented. The post-baseline value was defined as the maximum grade after the first dose date on or before the end of treatment. (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment
Intervention | participants (Number) |
---|
| QTcB: BL normal, post-BL normal | QTcB: BL normal, post-BL Grade 1 | QTcB: BL normal, post-BL Grade 2 | QTcF: BL normal, post-BL normal | QTcF: BL normal, post-BL Grade 1 |
---|
Rituximab + Inotuzumab Ozogamicin | 4 | 2 | 3 | 6 | 3 |
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Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Criteria for determining significant change from baseline in vital signs abnormalities: heart rate value of <40 beats per minute and value >150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, and body weight>=10% increase or decrease of body weight in kilogram (kg). (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)
Intervention | participants (Number) |
---|
| Baseline up to 42 days post-treatment | Disease follow up |
---|
Control Regimens R-CVP + R-FND | 1 | 2 |
,Rituximab + Inotuzumab Ozogamicin | 0 | 3 |
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Overall Survival Probability at Months 6, 12 and 24
Overall survival was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. Participants who withdrew or lost to follow-up from study without having death documented were censored at the date of last contact. Kaplan-Meier estimates of the probability of survival at 6, 12 and 24 months was used to estimate the survival function. (NCT00562965)
Timeframe: Baseline up to Month 6, 12, 24
Intervention | percent chance of survival (Number) |
---|
| Overall Survival: Baseline up to Month 6 | Overall Survival: Baseline up to Month 12 | Overall Survival: Baseline up to Month 24 |
---|
Control Regimens R-CVP + R-FND | 92.3 | 83.9 | 67.1 |
,Rituximab + Inotuzumab Ozogamicin | 100.0 | 86.7 | 86.7 |
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Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)
AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. TEAE=between first dose of study drug and up to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment
Intervention | participants (Number) |
---|
Rituximab + Inotuzumab Ozogamicin | 12 |
Control Regimens R-CVP + R-FND | 13 |
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Overall Survival
(NCT00574496)
Timeframe: up to 8 years
Intervention | months (Median) |
---|
High-Risk or Relapsed Hodgkin Lymphoma | 70.3 |
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Progression-free Survival at 1 Year
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00574496)
Timeframe: 1 year
Intervention | proportion of progression-free pts (Number) |
---|
High-Risk or Relapsed Hodgkin Lymphoma | 33.3 |
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Disease Relapse or Progression as Measured by CT Scan or PET
(NCT00574496)
Timeframe: 3 years
Intervention | months (Median) |
---|
High-Risk or Relapsed Hodgkin Lymphoma | 34.3 |
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Number of Participants With Progression Free Survival (10 Years) by Treatment
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00577993)
Timeframe: 10 years
Intervention | Participants (Count of Participants) |
---|
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 59 |
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 58 |
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Number of Participants With Overall Survival (10 Years) by Treatment
Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years. (NCT00577993)
Timeframe: 10 Years
Intervention | Participants (Count of Participants) |
---|
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 59 |
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 58 |
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Adverse Infusion Reactions Within 24 Hours Following the Second Rituximab Infusion.
Assessment of all adverse infusion reactions within 24 hours of receipt of the second rituximab infusion (NCT00580229)
Timeframe: 24 hours
Intervention | acute infusion reactions (Number) |
---|
Oral Prednisone as a Pretreatment to Rituximab | 48 |
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Adverse Events Assessed From Day 15 Through Week 26.
All adverse events reported from day 15 (24 hours after second infusion) through week 26. (NCT00580229)
Timeframe: 24 weeks
Intervention | events (Number) |
---|
Oral Prednisone as a Pretreatment to Rituximab | 48 |
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Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion
Open-label assessment of AIR's during and/or within 24 hours in patients pretreated with 40mg oral prednisone 30 minutes prior to initial rituximab infusion (NCT00580229)
Timeframe: 24 hours
Intervention | acute infusion reactions (Number) |
---|
Oral Prednisone as a Pretreatment to Rituximab | 50 |
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FEV1 Percent Predicted
(NCT00588406)
Timeframe: 4 hours post-randomization
Intervention | percent predicted of FEV1 (Mean) |
---|
Budesonide | 51.7 |
Placebo | 52.6 |
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Hospitalization
(NCT00588406)
Timeframe: 6 hours
Intervention | percentage of participants (Number) |
---|
Budesonide | 39 |
Placebo | 39 |
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Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12
A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome). (NCT00602641)
Timeframe: Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.
Intervention | units on a scale (Mean) |
---|
Arm I (MPT-T) | -2.8 |
Arm II (mPR-R) | 3.3 |
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Very Good Partial Response (VGPR) Rate
Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria. (NCT00602641)
Timeframe: Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.
Intervention | proportion of participants (Number) |
---|
Arm I (MPT-T) | 0.247 |
Arm II (mPR-R) | 0.316 |
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Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the earlier of progression or death of any cause. (NCT00602641)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
Intervention | months (Median) |
---|
Arm I (MPT-T) | 21.0 |
Arm II (mPR-R) | 18.7 |
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Overall Survival
Overall survival was defined as time from randomization to death from any cause. (NCT00602641)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
Intervention | months (Median) |
---|
Arm I (MPT-T) | 52.6 |
Arm II (mPR-R) | 47.7 |
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Biochemical Remission of (AIH) at Month 6.
Percent of patients that achieve biochemical remission of (AIH) at Month 6 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits. (NCT00608894)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
LCP-Tacro | 3 |
Azathioprine | 4 |
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Biochemical Remission by Month 3.
Percent of patients who achieve biochemical remission by Month 3 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits. (NCT00608894)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
LCP-Tacro | 2 |
Azathioprine | 4 |
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Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months
Percents of patients in each treatment group classified as having an incomplete response (defined as some or no improvement during therapy), a treatment failure (defined as permanent discontinuation of the regimen originally randomized to), or a case of relapse (recurrence following achievement of remission) (NCT00608894)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
| Incomplete response | Treatment failure | Relapse |
---|
Azathioprine | 1 | 1 | 0 |
,LCP-Tacro | 4 | 0 | 0 |
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Overall Survival (OS)
OS is defined as the time from date of first dose of study drug until the date of death. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those missing a recorded last date of contact will be censored at the last date the patient was known to be alive. (NCT00623766)
Timeframe: From first dose to 24 months
Intervention | Months (Median) |
---|
Ipilimumab, 10 mg/kg, IV in Corticosteroid-free Patients | 6.97 |
Ipilimumab, 10 mg/kg, IV in Corticosteroid-dependent Patients | 3.75 |
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Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
BORR is defined as the number of patients whose global best overall response (BOR) was complete (CR) or partial response (PR), divided by the total number of participants who received treatment. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. The global BOR is the best overall response (OR) designation over the study as a whole for an individual in the study based on overall tumor burden. Both central nervous system (CNS) (brain lesions) and non-CNS compartments (lesions outside the brain) are considered for the global BOR. For the analysis of global BOR of CR or PR (by both modified WHO criteria and immune-related response criteria [irRC]), the OR assessment must be confirmed by a second (confirmatory) evaluation meeting the criteria for response and must be performed no less than 4 weeks after the criteria for response are first met. (NCT00623766)
Timeframe: From Day 1, first dose until the last tumor assessment, Week 12
Intervention | Percentage of participants (Number) |
---|
| Global BORR (mWHO criteria) | BORR in brain (mWHO criteria) | BORR in non-CNS compartment (mWHO criteria) | Global BORR (irRC) | BORR in brain (irRC) | BORR in non-CNS compartment (irRC criteria ) |
---|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients | 4.8 | 4.8 | 4.8 | 4.8 | 4.8 | 4.8 |
,Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients | 9.8 | 15.7 | 13.7 | 9.8 | 15.7 | 13.7 |
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Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria
Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system. (NCT00623766)
Timeframe: From Day 1, first dose to end of Week 12
Intervention | Percentage of participants (Number) |
---|
| Global disease control rate | Disease control rate in brain |
---|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients | 4.8 | 9.5 |
,Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients | 17.6 | 23.5 |
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Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)
OS is defined as the time from the first dose of study drug until the date of death. Overall survival rate is the percentage of participants known to be alive at a timepoint. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those with a missing recorded last date of contact will be censored at the last date the patient was known to be alive. The survival rate at a specified time-point is the probability that a patient is alive at that time following randomization. The rate is calculated for each treatment group using the Kaplan-Meier product-limit method. A corresponding 2-sided 95% bootstrap confidence interval will be calculated. (NCT00623766)
Timeframe: From first dose to Months 6, 12, 18, 24, and 36 months
Intervention | Probability of being alive (Number) |
---|
| At 6 months | At 12 months | At 18 months | At 24 months | At 36 months |
---|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients | 0.38 | 0.19 | 0.19 | 0.10 | 0.10 |
,Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients | 0.55 | 0.31 | 0.26 | 0.26 | 0.26 |
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Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008
"The treatment efficacy was rated by investigators at the end of the evaluation period in autumn 2008. Investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: much worse, worse, the same, better, or much better.~The categories much better or better were grouped as improved. The categories the same, worse or much worse were grouped as not improved." (NCT00633919)
Timeframe: 8 weeks
Intervention | Participants (Number) |
---|
| Investigator evaluation: Improved | Investigator evaluation: Not improved | Investigator evaluation: Missing data |
---|
Active | 30 | 7 | 0 |
,Placebo | 24 | 17 | 0 |
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Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008
"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.~The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)." (NCT00633919)
Timeframe: 8 weeks
Intervention | Scores on a scale (Mean) |
---|
Active | 4.4 |
Placebo | 4.7 |
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Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007
"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.~The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)." (NCT00633919)
Timeframe: 8 weeks
Intervention | Scores on a scale (Mean) |
---|
Active | 4.1 |
Placebo | 3.6 |
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Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008
"The treatment efficacy was rated by subjects at the end of the evaluation period in autumn 2008. Subjects rated their asthma symptoms in comparison to previous autumn using the categories: much worse, worse, the same, better, or much better.~The categories much better or better were grouped as improved. The categories the same, worse or much worse were grouped as not improved." (NCT00633919)
Timeframe: 8 weeks
Intervention | Participants (Number) |
---|
| Subject evaluation: Improved | Subject evaluation: Not improved | Subject evaluation: Missing data |
---|
Active | 28 | 8 | 1 |
,Placebo | 28 | 13 | 0 |
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Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007
"The treatment efficacy was rated by both subject and investigator at the end of the evaluation period in autumn 2007. Subjects rated their asthma symptoms in comparison to previous autumns and investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: much worse, worse, the same, better, or much better.~The categories much better or better were grouped as improved. The categories the same, worse or much worse were grouped as not improved." (NCT00633919)
Timeframe: 8 weeks
Intervention | Participants (Number) |
---|
| Subject evalution: Improved | Subject evaluation: Not improved | Investigator evaluation: Improved | Investigator evaluation: Not improved |
---|
Active | 30 | 17 | 33 | 14 |
,Placebo | 33 | 14 | 30 | 17 |
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An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria
Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response. (NCT00634179)
Timeframe: Following completion of therapy, up to 2 years
Intervention | participants (Number) |
---|
| Complete Response (CR) | Partial Response (PR) | Overall Response Rate (ORR) |
---|
Phase I: Induction | 13 | 6 | 19 |
,Phase II: Maintenance | 19 | 10 | 29 |
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Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)
INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression. (NCT00634179)
Timeframe: Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks
Intervention | mg/m^2 (Number) |
---|
MTD of Bortezomib With Vincristine Capped at 1.5 mg | 1.62 |
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Progression Free Survival.
Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00634647)
Timeframe: 15 months
Intervention | Months (Median) |
---|
Satraplatin | 6.0 |
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Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00634647)
Timeframe: Date treatment consent signed to date off study, approximately 57 months.
Intervention | Participants (Count of Participants) |
---|
Satraplatin | 23 |
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Visual Analogue Scale for Pain (VAS-pain)
100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | mm (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
Placebo | 65.4 | 53.0 | 53.6 | 56.4 | 54.3 | 51.1 | 51.1 | 49.2 |
,TRU-015 Induction Dose | 61.6 | 49.6 | 49.0 | 47.0 | 44.8 | 40.8 | 39.1 | 43.9 |
,TRU-015 Single Dose | 62.5 | 47.7 | 48.9 | 45.8 | 42.3 | 39.3 | 39.5 | 39.2 |
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Physician Global Assessment (PGA) of Disease Activity
Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
Placebo | 6.8 | 5.5 | 5.0 | 5.0 | 4.8 | 4.6 | 4.4 | 4.3 |
,TRU-015 Induction Dose | 6.6 | 5.2 | 4.9 | 4.4 | 4.3 | 3.6 | 3.6 | 3.6 |
,TRU-015 Single Dose | 6.4 | 5.1 | 5.0 | 4.1 | 4.1 | 3.7 | 3.8 | 3.7 |
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Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | percentage of participants (Number) |
---|
| Week 2: good response | Week 2: moderate response | Week 2: no response | Week 4: good response | Week 4: moderate response | Week 4: no response | Week 8: good response | Week 8: moderate response | Week 8: no response | Week 12: good response | Week 12: moderate response | Week 12: no response | Week 16: good response | Week 16: moderate response | Week 16: no response | Week 20: good response | Week 20: moderate response | Week 20: no response | Week 24: good response | Week 24: moderate response | Week 24: no response |
---|
Placebo | 1.4 | 33.8 | 64.9 | 5.4 | 39.2 | 55.4 | 8.1 | 44.6 | 47.3 | 9.5 | 39.2 | 51.4 | 18.9 | 40.5 | 40.5 | 17.6 | 37.8 | 44.6 | 14.9 | 44.6 | 40.5 |
,TRU-015 Induction Dose | 2.7 | 39.7 | 57.5 | 8.2 | 45.2 | 46.6 | 12.3 | 53.4 | 34.2 | 16.4 | 52.1 | 31.5 | 20.5 | 56.2 | 23.3 | 26.0 | 54.8 | 19.2 | 30.1 | 50.7 | 19.2 |
,TRU-015 Single Dose | 6.7 | 38.7 | 54.7 | 14.7 | 41.3 | 44.0 | 14.7 | 44.0 | 41.3 | 21.3 | 53.3 | 25.3 | 34.7 | 41.3 | 24.0 | 29.3 | 52.0 | 18.7 | 26.7 | 46.7 | 26.7 |
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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 |
---|
Placebo | 0.0 | 6.8 | 12.2 | 14.9 | 16.2 | 16.2 |
,TRU-015 Induction Dose | 6.8 | 6.8 | 8.2 | 13.7 | 31.5 | 28.8 |
,TRU-015 Single Dose | 8.0 | 8.0 | 10.7 | 16.0 | 30.7 | 28.0 |
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Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
Placebo | 0.0 | 1.4 | 1.4 | 1.4 | 6.8 | 2.7 | 2.7 |
,TRU-015 Induction Dose | 1.4 | 0.0 | 1.4 | 2.7 | 6.8 | 6.8 | 9.6 |
,TRU-015 Single Dose | 1.3 | 1.3 | 2.7 | 2.7 | 8.0 | 6.7 | 9.3 |
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Patient Global Assessment (PtGA) of Disease Activity
Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
Placebo | 7.3 | 6.2 | 6.0 | 6.2 | 5.9 | 6.6 | 5.5 | 5.3 |
,TRU-015 Induction Dose | 7.0 | 5.6 | 5.6 | 5.3 | 5.2 | 4.6 | 4.5 | 4.7 |
,TRU-015 Single Dose | 6.9 | 5.6 | 5.4 | 5.2 | 4.8 | 4.4 | 4.5 | 4.6 |
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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
Placebo | 17.6 | 31.1 | 31.1 | 31.1 | 41.9 | 47.3 | 43.2 |
,TRU-015 Induction Dose | 26.0 | 34.2 | 42.5 | 49.3 | 61.6 | 64.4 | 67.1 |
,TRU-015 Single Dose | 21.3 | 34.7 | 44.0 | 52.0 | 64.0 | 62.7 | 61.3 |
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Number of Tender Joints
The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | tender joints (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
Placebo | 17.0 | 13.6 | 11.9 | 11.7 | 11.0 | 9.4 | 9.0 | 9.4 |
,TRU-015 Induction Dose | 17.7 | 13.0 | 11.6 | 10.1 | 9.6 | 8.4 | 7.6 | 7.6 |
,TRU-015 Single Dose | 16.8 | 11.9 | 10.7 | 9.8 | 8.8 | 7.3 | 7.6 | 8.1 |
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Number of Swollen Joints
The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. (NCT00634933)
Timeframe: Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | swollen joints (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
Placebo | 12.2 | 9.5 | 7.8 | 7.0 | 7.6 | 6.1 | 6.0 | 6.2 |
,TRU-015 Induction Dose | 13.9 | 10.2 | 9.0 | 7.7 | 7.1 | 5.9 | 5.1 | 5.0 |
,TRU-015 Single Dose | 12.3 | 9.0 | 8.5 | 6.9 | 6.0 | 5.1 | 4.8 | 4.7 |
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Health Assessment Questionnaire Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
Placebo | 1.8 | 1.5 | 1.4 | 1.5 | 1.5 | 1.4 | 1.4 | 1.4 |
,TRU-015 Induction Dose | 1.6 | 1.3 | 1.3 | 1.2 | 1.1 | 1.1 | 1.0 | 1.0 |
,TRU-015 Single Dose | 1.7 | 1.4 | 1.4 | 1.3 | 1.3 | 1.2 | 1.2 | 1.2 |
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Disease Activity Score Based on 28-joints Count (DAS28)
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 |
---|
Placebo | 6.1 | 5.4 | 5.2 | 5.1 | 5.0 | 4.7 | 4.7 | 4.7 |
,TRU-015 Induction Dose | 6.1 | 5.3 | 5.0 | 4.7 | 4.6 | 4.3 | 4.1 | 4.0 |
,TRU-015 Single Dose | 5.8 | 5.1 | 4.9 | 4.6 | 4.3 | 3.9 | 4.0 | 4.1 |
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Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP). (NCT00634933)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
Placebo | 16.2 |
TRU-015 Single Dose | 29.3 |
TRU-015 Induction Dose | 27.4 |
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Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline. (NCT00638690)
Timeframe: Up to 12 months
Intervention | Participants (Number) |
---|
Abiraterone Acetate | 232 |
Placebo | 22 |
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Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart. (NCT00638690)
Timeframe: Up to 12 months
Intervention | Days (Median) |
---|
Abiraterone Acetate | 309.0 |
Placebo | 200.0 |
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Overall Survival
Overall survival is defined as the time interval from the date of randomization to the date of death from any cause. (NCT00638690)
Timeframe: Up to 60 months
Intervention | Days (Median) |
---|
Abiraterone Acetate | 450.0 |
Placebo | 332.0 |
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Radiographic Progression-free Survival
Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion. (NCT00638690)
Timeframe: Up to 11 months
Intervention | Days (Median) |
---|
Abiraterone Acetate | 171.0 |
Placebo | 110.0 |
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Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)
PSA response was defined as a post-baseline PSA level decline of at least 50% relative to the baseline value. Response rate calculated as 100*n/N where n=the number of participants with responses and N=the total number of participants treated. (NCT00642018)
Timeframe: Baseline, 18 months
Intervention | percentage of participants (Number) |
---|
Docetaxel | 56.9 |
LY2181308 + Docetaxel | 56.1 |
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Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment
(NCT00642018)
Timeframe: Study treatment discontinuation up to 30 days post study treatment discontinuation
Intervention | Participants (Count of Participants) |
---|
Docetaxel | 1 |
LY2181308 + Docetaxel | 0 |
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Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes)
The FACT-P is a 39-item participant-rated questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. (NCT00642018)
Timeframe: 3 months
Intervention | units on a scale (Median) |
---|
Docetaxel | 117 |
LY2181308 + Docetaxel | 115 |
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Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms)
The total FACT-G is the sum of 4 subscale scores on the FACT-Prostate Cancer (FACT-P) participant-rated questionnaire representing general cancer symptoms: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-G score ranges from 0-108, with higher scores representing a better quality of life with fewer symptoms. (NCT00642018)
Timeframe: 3 months
Intervention | units on a scale (Median) |
---|
Docetaxel | 84 |
LY2181308 + Docetaxel | 80 |
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Estimate Overall Survival
Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact. Participants were still followed for overall survival after they stopped receiving study drug. (NCT00642018)
Timeframe: First treatment to death due to any cause up to 45.54 months
Intervention | months (Median) |
---|
Docetaxel | 29.04 |
LY2181308 + Docetaxel | 27.04 |
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Estimate Duration of Overall Response
The duration of response [complete response (CR) or partial response (PR)] was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. For participants who had no progression or death, the duration of response was censored at their last contact. (NCT00642018)
Timeframe: Time of response to time of measured progressive disease up to 41.00 months
Intervention | months (Median) |
---|
Docetaxel | 10.81 |
LY2181308 + Docetaxel | 9.66 |
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Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses)
G-CSF [international units per milliliter (IU/mL)] was used to estimate biomarker responses and is presented as the percentage change from baseline. (NCT00642018)
Timeframe: Baseline, 21 days
Intervention | percentage change (Number) |
---|
Docetaxel | -32.5 |
LY2181308 | 233.3 |
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Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone
PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug. (NCT00642018)
Timeframe: Baseline to measured progressive disease or death due to any cause up to 44.68 months
Intervention | months (Median) |
---|
Docetaxel | 9.00 |
LY2181308 + Docetaxel | 8.64 |
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Percentage of Participants With Complete Response or Partial Response (Overall Response Rate)
Overall response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. (NCT00642018)
Timeframe: Baseline to measured progressive disease up to 41.00 months
Intervention | percentage of participants (Number) |
---|
Docetaxel | 21.6 |
LY2181308 + Docetaxel | 10.2 |
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Number of Participants With Adverse Events (Safety)
Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months. (NCT00642018)
Timeframe: First treatment dose up to 19 months
Intervention | Participants (Count of Participants) |
---|
| Serious Adverse Events | Other Nonserious Adverse Events |
---|
Docetaxel | 11 | 50 |
,LY2181308 + Docetaxel | 47 | 94 |
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Adverse Event Profile
Data presented are the number of participants with all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), discontinuations due to SAEs and AEs, and deaths that occurred in this study that were assessed by investigators as possibly related to study drug. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months. (NCT00642018)
Timeframe: First treatment dose up to 19 months
Intervention | Participants (Count of Participants) |
---|
| TEAEs | SAEs | Discontinuations due to AEs | Discontinuations due to SAEs | Death |
---|
Docetaxel | 45 | 5 | 6 | 1 | 0 |
,LY2181308 + Docetaxel | 91 | 27 | 22 | 3 | 0 |
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Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)
(NCT00642018)
Timeframe: Predose up to 8 hours postdose in Cycle 1
Intervention | nanograms*hour per milliliter (ng*h/mL) (Geometric Mean) |
---|
Docetaxel | 825 |
LY2181308 + Docetaxel | 799 |
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ACR 20 Response Rate at Visit 4
"Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria:~> 20% reduction in the tender joint count (0-28)~> 20% reduction in the swollen joint count (0-28)~> 20% reduction in 3 out of the 5 following additional measures:~Patient's assessment of pain~Patient's global assessment of disease activity~Physician's global assessment of disease activity~Functional Disability Index of the Health Assessment Questionnaire~C-reactive protein or erythrocyte sedimentation rate" (NCT00650078)
Timeframe: Week 12
Intervention | participants (Number) |
---|
NP01 | 108 |
Placebo | 34 |
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Relative Reduction of Morning Stiffness
Data for the duration of morning stiffness were obtained from patient diaries. Duration of morning stiffness was the difference between the time of resolution of morning stiffness and the time of wake-up. Duration of morning stiffness is the average of the morning stiffness duration (minutes) over the last 7 days prior to visit day (including day of visit). If more than 4 assessments were missing, then the duration was set to missing. Baseline was the value recorded at Week -1 (Visit 0). (NCT00650078)
Timeframe: Week 12
Intervention | Relative Change from Baseline (%) (Median) |
---|
NP01 | -55.22 |
Placebo | -34.62 |
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The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.
The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment. (NCT00651040)
Timeframe: 1 year
Intervention | mg/kg (Mean) |
---|
Prednison1 | 124 |
Prednison Methotrexate 2 | 135 |
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Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Intervention | ug/mL*hr (Geometric Mean) |
---|
Aprepitant | 4.5 |
Control | 6.0 |
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Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Intervention | ng/mL*hr (Geometric Mean) |
---|
Aprepitant | 4416 |
Control | 3817 |
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Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Intervention | ug/mL*hr (Geometric Mean) |
---|
Aprepitant | 3.9 |
Control | 4.0 |
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Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Intervention | ug/mL*hr (Geometric Mean) |
---|
Aprepitant | 300 |
Control Group | 250 |
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Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Intervention | ng/mL*hr (Geometric Mean) |
---|
Aprepitant | 41 |
Control | 39 |
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Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)
Intervention | ng/mL*hr (Geometric Mean) |
---|
Aprepitant | 287 |
Control | 265 |
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Complete Response Rate to Rituximab and a Combination of Vorinostat With Cyclophosphamide, Etoposide, and Prednisone in Elderly Pts With Relapsed Diffuse Large B-cell Lymphoma Who Aren't Candidates for Autologous Stem Cell Transplantation.
"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate." (NCT00667615)
Timeframe: through study completion, an average of 1 year
Intervention | percentage of participants with CR (Number) |
---|
Relapsed or Refractory Diffuse Large B-cell Lymphoma | 32 |
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Maximum Tolerated Dose (MTD) of Vorinostat Given Orally for 10 Days in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma
Maximum Tolerated Dose (MTD) of Vorinostat reflects the highest dose of Ridaforolimus and Vorinostat that did not cause a new Grade 2 toxicity in >= 50% of participants (NCT00667615)
Timeframe: through study completion, an average of 1 year
Intervention | mg/m2 (Number) |
---|
Relapsed or Refractory Diffuse Large B-cell Lymphoma | 300 |
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Oswestry Disability Index, v2
The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability. (NCT00668434)
Timeframe: Baseline, Week 3 follow-up
Intervention | units on a scale (Mean) |
---|
Prednisone | -19.0 |
Placebo | -13.3 |
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Oswestry Disability Index, v2
The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability. (NCT00668434)
Timeframe: Baseline, Week 52 follow-up
Intervention | units on a scale (Mean) |
---|
Prednisone | -37.8 |
Placebo | -30.4 |
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Pain Numerical Rating Scale
Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain. (NCT00668434)
Timeframe: Baseline, Week 3 follow-up
Intervention | units on a scale (Mean) |
---|
Prednisone | -3.0 |
Placebo | -2.8 |
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Pain Numerical Rating Scale
Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain. (NCT00668434)
Timeframe: Baseline, Week 52 follow-up
Intervention | units on a scale (Mean) |
---|
Prednisone | -5.2 |
Placebo | -4.6 |
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Event-free > Survival at 12 Months (Phase 2, DLBCL/Mixed Dose Level 3)
Other Phase II Cohorts were not evaluable for event-free survival analysis. (NCT00670358)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Ph II, DLBCL/Mixed | 44 |
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Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
(NCT00670358)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
| Grade 3+ Adverse Event | Grade 4+ Adverse Event | Grade 3+ Hem Adverse Event | Grade 4+ Hem Adverse Event | Grade 3+ Non-Hem Adverse Event |
---|
Ph 1, DL 1 | 3 | 2 | 3 | 2 | 1 |
,Ph1, DL 2 | 3 | 1 | 3 | 1 | 1 |
,Ph1, DL 3 | 5 | 4 | 5 | 4 | 2 |
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Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)
Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half. (NCT00671034)
Timeframe: Post Day 29 of Induction and Post Day 22 of Consolidation
Intervention | hours (Mean) |
---|
| Asparaginase half-life during Consolidation | Asparaginase half-life during Induction |
---|
Arm I (Calaspargase Pegol 2100) | 415.8 | 305.1 |
,Arm II ( Calaspargase Pegol 2500) | 355.9 | 321.5 |
,Arm III (Pegaspargase 2500) | 117.2 | 126.9 |
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Pharmacodynamics (PD)
Plasma Asparaginase Concentration During consolidation and induction. (NCT00671034)
Timeframe: Day 29 of consolidation and induction
Intervention | mIU/mL (Median) |
---|
| Plasma Asparaginase Concentration- Consolidation | Plasma Asparaginase Concentration- Induction |
---|
Arm I (Calaspargase Pegol 2100) | 575.9 | 271.6 |
,Arm II (Calaspargase Pegol 2500) | 617.2 | 339.6 |
,Arm III (Pegaspargase 2500) | 562.1 | 72.8 |
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Asparaginase Level
The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar (NCT00671034)
Timeframe: Days 4, 15, 22 and 29 of Induction
Intervention | percentage of patients (Number) |
---|
| Level at least 0.1 IU/mL day 4 | Level at least 0.1 IU/mL day 15 | Level at least 0.1 IU/mL day 22 | Level at least 0.1 IU/mL day 29 | Level at least 0.4 IU/mL day 4 | Level at least 0.4 IU/mL day 15 | Level at least 0.4 IU/mL day 22 | Level at least 0.4 IU/mL day 29 |
---|
Arm I (Calaspargase Pegol 2100) | 0 | 98.4 | 98.2 | 94.9 | 0 | 75.8 | 37.5 | 13.6 |
,Arm II (Calaspargase Pegol 2500) | 0 | 100 | 100 | 95.0 | 0 | 95.0 | 62.5 | 27.5 |
,Arm III (Pegaspargase 2500) | 0 | 100 | 95.1 | 28.6 | 0 | 93.0 | 14.6 | 0 |
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Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction
Percentage of participants with Negative MRD (MRD<0.01%). (NCT00671034)
Timeframe: End of induction (Day 29)
Intervention | Percentage of participants (Number) |
---|
Arm I (Calaspargase Pegol 2100) | 65.2 |
Arm II (Calaspargase Pegol 2500) | 81 |
Arm III (Pegaspargase 2500) | 72.5 |
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Percentage of Participants With Complete Remission at the End of Induction
Complete Remission (CR) rate; where CR is defined as M1 marrow (< 5% lymphoblasts in the bone marrow) (NCT00671034)
Timeframe: End of induction (Day 29)
Intervention | Percentage of participants (Number) |
---|
Arm I (Calaspargase Pegol 2100) | 92.4 |
Arm II (Calaspargase Pegol 2500) | 97.6 |
Arm III (Pegaspargase 2500) | 94.1 |
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Immunogenicity
Number of Patients with Positive Immunogenicity tests (NCT00671034)
Timeframe: 25 Days Post-dose (Day 29)
Intervention | Participants (Count of Participants) |
---|
Arm I (Calaspargase Pegol 2100) | 2 |
Arm II (Calaspargase Pegol 2500) | 2 |
Arm III (Pegaspargase 2500) | 4 |
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Percentage of Participants With Event-free Survival (EFS)
Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free. (NCT00671034)
Timeframe: 5 Years
Intervention | Percentage of participants (Number) |
---|
Arm I (Calaspargase Pegol 2100) | 72.35 |
Arm II (Calaspargase Pegol 2500) | 80.8 |
Arm III (Pegaspargase 2500) | 79.34 |
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Plasma and CSF Concentrations of Asparagine in ug/ml
The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar. (NCT00671034)
Timeframe: 25 Days Post-dose (Day 29)
Intervention | ug/mL (Mean) |
---|
| CSF asparagine concentration (ug/mL) | Plasma asparagine concentration (ug/mL) |
---|
Arm I (Calaspargase Pegol 2100) | 0.2 | 0.2 |
,Arm II (Calaspargase Pegol 2500) | 0.19 | 0.25 |
,Arm III (Pegaspargase 2500) | 0.26 | 0.83 |
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Toxicities During Post Induction Intensification Therapy (All Grades)
The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events. (NCT00671034)
Timeframe: Up to 5 years
Intervention | Percentage of participants (Number) |
---|
| Alergic Reaction - Consolidation | Alergic Reaction - Delayed Intensification I | Alergic Reaction - Interim Maintenance I | CNS - Consolidation | CNS - Delayed Intensification I | CNS - Interim Maintenance I | Hyperbilirubinemia - Consolidation | Hyperbilirubinemia - Delayed Intensification I | Hyperbilirubinemia - Interim Maintenance I | Hyperglycemia - Consolidation | Hyperglycemia - Delayed Intensification I | Hyperglycemia - Interim Maintenance I | Hyperlipidemia - Consolidation | Hyperlipidemia - Delayed Intensification I | Hyperlipidemia - Interim Maintenance I | % patients w/INR increase - Consolidation | % pts w/INR increase - Delayed Intensification I | % patients w/INR increase - Interim Maintenance I | Pancreatitis - Consolidation | Pancreatitis -Delayed Intensification I | Pancreatitis - Interim Maintenance I | % pts w/prolongation of APT time - Consolidation | % pts w/prolongation APT time -Delayed Intension I | %pts w/prolongation APT time-Interim maintenance I | Thrombosis - Consolidation | Thrombosis - Delayed Intensification I | Thrombosis - Interim Maintenance I |
---|
Arm I (Calaspargase Pegol 2100) | 20.4 | 4.4 | 0.0 | 0.0 | 0.0 | 0.0 | 53.1 | 28.9 | 41.3 | 44.9 | 44.4 | 34.8 | 2.0 | 2.2 | 2.2 | 6.1 | 6.7 | 2.2 | 10.2 | 2.2 | 2.2 | 8.2 | 8.9 | 6.5 | 0.0 | 2.2 | 0.0 |
,Arm II (Calaspargase Pegol 2500) | 27.3 | 0.0 | 0.0 | 0.0 | 3.8 | 0.0 | 45.5 | 38.5 | 27.6 | 42.4 | 61.5 | 44.8 | 3.0 | 0.0 | 3.4 | 3.0 | 3.8 | 0.0 | 6.1 | 7.7 | 3.4 | 9.1 | 26.9 | 6.9 | 0.0 | 0.0 | 0.0 |
,Arm III (Pegaspargase 2500) | 23.3 | 0.0 | 2.1 | 0.0 | 2.6 | 0.0 | 30.2 | 10.5 | 33.3 | 46.5 | 36.8 | 33.3 | 7.0 | 0.0 | 2.6 | 7.0 | 0.0 | 2.6 | 7.0 | 0.0 | 2.6 | 7.0 | 18.4 | 7.7 | 2.3 | 0.0 | 0.0 |
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Percent of Participants With Objective Response (OR)
OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response. (NCT00676650)
Timeframe: Baseline, every 8 weeks up to 123 weeks
Intervention | percentage of participants (Number) |
---|
Sunitinib and Prednisone | 6.1 |
Placebo and Prednisone | 1.8 |
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Overall Survival (OS)
OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4. (NCT00676650)
Timeframe: Baseline up to 32 months
Intervention | months (Median) |
---|
Sunitinib and Prednisone | 13.1 |
Placebo and Prednisone | 11.8 |
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Progression-Free Survival (PFS)
PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02 (NCT00676650)
Timeframe: Baseline, every 8 weeks up to 123 weeks
Intervention | weeks (Median) |
---|
Sunitinib and Prednisone | 24.1 |
Placebo and Prednisone | 17.9 |
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Composite Progression-free Survival (cPFS) at 6-months
"Data presented are the percentage of participants without disease progression at 6 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
IMC-A12 + Mitoxantrone + Prednisone | 37.2 |
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | 59.2 |
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Composite Progression-free Survival (cPFS) at 12-months
"Data presented are the percentage of participants without disease progression at 12 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 12 months
Intervention | percentage of participants (Number) |
---|
IMC-A12 + Mitoxantrone + Prednisone | 12.4 |
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | 20.0 |
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Prostate Specific Antigen (PSA) Response Rate
PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline. (NCT00683475)
Timeframe: Baseline up to data cut-off date (up to 36.3 months)
Intervention | percentage of participants (Number) |
---|
IMC-A12 + Mitoxantrone + Prednisone | 18.5 |
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | 21.4 |
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Overall Survival (OS)
Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive. (NCT00683475)
Timeframe: First dose to death due to any cause up to 36.3 months
Intervention | months (Median) |
---|
IMC-A12 + Mitoxantrone + Prednisone | 10.8 |
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | 13.0 |
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Composite Progression-free Survival (cPFS)
"Defined as the median time from randomization to the earliest of:~Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST);~Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of >=2 new lesions;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression)~Symptomatic progression (for participants without measurable disease);~Other clinical events attributable to prostate cancer that require major interventions; or~Death from any cause~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: Randomization to composite progressive disease, up to 23.4 months
Intervention | months (Median) |
---|
IMC-A12 + Mitoxantrone + Prednisone | 4.1 |
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | 6.7 |
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Objective Response Rate (ORR)
"Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions.~Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100." (NCT00683475)
Timeframe: Baseline to date of progressive disease or death up to 36.3 months
Intervention | percentage of participants (Number) |
---|
IMC-A12 + Mitoxantrone + Prednisone | 15.2 |
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | 31.6 |
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Composite Progression-free Survival (cPFS) at 9-months
"Data presented are the percentage of participants without disease progression at 9 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 9 months
Intervention | percentage of participants (Number) |
---|
IMC-A12 + Mitoxantrone + Prednisone | 20.7 |
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | 35.9 |
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Summary Listing of Participants Reporting Treatment-Emergent Adverse Events
Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section. (NCT00683475)
Timeframe: Randomization to 36.3 months
Intervention | participants (Number) |
---|
| A12/1121B Related TEAE | A12/1121B Related Serious TEAE | A12/1121B Related Grade >= 3 TEAE | TEAE Leading to Dose Modification of A12/1121B | TEAE Leading to Discontinuation of A12/1121B |
---|
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | 63 | 16 | 31 | 35 | 25 |
,IMC-A12 + Mitoxantrone + Prednisone | 64 | 22 | 35 | 35 | 18 |
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Time to Radiographic Evidence of Disease Progression
"Time between date of randomization and earliest date of radiographic progression defined as either:~Tumor progression by RECIST;~Evidence of progression by bone scan;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression).~Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: Randomization to date of radiographic progression, up to 36.3 months
Intervention | months (Median) |
---|
IMC-A12 + Mitoxantrone + Prednisone | 7.5 |
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | 10.2 |
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Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment
Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra. (NCT00686335)
Timeframe: 4 weeks and 8 weeks
Intervention | number of nocturnal awakenings (Mean) |
---|
Lodotra | 2.1 |
Cortancyl | 10.0 |
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Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). (NCT00689936)
Timeframe: From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 25.5 |
Lenalidomide and Dexamethasone Rd18 | 20.7 |
Melphalan + Prednisone + Thalidomide (MPT) | 21.2 |
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Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | Percentage of participants (Number) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 70.0 |
Lenalidomide and Dexamethasone Rd18 | 69.7 |
Melphalan + Prednisone + Thalidomide (MPT) | 58.2 |
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Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.4 |
Lenalidomide and Dexamethasone Rd18 | 81.6 |
Melphalan + Prednisone + Thalidomide (MPT) | 70.6 |
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Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. (NCT00689936)
Timeframe: From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 16.9 |
Lenalidomide and Dexamethasone Rd18 | 17.2 |
Melphalan + Prednisone + Thalidomide (MPT) | 14.1 |
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Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of particpants (Number) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.4 |
Lenalidomide and Dexamethasone Rd18 | 74.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 61.0 |
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Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). (NCT00689936)
Timeframe: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 26.0 |
Lenalidomide and Dexamethasone Rd18 | 21.0 |
Melphalan + Prednisone + Thalidomide (MPT) | 21.9 |
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Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 60.5 |
Lenalidomide and Dexamethasone Rd18 | 76.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 57.5 |
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Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 46.2 |
Lenalidomide and Dexamethasone Rd18 | 53.1 |
Melphalan + Prednisone + Thalidomide (MPT) | 45.7 |
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Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.7 |
Lenalidomide and Dexamethasone Rd18 | 78.6 |
Melphalan + Prednisone + Thalidomide (MPT) | 67.5 |
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Percentage of Participants With an Objective Response Based on IRAC Review
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 75.1 |
Lenalidomide and Dexamethasone Rd18 | 73.4 |
Melphalan + Prednisone + Thalidomide (MPT) | 62.3 |
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Time to First Response Based on the Investigator Assessment at the Time of Final Analysis
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 |
Lenalidomide and Dexamethasone Rd18 | 1.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 2.8 |
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Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | 2.9 | -3.3 | -8.6 | -6.4 | -5.1 | -7.5 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.3 | -5.9 | -9.8 | -7.3 | -8.1 | -1.0 |
,Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | -6.2 | -13.5 | -10.5 | -12.2 | -2.6 |
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Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | -1.7 | 1.8 | 0.9 | -1.2 | -2.8 | -2.6 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | -1.2 | -0.7 | -0.9 | -1.6 | -2.2 | -4.9 |
,Melphalan + Prednisone + Thalidomide (MPT) | -1.8 | -1.5 | -0.3 | -0.6 | -0.7 | -7.1 |
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Change From Baseline in the EORTC QLQ-C30 Constipation Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | 6.3 | 0.0 | -5.1 | -5.2 | -5.9 | -7.5 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 8.3 | 1.8 | -2.4 | -2.4 | -4.5 | -7.9 |
,Melphalan + Prednisone + Thalidomide (MPT) | 18.4 | 13.9 | 6.8 | 3.7 | 0.0 | -2.2 |
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Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | 2.3 | 3.4 | 6.0 | 9.1 | 10.9 | 6.4 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 3.8 | 3.7 | 8.2 | 11.8 | 14.8 | 10.8 |
,Melphalan + Prednisone + Thalidomide (MPT) | -0.6 | -2.4 | -2.2 | -2.5 | -1.7 | -0.5 |
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Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | 3.6 | -1.9 | -2.9 | -1.6 | 2.9 | 0.8 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.9 | -0.8 | -2.3 | -3.5 | -1.8 | -1.0 |
,Melphalan + Prednisone + Thalidomide (MPT) | 4.2 | 2.0 | 0.1 | -1.6 | 0.4 | 7.8 |
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Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | 0.1 | 3.9 | 5.8 | 4.9 | 3.1 | 3.7 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.6 | 3.8 | 4.6 | 4.6 | 5.8 | 2.6 |
,Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | 2.1 | 5.5 | 5.1 | 5.1 | -0.0 |
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Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 35.0 |
Lenalidomide and Dexamethasone Rd18 | 22.1 |
Melphalan + Prednisone + Thalidomide (MPT) | 22.3 |
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Kaplan Meier Estimates of Time to Treatment Failure (TTF)
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 16.9 |
Lenalidomide and Dexamethasone Rd18 | 17.2 |
Melphalan + Prednisone + Thalidomide (MPT) | 14.1 |
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Time to First Response Based on the Review by the IRAC
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 |
Lenalidomide and Dexamethasone Rd18 | 1.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 2.8 |
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Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 31.5 |
Lenalidomide and Dexamethasone Rd18 | 21.5 |
Melphalan + Prednisone + Thalidomide (MPT) | 22.1 |
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Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)
Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 39.1 |
Lenalidomide and Dexamethasone Rd18 | 28.5 |
Melphalan + Prednisone + Thalidomide (MPT) | 26.7 |
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Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.
Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) |
---|
| Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade1 Baseline to Normal postbaseline Grade | Grade 1 Baseline to Grade 1 postbaseline | Grade 1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline Grade | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline Grade | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade 3 Baseline to Grade 4 postbaseline |
---|
Lenalidomide and Dexamethasone Rd18 | 197 | 211 | 30 | 12 | 5 | 3 | 38 | 19 | 12 | 1 | 0 | 1 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 1 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 197 | 216 | 24 | 15 | 4 | 1 | 34 | 15 | 10 | 2 | 0 | 0 | 3 | 3 | 1 | 0 | 0 | 0 | 0 | 2 |
,Melphalan + Prednisone + Thalidomide (MPT) | 165 | 208 | 27 | 31 | 11 | 6 | 51 | 7 | 10 | 1 | 0 | 2 | 1 | 2 | 2 | 0 | 0 | 1 | 1 | 0 |
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Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase
Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) |
---|
| Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade 1 Baseline to Normal postbaseline | Grade 1 Baseline to Grade 1 postbaseline | Grade1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade 3 Baseline to Grade 4 postbaseline | Grade 4 Baseline to Normal postbaseline | Grade 4 Baseline to Grade 1 postbaseline | Grade 4 Baseline to Grade 2 postbaseline | Grade 4 Baseline to Grade 3 postbaseline | Grade 4 Baseline to Grade 4 postbaseline |
---|
Lenalidomide and Dexamethasone Rd18 | 10 | 30 | 8 | 1 | 0 | 0 | 126 | 123 | 17 | 5 | 0 | 12 | 135 | 41 | 9 | 0 | 1 | 4 | 8 | 3 | 0 | 0 | 0 | 1 | 1 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 6 | 39 | 8 | 0 | 0 | 0 | 106 | 128 | 25 | 2 | 0 | 8 | 125 | 48 | 4 | 0 | 0 | 12 | 10 | 5 | 0 | 0 | 0 | 0 | 1 |
,Melphalan + Prednisone + Thalidomide (MPT) | 9 | 25 | 4 | 1 | 0 | 0 | 110 | 123 | 20 | 4 | 0 | 14 | 133 | 47 | 11 | 0 | 0 | 10 | 10 | 2 | 0 | 0 | 1 | 0 | 2 |
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Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase
Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) |
---|
| CrCl< 30 mL/min to CrCl< 30 mL/min | CrCl < 30 mL/min to CrCl ≥ 30 but < 50 mL/min | CrCl < 30 mL/min to CrCl ≥ 50 but < 80 mL/min | CrCl< 30 mL/min to ≥ 80 mL/min | CrCl≥ 30 but < 50 mL/min to < 30 mL/min | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 30 but < 50 mL | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 50 but < 80 mL | CrCl ≥ 30 but < 50 mL/min to ≥ 80 mL/min | CrCl ≥ 50 but < 80 mL to CrCl< 30 mL/min | CrCl ≥ 50 but < 80 mL to CrCl ≥ 30 but < 50 mL/min | CrCl ≥ 50 but < 80 mL to CrCl ≥ 50 but < 80 mL/min | CrCl ≥ 50 but < 80 mL to ≥ 80 mL/min | CrCl ≥ 80 mL/min to CrCl< 30 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 30 but < 50 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 50 but < 80 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 80 mL/min |
---|
Lenalidomide and Dexamethasone Rd18 | 17 | 14 | 8 | 2 | 2 | 41 | 55 | 12 | 0 | 1 | 130 | 99 | 1 | 0 | 10 | 114 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 15 | 18 | 7 | 2 | 1 | 37 | 67 | 9 | 0 | 4 | 112 | 107 | 0 | 0 | 6 | 109 |
,Melphalan + Prednisone + Thalidomide (MPT) | 19 | 19 | 5 | 0 | 0 | 41 | 65 | 2 | 0 | 4 | 102 | 97 | 0 | 0 | 9 | 121 |
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Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase
Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) |
---|
| Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade 1 Baseline to Normal postbaseline | Grade1 Baseline to Grade 1 postbaseline | Grade 1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade3 Baseline to Grade 4 postbaseline | Grade 4 Baseline to Normal postbaseline Grade | Grade 4 Baseline to Grade 1 postbaseline Grade | Grade 4 Baseline to Grade 2 postbaseline | Grade 4 Baseline Grade to Grade 3 postbaseline | Grade 4 Baseline to Grade 4 postbaseline |
---|
Lenalidomide and Dexamethasone Rd18 | 133 | 85 | 109 | 71 | 30 | 6 | 11 | 15 | 30 | 4 | 0 | 1 | 11 | 18 | 5 | 0 | 0 | 1 | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 103 | 96 | 121 | 70 | 21 | 7 | 8 | 17 | 25 | 9 | 1 | 1 | 14 | 18 | 9 | 0 | 0 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 0 |
,Melphalan + Prednisone + Thalidomide (MPT) | 37 | 79 | 128 | 141 | 45 | 2 | 2 | 11 | 20 | 21 | 0 | 1 | 7 | 21 | 10 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Adverse Events (AEs) During the Active Treatment Phase
A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. (NCT00689936)
Timeframe: From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | Participants (Number) |
---|
| ≥ 1 adverse event (AE) | ≥ 1 grade (Gr) 3 or 4 AE | ≥ 1 grade (Gr) 5 AE | ≥ 1 serious adverse event (SAE) | ≥ 1 AE related to Lenalidomide/Dex/Mel/Pred/Thal | ≥ 1 AE related to Lenalidomide | ≥ 1 AE related to dexamethasone | ≥ 1 AE related to melphalan | ≥ 1 AE related to prednisone | ≥ 1 AE related to thalidomide | ≥1 AE related to Lenalidomide/Dex or Mel/Pred/Thal | ≥ 1 Gr 3 or 4 AE related to Len/Dex/Mel/Pred/Thal | ≥ 1 grade 3 or 4 AE related to Lenalidomide | ≥ 1 grade 3 or 4 AE related to dexamethasone | ≥ 1 grade 3 or 4 AE related to melphalan | ≥ 1 grade 3 or 4 AE related to prednisone | ≥ 1 grade 3 or 4 AE related to Thalidomide | ≥1Gr 3 or 4 AE related to Len/Dex or Mel/Pred/Thal | ≥ 1 Grade 5 AE related to Len/Dex/Mel/Pred/Thal | ≥ 1 Grade 5 AE related to Lenalidomide | ≥ 1 Grade 5 AE related to Dexamethasone | ≥ 1 Grade 5 AE related to melphalan | ≥ 1 Grade 5 AE related to prednisone | ≥ 1 Grade 5 AE related to Thalidomide | ≥1 Grade 5 AE related to Len/Dex or Mel/Pred/Thal | ≥1 SAE related to Len/Dex/Mel/Pred/Thal | ≥1 SAE related to Lenalidomide | ≥1 SAE related to dexamethasone | ≥1 SAE related to melphalan | ≥1 SAE related to prednisone | ≥1 SAE related to thalidomide | ≥1 SAE related to Len/Dex or Mel/Pred/Thal | ≥1AE leading to Len/Dex/Mel/Pred/Thal Withdrawal | ≥1 AE leading to Lenalidomide withdrawal | ≥1 AE leading to dexamethasone withdrawal | ≥1 AE leading to melphalan withdrawal | ≥1 AE leading to prednisone withdrawal | ≥1 AE leading to Thalidomide withdrawal | ≥1AE leading to Len/DexOR Mel/Pred/Thal Withdrawal | ≥1AE leading to Len/Dex/Mel/Pred/Thal reduction | ≥1 AE leading to Lenalidomide reduction | ≥1 AE leading to dexamethasone reduction | ≥1 AE leading to melphalan reduction | ≥1 AE leading to prednisone reduction | ≥1 AE leading to thalidomide reduction | ≥1AE leading to Len/Dex or Mel/Pred/Thal reduction | ≥1 AE leading to Rd or MPT interruption | ≥1 AE leading to Lenalidomide interruption | ≥1 AE leading to dexamethasone interruption | ≥1 AE leading to melphalan interruption | ≥1 AE leading to prednisone interruption | ≥1 AE leading to Thalidomide interruption | ≥1 AE leading to Len and Dex or MPT interruption |
---|
Lenalidomide and Dexamethasone Rd18 | 536 | 433 | 36 | 308 | 501 | 481 | 410 | 0 | 0 | 0 | 269 | 326 | 290 | 177 | 0 | 0 | 0 | 104 | 11 | 9 | 7 | 0 | 0 | 0 | 5 | 158 | 130 | 97 | 0 | 0 | 0 | 64 | 109 | 93 | 104 | 0 | 0 | 0 | 84 | 214 | 155 | 118 | 0 | 0 | 0 | 20 | 321 | 301 | 280 | 0 | 0 | 0 | 241 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 529 | 453 | 50 | 359 | 506 | 482 | 429 | 0 | 0 | 0 | 269 | 373 | 342 | 229 | 0 | 0 | 0 | 131 | 17 | 12 | 16 | 0 | 0 | 0 | 11 | 195 | 165 | 130 | 0 | 0 | 0 | 95 | 157 | 109 | 152 | 0 | 0 | 0 | 96 | 279 | 203 | 170 | 0 | 0 | 0 | 30 | 368 | 353 | 319 | 0 | 0 | 0 | 290 |
,Melphalan + Prednisone + Thalidomide (MPT) | 539 | 480 | 38 | 270 | 527 | 0 | 0 | 441 | 326 | 493 | 145 | 423 | 0 | 0 | 307 | 118 | 316 | 49 | 10 | 0 | 0 | 6 | 5 | 5 | 2 | 142 | 0 | 0 | 75 | 62 | 94 | 27 | 153 | 0 | 0 | 83 | 78 | 146 | 71 | 348 | 0 | 0 | 199 | 47 | 254 | 2 | 419 | 0 | 0 | 328 | 324 | 388 | 249 |
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Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score
EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | -0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
,Melphalan + Prednisone + Thalidomide (MPT) | 0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | 4.0 | 1.2 | -0.4 | 1.2 | 2.3 | -1.0 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.5 | 1.0 | 1.7 | 1.9 | 2.2 | 0.6 |
,Melphalan + Prednisone + Thalidomide (MPT) | 5.6 | 3.5 | 2.9 | 4.7 | 4.3 | 3.8 |
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | 3.9 | 9.2 | 12.3 | 12.1 | 11.7 | 8.8 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 4.7 | 8.5 | 9.8 | 10.8 | 12.7 | 5.8 |
,Melphalan + Prednisone + Thalidomide (MPT) | 3.3 | 6.3 | 8.0 | 10.0 | 9.5 | 3.2 |
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s). (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | -4.1 | -10.0 | -9.9 | -8.7 | -6.2 | -4.5 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.0 | -9.1 | -8.8 | -7.8 | -8.7 | -3.5 |
,Melphalan + Prednisone + Thalidomide (MPT) | -4.4 | -7.0 | -7.9 | -6.5 | -7.9 | -3.7 |
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | -1.5 | 0.8 | 1.5 | -0.4 | -0.3 | 1.8 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.5 | -1.7 | -1.4 | -1.4 | -2.3 | -5.6 |
,Melphalan + Prednisone + Thalidomide (MPT) | -1.6 | -3.0 | -2.8 | -2.6 | -1.1 | -5.6 |
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Study discontinuation |
---|
Lenalidomide and Dexamethasone Rd18 | -1.3 | 4.7 | 5.4 | 3.2 | 5.7 | 5.0 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.4 | 4.8 | 5.9 | 4.8 | 6.4 | -0.1 |
,Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | 4.3 | 6.1 | 6.5 | 4.8 | 0.3 |
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Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | -2.2 | 2.0 | 5.2 | 3.8 | 3.2 | 2.7 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.3 | 0.7 | 4.0 | 2.9 | 4.2 | -1.2 |
,Melphalan + Prednisone + Thalidomide (MPT) | -1.4 | 2.4 | 3.4 | 5.8 | 6.0 | -3.5 |
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Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | -4.6 | 6.3 | 8.6 | 9.4 | 9.1 | 3.8 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | -2.7 | 2.4 | 6.3 | 7.8 | 8.0 | -0.3 |
,Melphalan + Prednisone + Thalidomide (MPT) | -2.4 | 4.1 | 8.2 | 11.8 | 14.5 | -1.0 |
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Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | -1.4 | 4.7 | 7.6 | 7.4 | 6.8 | 3.0 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | -1.7 | 3.4 | 4.7 | 5.0 | 6.9 | -0.1 |
,Melphalan + Prednisone + Thalidomide (MPT) | -0.9 | 2.2 | 5.3 | 6.9 | 8.3 | -0.1 |
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Change From Baseline in the EORTC QLQ-C30 Pain Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | -4.4 | -13.1 | -16.1 | -14.7 | -12.4 | -7.9 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | -5.4 | -13.4 | -14.4 | -14.0 | -14.4 | -8.0 |
,Melphalan + Prednisone + Thalidomide (MPT) | -7.8 | -12.1 | -13.4 | -14.3 | -14.7 | -6.0 |
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Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | -0.5 | -2.5 | -4.0 | -3.6 | -2.7 | -4.2 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 | -1.1 | -1.3 | -2.2 | -2.3 | 0.4 |
,Melphalan + Prednisone + Thalidomide (MPT) | 4.0 | -1.2 | -3.9 | -3.9 | -3.9 | 1.0 |
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Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | 3.2 | -1.3 | -1.9 | 1.1 | 1.4 | -1.6 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.1 | 0.2 | -1.2 | -1.0 | -0.5 | -5.2 |
,Melphalan + Prednisone + Thalidomide (MPT) | -10.5 | -8.9 | -11.6 | -9.6 | -6.0 | -4.5 |
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Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | -0.3 | -0.4 | -0.3 | 1.6 | 1.8 | 0.5 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.1 | 1.9 | 1.4 | 0.4 | 2.0 | 1.9 |
,Melphalan + Prednisone + Thalidomide (MPT) | 0.5 | 1.9 | 0.7 | 1.1 | 0.4 | 5.0 |
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Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation
Intervention | units on a scale (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
---|
Lenalidomide and Dexamethasone Rd18 | 4.4 | -3.4 | -5.9 | -2.3 | 0.1 | -1.6 |
,Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.6 | -2.5 | -3.7 | -4.3 | -3.1 | 0.3 |
,Melphalan + Prednisone + Thalidomide (MPT) | 2.8 | -1.8 | -4.5 | -3.9 | -4.3 | 2.7 |
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Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)
Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive. (NCT00689936)
Timeframe: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 59.1 |
Lenalidomide and Dexamethasone Rd18 | 62.3 |
Melphalan + Prednisone + Thalidomide (MPT) | 49.1 |
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Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis
Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months
Intervention | months (Median) |
---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 36.7 |
Lenalidomide and Dexamethasone Rd18 | 28.5 |
Melphalan + Prednisone + Thalidomide (MPT) | 26.7 |
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Progression Free Survival
Progression free survival (PFS) is defined for all subjects as the time from the date of initiation of treatment to the date of first documentation of relapse, progression, or death due to any cause. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). PFS survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals. (NCT00691704)
Timeframe: 2 years
Intervention | participants (Number) |
---|
| PFS at 2 years | PFS at 1 year |
---|
High-risk Multiple Myeloma | 3 | 9 |
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Overall Survival
Overall survival is defined as the time from the date of initiation of treatment to the date of death due to any cause. Overall response rate will be estimated with its 80% confidence interval, and the numbers of subjects achieving a sustained complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or stable disease (SD) will be tabulated. Overall survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals. (NCT00691704)
Timeframe: 6 years
Intervention | months (Mean) |
---|
High-risk Multiple Myeloma | 36 |
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Time to Response
Time to response will be measured in the population of subjects with a confirmed response as the time from the date of initiation of treatment to the date of the first documentation of a confirmed response. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). Time to response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals. (NCT00691704)
Timeframe: 6 months
Intervention | months (Mean) |
---|
High-risk Multiple Myeloma | 2 |
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Duration of Response
The duration of response, defined only among the responders, is measured from start of achieving Partial Response (PR) [first observation of PR before confirmation] to the time of disease progression, with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006). Duration of response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals. (NCT00691704)
Timeframe: 6 years
Intervention | months (Mean) |
---|
High-risk Multiple Myeloma | 11 |
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Time to Progression
Time to progression (TTP) is defined for all patients as the time from initiation of treatment to disease progression with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006). (NCT00691704)
Timeframe: 6 years
Intervention | months (Mean) |
---|
High-risk Multiple Myeloma | 11 |
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Mean Aqueous Humor Prednisolone Acetate Concentration
(NCT00699803)
Timeframe: 4 hours
Intervention | ng/mL (Mean) |
---|
T-Pred | 102.5 |
Pred Forte | 127.5 |
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Stimulation of Growth After 12 Months (Delta Z-score)
(NCT00707759)
Timeframe: 12 months
Intervention | units on a scale (Mean) |
---|
A: Withdrawal Steroids | 1.2 |
B: Control Steroids | 0.6 |
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Time in Days to Achieve a Clinical Response, Comparing the CSA/PEX Arm to the Steroids/PEX Arm.
Days to achieve a clinical response, defined as a normal platelet count (>150 x 109/L), normal LDH, and no new end organ injury. (NCT00713193)
Timeframe: Time to starting treatment until 6 months after the last PEX procedure
Intervention | Days (Median) |
---|
CSA Arm | 5 |
Prednisone Arm | 5 |
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Number of Participants With Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm
Number of Participants with Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm (NCT00713193)
Timeframe: From the start of treatment until 30 days after discharge from the last PEX procedure
Intervention | participants (Number) |
---|
CSA Arm | 3 |
Prednisone Arm | 1 |
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Number of Patients Who Experienced at Least One Serious Adverse Event
(NCT00715208)
Timeframe: From completion of informed consent through 30 days after the last dose of study drug
Intervention | participants (Number) |
---|
VELCADE R-CAP | 2 |
VELCADE R-CP | 12 |
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Percentage of Participants With Progression-free Survival (PFS) at 1 Year
PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better). (NCT00715208)
Timeframe: Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD
Intervention | percentage of participants (Number) |
---|
VELCADE R-CAP | 67 |
VELCADE R-CP | 63 |
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Number of Patients With Complete Response (CR)
Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria. (NCT00715208)
Timeframe: 30 weeks
Intervention | participants (Number) |
---|
VELCADE R-CAP | 1 |
VELCADE R-CP | 13 |
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Number of Participants With Overall Response (OR)
"OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria.~CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET." (NCT00715208)
Timeframe: 30 weeks
Intervention | participants (Number) |
---|
VELCADE R-CAP | 6 |
VELCADE R-CP | 37 |
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Duration of Response
"Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response.~CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria." (NCT00715208)
Timeframe: 2 years
Intervention | Months (Median) |
---|
VELCADE R-CP | 21.9 |
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Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)
(NCT00719472)
Timeframe: Cycle 2 through Cycle 6 or 8 (end of study)
Intervention | Percentage of participants (Number) |
---|
Rituximab 375 mg/m^2 | 98.6 |
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Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)
Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS). (NCT00719472)
Timeframe: Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)
Intervention | Percentage of participants (Number) |
---|
| Cycle 2 (n=338) | Cycle 6 (n=240) | Cycle 8 (n=32) |
---|
Rituximab 375 mg/m^2 | 50.5 | 68.3 | 87.5 |
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Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)
Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples. (NCT00719472)
Timeframe: Day 1 of Cycles 2 and either 6 or 8 (last cycle)
Intervention | µg/mL (Mean) |
---|
| Cycle 2 (n=335) | Cycle 6 (n=238) | Cycle 8 (n=36) |
---|
Rituximab 375 mg/m^2 | 228.0 | 275.0 | 299.0 |
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Duration of Rituximab Infusion Including Dose Interruption Times
The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported. (NCT00719472)
Timeframe: Day 1 of each of Cycles 1 to 6 or 8
Intervention | Minutes (Median) |
---|
| Cycle 1 (n=362) | Cycle 2 (n=363) | Cycle 3 (n=344) | Cycle 4 (n=329) | Cycle 5 (n=312) | Cycle 6 (n=303) | Cycle 7 (n=59) | Cycle 8 (n=59) |
---|
Rituximab 375 mg/m^2 | 245 | 91 | 91 | 91 | 91 | 91 | 91 | 91 |
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Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1
(NCT00719472)
Timeframe: Cycle 1
Intervention | Percentage of participants (Number) |
---|
Rituximab 375 mg/m^2 | 91.8 |
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Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay) (NCT00720109)
Timeframe: Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)
Intervention | Pts with DLTs (Number) |
---|
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 1 |
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Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used. (NCT00720109)
Timeframe: At end of consolidation (at 11 weeks)
Intervention | Percentage of participants (Number) |
---|
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 10.5 |
Standard-risk | 0 |
High-risk | 66.7 |
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Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
Percent of patients MRD Positive (MRD > 0.01%) at End of Induction. (NCT00720109)
Timeframe: At the end of induction therapy (at 5 weeks)
Intervention | Percentage of participants (Number) |
---|
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 40.7 |
Standard-risk | 29.2 |
High-risk | 100.0 |
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Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death. (NCT00720109)
Timeframe: From the time entry on study to first event or date of last follow-up, assessed up to 7 years
Intervention | percentage of patients (Number) |
---|
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 79.8 |
Standard-risk | 83.2 |
High-risk | 66.7 |
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Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed. (NCT00720109)
Timeframe: At 3 years
Intervention | Percent probability (Number) |
---|
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 79.8 |
Standard-risk | 83.2 |
High-risk | 66.7 |
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Overall Complete Response (CR + CRu)
Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
Intervention | Participants (Number) |
---|
| Overall complete response | CR | CRu |
---|
R-CHOP | 95 | 79 | 16 |
,VcR-CAP | 122 | 106 | 16 |
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Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug. (NCT00722137)
Timeframe: Up to 107.4 months
Intervention | Participants (Number) |
---|
R-CHOP | 239 |
VcR-CAP | 240 |
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18-Month Survival
18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate). (NCT00722137)
Timeframe: Up to month 18 from the time of randomization
Intervention | Percentage of Participants (Mean) |
---|
R-CHOP | 83.8 |
VcR-CAP | 84.9 |
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Duration of Response
The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH). (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
Intervention | Days (Median) |
---|
| Duration of response | Duration for Complete responders |
---|
R-CHOP | 459.0 | 563.0 |
,VcR-CAP | 1110.0 | 1282.0 |
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Treatment-free Interval (TFI)
The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
Intervention | Days (Median) |
---|
R-CHOP | 624.0 |
VcR-CAP | 1236.0 |
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Time to Progression (TTP)
Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
Intervention | Days (Median) |
---|
R-CHOP | 490.0 |
VcR-CAP | 929.0 |
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Time to Next Anti-lymphoma Treatment (TTNT)
The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive. (NCT00722137)
Timeframe: : Median duration of follow-up of 40 months
Intervention | Days (Median) |
---|
R-CHOP | 756.0 |
VcR-CAP | 1353.0 |
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Progression Free Survival (PFS)
PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
Intervention | Days (Median) |
---|
R-CHOP | 437.0 |
VcR-CAP | 751.0 |
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Overall Survival (OS) in Long Term Follow-up Period
OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive. (NCT00722137)
Timeframe: Up to 107.4 months
Intervention | Days (Median) |
---|
R-CHOP | 1695.0 |
VcR-CAP | 2760.0 |
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Overall Survival (OS)
OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
Intervention | Days (Median) |
---|
R-CHOP | 1714.0 |
VcR-CAP | NA |
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Overall Response Rate (ORR)
ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
Intervention | Participants (Number) |
---|
R-CHOP | 204 |
VcR-CAP | 211 |
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Number of Patients With Any Grade or Severe Adverse Event
Number of patients with any grade or severe, defined as ≥ grade 3 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0, adverse events as a measure of safety (NCT00734149)
Timeframe: At any time during the study and up to 30 days after stopping the study drug
Intervention | participants (Number) |
---|
Bortezomib+Melphalan+Prednisone | 34 |
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Response
Overall response rate equals complete response and partial response per Southwest Oncology Group Criteria. Measurable, quantifiable protein criteria must be present. Acceptable protein criteria are quantitative immunoglobulin IgG, IgA, IgD, IgE or IgM and/or urine M-component (Bence-Jones protein). If both are present, the quantitative immunoglobulin will be followed for response. Complete Remission: The absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-components on electrophoresis as by immunofixation studies. There must also be no evidence of increasing anemia. Partial Remission: A 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein). Stable/No Remission): A <50% reduction I nthe quantitative immunoglobulin, or if the patient has light-chain disease only, a <50% reduction in the urine M-component (Bence-Jones protein. (NCT00734149)
Timeframe: 6 weeks following completion of treatment
Intervention | participants (Number) |
---|
Bortezomib+Melphalan+Prednisone | 42 |
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Number of Participants With Microarray Testing Results Are Completed Within 7 Days.
(NCT00736450)
Timeframe: Upto 7 days
Intervention | Participants (Count of Participants) |
---|
| results within 7 days or less | results in more than 7 days |
---|
Arm I | 11 | 2 |
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Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present. (NCT00744497)
Timeframe: At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)
Intervention | Percentage of participants (Number) |
---|
Placebo | 31.85 |
Dasatinib | 30.45 |
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Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline
The percentage of participants who had an on-study uNTx value confirmed (at least 3 weeks later) within normal limits (or ≥3 and <60 nmol/mmol creatinine, if normal limits were missing) or an on-study uNTx level reduction from baseline of ≥35%, even when on-study uNTx value remained abnormal. (NCT00744497)
Timeframe: At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)
Intervention | Percentage of participants (Number) |
---|
Placebo | 60.60 |
Dasatinib | 66.04 |
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Percentage of Participants With a Reduction in Pain Intensity From Baseline
The percentage of participants with a reduction in pain intensity from baseline was defined as the number of participants who achieved a 30% or more decrease in pain intensity from baseline for at least 2 consecutive pain assessments (at least 14 days apart) within 14 days of end of dosing divided by the number of randomized participants who had a baseline pain intensity of at least 2. Pain intensity was assessed based on question 3 of the brief pain inventory questionnaire. (NCT00744497)
Timeframe: At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)
Intervention | Percentage of participants (Number) |
---|
Placebo | 71.52 |
Dasatinib | 66.59 |
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Overall Survival: Time From Randomization to Date of Death
Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive. (NCT00744497)
Timeframe: From randomization to death or date of last contact (maximum reached: 45 months)
Intervention | Months (Median) |
---|
Placebo | 21.2 |
Dasatinib | 21.5 |
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Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval
QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included. (NCT00744497)
Timeframe: At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing
Intervention | Participants (Number) |
---|
| 0 to 30 msecs increase (n=591, 540) | >30 to 60 msecs increase (n=591, 540) | >60 msecs increase (n=591, 540) | Decrease (n=591, 540) |
---|
Dasatinib | 199 | 47 | 26 | 268 |
,Placebo | 203 | 52 | 32 | 304 |
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Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study
BL=baseline; OS=on-study (NCT00744497)
Timeframe: At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated
Intervention | Participants (Number) |
---|
| Pericardial effusion at BL/absent OS | Pericardial effusion at BL/present OS | Pericardial effusion at BL/not reported OS | Pericardial effusion absent at BL/ absent OS | Pericardial effusion absent at BL/present OS | Pericardial effusion absent at BL/not reported OS | Pericardial not reported at BL | LVEF OS <40% | LVEF OS >=40% | LVEF not reported OS |
---|
Dasatinib | 1 | 1 | 0 | 545 | 26 | 184 | 5 | 2 | 566 | 194 |
,Placebo | 3 | 0 | 1 | 584 | 24 | 132 | 16 | 2 | 607 | 151 |
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Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology
Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening ). Grade 3 and 4 criteria are defined as follows: Absolute neutrophil count, Grade 3, neutrophils <1.0-0.5*10^9/L; Grade 4, <0.5*10^9/L. Hemoglobin, Grade 3, <4.9-4.0 mmol/L; Grade 4, <4.0 mmol/L. Platelets, Grade 3, <50.0-25.0*10^9/L; Grade 4, <25.0*10^9/L. Leukocytes, Grade 3, <2.0-1.0*10^9/L; Grade 4, <1.0*10^9/L. (NCT00744497)
Timeframe: At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle.
Intervention | Participants (Number) |
---|
| Absolute neutrophil count (All grades) | Absolute neutrophil count (Grades 3 and 4) | Hemoglobin (All grades) | Hemoglobin (Grades 3 and 4) | Platelets (All grades) | Platelets (Grades 3 and 4) | Leukocytes (All grades) | Leukocytes (Grades 3 and 4) |
---|
Dasatinib | 161 | 46 | 720 | 59 | 100 | 3 | 149 | 30 |
,Placebo | 84 | 41 | 712 | 44 | 108 | 6 | 128 | 32 |
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Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening). ALP, ALT, and AST, Grade 3, >5.0-20.0*ULN; Grade 4, >20.0*ULN. Total bilirubin, Grade 3, >3.0-10.0*ULN; Grade 4, >10.0*ULN. Creatinine, Grade 3, >3.0-6.0*ULN; Grade 4, >6.0*ULN. Hypercalcemia(serum calcium, mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia (serum calcium, mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia(serum calcium, mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia(serum calcium, mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (serum calcium, mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (serum sodium, mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (serum sodium, mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3. (NCT00744497)
Timeframe: At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.
Intervention | Participants (Number) |
---|
| ALP (All grades) | ALP (Grades 3 and 4) | ALT (All grades) | ALT (Grades 3 and 4) | AST (All grades) | AST (Grades 3 and 4) | Total bilirubin (All grades) | Total bilirubin (Grades 3 and 4) | Creatinine (All grades) | Creatinine (Grades 3 and 4) | Hypercalcemia (All grades) | Hypercalcemia (Grades 3 and 4) | Hypocalcemia (All grades) | Hypocalcemia (Grades 3 and 4) | Hyperkalemia (All grades) | Hyperkalemia (Grades 3 and 4) | Hypokalemia (All grades) | Hypokalemia (Grades 3 and 4) | Hypernatremia (All grades) | Hypernatremia (Grades 3 and 4) | Hyponatremia (All grades) | Hyponatremia (Grades 3 and 4) | Phosporus (All grades) | Phosphorus (Grades 3 and 4) |
---|
Dasatinib | 375 | 68 | 256 | 6 | 266 | 5 | 41 | 3 | 184 | 5 | 34 | 1 | 377 | 25 | 152 | 14 | 152 | 16 | 101 | 0 | 241 | 43 | 257 | 93 |
,Placebo | 447 | 91 | 186 | 5 | 212 | 4 | 49 | 1 | 153 | 3 | 56 | 1 | 308 | 23 | 164 | 11 | 107 | 6 | 93 | 0 | 230 | 36 | 189 | 43 |
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Number of Participants With Abnormal Results in Urinalysis
Abnormal=positive, defined as the presence of >=30 mg/dL of protein; a small, moderate, or large amount of blood; or >0 g/dL glucose in urine. BL=baseline; neg=negative (NCT00744497)
Timeframe: At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.
Intervention | Participants (Number) |
---|
| Protein, urine: postive | Blood, urine: positive | Glucose, urine: positive |
---|
Dasatinib | 336 | 307 | 154 |
,Placebo | 246 | 289 | 179 |
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Number of Participants by Maximal On-study Fridericia-corrected QTc Interval
QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included. (NCT00744497)
Timeframe: At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing
Intervention | Participants (Number) |
---|
| <450 msecs (n=600, 548) | 450-500 msecs (n=600, 548) | >500 msecs (n=600, 548) |
---|
Dasatinib | 497 | 48 | 3 |
,Placebo | 550 | 43 | 7 |
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Time to Prostate Specific Antigen (PSA) Progression
PSA progression is defined as the time from randomization to the date of the first PSA level measurement that led to confirmed PSA progression, for participants who had not started subsequent cancer therapy. For participants who did not progress or who progressed on cancer therapy, PSA progression is defined as the time from randomization to the date of the last PSA level measurement before the start of cancer therapy, if any. Participants who had no on-study PSA level measurements were censored on the day they were randomized. (NCT00744497)
Timeframe: From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)
Intervention | Months (Median) |
---|
Placebo | 6.9 |
Dasatinib | 7.2 |
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Progression-free Survival (PFS)
PFS is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Those who progressed or died while on subsequent cancer therapy and those who did not die or progress were censored at their last radiologic bone scan/imaging, skeletal related-event, or tumor assessment or at measurement of prostate specific antigen levels, whichever occurred last prior to start of subsequent cancer therapy ,if any. Participants with no assessments were censored on the day of randomization. (NCT00744497)
Timeframe: From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)
Intervention | Months (Median) |
---|
Placebo | 11.1 |
Dasatinib | 11.8 |
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Synovial Blood Flow
Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow. (NCT00746512)
Timeframe: Baseline and Day 14
Intervention | pixel count (Mean) |
---|
| Baseline | Day 14 | Change from Baseline at Day 14 |
---|
Placebo 15 mg | 10.55 | 13.37 | 2.82 |
,Placebo 7.5 mg | 9.78 | 9.15 | -0.64 |
,Prednisone 15 mg | 9.48 | 6.52 | -2.96 |
,Prednisone 7.5 mg | 8.31 | 4.44 | -3.88 |
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Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])
"The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) & swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale [VAS]), and the CRP (in mg/L measured from lab test). The scoring formula was:~DAS28(CRP) = 0.56*SQR(TJC28) + 0.28*SQR(SJC28) + 0.36*ln(CRP+1) + 0.014*GH(VAS) + 0.96.~Where SQR is square root and ln is natural log.~The formula produces a score from 0 to 10: >5.1 means high disease activity; <3.2 means low disease activity, <2.6 is generally considered remission." (NCT00746512)
Timeframe: Baseline and Day 14
Intervention | score on scale (Mean) |
---|
| Baseline | Day 14 | Change from Baseline at Day 14 |
---|
Placebo 15 mg | 5.45 | 5.04 | -0.41 |
,Placebo 7.5 mg | 5.62 | 5.38 | -0.23 |
,Prednisone 15 mg | 5.17 | 3.57 | -1.61 |
,Prednisone 7.5 mg | 5.31 | 4.57 | -0.74 |
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Percentage of Participants With 3-year Progression-free Survival (PFS)
Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression. (NCT00770224)
Timeframe: 0-3 years
Intervention | percentage of participants (Number) |
---|
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | 90 |
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5-year Overall Survival
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00770224)
Timeframe: 0-5 years
Intervention | percentage of participants (Number) |
---|
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | 94 |
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5-year Progression-free Survival
Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression. (NCT00770224)
Timeframe: 0-5 years
Intervention | percentage of participants (Number) |
---|
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | 85 |
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Overall Survival (OS)
Overall survival (OS) will be measured as the time from date of enrollment to death from any cause. For patients who remain alive, survival time will be censored at the date of last contact. (NCT00772668)
Timeframe: Up to 5 years
Intervention | months (Number) |
---|
RCVELP | NA |
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Progression-free Survival (PFS)
Progression free-survival will be assessed according to according to the International Workshop Criteria (IWC). Progression-free survival will be measured as the time from date of enrollment to relapse, progression or death due to follicular lymphoma (FL) or marginal zone lymphoma (MZL), whichever occurs first. Participants who do not experience relapse or progression, and those who die from causes other than cancer, will be censored at the date of last contact. (NCT00772668)
Timeframe: Up to 5 years
Intervention | months (Number) |
---|
RCVELP | NA |
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Rate of Toxicity in Study Participants
Safety and tolerance to protocol therapy as evidenced by the rate of toxicity (serious adverse events and study-related adverse events) in study participants (NCT00772668)
Timeframe: Up to 5 years
Intervention | participants (Number) |
---|
RCVELP | 1 |
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Relative Efficacy of the 2 Groups
The goal is to see if there are major differences between the two arms for each group in term of efficacy and of toxicity both overall and in comparison to the previous responses to rituximab alone. The comparisons are for level of response eg CR (>100k) vs PR (230-100k) vs NR (<30k) and for duration of response-----duration of response is controlled by comparison to duration of response from initial rituximab infusions (NCT00774202)
Timeframe: 2 years
Intervention | number of responders (Number) |
---|
| CR | PR | response longer than previous response |
---|
High Dose Rituximab | 4 | 0 | 0 |
,Rituximab, C, V, P | 4 | 1 | 0 |
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Number of Participants With SAEs
How many participants had SAEs among those receiving R-CVP or among those receiving double dose rituximab and did participants in one arm have substantially more SAEs than those in the other arm (NCT00774202)
Timeframe: 2 years
Intervention | number of patients with SAEs (Number) |
---|
Rituximab + CVP | 0 |
Double Dose Rituximab | 1 |
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Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study
A participant who did not meet the criteria for either a complete response or a partial response at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the site investigator judged that the participant could benefit from continued participation. Non responders did not respond to treatment and lupus activity is moderate to severe. (NCT00774852)
Timeframe: Week 104
Intervention | participants (Number) |
---|
Week 24 Non-Responder: Abatacept | 0 |
Week 24 Non-Responder: Placebo | 0 |
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Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52
Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs are those who successfully responded to treatment and had minimal activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 52
Intervention | participants (Number) |
---|
Week 24 Complete Response: Abatacept | 11 |
Week 24 Complete Response: Placebo | 13 |
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Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response
A partial proteinuria and prednisone response is defined as an improvement (reduction) of >=50% in the urine protein-to-creatinine ratio at either visit -1 or 0, and prednisone dose has been tapered to 10 mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24
Intervention | participants (Number) |
---|
Abatacept | 39 |
Placebo | 42 |
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Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response
A complete proteinuria and prednisone response is defined as urine protein-to-creatinine ratio <0.5 and prednisone dose tapered to <= 10mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Complete responders are those who successfully responded to treatment and have minimal activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24
Intervention | participants (Number) |
---|
Abatacept | 22 |
Placebo | 21 |
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Lupus Disease Activity - Total BILAG-2004
BILAG-2004 has 5 categories of scoring.Category A:defined by severe disease activity requiring any of the following treatments: 1) systemic high dose oral glucocorticoids, 2) IV pulse glucocorticoids, 3) systemic immunomodulators, or 4)therapeutic high dose anticoagulation in the presence of high dose steroids or immunomodulators. Category B:defined by moderate disease activity requiring any of the following treatments:1) systemic low dose oral glucocorticoids, 2) intramuscular or intra-articular or soft tissue glucocorticoids injection,3) topical glucocorticoids, 4) topical immunomodulators,5) antimalarials or thalidomide or prasterone or acitretin, or 6) symptomatic therapy.Category C:defined by mild disease.Category D is defined by inactive disease, previously affected.Category E is defined as the system never being involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity. (NCT00774852)
Timeframe: Week 52
Intervention | units on a scale (Mean) |
---|
Week 24 Complete Response: Abatacept | 1.8 |
Week 24 Complete Response: Placebo | 1.9 |
Week 24 Partial Response: Abatacept | 3.2 |
Week 24 Partial Response: Placebo | 3.5 |
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Number of Participants With a Complete or Partial Response
"Complete response: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder.~Partial response: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol.~Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs successfully responded to treatment and have minimal activity of their lupus nephritis. Partial responders showed some response to treatment and low activity of their lupus nephritis." (NCT00774852)
Timeframe: Week 52
Intervention | participants (Number) |
---|
Week 24 Complete Response: Abatacept | 12 |
Week 24 Complete Response: Placebo | 14 |
Week 24 Partial Response: Abatacept | 13 |
Week 24 Partial Response: Placebo | 13 |
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Lupus Disease Activity - Patient Global Assessment
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease." (NCT00774852)
Timeframe: Week 104
Intervention | units on a scale (Mean) |
---|
Abatacept | 13.2 |
Placebo | 18.7 |
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Number of Participants With Complete Response
Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24
Intervention | participants (Number) |
---|
Abatacept | 22 |
Placebo | 21 |
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Number of Participants With Partial Response
Outcome measure description: Partial response definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as complete response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24
Intervention | participants (Number) |
---|
Abatacept | 39 |
Placebo | 40 |
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Lupus Disease Activity - Frequency of Flares
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Flares can be renal or non-renal. A renal flare is defined as two successive evaluations at least 1 week apart as proteinuria >1 gm/24h for participants who attain a complete response at Week 12 and for all other participants either 1) Increasing serum creatinine and persistent proteinuria, or 2) Worsening proteinuria. A non-renal flare is defined as any new post-baseline BILAG A in a non-renal organ system using BILAG-2004. This outcome measures the number of participants with the presence of renal and non-renal flares from Week 24 through Week 52 by response status. Having flares is indicative of more lupus disease activity." (NCT00774852)
Timeframe: Week 52
Intervention | participants (Number) |
---|
| Participants with a Renal Flare | Participants with at least 1 Non-renal Flare |
---|
Week 24 Complete Response: Abatacept | 0 | 1 |
,Week 24 Complete Response: Placebo | 2 | 1 |
,Week 24 No Response: Abatacept | 1 | 1 |
,Week 24 No Response: Placebo | 0 | 0 |
,Week 24 Partial Response: Abatacept | 1 | 0 |
,Week 24 Partial Response: Placebo | 3 | 1 |
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Lupus Disease Activity - Presence of Hypocomplementemia
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants were categorized as having hypocomplementemia if their serum complement test results (C3, and C4) were below the normal range at the site. Below normal complement test results are indicative of active lupus erythematosus." (NCT00774852)
Timeframe: Week 104
Intervention | participants (Number) |
---|
| C3 Hypocomplementemia | C4 Hypocomplementemia |
---|
Abatacept | 12 | 11 |
,Placebo | 11 | 8 |
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Lupus Disease Activity - SF-36 Scores
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life." (NCT00774852)
Timeframe: Week 104
Intervention | Score (Mean) |
---|
| Week 104 Physical Component Score | Week 104 Mental Component Score |
---|
Abatacept | 49.3 | 50.9 |
,Placebo | 45.3 | 49.2 |
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Lupus Disease Activity - SF-36 Scores Percent Change From Baseline
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life." (NCT00774852)
Timeframe: Week 104
Intervention | percent change (Mean) |
---|
| Percent Change From Baseline on Physical Component | Percent Change from Baseline Mental Component Scor |
---|
Abatacept | 32.1 | 39.6 |
,Placebo | 28.2 | 37.1 |
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Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104
"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. One measure used to assess disease activity is the number of participants who were anti-dsDNA positive at baseline but negative at Week 104. Going from positive to negative is indicative of lowered lupus activity." (NCT00774852)
Timeframe: Week 104
Intervention | participants (Number) |
---|
Abatacept | 3 |
Placebo | 3 |
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Proportion of Vaccinated Participants With a Competent Immune Response
"Among participants who are vaccinated, the number of who have a competent immune response at Week 52 as defined as having met both of the following criteria:~Pneumococcal vaccination response - absolute value >= 0.35 ug/mL and, when measured 4-6 weeks after vaccination, a >=2-fold increase from baseline in serotype-specific antibody titer for at least 50% of the serotypes tested.~Tetanus toxoid vaccination response - absolute value >=0.015 IU/mL and, when measured 4-6 weeks after vaccination, a 2-fold increase from baseline in antigen-specific antibody titer~Competent immune response is indicative of low disease activity." (NCT00774852)
Timeframe: Week 52
Intervention | percentage of participants (Number) |
---|
| Pneumococcal Vaccines | Tetanus Toxoid Vaccines |
---|
Week 24 Complete Response: Abatacept | 67 | 50 |
,Week 24 Complete Response: Placebo | 100 | 100 |
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Lupus Disease Activity - Patient Global Assessment Percent Change From Baseline
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease." (NCT00774852)
Timeframe: Week 104
Intervention | percent change (Mean) |
---|
Abatacept | 26 |
Placebo | -35.2 |
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Lupus Disease Activity - Negative Anti-dsDNA
"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. This measure was the number of participants who had negative anti-dsDNA at Week 104. Having a negative score is indicative of low lupus disease activity." (NCT00774852)
Timeframe: Week 104
Intervention | participants (Number) |
---|
Abatacept | 7 |
Placebo | 10 |
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Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat
MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD. (NCT00787527)
Timeframe: 21 Days
Intervention | participants (Number) |
---|
Schedule A - Vorinostat Once Daily | 1 |
Schedule A - Vorinostat Twice Daily | 2 |
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Phase II MTD of Vorinostat
MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle). (NCT00787527)
Timeframe: 21 Days
Intervention | mg/three times daily (Number) |
---|
Schedule B - Vorinostat Three Times Daily | 300 |
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Phase I Maximum Tolerated Dose (MTD) of Vorinostat
MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle). (NCT00787527)
Timeframe: 21 Days
Intervention | mg/day (Number) |
---|
Schedule A - Vorinostat Once or Twice Daily | 300 |
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Number of Participants With Treatment Failure by 90 Days Assignment
In the etanercept group 16/40 (40%) failed treatment compared with 12/38 (32%) in the prednisone group. (NCT00789997)
Timeframe: Day 0 to Day 90
Intervention | participants (Number) |
---|
Etanercept | 16 |
Prednisone | 12 |
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Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1)
"FEV1 was obtained using calibrated spirometers at approximately the same time of day at all visits throughout the study. The highest acceptable FEV1 and the highest FVC measurement each obtained on any of three blows (even if not from the same curve) meeting the American Thoracic Society criteria constituted the data for that test set.~Not all participants had Day 14 FEV1 measures collected" (NCT00789997)
Timeframe: Day 0 to Day 14
Intervention | percentage of change in FEV1 (Mean) |
---|
Etanercept | 15.2 |
Prednisone | 20.1 |
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Overall Survival (OS)
OS will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: From the date of initial registration on the study until death from any cause, assessed up to 5 years
Intervention | Probability of surviving 12 months (Number) |
---|
Treatment | 0.88 |
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Continuous Complete Remission (CCR) Rate
Will be testing using an exact binomial test (NCT00792948)
Timeframe: 18 months
Intervention | percentage of participants (Number) |
---|
Treatment | 57 |
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Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
Will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: 12 months
Intervention | Probability of 12-month RFS (Number) |
---|
Treatment | 0.83 |
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Change in Renal Function
Change in renal function as seen in serum creatinine values from baseline until study completion or participant termination. Baseline is defined as the lowest serum creatinine collected during stabilization period or in the four weeks following the end of the stabilization period. The stabilization period is defined as four consecutive creatinine values close in value (not differing more than 0.3 mg/dL). Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (up to five years)
Intervention | mg/dL (Mean) |
---|
| Baseline Serum Creatinine | Study Termination/Completion | Change from Baseline |
---|
MEDI-507 | 1.9 | 3.2 | 1.2 |
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Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks
A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first. (NCT00801632)
Timeframe: 48 months post-transplant
Intervention | participants (Number) |
---|
MEDI-507 | 3 |
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Percentage of Participants Experiencing Acute Rejection
"The percentage of participants who experience an acute rejection. Acute rejection is defined as a biopsy with findings of Banff score of grade IA or higher. The Banff classification is as follows: grade IA is >25% of parenchyma affected and foci of moderate tubulitis; Grade IB is >25% of parenchyma affected and foci of severe tubulitis; Grade IIA is mild to moderate intimal arteritis; Grade IIB is severe intimal arteritis comprising >25% of the luminal area; Grade III is transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation." (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (up to five years)
Intervention | Percentage of Participants (Number) |
---|
MEDI-507 | 40 |
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Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection
Clinically significant invasive or resistant opportunistic infections include cytomegalovirus, herpes zoster, and candida. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)
Intervention | Percentage of Participants (Number) |
---|
MEDI-507 | 0 |
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Time to Platelet Recovery Following Transplant
Time (in days) until platelet recovery following transplant. Platelet recovery is defined as a platelet count >20,000 /mm^3 and where no transfusion is required. Time to recovery is time from transplantation until platelet value recovers. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)
Intervention | days (Mean) |
---|
MEDI-507 | 1.0 |
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Time to Neutrophil Recovery Following Transplant
Time (in days) until neutrophil recovery following transplant. Neutrophil recovery is defined as an absolute neutrophil count (ANC) > 500/mm^3 at three consecutive assessments on different days post-transplant. Time to recovery is time from transplantation until the first assessment date used to confirm the recovery. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)
Intervention | days (Mean) |
---|
MEDI-507 | 14.0 |
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Percentage of Participants With Graft Survival Through 156 Weeks
The percentage of participants with graft survival from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. Graft survival is defined as the time to week 156 or graft loss. Graft loss is defined as the day on which a graft is deemed irreversibly nonfunctional and dialysis is begun, a transplantectomy is performed, or the participant is re-transplanted, whichever comes first. Six consecutive weeks of dialysis are required for the diagnosis of graft loss, though the date of graft loss will be defined as the date of first dialysis. (NCT00801632)
Timeframe: Transplantation until week 156
Intervention | Percentage of Participants (Number) |
---|
MEDI-507 | 80 |
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Percentage of Participants Surviving Through 156 Weeks
The percentage of participants who survived from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. (NCT00801632)
Timeframe: Transplantation until week 156
Intervention | Percentage of Participants (Number) |
---|
MEDI-507 | 100 |
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Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD
The participants' total daily steroid dose was recorded at baseline and after a 15 week course of treatment. Starting at a dose of 0.5-1 mg/kg, dose reduction of steroids was permitted after 1 cycle of therapy. The suggested taper was 10-25% every 1-2 weeks. . (NCT00815919)
Timeframe: After 15 weeks of bortezomib plus prednisone therapy
Intervention | participants (Number) |
---|
Velcade (Bortezomib) | 14 |
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Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD
"Participants had their cGVHD evaluated per NIH consensus criteria:~Complete response: resolution of all reversible manifestations of cGVHD.~Partial response: a decrease ≥ 1 point on a 3-point organ-specific scale or 2 points or more on a 10-point global scale without progression in any organ sites.~Stable disease: no evidence of cGVHD response without evidence of progressive cGVHD.~Progressive cGVHD: increase of ≥ 1 point on an organ-specific 3-point scale, addition of a new immunosuppressive agent prior to the completion of 15 weeks of combination therapy, or requirement an increase in the total daily dose of corticosteroids above a participant's baseline corticosteroid dose during the 15-week combined treatment period.~Mixed response: a response in primary sites of cGVHD involvement but interval progressive cGVHD in other organs or sites.~Responses were not scored for oral or ocular cGVHD, since topical therapies were permitted during the study." (NCT00815919)
Timeframe: Patients had their cGVHD assessed at Baseline and at 15 weeks or end of therapy
Intervention | participants (Number) |
---|
| Participants with a complete response in cGVHD | Participants with an partial response in cGVHD | Participants with stable cGVHD | Participants with progressive cGVHD | Participants with mixed response |
---|
Velcade (Bortezomib) | 2 | 14 | 1 | 2 | 1 |
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Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy
Participants who were still being followed 1 year after the start of therapy had their prednisone dose recorded. (NCT00815919)
Timeframe: 1 year after the start of study treatment
Intervention | participants (Number) |
---|
| Participants still requiring prednisone | Participants off prednisone |
---|
Velcade (Bortezomib) | 11 | 6 |
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The Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD
Participants' toxicities were graded based on the CTCAE version 3.0. The toxicities were then given an attribution to the velcade treatment: unrelated, unlikely, possible, probable, definite. (NCT00815919)
Timeframe: Toxicities were collected from the start of treatment through 15 weeks of therapy or end of study treatmetn
Intervention | participants (Number) |
---|
| Participants with >= Grade 3, unrelated/unlikely | Participants with >= Grade 3, possible | Participants with >= Grade 3, probable/definite |
---|
Velcade (Bortezomib) | 7 | 1 | 0 |
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Overall and cGVHD Progression-free Survival by 1 Year After Therapy
(NCT00815919)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
| 2-year Cum-incidence of Non-relapse mortality | 2-year Cum-incidence of malignant relapse | 2 year progression-free survival | 2-year Overall survival |
---|
Velcade (Bortezomib) | 14 | 14 | 73 | 73 |
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Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00822120)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
HIV-negative:2 Cycles of ABVD Followed by PET-directed Therapy | 98 |
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Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP | 64 |
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Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site. (NCT00822120)
Timeframe: 7 months after registration
Intervention | percentage of patients (Number) |
---|
PET-negative: Continued ABVD After 2 Cycles of ABVD | 100 |
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | 93 |
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Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00822120)
Timeframe: 5 years
Intervention | percentage of participants (Number) |
---|
HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap | 89 |
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Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is >1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years
Intervention | percentage of patients (Number) |
---|
HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap | 83 |
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Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | 79 |
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Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration
Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo (NCT00828061)
Timeframe: Baseline and Hour 8 post nasal allergen challenge
Intervention | Fold Change (Geometric Mean) |
---|
Placebo | 26.94 |
10 mg Prednisone | 6.70 |
25 mg Prednisone | 1.86 |
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Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils
Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg or 25 mg Prednisone Relative to Placebo (NCT00828061)
Timeframe: Baseline and Hour 8 post nasal allergen challenge
Intervention | Percentage of cells that are eosinophils (Least Squares Mean) |
---|
Placebo | 2.28 |
10 mg Prednisone | 3.17 |
25 mg Prednisone | 6.02 |
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Percentage Change in Morning Stiffness
How long was your morning stiffness today? Pre-treatment (Night A) value minus post-treatment (Night B) value divided by pre-treatment value. (NCT00836810)
Timeframe: 2 weeks
Intervention | percentage of baseline morning stiffness (Mean) |
---|
Timed Release Tablet Prednisone | 75.0 |
Standard Prednisolone | 115.0 |
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Change in Peak Serum IL-6 Concentration
Pre-treatment (Night A) peak minus post-treatment (Night B) peak. Peaks defined as the highest value for each patient from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B) and the peak identified for each one. (NCT00836810)
Timeframe: 24 hours
Intervention | pg/ml (Mean) |
---|
Timed Release Tablet Prednisone | 11.5 |
Standard Prednisolone | 29.3 |
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Pain (Severity)
100mm visual analogue scale. Question: How much pain have you had in the last 24 hours? Anchors: No pain; Severe pain. Min score 0, Max score 100. Higher value is worse outcome. (NCT00836810)
Timeframe: 24 hour period after 2 weeks of treatment
Intervention | mm (Mean) |
---|
Timed Release Tablet Prednisone | 26.5 |
Standard Prednisolone | 19.5 |
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Clinician's Opinion of Disease Activity.
100mm visual analogue scale. Question: Clinician's opinion of disease activity. Anchors: None; Severe Min 0 Max 100 (worse) (NCT00836810)
Timeframe: Current at baseline and after 2 weeks treatment
Intervention | mm (Mean) |
---|
Timed Release Tablet Prednisone | 19.0 |
Standard Prednisolone | 20.3 |
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Change in Area Under the Curve (AUC) of Plasma IL-6
Pre-treatment (Night A) AUC minus post-treatment (Night B) AUC. AUC calculated from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B). (NCT00836810)
Timeframe: 24 hour measurements 2 weeks apart
Intervention | pg*hr/ml (Mean) |
---|
Timed Release Tablet Prednisone | 113.5 |
Standard Prednisolone | 97.9 |
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Patient's Opinion of Condition
100mm visual analogue scale. Question: Considering all the ways your pain and/or stiffness affect(s) you, please mark on the line how well you are doing. Anchors: Very well; Very badly. Min 0 Max 100 (poor outcome). (NCT00836810)
Timeframe: Current value at baseline and after 2 weeks treatment
Intervention | mm (Mean) |
---|
Timed Release Tablet Prednisone | 17.8 |
Standard Prednisolone | 26.0 |
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Means Aqueous Humor Prednisolone Acetate Concentration
(NCT00854061)
Timeframe: 35 days
Intervention | ng/mL (Mean) |
---|
T-Pred | 100.02 |
Pred Forte | 131.65 |
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AALL08P1 Safety Outcome
Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol. (NCT00866307)
Timeframe: Consolidation through Delayed Intensification
Intervention | percentage of participants (Number) |
---|
Group B (High Risk-High) | 50.0 |
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AALL08P1 Feasibility Outcome
Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol. (NCT00866307)
Timeframe: Consolidation through Delayed Intensification
Intervention | percentage of participants (Number) |
---|
Group B (High Risk-High) | 53.3 |
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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1. (NCT00873093)
Timeframe: End of Block 1 (Day 36 of Block 1) of re-induction therapy
Intervention | percentage of participants (Number) |
---|
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 35.4 |
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 25 |
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Severe Adverse Events (SAE) Rate.
The proportion of SAE rate among all eligible patients (NCT00873093)
Timeframe: 4 months
Intervention | percentage of participants (Number) |
---|
Overall | 8.2 |
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Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy
The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy. (NCT00873093)
Timeframe: The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.
Intervention | Percentage of participants (Number) |
---|
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 72.2 |
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 63 |
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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3. (NCT00873093)
Timeframe: End of Block 3 (Day 36 of Block 3) of re-induction therapy
Intervention | Percentage of participants (Number) |
---|
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 80 |
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 63.6 |
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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2
Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2. (NCT00873093)
Timeframe: End of Block 2 (Day 36 of Block 2) of re-induction therapy
Intervention | percentage of participants (Number) |
---|
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 66.7 |
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 42.1 |
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Toxic Death Rate
The proportion of toxic death rate among all eligible patients. (NCT00873093)
Timeframe: 4 months
Intervention | percentage of participants (Number) |
---|
Overall | 2.1 |
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Event Free Survival
Percentage of patients who were event free at 4 months (NCT00873093)
Timeframe: 4 months after enrollment
Intervention | Percentage of participants (Number) |
---|
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 68.5 |
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 37.8 |
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Worst Overall CTCAE Grade for Hematology Laboratory Test Results
Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles). (NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)
Intervention | participants (Number) |
---|
| Absolute Neutrophil Count: Grade 1 | Absolute Neutrophil Count: Grade 2 | Absolute Neutrophil Count: Grade 3 | Absolute Neutrophil Count: Grade 4 | Absolute Neutrophil Count: Grades 1-4 | Hemoglobin: Grade 1 | Hemoglobin: Grade 2 | Hemoglobin: Grade 3 | Hemoglobin: Grade 4 | Hemoglobin: Grades 1-4 | Lymphocytes Absolute: Grade 1 | Lymphocytes Absolute: Grade 2 | Lymphocytes Absolute: Grade 3 | Lymphocytes Absolute: Grade 4 | Lymphocytes Absolute: Grades 1-4 | Platelets: Grade 1 | Platelets: Grade 2 | Platelets: Grade 3 | Platelets: Grade 4 | Platelets: Grades 1-4 | White Blood Cells: Grade 1 | White Blood Cells: Grade 2 | White Blood Cells: Grade 3 | White Blood Cells: Grade 4 | White Blood Cells: Grades 1-4 |
---|
Bendamustine and Rituximab (BR) | 22 | 51 | 48 | 50 | 171 | 129 | 42 | 5 | 1 | 177 | 1 | 5 | 54 | 83 | 143 | 106 | 14 | 9 | 7 | 136 | 41 | 79 | 65 | 19 | 204 |
,R-CHOP/R-CVP | 14 | 20 | 47 | 104 | 185 | 129 | 51 | 7 | 2 | 189 | 6 | 55 | 55 | 9 | 125 | 72 | 14 | 7 | 8 | 101 | 22 | 49 | 89 | 27 | 187 |
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Kaplan-Meier Estimate for Duration of Response (DOR)
DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
Intervention | months (Median) |
---|
Bendamustine and Rituximab (BR) | 26.5 |
R-CHOP/R-CVP | 32.1 |
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Kaplan-Meier Estimate for Event-free Survival (EFS)
"EFS was defined as the time from randomization to treatment failure, disease progression or relapse, other malignancies, or death from any cause, whichever occurred first.~Treatment failure was defined as failure to achieve a CR or PR after 6 cycles of treatment. If a patient failed to achieve CR or PR by the time of data analysis or early withdrawal, the treatment failure date was set at 126 days (6 cycles of treatment) after randomization or the new anticancer treatment date, whichever is earlier." (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
Intervention | months (Median) |
---|
Bendamustine and Rituximab (BR) | 31.8 |
R-CHOP/R-CVP | 32.6 |
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Kaplan-Meier Estimate for Progression-free Survival (PFS)
PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
Intervention | months (Median) |
---|
Bendamustine and Rituximab (BR) | 31.8 |
R-CHOP/R-CVP | 33.4 |
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Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
Intervention | months (Median) |
---|
Bendamustine and Rituximab (BR) | 65.0 |
R-CHOP/R-CVP | 64.1 |
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Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period
"Relapsed disease (after CR) and progressive disease (PD) (after PR or SD):~Lymph nodes were considered abnormal if the long axis was greater than 1.5 cm. Lymph nodes with a long axis of 1.1 to 1.5 cm were considered abnormal if its short axis was greater than 1.0 cm.~In patients with no prior history of pulmonary lymphoma, new lung nodules identified by CT require histologic confirmation.~>= 50% increase from nadir in sum of the products of the greatest diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must have increased by 2: 50% and to a size of 1.5 cm by 1.5 cm, or more than 1.5 cm in the long axis~other conditions as specified in the protocol" (NCT00877006)
Timeframe: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period
Intervention | Participants (Count of Participants) |
---|
Bendamustine and Rituximab (BR) | 36 |
R-CHOP/R-CVP | 30 |
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Percentage of Participants With Complete Response (CR) at End of Treatment Period
CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies. (NCT00877006)
Timeframe: 6 to 8 21 or 28-day cycles (18-32 weeks)
Intervention | percentage of participants (Number) |
---|
Bendamustine and Rituximab (BR) | 31 |
R-CHOP/R-CVP | 25 |
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Percentage of Participants With Overall Response at End of Treatment Period
Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria. (NCT00877006)
Timeframe: 6 to 8 21 or 28-day cycles (18-32 weeks)
Intervention | percentage of participants (Number) |
---|
Bendamustine and Rituximab (BR) | 97 |
R-CHOP/R-CVP | 91 |
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Clinically Significant Abnormal Vital Signs
(NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
Intervention | participants (Number) |
---|
| Heart Rate >=120 and ↑ >=15 bpm | Heart Rate <=50 and ↓ >=15 bpm | Systolic Blood Pressure(BP) >=180 and ↑ >=20 mm Hg | Systolic BP <=90 and ↓ >=20 mm Hg | Diastolic BP >=105 and ↑ from Baseline >=15 mm Hg | Diastolic BP <=50 and ↓ from Baseline >=15 mm Hg |
---|
Bendamustine and Rituximab (BR) | 0 | 2 | 2 | 6 | 1 | 2 |
,R-CHOP/R-CVP | 1 | 2 | 2 | 2 | 2 | 2 |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period
AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one's ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event. (NCT00877006)
Timeframe: 32 weeks
Intervention | participants (Number) |
---|
| Any AE | Severe AEs (grades 3, 4, 5) | Treatment-related AEs | Deaths | SAEs | Withdrawn due to AEs |
---|
Bendamustine and Rituximab (BR) | 221 | 130 | 209 | 12 | 60 | 10 |
,R-CHOP/R-CVP | 213 | 127 | NA | 9 | 49 | 3 |
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Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period
Death is due to any cause. Data are broken out by patients who died within 30 days of the last dose of study medications, and those who died greater than 30 days of the last dose of study medications. (NCT00877006)
Timeframe: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period
Intervention | Participants (Count of Participants) |
---|
| All Deaths | Deaths within 30 days of study treatment | Deaths greater than 30 days of study treatment |
---|
Bendamustine and Rituximab (BR) | 40 | 2 | 38 |
,R-CHOP/R-CVP | 32 | 1 | 31 |
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Potentially Clinically Significant Abnormal Weight
Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of >=10% were considered potentially clinically significant. (NCT00877006)
Timeframe: Baseline, Week 32
Intervention | participants (Number) |
---|
| Increase >=10% | Decrease >=10% |
---|
Bendamustine and Rituximab (BR) | 8 | 18 |
,R-CHOP/R-CVP | 5 | 8 |
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Therapeutic Classification of Concomitant Medications
(NCT00877006)
Timeframe: 32 weeks
Intervention | participants (Number) |
---|
| Psycholeptics | Sex Hormones and Modulators of the Genital System | Stomatological Preparations | Throat Preparations | Thyroid Therapy | Topical Preparations for Join and Muscular Pain | Unspecified Herbal | Urologicals | Vaccines | Vasoprotectives | Vitamins |
---|
Bendamustine and Rituximab (BR) | 69 | 6 | 23 | 3 | 3 | 1 | 3 | 5 | 11 | 1 | 16 |
,R-CHOP/R-CVP | 74 | 4 | 29 | 2 | 1 | 2 | 5 | 4 | 11 | 8 | 21 |
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Therapeutic Classification of Prior Medications
(NCT00877006)
Timeframe: prior to start of treatment
Intervention | participants (Number) |
---|
| Psycholeptics | Sex Hormones and Modulators of the Genital System | Stomatological Preparations | Throat Preparations | Thyroid Therapy | Topical Products for Join and Muscular Pain | Unspecified Herbal | Urologicals | Vaccines | Vasoprotectives | Vitamins |
---|
Bendamustine and Rituximab (BR) | 57 | 11 | 0 | 0 | 16 | 1 | 10 | 20 | 2 | 0 | 70 |
,R-CHOP/R-CVP | 59 | 12 | 0 | 0 | 17 | 0 | 10 | 11 | 7 | 0 | 61 |
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Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results
Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles). (NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
Intervention | participants (Number) |
---|
| Albumin: Grade 1 | Albumin: Grade 2 | Albumin: Grade 3 | Albumin: Grade 4 | Albumin: Grades 1-4 | Alkaline Phosphatase: Grade 1 | Alkaline Phosphatase: Grade 2 | Alkaline Phosphatase: Grade 3 | Alkaline Phosphatase: Grade 4 | Alkaline Phosphatase: Grades 1-4 | Creatinine: Grade 1 | Creatinine: Grade 2 | Creatinine: Grade 3 | Creatinine: Grade 4 | Creatinine: Grades 1-4 | Gamma-glutamyl transferase: Grade 1 | Gamma-glutamyl transferase: Grade 2 | Gamma-glutamyl transferase: Grade 3 | Gamma-glutamyl transferase: Grade 4 | Gamma-glutamyl transferase: Grades 1-4 | Hypercalcemia: Grade 1 | Hypercalcemia: Grade 2 | Hypercalcemia: Grade 3 | Hypercalcemia: Grade 4 | Hypercalcemia: Grades 1-4 | Hyperglycemia: Grade 1 | Hyperglycemia: Grade 2 | Hyperglycemia: Grade 3 | Hyperglycemia: Grade 4 | Hyperglycemia: Grades 1-4 | Hyperkalemia: Grade 1 | Hyperkalemia: Grade 2 | Hyperkalemia: Grade 3 | Hyperkalemia: Grade 4 | Hyperkalemia: Grades 1-4 | Hypernatremia: Grade 1 | Hypernatremia: Grade 2 | Hypernatremia: Grade 3 | Hypernatremia: Grade 4 | Hypernatremia: Grades 1-4 | Hypocalcemia: Grade 1 | Hypocalcemia: Grade 2 | Hypocalcemia: Grade 3 | Hypocalcemia: Grade 4 | Hypocalcemia: Grades 1-4 | Hypoglycemia: Grade 1 | Hypoglycemia: Grade 2 | Hypoglycemia: Grade 3 | Hypoglycemia: Grade 4 | Hypoglycemia: Grades 1-4 | Hypokalemia: Grade 1 | Hypokalemia: Grade 2 | Hypokalemia: Grade 3 | Hypokalemia: Grade 4 | Hypokalemia: Grades 1-4 | Hyponatremia: Grade 1 | Hyponatremia: Grade 2 | Hyponatremia: Grade 3 | Hyponatremia: Grade 4 | Hyponatremia: Grades 1-4 | Magnesium: Grade 1 | Magnesium: Grade 2 | Magnesium: Grade 3 | Magnesium: Grade 4 | Magnesium: Grades 1-4 | Phosphorus: Grade 1 | Phosphorus: Grade 2 | Phosphorus: Grade 3 | Phosphorus: Grade 4 | Phosphorus: Grades 1-4 | Aspartate Aminotransferase: Grade 1 | Aspartate Aminotransferase: Grade 2 | Aspartate Aminotransferase: Grade 3 | Aspartate Aminotransferase: Grade 4 | Aspartate Aminotransferase: Grades 1-4 | Alanine Aminotransferase: Grade 1 | Alanine Aminotransferase: Grade 2 | Alanine Aminotransferase: Grade 3 | Alanine Aminotransferase: Grade 4 | Alanine Aminotransferase: Grades 1-4 | Total Bilirubin: Grade 1 | Total Bilirubin: Grade 2 | Total Bilirubin: Grade 3 | Total Bilirubin: Grade 4 | Total Bilirubin: Grades 1-4 | Uric Acid: Grade 1 | Uric Acid: Grade 2 | Uric Acid: Grade 3 | Uric Acid: Grade 4 | Uric Acid: Grades 1-4 |
---|
Bendamustine and Rituximab (BR) | 33 | 14 | 3 | 0 | 50 | 41 | 1 | 0 | 0 | 42 | 19 | 3 | 1 | 0 | 23 | 31 | 18 | 3 | 0 | 52 | 6 | 0 | 1 | 0 | 7 | 94 | 20 | 15 | 0 | 129 | 7 | 3 | 1 | 0 | 11 | 8 | 0 | 0 | 0 | 8 | 36 | 8 | 1 | 3 | 48 | 15 | 1 | 0 | 0 | 16 | 18 | 0 | 0 | 0 | 18 | 40 | 0 | 0 | 0 | 40 | 46 | 0 | 0 | 0 | 46 | 7 | 25 | 3 | 0 | 35 | 42 | 2 | 1 | 0 | 45 | 46 | 6 | 2 | 0 | 54 | 14 | 1 | 0 | 0 | 15 | 41 | 0 | 0 | 1 | 42 |
,R-CHOP/R-CVP | 44 | 13 | 0 | 0 | 57 | 25 | 3 | 0 | 0 | 28 | 25 | 1 | 0 | 0 | 26 | 37 | 10 | 6 | 0 | 53 | 6 | 0 | 0 | 0 | 6 | 74 | 34 | 15 | 1 | 124 | 8 | 1 | 0 | 0 | 9 | 10 | 0 | 0 | 0 | 10 | 28 | 6 | 0 | 0 | 34 | 10 | 0 | 0 | 0 | 10 | 16 | 0 | 1 | 0 | 17 | 28 | 0 | 5 | 0 | 33 | 44 | 1 | 1 | 0 | 46 | 5 | 22 | 3 | 1 | 31 | 32 | 2 | 1 | 0 | 35 | 38 | 3 | 1 | 0 | 42 | 7 | 0 | 0 | 0 | 7 | 42 | 0 | 0 | 0 | 42 |
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Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life. (NCT00877006)
Timeframe: Day 1 (prior to treatment), 32 weeks
Intervention | units on a scale (Mean) |
---|
Bendamustine and Rituximab (BR) | 3.6 |
R-CHOP/R-CVP | -5.1 |
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Response to Treatment
Response includes both complete remission (defined as <5% leukemic blasts in the bone marrow) and partial remission (defined as a greater than 35% reduction in the bone marrow leukemia blast percentage at day 33) (NCT00882206)
Timeframe: Day 33
Intervention | participants (Number) |
---|
Decitabine / Vorinostat | 6 |
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Level of Methylation
the percentage of methylated DNA (NCT00882206)
Timeframe: Day 5
Intervention | percentage of DNA (Mean) |
---|
Decitabine / Vorinostat | 79.82 |
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Level of Methylation
the percentage of methylated DNA (NCT00882206)
Timeframe: Day 33
Intervention | percentage of DNA (Mean) |
---|
Decitabine / Vorinostat | 86.1 |
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Level of Methylation
the percentage of methylated DNA (NCT00882206)
Timeframe: Day 0
Intervention | percentage of DNA (Mean) |
---|
Decitabine / Vorinostat | 84.98 |
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Number of Participants With Treatment Emergent Adverse Events
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. (NCT00887198)
Timeframe: From first dose of study drug up to 30 days after the last dose of study drug
Intervention | Participants (Number) |
---|
| With Treatment-Emergent Adverse Events | With Treatment-Emergent Serious Adverse Events |
---|
Abiraterone Acetate + Prednisone (AAP) | 541 | 208 |
,Placebo | 524 | 148 |
,Placebo to Abiraterone Acetate | 93 | 39 |
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Radiographic Progression-free Survival (rPFS)
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause. (NCT00887198)
Timeframe: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
Intervention | Months (Median) |
---|
Abiraterone Acetate + Prednisone (AAP) | NA |
Placebo | 8.28 |
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Time to Opiate Use for Prostate Cancer Pain
The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to first opiate use or end of study (Month 60)
Intervention | Months (Median) |
---|
Abiraterone Acetate + Prednisone (AAP) | 33.38 |
Placebo | 23.39 |
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Overall Survival
Overall survival is defined as the time from randomization to date of death from any cause. (NCT00887198)
Timeframe: From randomization (Day 1) up to end of study (Month 60)
Intervention | Months (Median) |
---|
Abiraterone Acetate + Prednisone (AAP) | 34.66 |
Placebo | 30.29 |
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Time to Prostate-specific Antigen (PSA) Progression
The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
Intervention | Months (Median) |
---|
Abiraterone Acetate + Prednisone (AAP) | 11.07 |
Placebo | 5.55 |
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Time to Initiation of Cytotoxic Chemotherapy
The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)
Intervention | Months (Median) |
---|
Abiraterone Acetate + Prednisone (AAP) | 25.17 |
Placebo | 16.82 |
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The Number of Patients With a Response (Complete Response and Partial Response)
Treatment success was defined as > 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p). (NCT00890617)
Timeframe: 3 weeks post-Percutaneous Cryotherapy (PTC)
Intervention | Participants (Count of Participants) |
---|
Prednisone & Cryotherapy | 8 |
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Progression-free Survival Time
Delay between the date of randomization and the date of progression or death. Progression is defined according to the Cheson criteria. (NCT00911183)
Timeframe: from randomization, up to 5 years
Intervention | months (Median) |
---|
Arm I (R-COP Regimen) | 10.4 |
Arm II (R-COPY Regimen) | 18.0 |
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Number of Participants in Complete Remission 6 Months After Randomization
"Complete remission [CR] is defined according to Cheson criteria. CR requires the following:~Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities.~All lymph nodes and nodal masses must have regressed to normal size. Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to ≤1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).~The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination.~If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site." (NCT00911183)
Timeframe: 6 months after randomization
Intervention | Participants (Count of Participants) |
---|
Arm I (R-COP Regimen) | 14 |
Arm II (R-COPY Regimen) | 9 |
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Number of Participants With Severe Toxicity
"Severe toxicity, defined as febrile neutropenia or toxic death. Febrile neutropenia is defined in the International CTC toxicity scale as fever of unknown origin without clinically or microbiologically documented infection: neutrophils < 1.0 x 109/l and fever ≥ 38.5° C.~Toxic death is defined as any death which occur during treatment (from day 1 of the first cycle of chemotherapy up to day 30 of the last cycle) and is not related to lymphoma." (NCT00911183)
Timeframe: 6 months after randomization
Intervention | Participants (Count of Participants) |
---|
Arm I (R-COP Regimen) | 10 |
Arm II (R-COPY Regimen) | 8 |
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Overall Survival Time
OS is defined as the delay between the date of randomization and the date of death (NCT00911183)
Timeframe: from randomization, up to 5 years
Intervention | months (Median) |
---|
Arm I (R-COP Regimen) | 20.1 |
Arm II (R-COPY Regimen) | 25.4 |
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Overall Survival
Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause. (NCT00911859)
Timeframe: From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)
Intervention | Days (Median) |
---|
Part 2: VMP (Velcade+Melphalan+Prednisone) | NA |
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | NA |
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Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria
CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks. (NCT00911859)
Timeframe: Up to disease progression, approximately 3 years
Intervention | Percentage of participants (Number) |
---|
Part 2: VMP (Velcade+Melphalan+Prednisone) | 22.4 |
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 26.5 |
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Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria
CR or PR was assessed using EBMT criteria. CR: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks; PR: >=50% reduction in the level of serum monoclonal paraprotein for at least 2 determinations 6 weeks apart, if present, reduction in 24-hour urinary light chain excretion by either >=90% or to <200 mg for at least 2 determinations 6 weeks apart, >=50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least 6 weeks, if skeletal survey is available: no increase in size or number of lytic bone lesions (NCT00911859)
Timeframe: Up to disease progression, approximately 3 years
Intervention | Percentage of participants (Number) |
---|
Part 2: VMP (Velcade+Melphalan+Prednisone) | 79.6 |
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 87.8 |
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Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria
sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, <=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence (NCT00911859)
Timeframe: Up to disease progression, approximately 3 years
Intervention | Percentage of participants (Number) |
---|
Part 2: VMP (Velcade+Melphalan+Prednisone) | 6.1 |
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 4.1 |
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Progression-Free Survival (PFS)
PFS was defined as the time between randomization and either disease progression or death, whichever occurred first. (NCT00911859)
Timeframe: From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)
Intervention | Days (Median) |
---|
Part 2: VMP (Velcade+Melphalan+Prednisone) | 518 |
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 519 |
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1-year Survival Rate
Percentage of participants who are alive at the end of year 1 after randomization (NCT00911859)
Timeframe: 1 year
Intervention | Percentage of participants (Number) |
---|
Part 2: VMP (Velcade+Melphalan+Prednisone) | 87.8 |
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 87.5 |
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Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
"Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher (better) health and quality of life." (NCT00911859)
Timeframe: Baseline (Day 1 predose) and Cycle 9 (Week 54)
Intervention | Scores on a scale (Mean) |
---|
Part 2: VMP (Velcade+Melphalan+Prednisone) | 14.78 |
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 8.33 |
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Duration of Response (DOR)
DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression. (NCT00911859)
Timeframe: From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication
Intervention | Days (Median) |
---|
Part 2: VMP (Velcade+Melphalan+Prednisone) | 497 |
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 583 |
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1-year Progression-Free Survival (PFS) Rate
The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death. (NCT00911859)
Timeframe: 1 year
Intervention | Percentage of participants (Number) |
---|
Part 2: VMP (Velcade+Melphalan+Prednisone) | 77.5 |
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 72.1 |
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Testosterone Concentration in Prostate Tissue
Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12. (NCT00924469)
Timeframe: Week 12
Intervention | Picogram per milligram (pg/mg) (Mean) |
---|
Abiraterone Plus Leuprolide Plus Prednisone | 0.089 |
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | 0.228 |
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Dihydrotestosterone (DHT) Concentration in Prostate Tissue
The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12. (NCT00924469)
Timeframe: Week 12
Intervention | Picogram per milligram (pg/mg) (Mean) |
---|
Abiraterone Plus Leuprolide Plus Prednisone | 4.311 |
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | 2.170 |
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Percentage of Participants With Pathologic Complete Response (CR)
Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion. (NCT00924469)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
Abiraterone Plus Leuprolide Plus Prednisone | 10.3 |
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | 3.7 |
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Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue
Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24. (NCT00924469)
Timeframe: Week 12 and 24
Intervention | Picogram per milligram (pg/mg) (Mean) |
---|
| Androstenedione: Week 12 (n=28,27) | Androstenedione: Week 24 (n=28,26) | DHEA: Week 12 (n=28,27) | DHEA: Week 24 (n=28,26) |
---|
Abiraterone Plus Leuprolide Plus Prednisone | 0.082 | 0.090 | 1.994 | 3.138 |
,Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | 0.277 | 0.070 | 29.241 | 2.170 |
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Percentage of Participants With Prostate-specific Antigen (PSA) Response
The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation. (NCT00924469)
Timeframe: Weeks 12 and 24
Intervention | Percentage of participants (Number) |
---|
| Week 12 | Week 24 |
---|
Abiraterone Plus Leuprolide Plus Prednisone | 86.7 | 86.7 |
,Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | 3.6 | 82.1 |
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Serum Levels of Androgens
Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24. (NCT00924469)
Timeframe: Week 12 and 24
Intervention | Nanogram per deciliter (ng/dL) (Mean) |
---|
| Testosterone: Week 12 (n=28,28) | Testosterone: Week 24 (n=25,25) | DHT: Week 12 (n=28,28) | DHT: Week 24 (n=26,26) | Androsterone: Week 12 (n=28,28) | Androsterone: Week 24 (26,26) | DHEA: Week 12 (n=28,28) | DHEA: Week 24 (n=26,26) | DHEA-Glucuronide: Week 12 (n=29,28) | DHEA-Glucuronide: Week 24 (n=27,27) | DHEA-Sulfate: Week 12 (n=28,28) | DHEA-Sulfate: Week 24 (n=26,26) | Delta-4-Androstenedione:Week 12(n=28,28) | Delta-4-Androstenedione:Week 24(n=26,26) |
---|
Abiraterone Plus Leuprolide Plus Prednisone | 1.049 | 0.648 | 6.143 | 5.932 | 0.619 | 1.752 | 10.684 | 20.922 | 69.724 | 51.675 | 7156.270 | 9047.406 | 3.315 | 5.192 |
,Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | 10.014 | 3.122 | 5.797 | 6.730 | 3.100 | 0.500 | 180.307 | 7.617 | 583.036 | 51.759 | 133338.875 | 9207.345 | 33.330 | 2.831 |
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Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue
Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24. (NCT00924469)
Timeframe: Week 24
Intervention | Picogram per milligram (pg/mg) (Mean) |
---|
| Testosterone | DHT |
---|
Abiraterone Plus Leuprolide Plus Prednisone | 0.216 | 1.340 |
,Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | 0.062 | 2.456 |
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Prednisone-associated Toxicity as Assessed by Hyperglycemia
Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone. (NCT00929695)
Timeframe: Baseline and then through 42 days after starting treatment
Intervention | mg/dL (Mean) |
---|
Group A (Low-dose) | 140 |
Group B (Standard-dose) | 142 |
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Prednisone-associated Toxicity as Assessed by Hypertension
The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured. (NCT00929695)
Timeframe: Baseline and then through 42 days after starting treatment
Intervention | medications (Mean) |
---|
Group A (Low-dose) | -0.29 |
Group B (Standard-dose) | -0.24 |
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Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)
The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected. (NCT00929695)
Timeframe: Baseline and through 100 days of treatment
Intervention | percentage of participants (Number) |
---|
Group A (Low-dose) | 52 |
Group B (Standard-dose) | 53 |
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Non-relapse Mortality
Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression. (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy
Intervention | percentage of participants (Number) |
---|
Group A (Low-dose) | 15 |
Group B (Standard-dose) | 16 |
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Chronic Extensive GVHD
Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy
Intervention | percentage of participants (Number) |
---|
Group A (Low-dose) | 47 |
Group B (Standard-dose) | 54 |
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Prednisone-associated Toxicity as Assessed by Quality of Life
Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured. (NCT00929695)
Timeframe: Baseline and then every other week until 42 days after starting treatment
Intervention | units on a scale (Mean) |
---|
Group A (Low-dose) | -2.3 |
Group B (Standard-dose) | -1.9 |
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Progression to Grade III-IV Acute GVHD
Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods. (NCT00929695)
Timeframe: At approximately 100 days after transplant
Intervention | percentage of participants (Number) |
---|
Group A (Low-dose) | 6 |
Group B (Standard-dose) | 13 |
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Recurrent or Progressive Malignancy
Percentage of relapse estimated by cumulative incidence methods (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy
Intervention | percentage of participants (Number) |
---|
Group A (Low-dose) | 21 |
Group B (Standard-dose) | 21 |
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Secondary Therapy for Acute GVHD Beyond Prednisone
This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods. (NCT00929695)
Timeframe: At approximately 100 days after transplant
Intervention | percentage of participants (Number) |
---|
Group A (Low-dose) | 23 |
Group B (Standard-dose) | 7 |
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Prednisone-associated Toxicity as Assessed by Myopathy
Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position. (NCT00929695)
Timeframe: Baseline and then weekly until 42 days after starting treatment
Intervention | units on a scale (Mean) |
---|
Group A (Low-dose) | -0.18 |
Group B (Standard-dose) | -0.18 |
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Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment
The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42. (NCT00929695)
Timeframe: At day 42 after initiation of treatment
Intervention | milligrams per kilogram (Mean) |
---|
Grade IIa GVHD; 0.5 mg/kg/d Prednisone | 22.2 |
Grade IIa GVHD; 1.0 mg/kg/d Prednisone | 27.1 |
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone | 38.4 |
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone | 41.3 |
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Overall Survival
Percentage of patients surviving as estimated by Kaplan-Meier. (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy
Intervention | percentage of participants (Number) |
---|
Group A (Low-dose) | 77 |
Group B (Standard-dose) | 77 |
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Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category
Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. (NCT00931918)
Timeframe: First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)
Intervention | percentage of participants (Number) |
---|
| At Least 1 TEAE | Drug-related, TEAEs | Grade 3 or higher TEAEs | Grade 3 or Higher Drug-related, TEAEs | TEAEs Resulting in Study Drug Discontinuation | Serious TEAEs |
---|
RCHOP | 100 | 88 | 71 | 55 | 4 | 31 |
,Vc-RCHOP | 99 | 95 | 79 | 68 | 6 | 34 |
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Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher
Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE. (NCT00931918)
Timeframe: Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment)
Intervention | percentage of participants (Number) |
---|
| Lymphocytes | WBC Count | Neutrophils | Platelets | Hemoglobin | Hyperglycemia | Hypokalemia | Hypophosphatemia | Hyponatremia | Alanine aminotransferase (ALT) increased | Aspartate aminotransferase (AST) increased |
---|
RCHOP | 70 | 68 | 65 | 18 | 10 | 14 | 13 | 7 | 4 | 2 | 1 |
,Vc-RCHOP | 86 | 69 | 70 | 39 | 15 | 9 | 14 | 10 | 3 | 1 | 2 |
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Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate
FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point. (NCT00931918)
Timeframe: End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Intervention | percentage of participants (Number) |
---|
| End of Cycle 2 | End of Treatment (Cycle 6) |
---|
RCHOP | 42 | 53 |
,Vc-RCHOP | 37 | 59 |
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Duration of Response
Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Intervention | months (Median) |
---|
RCHOP | NA |
Vc-RCHOP | NA |
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Overall Response Rate (ORR)
ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites. (NCT00931918)
Timeframe: End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Intervention | percentage of participants (Number) |
---|
| End of Cycle 2 | End of Treatment (Cycle 6) | Best Overall Response Rate |
---|
RCHOP | 93 | 88 | 98 |
,Vc-RCHOP | 90 | 84 | 96 |
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Complete Response Rate
Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease. (NCT00931918)
Timeframe: End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Intervention | percentage of participants (Number) |
---|
| End of Cycle 2 | End of Treatment (Cycle 6) | Best Complete Response Rate |
---|
RCHOP | 23 | 45 | 49 |
,Vc-RCHOP | 16 | 56 | 56 |
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Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Intervention | months (Median) |
---|
RCHOP | NA |
Vc-RCHOP | NA |
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Progression-Free Survival Rate
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years. (NCT00931918)
Timeframe: 2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)
Intervention | percentage of participants (Number) |
---|
RCHOP | 78 |
Vc-RCHOP | 82 |
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Time to Progression (TTP)
TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Intervention | months (Median) |
---|
RCHOP | NA |
Vc-RCHOP | NA |
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Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Intervention | months (Median) |
---|
RCHOP | NA |
Vc-RCHOP | NA |
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Change From Baseline in Eosinophil Counts at Day 1, 7 and 14
(NCT00938587)
Timeframe: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
Intervention | 10^3 cells per microliter (Mean) |
---|
| Baseline | Change at Day 1: 1 hour | Change at Day 1: 2 hour | Change at Day 1: 3 hour | Change at Day 1: 4 hour | Change at Day 7: 0 hour | Change at Day 7: 1 hour | Change at Day 7: 2 hour | Change at Day 7: 3 hour | Change at Day 7: 4 hour | Change at Day 14: 0 hour | Change at Day 14: 1 hour | Change at Day 14: 2 hour | Change at Day 14: 3 hour | Change at Day 14: 4 hour |
---|
PF-04171327 10 mg + Placebo | 0.19 | -0.02 | -0.01 | -0.01 | -0.01 | -0.03 | -0.02 | -0.03 | -0.04 | -0.04 | -0.03 | -0.04 | -0.05 | -0.05 | -0.05 |
,PF-04171327 25 mg + Placebo | 0.19 | -0.02 | -0.01 | -0.01 | -0.03 | -0.04 | -0.03 | -0.07 | -0.08 | -0.06 | -0.05 | -0.05 | -0.07 | -0.07 | -0.07 |
,Placebo | 0.15 | -0.00 | -0.00 | -0.00 | -0.01 | 0.00 | -0.01 | 0.01 | 0.00 | 0.00 | 0.01 | -0.01 | 0.01 | 0.01 | -0.01 |
,Prednisone 5 mg + Placebo | 0.20 | -0.02 | -0.03 | -0.03 | -0.04 | -0.02 | -0.02 | -0.04 | -0.07 | -0.09 | -0.02 | -0.03 | -0.05 | -0.09 | -0.11 |
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Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14
DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, CRP (normal range of CRP is less than (<) 10 milligram per liter [mg/L], decrease in the level of CRP indicates reduction in inflammation) and participant global assessment (PGA) of disease activity (participant global assessment of diseases condition scores ranging from 0 [very well condition] to 100 [very poor condition], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: less than equal to (<=) 3.2 implied low disease activity; greater than (>) 3.2 to 5.1 implied moderate to high disease activity. (NCT00938587)
Timeframe: Baseline, Day 14
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Day 14 |
---|
PF-04171327 10 mg + Placebo | 6.04 | -1.79 |
,PF-04171327 25 mg + Placebo | 6.14 | -2.22 |
,Placebo | 6.03 | -0.96 |
,Prednisone 5 mg + Placebo | 5.92 | -1.15 |
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Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42
DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (normal range of CRP is <10 mg/L, decrease in the level of CRP indicates reduction in inflammation). Total DAS28-3 (CRP) score range: 0 (least severe) to 9.4 (most severe), higher scores indicate more disease activity. (NCT00938587)
Timeframe: Baseline, Day 7, 14, 42
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 | Change at Day 42 |
---|
PF-04171327 10 mg + Placebo | 5.80 | -1.07 | -1.57 | -0.81 |
,PF-04171327 25 mg + Placebo | 5.87 | -1.51 | -2.01 | -1.26 |
,Placebo | 5.72 | -0.50 | -0.87 | -1.12 |
,Prednisone 5 mg + Placebo | 5.59 | -0.55 | -0.92 | -1.17 |
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Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than (<) 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. (NCT00938587)
Timeframe: Baseline, Day 7, 14, 42
Intervention | mg/L (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 | Change at Day 42 |
---|
PF-04171327 10 mg + Placebo | 20.24 | -13.78 | -18.13 | 3.14 |
,PF-04171327 25 mg + Placebo | 30.15 | -23.60 | -24.12 | -13.09 |
,Placebo | 16.97 | 1.31 | -1.32 | -5.11 |
,Prednisone 5 mg + Placebo | 20.02 | -4.64 | -7.63 | -8.02 |
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Change From Baseline in Body Weight at Day 7 and 14
(NCT00938587)
Timeframe: Baseline, Day 7, 14
Intervention | kilogram (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 |
---|
PF-04171327 10 mg + Placebo | 83.7 | 0.12 | 0.35 |
,PF-04171327 25 mg + Placebo | 74.1 | -0.04 | 0.20 |
,Placebo | 75.0 | -0.05 | -0.04 |
,Prednisone 5 mg + Placebo | 78.4 | -0.02 | 0.18 |
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Change From Baseline in Adiponectin Level at Day 7 and 14
(NCT00938587)
Timeframe: Baseline, Day 7 and 14
Intervention | ng/mL (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 |
---|
PF-04171327 10 mg + Placebo | 7251.43 | -434.21 | 1023.16 |
,PF-04171327 25 mg + Placebo | 8349.09 | 1664.76 | 2692.86 |
,Placebo | 10080.95 | -430.95 | 193.16 |
,Prednisone 5 mg + Placebo | 7732.38 | -12.00 | 438.50 |
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Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Methotrexate was used as a background therapy by participants. (NCT00938587)
Timeframe: Pre-dose (0 hour), 1, 2, 3 and 4 hours post-dose
Intervention | ratio (Mean) |
---|
PF-04171327 10 mg + Placebo | 1.24 |
PF-04171327 25 mg + Placebo | 0.98 |
Prednisone 5 mg + Placebo | 1.14 |
Placebo | 0.93 |
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Number of Participants With Clinically Significant Vital Signs Abnormalities
Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, heart rate and body temperature. Vital sign measurements were performed with the participant in the seated position. Clinical significance vital sign abnormality was determined by investigator. (NCT00938587)
Timeframe: Baseline up to Day 45
Intervention | participants (Number) |
---|
PF-04171327 10 mg + Placebo | 0 |
PF-04171327 25 mg + Placebo | 0 |
Prednisone 5 mg + Placebo | 0 |
Placebo | 0 |
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Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25% increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=200 msec or >=25% increase from baseline (if baseline PR interval >100 msec) or >=50% increase (if baseline PR interval <= 100 msec); QT interval >=500 msec, corrected QT interval >=500 msec. (NCT00938587)
Timeframe: Baseline up to Day 45
Intervention | participants (Number) |
---|
PF-04171327 10 mg + Placebo | 0 |
PF-04171327 25 mg + Placebo | 0 |
Prednisone 5 mg + Placebo | 0 |
Placebo | 0 |
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Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Criteria for laboratory abnormalities: Hematology (hemoglobin, hematocrit <0.8*baseline; platelet count <75 or >700*10^3 per mm^3; leucocytes <2.5 or >17.5*10^3 per mm^3); chemistry (total bilirubin >1.5*upper limit of reference range [ULN]; aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, >3.0*ULN; total protein, albumin <0.8*lower limit of reference range [LLN] or >1.2*ULN; blood urea nitrogen [BUN]/urea, creatinine >1.3*ULN; glucose [fasting] <0.6*LLN or >1.5*ULN; uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN; potassium, calcium <0.9*LLN or >1.1*ULN; albumin, total protein <0.8*LLN or >1.2*ULN; urinalysis (urine white blood cell (WBC) =>6/ high power field (hpf); urine red blood cell (RBC) =>6/hpf). Number of participants with clinically significant change from baseline in laboratory abnormalities identified by investigator were reported. (NCT00938587)
Timeframe: Baseline up to Day 45
Intervention | participants (Number) |
---|
PF-04171327 10 mg + Placebo | 0 |
PF-04171327 25 mg + Placebo | 0 |
Prednisone 5 mg + Placebo | 0 |
Placebo | 0 |
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Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7
DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from SJC and TJC using the 28 joints count, CRP (normal range of CRP is <10 mg/L, decrease in the level of CRP indicates reduction in inflammation) and PGA of disease activity (participant global assessment of diseases condition scores ranging from 0 [very well condition] to 100 [very poor condition], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: <=3.2 implied low disease activity; >3.2 to 5.1 implied moderate to high disease activity. (NCT00938587)
Timeframe: Baseline, Day 7
Intervention | units on a scale (Mean) |
---|
PF-04171327 10 mg + Placebo | -1.21 |
PF-04171327 25 mg + Placebo | -1.63 |
Prednisone 5 mg + Placebo | -0.67 |
Placebo | -0.55 |
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Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14
(NCT00938587)
Timeframe: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
Intervention | ng/mL (Mean) |
---|
| Baseline | Change at Day 1: 1 hour | Change at Day 1: 2 hour | Change at Day 1: 3 hour | Change at Day 1: 4 hour | Change at Day 7: 0 hour | Change at Day 7: 1 hour | Change at Day 7: 2 hour | Change at Day 7: 3 hour | Change at Day 7: 4 hour | Change at Day 14: 0 hour | Change at Day 14: 1 hour | Change at Day 14: 2 hour | Change at Day 14: 3 hour | Change at Day 14: 4 hour |
---|
PF-04171327 10 mg + Placebo | 106.85 | -26.40 | -29.12 | -20.05 | -16.47 | -92.06 | -93.92 | -93.69 | -94.81 | -98.82 | -92.02 | -98.93 | -101.65 | -101.78 | -102.85 |
,PF-04171327 25 mg + Placebo | 110.50 | -30.94 | -37.17 | -24.19 | -21.05 | -103.76 | -104.69 | -104.96 | -105.01 | -104.69 | -104.86 | -105.41 | -105.70 | -105.29 | -105.25 |
,Placebo | 105.14 | -27.71 | -32.92 | -21.80 | -9.16 | 7.20 | -25.39 | -35.19 | -26.69 | -20.38 | 3.49 | -25.38 | -33.54 | -23.01 | -24.87 |
,Prednisone 5 mg + Placebo | 106.38 | -13.81 | -22.81 | -14.95 | -21.49 | 6.72 | -51.94 | -66.70 | -77.36 | -83.46 | -14.46 | -55.14 | -70.60 | -81.66 | -86.27 |
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Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14
Plasma concentration of PF-00251802 versus time summary, a metabolite of PF-04171327 was reported in this outcome measure. (NCT00938587)
Timeframe: 0, 1, 2, 3 and 4 hours post-dose on Day 7, 14
Intervention | nanogram per milliliter (ng/mL) (Mean) |
---|
| Day 7 (0 hour) | Day 7 (1 hour) | Day 7 (2 hour) | Day 7 (3 hour) | Day 7 (4 hour) | Day 14 (0 hour) | Day 14 (1 hour) | Day 14 (2 hour) | Day 14 (3 hour) | Day 14 (4 hour) |
---|
PF-04171327 10 mg + Placebo | 53.07 | 90.28 | 118.1 | 116.3 | 107.5 | 53.94 | 115.7 | 133.9 | 123.7 | 106.3 |
,PF-04171327 25 mg + Placebo | 136.8 | 257.9 | 281.3 | 230.7 | 220.6 | 136.3 | 216.4 | 284.9 | 296.6 | 243.3 |
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14
ACR70 responder: participants who achieved at =70% improvement in tender and swollen 28-joints count, and >=70% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0[no pain] to 100[most severe pain], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0[no difficulty] to 3[extreme difficulty], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is <10 mg/L, decrease in the level of CRP=reduction in inflammation). (NCT00938587)
Timeframe: Day 7, 14
Intervention | percentage of participants (Number) |
---|
| Day 7 | Day 14 |
---|
PF-04171327 10 mg + Placebo | 4.76 | 0.00 |
,PF-04171327 25 mg + Placebo | 4.76 | 14.29 |
,Placebo | 0.00 | 0.00 |
,Prednisone 5 mg + Placebo | 0.00 | 0.00 |
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14
ACR50 responder: participants who achieved at =50% improvement in tender and swollen 28-joints count, and >=50% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0[no pain] to 100[most severe pain], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0[no difficulty] to 3[extreme difficulty], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is <10 mg/L, decrease in the level of CRP=reduction in inflammation). (NCT00938587)
Timeframe: Day 7, 14
Intervention | percentage of participants (Number) |
---|
| Day 7 | Day 14 |
---|
PF-04171327 10 mg + Placebo | 9.52 | 22.22 |
,PF-04171327 25 mg + Placebo | 19.05 | 47.62 |
,Placebo | 0.00 | 14.29 |
,Prednisone 5 mg + Placebo | 0.00 | 20.00 |
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14
ACR20 responder: participants who achieved at =20% improvement in tender and swollen 28-joints count, and >=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0[no pain] to 100[most severe pain], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0[no difficulty] to 3[extreme difficulty], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is <10 mg/L, decrease in the level of CRP=reduction in inflammation). (NCT00938587)
Timeframe: Day 7, 14
Intervention | percentage of participants (Number) |
---|
| Day 7 | Day 14 |
---|
PF-04171327 10 mg + Placebo | 28.57 | 55.56 |
,PF-04171327 25 mg + Placebo | 52.38 | 66.67 |
,Placebo | 27.27 | 38.10 |
,Prednisone 5 mg + Placebo | 14.29 | 45.00 |
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 31 days after last dose (Day 45) that were absent before treatment or that worsened relative to pretreatment state. (NCT00938587)
Timeframe: Baseline up to Day 45
Intervention | participants (Number) |
---|
| AE | SAE |
---|
PF-04171327 10 mg + Placebo | 8 | 0 |
,PF-04171327 25 mg + Placebo | 3 | 0 |
,Placebo | 12 | 0 |
,Prednisone 5 mg + Placebo | 4 | 0 |
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Change From Baseline in Tender Joints Count at Day 7, 14, 42
Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. (NCT00938587)
Timeframe: Baseline, Day 7, 14, 42
Intervention | tender joints (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 | Change at Day 42 |
---|
PF-04171327 10 mg + Placebo | 17.10 | -5.14 | -7.22 | -5.21 |
,PF-04171327 25 mg + Placebo | 16.86 | -5.95 | -8.14 | -6.52 |
,Placebo | 17.09 | -4.18 | -5.67 | -6.81 |
,Prednisone 5 mg + Placebo | 15.05 | -3.05 | -4.15 | -5.10 |
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Change From Baseline in Swollen Joints Count at Day 7, 14 and 42
Number of swollen joints was determined by examination of 28 joints and identifying if swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. (NCT00938587)
Timeframe: Baseline, Day 7, 14, 42
Intervention | swollen joints (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 | Change at Day 42 |
---|
PF-04171327 10 mg + Placebo | 11.95 | -3.19 | -5.50 | -3.26 |
,PF-04171327 25 mg + Placebo | 11.73 | -5.19 | -6.71 | -4.81 |
,Placebo | 11.64 | -2.91 | -5.24 | -4.71 |
,Prednisone 5 mg + Placebo | 10.67 | -2.90 | -4.85 | -6.15 |
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Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14
Unit of ratio of urinary N-terminal telopeptide of type 1 collagen (uNTX-I) level to urinary creatinine (uCr) level was nanomoles bone collagen equivalents (nmol bce) per millimole creatinine (mmol cr). (NCT00938587)
Timeframe: Baseline, Day 7 and 14
Intervention | nmol BCE/mmol cr (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 |
---|
PF-04171327 10 mg + Placebo | 63.56 | 7.94 | 11.79 |
,PF-04171327 25 mg + Placebo | 62.00 | 16.40 | 18.15 |
,Placebo | 79.63 | -13.42 | -9.44 |
,Prednisone 5 mg + Placebo | 77.75 | -3.58 | -3.84 |
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Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14
PhGA included assessment of severity of arthritis pain where physicians were asked to rate the severity of the participant's overall arthritis. The physician's response was recorded using a visual analog scale between 0 mm (very good condition) to 100 mm (very poor condition). Higher scores indicate higher degree of arthritis. (NCT00938587)
Timeframe: Baseline, Day 7, 14
Intervention | mm (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 |
---|
PF-04171327 10 mg + Placebo | 58.10 | -13.38 | -22.16 |
,PF-04171327 25 mg + Placebo | 62.27 | -20.42 | -32.19 |
,Placebo | 59.87 | -13.58 | -14.87 |
,Prednisone 5 mg + Placebo | 57.86 | -9.71 | -20.90 |
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Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14
"PGA was a questionnaire where participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participants' response were recorded using a 100 mm visual analog scale placing a mark on the scale, between 0 mm (very well condition) to 100 mm (very poor condition). Higher scores indicate higher degree of arthritis." (NCT00938587)
Timeframe: Baseline, Day 7, 14
Intervention | mm (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 |
---|
PF-04171327 10 mg + Placebo | 60.71 | -16.05 | -22.63 |
,PF-04171327 25 mg + Placebo | 63.55 | -18.75 | -27.97 |
,Placebo | 65.26 | -7.94 | -11.77 |
,Prednisone 5 mg + Placebo | 65.89 | -11.87 | -22.43 |
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Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14
Participant assessment of arthritis pain included assessment of severity of arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). Participants placed a mark on the VAS between 0 mm (no pain) and 100 mm (most severe pain), which corresponded to the magnitude of their pain, higher scores indicate more pain. (NCT00938587)
Timeframe: Baseline, Day 7, 14
Intervention | mm (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 |
---|
PF-04171327 10 mg + Placebo | 62.45 | -12.03 | -25.83 |
,PF-04171327 25 mg + Placebo | 60.49 | -16.95 | -27.29 |
,Placebo | 66.65 | -11.00 | -14.69 |
,Prednisone 5 mg + Placebo | 63.17 | -8.67 | -21.47 |
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Change From Baseline in Osteocalcin Level at Day 1, 7 and 14
(NCT00938587)
Timeframe: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
Intervention | ng/mL (Mean) |
---|
| Baseline | Change at Day 1: 1 hour | Change at Day 1: 2 hour | Change at Day 1: 3 hour | Change at Day 1: 4 hour | Change at Day 7: 0 hour | Change at Day 7: 1 hour | Change at Day 7: 2 hour | Change at Day 7: 3 hour | Change at Day 7: 4 hour | Change at Day 14: 0 hour | Change at Day 14: 1 hour | Change at Day 14: 2 hour | Change at Day 14: 3 hour | Change at Day 14: 4 hour |
---|
PF-04171327 10 mg + Placebo | 21.76 | -1.78 | -2.22 | -2.67 | -3.15 | -5.26 | -5.88 | -5.71 | -5.77 | -5.78 | -6.01 | -6.28 | -5.80 | -6.42 | -7.45 |
,PF-04171327 25 mg + Placebo | 17.52 | -1.45 | -2.07 | -1.07 | -1.77 | -3.82 | -4.42 | -4.22 | -3.68 | -3.87 | -4.56 | -4.90 | -5.11 | -5.74 | -5.40 |
,Placebo | 15.29 | -0.50 | -0.73 | -1.30 | -0.93 | 0.69 | -0.37 | -0.52 | -0.33 | -1.05 | 0.63 | -0.25 | -0.35 | 0.56 | -0.41 |
,Prednisone 5 mg + Placebo | 29.36 | -1.94 | -1.19 | -1.35 | -3.10 | -3.08 | -0.66 | -2.74 | -2.83 | -2.48 | -3.04 | -2.66 | -4.21 | -5.88 | -4.19 |
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Change From Baseline in Neutrophil Counts at Day 1, 7 and 14
(NCT00938587)
Timeframe: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
Intervention | 10^3 cells per microliter (Mean) |
---|
| Baseline | Change at Day 1: 1 hour | Change at Day 1: 2 hour | Change at Day 1: 3 hour | Change at Day 1: 4 hour | Change at Day 7: 0 hour | Change at Day 7: 1 hour | Change at Day 7: 2 hour | Change at Day 7: 3 hour | Change at Day 7: 4 hour | Change at Day 14: 0 hour | Change at Day 14: 1 hour | Change at Day 14: 2 hour | Change at Day 14: 3 hour | Change at Day 14: 4 hour |
---|
PF-04171327 10 mg + Placebo | 5.43 | 0.04 | 0.01 | -0.06 | -0.28 | 0.16 | 0.63 | 0.79 | 1.19 | 1.13 | 0.32 | 0.40 | 0.56 | 1.10 | 1.09 |
,PF-04171327 25 mg + Placebo | 5.53 | 0.42 | 0.12 | 0.49 | 0.34 | 0.06 | 0.21 | 0.80 | 1.19 | 0.84 | 0.77 | 1.00 | 1.11 | 1.57 | 1.39 |
,Placebo | 5.03 | 0.09 | -0.07 | -0.05 | -0.25 | -0.21 | 0.07 | -0.06 | -0.13 | -0.47 | -0.11 | -0.16 | -0.35 | -0.41 | -0.65 |
,Prednisone 5 mg + Placebo | 5.90 | 0.45 | 0.38 | 0.22 | -0.03 | 0.22 | 0.64 | 1.66 | 2.14 | 2.01 | -0.79 | -0.09 | 0.74 | 1.14 | 1.07 |
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Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14
(NCT00938587)
Timeframe: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
Intervention | 10^3 cells per microliter (Mean) |
---|
| Baseline | Change at Day 1: 1 hour | Change at Day 1: 2 hour | Change at Day 1: 3 hour | Change at Day 1: 4 hour | Change at Day 7: 0 hour | Change at Day 7: 1 hour | Change at Day 7: 2 hour | Change at Day 7: 3 hour | Change at Day 7: 4 hour | Change at Day 14: 0 hour | Change at Day 14: 1 hour | Change at Day 14: 2 hour | Change at Day 14: 3 hour | Change at Day 14: 4 hour |
---|
PF-04171327 10 mg + Placebo | 1.85 | -0.01 | 0.28 | 0.21 | 0.28 | 0.79 | 0.64 | 0.76 | 0.77 | 0.72 | 0.89 | 0.81 | 0.74 | 0.81 | 0.77 |
,PF-04171327 25 mg + Placebo | 1.80 | 0.02 | 0.05 | 0.07 | 0.05 | 0.83 | 0.62 | 0.76 | 0.85 | 0.69 | 0.82 | 0.66 | 0.62 | 0.75 | 0.57 |
,Placebo | 1.79 | 0.04 | 0.09 | 0.04 | 0.03 | 0.05 | -0.03 | 0.10 | 0.15 | 0.19 | -0.07 | -0.03 | 0.04 | 0.20 | 0.08 |
,Prednisone 5 mg + Placebo | 1.68 | 0.13 | 0.09 | 0.10 | 0.07 | 0.26 | 0.13 | -0.03 | -0.25 | -0.23 | 0.29 | 0.22 | -0.03 | -0.35 | -0.45 |
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14
HAQ-DI assessed the ability of participants to perform task in 8 domains of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities. Each item was scored on a 4-point scale ranging from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do, higher scores indicate more difficulty. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score range: 0 (no difficulty) to 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. (NCT00938587)
Timeframe: Baseline, Day 7, 14
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Day 7 | Change at Day 14 |
---|
PF-04171327 10 mg + Placebo | 1.76 | -0.24 | -0.58 |
,PF-04171327 25 mg + Placebo | 1.41 | -0.24 | -0.43 |
,Placebo | 1.73 | -0.10 | -0.24 |
,Prednisone 5 mg + Placebo | 1.62 | -0.24 | -0.25 |
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Count of Participants With a Radiologic Response
Radiologic response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 criteria. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT00942578)
Timeframe: median time of potential follow-up of 47.5 months
Intervention | Participants (Count of Participants) |
---|
| Confirmed radiologic PR | Complete Response | Stable Disease |
---|
15 mg Lenalidomide | 3 | 0 | 1 |
,20 mg Lenalidomide | 2 | 2 | 0 |
,25 mg Lenalidomide | 20 | 0 | 3 |
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Survival Based on Expression of T Cell Immunoglobulin and Mucin Domain (TIM-3) on Cluster of Differentiation 8 (CD8) + T Cells
Expression of TIM-3 on CD8 + T cells was evaluated by flow cytometry. (NCT00942578)
Timeframe: 46.5 months
Intervention | Months (Median) |
---|
| Low expression | High expression |
---|
15 mg Lenalidomide | 23.6 | NA |
,20 mg Lenalidomide | NA | NA |
,25 mg Lenalidomide | 20.2 | 12.7 |
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Survival Based on Expression of Programmed Cell Death Protein 1 (PD-1) on Cluster of Differentiation 8 (CD8) + T Cells
Expression of PD-1 on CD8 + T cells was evaluated by flow cytometry. High and low expression are based on the median values. Patients with a low expression of PD-1 proteins had better survival than those with a high expression. (NCT00942578)
Timeframe: median time of potential follow-up of 47.5 months
Intervention | Months (Median) |
---|
| Low expression | High expression |
---|
15 mg Dose Lenalidomide | 21.4 | 22.4 |
,20 mg Dose Lenalidomide | 17.8 | 26.1 |
,25 mg Dose Lenalidomide | 28.9 | 14.8 |
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Count of Participants With Prostatic Antigen-Specific (PSA) Declines
PSA decline is defined as a ≥50% decline in measurable disease. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm by chest x-ray, as ≥10 mm with computed tomography, or ≥10 mm with calipers by clinical exam. (NCT00942578)
Timeframe: median time of potential follow-up of 47.5 months
Intervention | Participants (Count of Participants) |
---|
| Participants with PSA>30% | Participants with PSA>50% | Participants with PSA>90% | Not Evaluable |
---|
15 mg Lenalidomide | 13 | 12 | 5 | 1 |
,20 mg Lenalidomide | 3 | 3 | 1 | 0 |
,25 mg Lenalidomide | 41 | 40 | 27 | 1 |
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Count of Participants With Changes in Circulating Apoptotic Endothelial Cells (CAEC) From Baseline After Drug Administration
The definition of an increase is any increase (any number greater than zero) in the percent CAEC among total peripheral blood mononuclear cells comparing each patient's percent CAEC among total peripheral blood mononuclear cells at baseline to each patient's percent CAEC among total peripheral blood mononuclear cells at cycle 3 day 1. The definition of a decrease is any decrease (any number less than zero) in the percent CAEC among total peripheral blood mononuclear cells comparing each patient's percent CAEC among total peripheral blood mononuclear cells at baseline to each patient's percent CAEC among total peripheral blood mononuclear cells at cycle 3 day 1. (NCT00942578)
Timeframe: After drug administration, an average of 3 months
Intervention | Participants (Count of Participants) |
---|
| Increase in CAEC after 3 months | decrease in CAEC after 3 months |
---|
Single Arm - 4 Drug Combination | 30 | 20 |
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Recommended Phase 2 Dose (RP2D)
The RP2D is the dose at which there are no dose-limiting toxicities (defined as a ≥grade 3 hematological toxicity related to lenalidomide). (NCT00942578)
Timeframe: 3 weeks
Intervention | mg (Number) |
---|
Single Arm - 4 Drug Combination | 25 |
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Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered the Four-Drug Combination
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00942578)
Timeframe: Date treatment consent signed to date off study, approximately 93 months and 22 days.
Intervention | Participants (Count of Participants) |
---|
15 mg Dose Lenalidomide | 14 |
20 mg Dose Lenalidomide | 3 |
25 mg Dose Lenalidomide | 46 |
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Count of Participants With Dose-Limiting Toxicities (DLT)
DLT is defined as a ≥grade 3 non-hematological toxicity related to lenalidomide. (NCT00942578)
Timeframe: First 28 days of treatment.
Intervention | Participants (Count of Participants) |
---|
Single Arm - 4 Drug Combination | 0 |
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Number of Participants With Best Overall Response
Primary endpoint is best overall response. An evaluable subject classified as a treatment success for the primary endpoint if the subject's best overall response is clinical improvement (CI) as determined by International Working Group Criteria over the first 6 cycles of study treatment. International Working Group (IWG) consensus criteria for treatment response in myelofibrosis - Clinical improvement (CI) in anemia 1/ A minimum 20g/L increase in hemoglobin level or 2. becoming transfusion independent for at least 8 week duration. (NCT00946270)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Group 1 CC-4047 | 0 |
Group 2 | 3 |
Group 3 CC-4047 + Prednisone | 6 |
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Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL
Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. (NCT00972478)
Timeframe: Up to week 26
Intervention | Participants (Number) |
---|
| Abdominal pain | Acute kidney injury | Alanine aminotransferase increased | Anemia | Anorexia | Aspartate aminotransferase increased | Atrial fibrillation | Bladder spasm | Bronchial infection | CD4 lymphocytes decreased | CPK increased | Carbon monoxide diffusing capacity decreased | Colitis | Creatinine increased | Cystitis noninfective | Dehydration | Depression | Diarrhea | Disseminated intravascular coagulation | Dizziness | Duodenal perforation | Dysphagia | Dyspnea | Electrocardiogram QT corrected interval prolonged | Fatigue | Febrile neutropenia | Fecal incontinence | Gastrointestinal disorders - Other, specify | Generalized muscle weakness | Hematuria | Hiccups | Hyperglycemia | Hypoalbuminemia | Hypocalcemia | Hypokalemia | Hyponatremia | Hypophosphatemia | Hypotension | Infections and infestations - Other, specify | Jejunal perforation | Left ventricular systolic dysfunction | Leukocytosis | Lung infection | Lymphocyte count decreased | Mucosal infection | Mucositis oral | Multi-organ failure | Myalgia | Myocardial infarction | Nausea | Neutrophil count decreased | Obstruction gastric | Pain | Paronychia | Peripheral motor neuropathy | Platelet count decreased | Pneumonitis | Recurrent laryngeal nerve palsy | Respiratory failure | Sepsis | Sinus tachycardia | Sinusitis | Small intestinal obstruction | Stoma site infection | Syncope | Urinary tract infection | Urinary tract pain | Urine output decreased | Vasovagal reaction | Visceral arterial ischemia | Vomiting | Weight loss | White blood cell decreased |
---|
Ph I: R-CHOP+Vorinostat (400mg D1-9) | 1 | 0 | 0 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 2 | 1 | 2 | 1 | 1 | 0 | 0 | 0 | 1 | 3 | 3 | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 1 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 0 | 1 | 1 | 1 | 0 | 1 | 8 | 0 | 0 | 0 | 1 | 4 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 7 |
,Ph II: R-CHOP+Vorinostat | 3 | 1 | 1 | 22 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 4 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 1 | 9 | 24 | 1 | 1 | 2 | 0 | 1 | 4 | 3 | 0 | 8 | 6 | 2 | 3 | 3 | 1 | 1 | 1 | 4 | 20 | 1 | 3 | 0 | 2 | 2 | 3 | 37 | 1 | 1 | 1 | 0 | 22 | 1 | 1 | 1 | 11 | 1 | 1 | 1 | 1 | 4 | 3 | 2 | 0 | 1 | 0 | 2 | 3 | 32 |
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Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)
Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite). (NCT00972478)
Timeframe: 21 days
Intervention | mg PO Once daily Days 1-9 (Number) |
---|
Ph I: R-CHOP+Vorinostat (400mg D1-9) | 400 |
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Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)
Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00972478)
Timeframe: Up to week 26
Intervention | percentage of participants (Number) |
---|
Ph II: R-CHOP+Vorinostat | 81 |
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Progression-free Survival (Phase II)
From date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. (NCT00972478)
Timeframe: Up to 2 years
Intervention | percentage of participants (Number) |
---|
Ph II: R-CHOP+Vorinostat | 73 |
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Overall Survival (Phase II)
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00972478)
Timeframe: Up to 2 years
Intervention | percentage of participants (Number) |
---|
Ph II: R-CHOP+Vorinostat | 86 |
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Overall Survival at One Year
The number of participants alive one year after baseline. (NCT00973752)
Timeframe: 1 years
Intervention | Participants (Count of Participants) |
---|
Experimental | 19 |
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Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial
Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial. (NCT00988208)
Timeframe: The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days
Intervention | percentage of participants (Number) |
---|
| Invasive Secondary Primary Malignancies | Non-invasive Secondary Primary Malignancies |
---|
Docetaxel/Prednisone/Lenalidomide (DPL) | 1.7 | 1.0 |
,Docetaxel/Prednisone/Placebo (DP) | 1.3 | 0.4 |
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Time to Onset of Secondary Primary Malignancies
Time of Onset of Secondary Primary Malignancies was considered an event of interest (NCT00988208)
Timeframe: The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days
Intervention | months (Median) |
---|
Docetaxel/Prednisone/Placebo (DP) | 29.7 |
Docetaxel/Prednisone/Lenalidomide (DPL) | 19.7 |
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Progression-Free Survival (PFS)
PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan (NCT00988208)
Timeframe: From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months
Intervention | Weeks (Median) |
---|
Docetaxel/Prednisone/Placebo (DP) | 46 |
Docetaxel/Prednisone/Lenalidomide (DPL) | 45 |
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Number of Participants With Treatment Emergent Adverse Events (AEs)
A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal; (NCT00988208)
Timeframe: From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL
Intervention | participants (Number) |
---|
| Any TEAE | Any TEAE related to lenalidomide or placebo | Any TEAE related to docetaxel/prednisone | Any severity grade 3-4 TEAE | Any serious AE (SAE) | Any SAE related to lenalidomide or placebo | Any SAE related to docetaxel/prednisone | Any AE causing discontinuation of lenalidomide/PBO | Any AE causing withdrawal of docetaxel/prednisone | Any TEAE leading to death |
---|
Docetaxel/Prednisone/Lenalidomide (DPL) | 517 | 412 | 481 | 381 | 279 | 167 | 182 | 150 | 169 | 24 |
,Docetaxel/Prednisone/Placebo (DP) | 512 | 379 | 475 | 303 | 171 | 62 | 86 | 82 | 127 | 16 |
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Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria
Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones (NCT00988208)
Timeframe: From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months
Intervention | percentage of participants (Number) |
---|
Docetaxel/Prednisone/Placebo (DP) | 24.3 |
Docetaxel/Prednisone/Lenalidomide (DPL) | 22.1 |
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Percentage of Participants Who Received Post-Study Therapies
Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer. (NCT00988208)
Timeframe: The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017
Intervention | Percentage of Participants (Number) |
---|
Docetaxel/Prednisone/Placebo (DP) | 70.8 |
Docetaxel/Prednisone/Lenalidomide (DPL) | 69.0 |
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Overall Survival (OS)
Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley. (NCT00988208)
Timeframe: From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months
Intervention | weeks (Median) |
---|
Docetaxel/Prednisone/Placebo (DP) | NA |
Docetaxel/Prednisone/Lenalidomide (DPL) | 77 |
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The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.
(NCT00991939)
Timeframe: From 60 days through 365 days after study entry.
Intervention | percentage of subjects (Number) |
---|
High Dose Pulse Dexamethasone | 0 |
Standard Prednisone Therapy | 0 |
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Change in Quality of Life as Measured by the 10-Item Neuro-ophthalmological Supplement to the NEI-VFQ-25
(NCT00995722)
Timeframe: 4 months
Intervention | units on a scale (Mean) |
---|
Prednisone | 15.28 |
Placebo | -1.7 |
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Treatment Failure
Failure to achive sustatined minimal manifestation status by week 16 (NCT00995722)
Timeframe: 4 months
Intervention | percentage of participants (Number) |
---|
Prednisone | 17 |
Placebo | 100 |
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Change in Quality of Life as Measured by the MG-QOL-15 Score
(NCT00995722)
Timeframe: 4 Months
Intervention | units on a scale (Mean) |
---|
Prednisone | -6.3 |
Placebo | -2.5 |
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Change in Ocular Quantitative Myasthenia Score From Baseline to Week 16
(NCT00995722)
Timeframe: 4 months
Intervention | units on a scale (Mean) |
---|
Prednisone | -2.25 |
Placebo | -0.05 |
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Change in Quality of Life as Measured by the NEI-VFQ-25 Measures
(NCT00995722)
Timeframe: 4 months
Intervention | units on a scale (Mean) |
---|
Prednisone | 10.7 |
Placebo | 4.14 |
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Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads
(NCT01000285)
Timeframe: 6 months
Intervention | copies/peripheral blood mononuclear cell (Mean) |
---|
| Baseline | Study completion |
---|
Non-responders | 0.417 | 0.033 |
,Responders | 0.372 | 0.0128 |
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Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA
(NCT01000285)
Timeframe: 6 months
Intervention | copies/peripheral blood mononuclear cell (Mean) |
---|
| Baseline | Study completion |
---|
Non-responders | 41.9 | 35.7 |
,Responders | 37.0 | 7.33 |
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Effects of HTLV-1 Integration Sites After Treatment
(NCT01000285)
Timeframe: 6 months
Intervention | number of integration sites (Mean) |
---|
| Baseline | Study completion |
---|
EPOCH Chemotherapy & Bortezomib | 1.31 | 1.00 |
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Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence
(NCT01000285)
Timeframe: 6 months
Intervention | percentage of nucleotide divergence (Mean) |
---|
| Baseline | Study completion |
---|
EPOCH Chemotherapy & Bortezomib | 0.49 | 0.52 |
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Time to Progression
-The progression definitions used for this study are from the 2007 Cheson criteria. (NCT01000285)
Timeframe: Up to 4 years following completion of therapy
Intervention | days (Median) |
---|
| Best response of complete response | Best response of partial response | Best response of stable disease | All participants |
---|
EPOCH Chemotherapy & Bortezomib | 199 | 143 | 88 | 127 |
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Relation of NFκB Gene Expression Profile on Response
Standard error represents the standard error of the fold expression of protein coding transcripts for each gene indicated. (NCT01000285)
Timeframe: 6 months
Intervention | fold expression (Mean) |
---|
| BLK | CADMI | CD25 | CD4 | CD45 |
---|
Patient A (Responder) Post-Therapy | 0.178 | 0.011 | 0.035 | 1.380 | 1.718 |
,Patient A (Responder) Pre-Therapy | 1.000 | 1.000 | 1.000 | 1.000 | 1.000 |
,Patient B (Responder) Post-Therapy | 0.172 | 0.007 | 0.015 | 0.607 | 0.959 |
,Patient B (Responder) Pre-Therapy | 0.889 | 0.623 | 0.303 | 1.437 | 2.049 |
,Patient C (Non-responder) Post-Therapy | 77.590 | 1.816 | 0.691 | 1.923 | 1.640 |
,Patient C (Non-responder) Pre-Therapy | 68.856 | 1.494 | 0.862 | 1.319 | 1.163 |
,Patient D (Non-responder) Post-Therapy | 46.801 | 0.470 | 0.512 | 0.648 | 0.714 |
,Patient D (Non-responder) Pre-Therapy | 233.179 | 2.013 | 2.897 | 3.057 | 0.594 |
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Efficacy of Treatment as Measured by Best Overall Response
-The response definitions used for this study are the 2007 Cheson criteria. (NCT01000285)
Timeframe: Up to 4 years following completion of therapy
Intervention | participants (Number) |
---|
| Progressive Disease | Stable disease | Partial response | Complete response |
---|
EPOCH Chemotherapy & Bortezomib | 3 | 3 | 9 | 3 |
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Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. (NCT01000285)
Timeframe: Up to 30 days after completion of treatment
Intervention | participants (Number) |
---|
| Fatigue | Vomiting | Spontaneous bacterial peritonitis | Abdominal distension | Hemoglobin | Leukocytes (WBC) | Lymphopenia | Neutrophils | Platelets | Infection without neutropenia | Infection with neutropenia | Omaya port infection | IV port infection | Sepsis | Neutropenic fever | Hypoglycemia | Hyperglycemia | Magnesium | Hypokalemia | Hypertriglyceridemia | Confusion | Headache | Encephalitis | Abdominal pain | Cough | Dyspnea |
---|
EPOCH Chemotherapy & Bortezomib | 1 | 1 | 1 | 2 | 6 | 7 | 1 | 6 | 6 | 1 | 1 | 1 | 1 | 2 | 3 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
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Blood Pressure
Diastolic pressure (mmHg) (NCT01002339)
Timeframe: 1 year
Intervention | mmHg (Mean) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 76.67 |
Tacrolimus With Steroids Minimization | 74.59 |
CsA With Steroid Minimization | 76.64 |
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Blood Pressure
Systolic pressure (mmHg) (NCT01002339)
Timeframe: 1 year
Intervention | mmHg (Mean) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 135.36 |
Tacrolimus With Steroids Minimization | 133.97 |
CsA With Steroid Minimization | 136.28 |
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Lipidic Profile (Cholesterol)
Lipidic Profile (total cholesterol) (NCT01002339)
Timeframe: 1 year
Intervention | mg/dl (Mean) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 169.05 |
Tacrolimus With Steroids Minimization | 178.24 |
CsA With Steroid Minimization | 168.89 |
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Lipidic Profile (HDL-c)
(NCT01002339)
Timeframe: 1 year
Intervention | mg/dl (Mean) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 44.84 |
Tacrolimus With Steroids Minimization | 49.29 |
CsA With Steroid Minimization | 48.35 |
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Lipidic Profile (LDL-c)
(NCT01002339)
Timeframe: 1 year
Intervention | mg/dl (Mean) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 94.00 |
Tacrolimus With Steroids Minimization | 95.43 |
CsA With Steroid Minimization | 88.65 |
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Lipidic Profile (Triglycerides)
(NCT01002339)
Timeframe: 1 year
Intervention | mg/dl (Mean) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 159.44 |
Tacrolimus With Steroids Minimization | 145.59 |
CsA With Steroid Minimization | 160.78 |
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"Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)"
American Diabetes Association criteria (ADA) including an oral glucose tolerance test. (NCT01002339)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
| % of patients with NODAT | % of patients without NODAT |
---|
CsA With Steroid Minimization | 7.9 | 92.1 |
,Tacrolimus With Rapid Steroid Withdrawal | 34.1 | 65.9 |
,Tacrolimus With Steroids Minimization | 23.1 | 76.9 |
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Number of Antihypertensive Drugs Patients Reported Taking.
(NCT01002339)
Timeframe: 1 year
Intervention | number of antihypertensive drugs (Median) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 2 |
Tacrolimus With Steroids Minimization | 2 |
CsA With Steroid Minimization | 2 |
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Patients Treated With Insulin or Oral Antidiabetic Drugs
(NCT01002339)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 20 |
Tacrolimus With Steroids Minimization | 15.4 |
CsA With Steroid Minimization | 2.6 |
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Percentage of Patients Using Acetylsalicylic Acid (ASA)
(NCT01002339)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 53.9 |
Tacrolimus With Steroids Minimization | 48.7 |
CsA With Steroid Minimization | 52.8 |
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Percentage of Patients Using Statins
(NCT01002339)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 56. |
Tacrolimus With Steroids Minimization | 61.5 |
CsA With Steroid Minimization | 73.7 |
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Primary Outcome Measure (Glucose Intolerance)
Glycemia >=140 and <200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria. (NCT01002339)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 26.9 |
Tacrolimus With Steroids Minimization | 31.0 |
CsA With Steroid Minimization | 33.3 |
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Proteinuria
(NCT01002339)
Timeframe: 1 year
Intervention | mg/day (Mean) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 208 |
Tacrolimus With Steroids Minimization | 241 |
CsA With Steroid Minimization | 343.2 |
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Rejection
Biopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection. (NCT01002339)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 11.4 |
Tacrolimus With Steroids Minimization | 4.8 |
CsA With Steroid Minimization | 21.4 |
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Renal Function
Estimated Glomerular Filtration Rate (ml/min/1.73 m^2) (NCT01002339)
Timeframe: 1 year
Intervention | ml/min/1.73 m^2 (Mean) |
---|
Tacrolimus With Rapid Steroid Withdrawal | 51.9 |
Tacrolimus With Steroids Minimization | 47.4 |
CsA With Steroid Minimization | 44.6 |
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Complete Response
Complete Response (NCT01004991)
Timeframe: 13 months
Intervention | Participants (Count of Participants) |
---|
All Patients | 11 |
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Percentage of Participants Positive for de Novo Donor-Specific Alloantibody Production in the First Year Post-Transplantation
A de novo donor-specific alloantibody (DSA) is a newly developed alloantibody that is against the donor organ. This measure includes all de novo DSA (≥1000 MFI) regardless of is persistence or timing within the first year post-transplant. Alloantibodies are important mediators of acute and chronic rejection. (NCT01005316)
Timeframe: Transplantation to first year post transplant (up to 12 months post transplant).
Intervention | percentage of participants (Number) |
---|
Cohort A: Non-Sensitized | 22.7 |
Cohort B: Sensitized, Crossmatch Positive | 50.0 |
Cohort B: Sensitized, Crossmatch Negative | 37.8 |
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Percentage of Participants Experiencing Acute Rejection
Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT)) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression). (NCT01005316)
Timeframe: Transplantation to the end of study.
Intervention | percentage of participants (Number) |
---|
Cohort A: Non-Sensitized | 27.8 |
Cohort B: Sensitized, Crossmatch Positive | 75.0 |
Cohort B: Sensitized, Crossmatch Negative | 49.6 |
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Percentage of Participants With the Presence of Anti-MICA Antibodies by Luminex TM Assay
Major histocompatibility complex class I chain-related gene A (MICA) is an antigen that is a potential marker of rejection. Luminex TM assay was used to detect its presence. (NCT01005316)
Timeframe: Pre-Transplantation
Intervention | percentage of participants (Number) |
---|
Cohort A: Non-Sensitized | 8.2 |
Cohort B: Sensitized, Crossmatch Positive | 18.8 |
Cohort B: Sensitized, Crossmatch Negative | 11.0 |
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Percentage of Participants -Quantification of Anti-HLA IgG Antibodies by Luminex SA Testing
Quantification of anti-HLA IgG antibodies is measured in mean fluorescence intensity (MFI). The maximum MFI for the given subject is provided. (NCT01005316)
Timeframe: Pre-transplantation
Intervention | percentage of participants (Number) |
---|
| Missing | None | MFI 1000-3999 | MFI 4000-7999 | MFI ≥8000 |
---|
Cohort A: Non-Sensitized | 0 | 77.3 | 20.6 | 1.0 | 1.0 |
,Cohort B: Sensitized, Crossmatch Negative | 2.4 | 29.1 | 29.9 | 14.2 | 24.4 |
,Cohort B: Sensitized, Crossmatch Positive | 0 | 18.8 | 6.3 | 12.5 | 62.5 |
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Percentage of Participants With the Presence of Anti-HLA IgG Antibodies by Luminex SA Testing
Luminex SA testing was used to detect the presence of anti-HLA IgG Antibodies for all samples at a central laboratory. (NCT01005316)
Timeframe: Pre-transplantation
Intervention | percentage of participants (Number) |
---|
Cohort A: Non-Sensitized | 22.7 |
Cohort B: Sensitized, Crossmatch Positive | 81.3 |
Cohort B: Sensitized, Crossmatch Negative | 68.5 |
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Percentage of Participants With Occurrence of Re-Hospitalization(s)
Hospitalization is defined as any hospitalization lasting greater than 24 hours. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).
Intervention | percentage of participants (Number) |
---|
Cohort A: Non-Sensitized | 66.0 |
Cohort B: Sensitized, Crossmatch Positive | 75.0 |
Cohort B: Sensitized, Crossmatch Negative | 62.2 |
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Time to Production of Post-Transplant de Novo Donor-specific Alloantibodies
Time (in days) from transplant to development of de novo donor-specific alloantibodies (DSA). This measure is calculated as time from transplant until the earliest time of development of any de novo DSA. The DSA is a newly developed alloantibody that is against the donor organ. Alloantibodies are important mediators of acute and chronic rejection. (NCT01005316)
Timeframe: Transplantation to first year post transplant (up to 12 months post transplant).
Intervention | Days (Mean) |
---|
Cohort A: Non-Sensitized | 28.1 |
Cohort B: Sensitized, Crossmatch Positive | 15.4 |
Cohort B: Sensitized, Crossmatch Negative | 55.1 |
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Time to Post-Transplantation Lymphoproliferative Disorder
Time (in days) post-transplant lymphoproliferative disorder (PTLD). PTLD is defined as histopathological evidence of lymphoid proliferation (nodal or extranodal) fulfilling the criteria of the revised classification of the WHO 2008 (Swerdlow 2008). Time to PTLD is time from transplantation until the diagnosis of PTLD. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).
Intervention | Days (Mean) |
---|
Cohort A: Non-Sensitized | 910 |
Cohort B: Sensitized, Crossmatch Positive | NA |
Cohort B: Sensitized, Crossmatch Negative | 118.7 |
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Time to New-Onset Diabetes Mellitus
Time (in days) to new-onset diabetes mellitus. New-onset diabetes mellitus is defined as the new onset of insulin dependency or the need for oral hypoglycemic agents lasting more than 30 days post-transplant. Time to new-onset diabetes is time from transplantation until the diagnosis of new-onset diabetes. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).
Intervention | Days (Mean) |
---|
Cohort A: Non-Sensitized | 73 |
Cohort B: Sensitized, Crossmatch Positive | 48 |
Cohort B: Sensitized, Crossmatch Negative | 283.4 |
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Time to Diagnosis of Chronic Rejection
Time (in days) to the diagnosis of chronic rejection. Chronic rejection is defined as stenosis, irregularity, or ectasia of the epicardial vessels, or severe peripheral pruning of the distal coronary artery tree. Time to diagnosis is time from transplantation until the first diagnosis of chronic rejection. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).
Intervention | Days (Mean) |
---|
Cohort A: Non-Sensitized | 606.8 |
Cohort B: Sensitized, Crossmatch Positive | NA |
Cohort B: Sensitized, Crossmatch Negative | 398.9 |
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Time to Acute Rejection
Time (in days) to acute rejection. Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression). Time to acute rejection is time from transplantation to first acute rejection date. (NCT01005316)
Timeframe: Transplantation to the end of study.
Intervention | Days (Mean) |
---|
Cohort A: Non-Sensitized | 151.0 |
Cohort B: Sensitized, Crossmatch Positive | 74.5 |
Cohort B: Sensitized, Crossmatch Negative | 124.7 |
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Time From Participant Listing on Organ Wait-List to Receiving Organ Transplant, Death or De-Listing
Time (in days) from listing on the organ wait-list to receiving an organ transplant, death or de-listing. This measure is calculated as time from listing on the organ wait-list until the earliest time among transplantation, death and de-listing. (NCT01005316)
Timeframe: Study enrollment to transplantation
Intervention | Days (Mean) |
---|
Enrolled | 128.3 |
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Presence of C4d on Endomyocardial Biopsy (EMB)
The biopsy of the heart stained positive for the presence of C4d, a potential marker of rejection. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).
Intervention | percentage of participants (Number) |
---|
Cohort A: Non-Sensitized | 18.6 |
Cohort B: Sensitized, Crossmatch Positive | 62.5 |
Cohort B: Sensitized, Crossmatch Negative | 34.6 |
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Percentage of Participants- Mortality While on Transplantation Wait-List
Death that occurred while on the transplantation wait-list, and thus before receiving a heart transplant. (NCT01005316)
Timeframe: Pre-transplantation
Intervention | percentage of participants (Number) |
---|
Enrolled, Not Transplanted | 39.2 |
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Percentage of Participants Positive for Severe Infection(s)
Severe infections are defined as a clinical illness considered likely infectious in origin that leads to hospitalization. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).
Intervention | percentage of participants (Number) |
---|
Cohort A: Non-Sensitized | 34.0 |
Cohort B: Sensitized, Crossmatch Positive | 43.8 |
Cohort B: Sensitized, Crossmatch Negative | 30.7 |
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Percentage of Participants Positive for Event of Death, Graft Loss or Rejection With Hemodynamic Compromise at 12 Months Post-Transplantation
"This is a composite outcome of death, graft loss or rejection with hemodynamic compromise.~Rejection was considered to be with hemodynamic compromise if the rejection event had new onset echocardiographically measured from fractional shortening <26% with ≥5% fall from last echocardiogram or the rejection event had new onset of heart failure." (NCT01005316)
Timeframe: 12 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Cohort A: Non-Sensitized | 5.2 |
Cohort B: Sensitized, Crossmatch Positive | 12.5 |
Cohort B: Sensitized, Crossmatch Negative | 11.8 |
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Percentage of Participants -Overall Participant and Graft Survival
This measure looks at the participants who did not die and/or did not receive a subsequent heart transplant. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).
Intervention | percentage of participants (Number) |
---|
Cohort A: Non-Sensitized | 93.8 |
Cohort B: Sensitized, Crossmatch Positive | 93.8 |
Cohort B: Sensitized, Crossmatch Negative | 87.4 |
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Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method. (NCT01023061)
Timeframe: Up to 24 months after initiation of radiation therapy
Intervention | Participants (Count of Participants) |
---|
Treatment (Antihormone Therapy and Radiation Therapy) | 6 |
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Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry
The levels from patients treated in this study will be compared to a control set of biopsies acquired from a separate but similar population of men with intermediate and high risk prostate cancer treated with three months of combined Luteinizing hormone releasing hormone agonist and bicalutamide as part of standard of care. (NCT01023061)
Timeframe: Week 12
Intervention | pg/mg (Median) |
---|
Treatment (Antihormone Therapy and Radiation Therapy) | 0.050 |
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Overall Survival
Survival from enrollment to death. (NCT01026220)
Timeframe: At 3 years from enrollment
Intervention | Probability of survival (Number) |
---|
Group 1 | 0.97 |
Group 2 | 0.97 |
Group 3 | 0.97 |
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Relapse-free Survival
A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy. (NCT01026220)
Timeframe: 3 years from enrollment
Intervention | Probability of survival (Number) |
---|
Group 1 | 0.82 |
Group 6 | 0.83 |
Group 7 | 0.79 |
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Safety Analysis and Monitoring of Toxic Death
The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment. (NCT01026220)
Timeframe: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).
Intervention | participants (Number) |
---|
Group 1 | 0 |
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Second-event-free Survival
Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event. (NCT01026220)
Timeframe: At 4 years from enrollment
Intervention | Probability of survival (Number) |
---|
Group 1 | 0.91 |
,Group 2 | 0.94 |
Group 3 | 0.88 |
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Event Free Survival
Survival from enrollment to first event: relapse/progression, second malignancy, or death. (NCT01026220)
Timeframe: At 3 years from enrollment
Intervention | Probability of survival (Number) |
---|
Group 1 | 0.81 |
Group 2 | 0.83 |
Group 3 | 0.78 |
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Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles. (NCT01026220)
Timeframe: 3 years from enrollment
Intervention | Probability of survival (Number) |
---|
Group 1 | 0.84 |
Group 4 | 0.82 |
Group 5 | 0.90 |
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Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy
The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy. (NCT01026220)
Timeframe: During and after completion of study treatment.
Intervention | participants (Number) |
---|
Group 1 | 72 |
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Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC)
Clinical response was assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas. Complete remission is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed is as per complete remission except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Relapsed disease is appearance of any new lesion or increase by ≥50% in the size of the previously involved sites. Stable disease is defined as less than a partial response but not progressive disease. Progression is ≥50% increase from nadir in the SPD of diameters of any previously identified abnormal node for partial response or non-responders; and an appearance of any new lesion during or at the end of therapy. (NCT01030900)
Timeframe: On study and at relapse after study treatment, approximately 10 months
Intervention | Participants (Count of Participants) |
---|
| Complete remission | Complete response unconfirmed | Partial response | Stable disease | Relapsed disease | Progressive disease |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath | 17 | 0 | 13 | 2 | 0 | 14 |
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Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01030900)
Timeframe: Date treatment consent signed to date off study, approximately 58 months and 18 days.
Intervention | Participants (Count of Participants) |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath | 48 |
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Overall Survival (OS)
OS is from enrollment to the day of death estimated using the Kaplan-Meier curve. (NCT01030900)
Timeframe: Median overall survival from enrollment to the day of death, approximately 17.9 months
Intervention | months (Median) |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath | 17.9 |
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Progression Free Survival (PFS)
PFS is the time interval from start of treatment to documented evidence of disease progression estimated using a Kaplan Meier curve. Progression was assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas and is defined as ≥50% increase from nadir in the sum of the products of diameters of any previously identified abnormal node for partial response or non-responders. And an appearance of any new lesion during or at the end of therapy. (NCT01030900)
Timeframe: Time of progression or death, approximately 10 months
Intervention | months (Median) |
---|
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath | 6.6 |
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Dose-Normalized C0
"Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720)" (NCT01033864)
Timeframe: Day 1 predose
Intervention | mg/L (Mean) |
---|
MMF/Prednisone | 2.962 |
EC-MPS/Prednisone | 4.658 |
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Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)
(NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Intervention | percentage of participants (Number) |
---|
| Tmax equals (=) 0.5333 hours (hrs) | Tmax=0.6000 hrs | Tmax=0.7333 hrs | Tmax=0.7667 hrs | Tmax=1.0667 hrs | Tmax=1.0833 hrs | Tmax=1.1167 hrs | Tmax=1.2167 hrs | Tmax=2.0167 hrs | Tmax=2.0833 hrs | Tmax=2.1000 hrs | Tmax=2.1167 hrs | Tmax=2.1667 hrs | Tmax=3.1167 hrs | Tmax=3.1833 hrs |
---|
EC-MPS/Prednisone | 0.0 | 0.0 | 0.0 | 0.0 | 9.1 | 0.0 | 0.0 | 0.0 | 9.1 | 18.2 | 9.1 | 27.3 | 9.1 | 9.1 | 9.1 |
,MMF/Prednisone | 16.7 | 16.7 | 16.7 | 8.3 | 8.3 | 16.7 | 8.3 | 8.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
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Pre-dose Trough Concentration (C0)
The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment). (NCT01033864)
Timeframe: Day 1 predose
Intervention | mg/L (Mean) |
---|
MMF/Prednisone | 2.387 |
EC-MPS/Prednisone | 2.944 |
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MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)
The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1. (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Intervention | mg*h/L (Mean) |
---|
MMF/Prednisone | 50.36348 |
EC-MPS/Prednisone | 57.06682 |
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Minimum Plasma Concentration (Cmin)
The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Intervention | mg/L (Mean) |
---|
MMF/Prednisone | 1.385 |
EC-MPS/Prednisone | 1.620 |
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Maximum Plasma Concentration (Cmax)
The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1. (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Intervention | mg/L (Mean) |
---|
MMF/Prednisone | 15.385 |
EC-MPS/Prednisone | 17.827 |
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Dose-Normalized MPA AUC0-12
"Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720)" (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Intervention | mg*h/L (Mean) |
---|
MMF/Prednisone | 61.53862 |
EC-MPS/Prednisone | 94.65765 |
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Dose-Normalized Cmin
"Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720)" (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Intervention | mg/L (Mean) |
---|
MMF/Prednisone | 1.702 |
EC-MPS/Prednisone | 2.613 |
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Dose-Normalized Cmax (mg/L)
"Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720)" (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Intervention | mg/L (Mean) |
---|
MMF/Prednisone | 18.402 |
EC-MPS/Prednisone | 29.996 |
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Regression Coefficients For Participants Receiving MMF
The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L). (NCT01033864)
Timeframe: Day 1 at 30 minutes and 1 and 2 hours postdose
Intervention | mg/L (Number) |
---|
| Intercept | Concentration at 30 minutes (C0.5) | Concentration at 1 hour (C1) | Concentration at 2 hours (C2) |
---|
MMF/Prednisone | 2.17192 | 0.74031 | 1.89323 | 2.85923 |
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Subsequent Anti-lymphoma Therapy Rate at 1-year
Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive. (NCT01040871)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
VR-CAP | 71.1 |
R-CHOP | 80.2 |
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Rate of Durable Response
Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma. (NCT01040871)
Timeframe: Median follow up approx. 12 months
Intervention | percentage of participants (Number) |
---|
VR-CAP | 53.9 |
R-CHOP | 67.6 |
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Rate of Durable Complete Response
Proportion of subjects who achieved a CR with duration of at least 6 months (NCT01040871)
Timeframe: Median follow up approx 12 months
Intervention | percentage of participants (Number) |
---|
VR-CAP | 44.7 |
R-CHOP | 47.3 |
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Progression-free Survival (PFS)Rate at 1-year
Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death. (NCT01040871)
Timeframe: 1 year
Intervention | percentage of partipants (Number) |
---|
VR-CAP | 78.9 |
R-CHOP | 83.9 |
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Overall Survival Rate at 1-year
Kaplan-meier estimate of overall survival at 1-year measured from date of randomization. (NCT01040871)
Timeframe: 1 year
Intervention | percentage of partipants (Number) |
---|
VR-CAP | 94.1 |
R-CHOP | 84.2 |
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Complete Response (CR) Rate
"Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~PET scan was negative.~The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared.~If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy.~No new sites of disease were detected." (NCT01040871)
Timeframe: 6 cycles
Intervention | percentage of participants (Number) |
---|
VR-CAP | 64.5 |
R-CHOP | 63.5 |
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Overall Response Rate
"Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses." (NCT01040871)
Timeframe: 6 cycles
Intervention | percentage of participants (Number) |
---|
VR-CAP | 93.4 |
R-CHOP | 98.6 |
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Number of Participants With Reported Side Effects
(NCT01042145)
Timeframe: 12 days
Intervention | percentage of participants (Number) |
---|
Prednisone | 26 |
Dexamethasone | 24 |
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Time Missed From Work
(NCT01042145)
Timeframe: 12 days
Intervention | Hours (Mean) |
---|
Prednisone | 3.79 |
Dexamethasone | 4.06 |
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Parental Stress
Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0. (NCT01042145)
Timeframe: 12 days
Intervention | days (Mean) |
---|
Prednisone | 1.56 |
Dexamethasone | 1.39 |
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Additional Health Care
The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care. (NCT01042145)
Timeframe: 11 days
Intervention | percentage of participants (Number) |
---|
Prednisone | 7 |
Dexamethasone | 2 |
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Duration of Croup Symptoms
(NCT01042145)
Timeframe: 12 days
Intervention | days (Mean) |
---|
Prednisone | 2.2 |
Dexamethasone | 2.8 |
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Nights With Disturbed Sleep
(NCT01042145)
Timeframe: 12 days
Intervention | nights (Mean) |
---|
Prednisone | 1.21 |
Dexamethasone | 0.68 |
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Number of Participants With Toxicity as Measured by NCI CTCAE v3.0 Criteria
Number of Participants with Grade 3/4 Toxicity as measured by NCI CTCAE v3.0 criteria (NCT01051570)
Timeframe: Day 1 of each cycle (every 21 days), through study completion, an average of 6 months
Intervention | Participants (Count of Participants) |
---|
| Anemia | Thrombocytopenia | Lymphopenia | Leukopenia | Infection without neutropenia | Hypophosphatemia | Neutropenia | Dehydration | Hyperglycemia | Hyponatremia | Pulmonary embolism | Fatigue | Hypercholesterolemia | Rash | AST | Hypomagnesemia | Hypokalemia |
---|
Carboplatin, RAD 001 & Prednisone | 10 | 9 | 6 | 4 | 4 | 4 | 3 | 3 | 3 | 3 | 2 | 2 | 1 | 1 | 1 | 1 | 1 |
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Association of PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6)
PSA response defined as a decrease of 30% or more will be tabled against mTOR, pAKT, and p70S6 (1+, 2+, 3+ vs ND) (NCT01051570)
Timeframe: Archival tissue will be collected if available. Optional biopsies pre-treatment and 24 hours after first everolimus and carboplatin dose
Intervention | participants (Number) |
---|
| pAKT(ND) vs Responder | mTOR(ND) vs Responder | p70S6(ND) vs Responder |
---|
Carboplatin, RAD 001 & Prednisone | 1 | 0 | 1 |
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PSA Response Rate
PSA response rate with response defined as => a 30% reduction in PSA (NCT01051570)
Timeframe: Day 1 of each cycle (every 21 days), through study completion, an average of 6 months
Intervention | percentage of participants (Number) |
---|
Carboplatin, RAD 001 & Prednisone | 15 |
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Pharmacokinetics: Observed Carboplatin AUC Was Estimated Based on the Concentration in the 2.75-h Sample.
Using a limited sampling model (i.e., AUC = 0.52 × C2.75h + 0.92) (Sorensen et al., 1993), observed carboplatin AUC was estimated based on the concentration in the 2.75-h sample. (NCT01051570)
Timeframe: Samples were collected Cycle 2, Day 1
Intervention | mg/ml*min (Mean) |
---|
Carboplatin, RAD 001 & Prednisone | 5.8 |
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Overall Survival
Overall Survival as measured by the Kaplan-Meier method (NCT01051570)
Timeframe: After treatment, participants will be contacted every 3 months up to 4 years
Intervention | months (Median) |
---|
Carboplatin, RAD 001 & Prednisone | 12.5 |
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Time to Progression (TTP)
Progression defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01051570)
Timeframe: Up to 63 days while on treatment, then up 90 days thereafter. From date of registration to date of progressive disease.
Intervention | months (Median) |
---|
Carboplatin, RAD 001 & Prednisone | 2.5 |
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Response Rate
Response rate in older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy. The study used the uniform response assessment of the International Myeloma Working Group with the addition of MR (minimal response) (Durie et al, 2006; Kumar et al, 2016). MR was defined as a 25-49% decrease in serum M spike, and a 50-89% improvement in urine M spike. For patients without a measurable serum or urine M spike, a 25-49% decrease in the difference between the involved and uninvolved free light chains was required. The response in this trial is defined as complete remission (CR), stringent complete remission (SRC), very good partial remission (VGPR) and partial remission (PR) and minimal response (MR). (NCT01054144)
Timeframe: Every 8 weeks up to 12 months
Intervention | Participants (Count of Participants) |
---|
| Complete Response & Stringent Complete Response | Very Good Partial Response (VGPR) | Partial Response (PR) | Minimal Response (MR) | Stable Disease | Overall Response >/= PR |
---|
Response Adapted Therapy | 1 | 1 | 2 | 5 | 0 | 4 |
,Single Agent Lenalidomide | 4 | 3 | 12 | 4 | 3 | 19 |
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Number of Participants With 1 Year Overall Survival (OS)
The 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (NCT01054144)
Timeframe: 1 Year
Intervention | participants (Number) |
---|
Response Adapted Therapy | 27 |
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Number of Participants With Serious Adverse Events
Number of participants with serious adverse events (NCT01054144)
Timeframe: Day 1 through Off Study Date, an average of 48 months
Intervention | participants (Number) |
---|
Response Adapted Therapy | 20 |
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Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1
DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. (NCT01055496)
Timeframe: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.
Intervention | Participants (Count of Participants) |
---|
Cohort 1, Arm 1 | 0 |
Cohort 2, Arm 1 | 0 |
Cohort 3, Arm 1 | 1 |
Cohort 4, Arm 1 | 2 |
MTD Confirmation Cohort, Arm 1 | 2 |
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Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts
OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: 6, 12, and 24 months
Intervention | Percent Probability (Number) |
---|
| 6 months | 12 months | 24 months |
---|
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 100.00 | 80.00 | 80.00 |
,DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 74.07 | 62.96 | 55.09 |
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Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts
PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with OR of CR, PR, SD, or PD, but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks
Intervention | Months (Median) |
---|
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 14.36 |
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 6.14 |
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Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts
OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period
Intervention | Months (Median) |
---|
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | NA |
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | NA |
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Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts
OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period
Intervention | Months (Median) |
---|
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | NA |
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | NA |
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Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts
Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. (NCT01055496)
Timeframe: 6, 12 and 24 months
Intervention | Percent Probability (Number) |
---|
| 6 months | 12 months | 24 months |
---|
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 80.00 | 66.67 | 22.22 |
,DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 60.98 | 47.92 | 33.54 |
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Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts
OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 centimeters [cm] in their greatest transverse diameter (GTD) for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.
Intervention | Percentage of participants (Number) |
---|
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 81.3 |
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 53.6 |
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Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.
Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. (NCT01055496)
Timeframe: 6, 12, and 24 months
Intervention | Percent Probability (Number) |
---|
| 6 months | 12 months | 24 months |
---|
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 61.85 | 51.54 | 44.67 |
,MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 54.74 | 24.88 | NA |
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Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts
OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: 6, 12, and 24 Months
Intervention | Percent Probability (Number) |
---|
| 6 months | 12 months | 24 months |
---|
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 84.38 | 78.13 | 71.61 |
,MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 88.00 | 59.11 | 53.74 |
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Mean Inotuzumab Ozogamicin Serum Concentrations
Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. (NCT01055496)
Timeframe: Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.
Intervention | ng/mL (Mean) |
---|
| Cycle 1 Day 2, 0h |
---|
Cohort 1, Arm 2 | NA |
,Cohort 3b, Arm 2 | NA |
,Cohort 4, Arm 1 | NA |
,Cohort 4, Arm 2 | NA |
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Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy
"The following parameters were analyzed for hematology: lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling." (NCT01055496)
Timeframe: Within 3 days prior to the start of each cycle, Day 8 of each cycle, Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.
Intervention | Percentage of Participants (Number) |
---|
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | 91.7 |
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | 96.4 |
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Percentage of Participants With a Treatment Emergent AE
An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event may not necessarily have had a causal relationship with the treatment or usage. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as those occurring on or after the first study drug dose day through and including 56 days post last dose of study drug. The severity of all AEs was graded by the investigator using the National Cancer Institute Common Terminology Criteria for AE Version 3.0 (NCI CTCAE v3.0). (NCT01055496)
Timeframe: SAEs were assessed from informed consent through and including the end of treatment visit (at least 28 calendar days after last study drug administration). Non-SAEs were recorded from time of the first dose of study drug through last participant visit.
Intervention | Percentage of Participants (Number) |
---|
| Subjects with AEs | Subjects with SAEs | Subjects with Grade 3 or 4 AEs | Subjects with Grade 5 AEs | Subjects discontinued due to AEs | Subjects with dose reduced due to AEs | Subjects with temporary discontinuation due to AEs |
---|
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | 100 | 31.3 | 89.6 | 4.2 | 27.1 | 16.7 | 54.2 |
,Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | 100 | 45.5 | 96.4 | 5.5 | 36.4 | 32.7 | 67.3 |
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Mean Inotuzumab Ozogamicin Serum Concentrations
Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. (NCT01055496)
Timeframe: Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.
Intervention | ng/mL (Mean) |
---|
| Cycle 1 Day 2, 0h | Cycle 3 Day 2, 0h | Cycle 3 Day 2, 1h | Cycle 3 Day 2, 3h | Cycle 3 Day 3, 24h | Cycle 3 Day 8, 168h |
---|
Cohort 2b/MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | NA | 25.00 | 283.27 | 280.33 | 154.25 | NA |
,Cohort 3/MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | NA | NA | 189.74 | 213.95 | 110.39 | NA |
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Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy
"The following parameters were analyzed for blood chemistry: blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling." (NCT01055496)
Timeframe: Within 3 days prior to the start of each cycle, on Day 8 of each cycle, on Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.
Intervention | Percentage of Participants (Number) |
---|
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | 21.3 |
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | 36.4 |
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Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts
OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their GTD for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.
Intervention | Percentage of participants (Number) |
---|
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 81.3 |
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 51.9 |
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Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts
PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with overall response of CR, PR, stable disease (SD), or disease progression (PD), but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks
Intervention | Months (Median) |
---|
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 16.36 |
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 10.12 |
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Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2
DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. (NCT01055496)
Timeframe: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.
Intervention | Participants (Count of Participants) |
---|
Cohort 1, Arm 2 | 0 |
Cohort 2a, Arm 2 | 2 |
Cohort 2b, Arm 2 | 1 |
Cohort 3b, Arm 2 | 2 |
Cohort 4, Arm 2 | 0 |
MTD Confirmation Cohort, Arm 2 | 3 |
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Phase 2: Time to Radiographic Disease Progression
Time to Radiographic Disease Progression was defined as (date of Radiographic Disease progression) - (date of first dose of drug) + 1. Radiographic disease progression is defined as the presence of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) criteria and/or bone scan progression determined according to second Prostate Cancer Clinical Trials Working Group (PCWG2) bone scan criteria. (NCT01084655)
Timeframe: Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)
Intervention | days (Median) |
---|
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | 393 |
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Phase 2: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel
(NCT01084655)
Timeframe: Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion
Intervention | nanogram*hour per milliliter (ng*hr/mL) (Geometric Mean) |
---|
Phase 2 Cycle 1: Docetaxel 75 mg/m^2 + Prednisone 5 mg | 1180 |
Phase 2 Cycle 2: Orteronel 400 mg BID + Docetaxel + Prednisone | 1270 |
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Phase 2: Best PSA Response
Best PSA response was defined as the maximum PSA percent reduction from baseline at any time beyond Cycle 1. (NCT01084655)
Timeframe: Cycle 2 Day 1 up to Cycle 12 Day 21
Intervention | percent change (Mean) |
---|
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | -61.72 |
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Phase 2: Time to PSA Progression
Time to PSA progression was defined as (date of PSA progression) - (date of first dose of drug) + 1, where PSA progression was defined as: For participants whose PSA concentrations never declined before the end of Cycle 4 of treatment: a) >=25% increase over the baseline level and an increase in absolute PSA concentration >=2 ng/mL; For participants who initially experienced a PSA decline: a) >=25% increase in PSA above the nadir concentration and an increase in absolute PSA concentration >=2 ng/mL. (NCT01084655)
Timeframe: Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)
Intervention | days (Median) |
---|
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | 203 |
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Phase 2: Cmax: Maximum Observed Plasma Concentration for Docetaxel
(NCT01084655)
Timeframe: Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion
Intervention | nanogram per milliliter (ng/mL) (Geometric Mean) |
---|
Phase 2 Cycle 1: Docetaxel 75 mg/m^2 + Prednisone 5 mg | 1330 |
Phase 2 Cycle 2: Orteronel 400 mg BID + Docetaxel + Prednisone | 1600 |
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Phase 2: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for Orteronel
(NCT01084655)
Timeframe: Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel
Intervention | ng/mL (Geometric Mean) |
---|
Phase 2 Cycle 1: Orteronel 400 mg BID + Docetaxel + Prednisone | 2660 |
Phase 2 Cycle 2: Orteronel 400 mg BID + Docetaxel + Prednisone | 3000 |
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Phase 2: AUC 0-tau: Area Under the Plasma Concentration Versus Time Curve Zero to the Time of the End of the Dosing Interval for Orteronel
(NCT01084655)
Timeframe: Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel
Intervention | ng*hr/mL (Geometric Mean) |
---|
Phase 2 Cycle 1: Orteronel 400 mg BID + Docetaxel + Prednisone | 18000 |
Phase 2 Cycle 2: Orteronel 400 mg BID + Docetaxel + Prednisone | 871 |
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Phase 2: Percentage of Participants With Prostate-specific Antigen (PSA) Response of 30 Percent (%), 50%, and 90%
PSA response rates (PSA-30, PSA-50, and PSA-90) were defined as greater than or equal to (>=) 30%, 50%, and 90% reductions, respectively, from baseline in PSA concentration. (NCT01084655)
Timeframe: Cycle 4 Day 21
Intervention | percentage of participants (Number) |
---|
| PSA-30 | PSA-50 | PSA-90 |
---|
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | 68 | 59 | 23 |
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Phase 2: Percentage of Participants With Objective Measurable Disease Response
Percentage of participants with objective measurable disease response based assessment of complete response (CR), partial response (PR), stable disease or PD according to RECIST (Version 1.1). A CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to less than (<)10 millimeter (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes. (NCT01084655)
Timeframe: Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)
Intervention | percentage of participants (Number) |
---|
| Complete response | Partial response | Stable Disease | Progressive Disease |
---|
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | 0 | 70 | 30 | 0 |
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Phase 2: Change From Baseline in Circulating Tumor Cells (CTCs)
Baseline is defined as the last scheduled observed measurement prior to the first dose of drug. (NCT01084655)
Timeframe: Cycle 2 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1, End of treatment (approximately up to Cycle 48), Last assessment (30 days after last dose of study drug, approximately up to 1038 days)
Intervention | milliliter (mL) (Mean) |
---|
| Baseline (n=21) | Change at Cycle 2 Day 1 (n=12) | Change at Cycle 5 Day 1 (n=16) | Change at Cycle 9 Day 1 (n=6) | Change at Cycle 13 Day 1 (n=7) | Change at Cycle 17 Day 1 (n=5) | Change at Cycle 21 Day 1 (n=1) | Change at End of treatment (n=11) | Change at Last assessment (n=18) |
---|
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | 47.9 | -11.9 | -39.0 | -25.5 | -11.3 | -18.8 | -5.0 | -40.2 | -35.0 |
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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE)
(NCT01084655)
Timeframe: Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21)
Intervention | participants (Number) |
---|
| TEAE | SAE |
---|
Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone | 6 | 5 |
,Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone | 8 | 5 |
,Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | 23 | 16 |
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Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. (NCT01085097)
Timeframe: Baseline up to Week 28
Intervention | participants (Number) |
---|
Placebo | 14 |
Laquinimod 0.5 mg | 15 |
Laquinimod 1 mg | 15 |
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Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula. (NCT01085097)
Timeframe: Baseline, Week 24
Intervention | percent change (Mean) |
---|
Placebo | 12.1 |
Laquinimod 0.5 mg | 18.0 |
Laquinimod 1 mg | 24.3 |
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All-Cause Mortality: From Treatment Initiation to Week 104
Death from any cause occurring after randomization and ≤ Week 104. (NCT01086540)
Timeframe: Day 0 (Treatment Randomization) to Week 104
Intervention | Participants (Count of Participants) |
---|
Rituximab | 8 |
Placebo | 5 |
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Time to Clinical Worsening
"Assessment of time to clinical worsening, censored at Week 48, defined as the first occurrence of any of the following:~death,~hospitalization for Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH),~lung transplantation,~atrial septostomy,~addition of other Pulmonary Arterial Hypertension (PAH) therapeutic agents, or~worsening of the six minute walk distance by > 20% and an increase in New York Heart Association functional class.~Time to clinical worsening was defined as the first date that met any of the above criteria and was calculated in study days as: date of first event minus (-) date of treatment randomization. If a participant did not experience any of the referenced events by Week 48 or, if the date of death was after the 48 week follow-up period, time to clinical worsening was equal to the participant's duration of follow-up in the study." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48
Intervention | Weeks (Mean) |
---|
Rituximab | 21.2 |
Placebo | 26.2 |
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Change From Baseline in Distance Walked During a Six Minute Walk Test
The six minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24
Intervention | Meters (Least Squares Mean) |
---|
Rituximab | 23.6 |
Placebo | 0.5 |
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Change in Carbon Monoxide Diffusing Capacity (DLCO)
"Carbon Monoxide Diffusing Capacity (DLCO) is a measure of lung function. Predicted values for DLCO were computed according to the Global Lung Function Initiative (GLI) all-age reference values and corrected for hemoglobin. Lower DLCO values indicate worse disease activity.~DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)" (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48
Intervention | Percent Predicted Value (Least Squares Mean) |
---|
| Change from Baseline to Week 24 | Change from Baseline to Week 48 |
---|
Placebo | 0.4 | 0.7 |
,Rituximab | -0.3 | -0.5 |
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Time to the Change or Addition of New Pulmonary Arterial Hypertension (PAH) Therapeutic Medications
Per protocol, from the time of study entry, participants were to remain on background PAH medical therapy with either a single agent or a combination of prostanoid, endothelin receptor antagonist, PDE-5 inhibitor, and/or guanylate cyclase stimulators as per the entry criteria. Doses should have remained stable through the Week 24 primary outcome/endpoint visit. If a dose of a background PAH medication was changed or a new PAH medication was added during the course of the trial, the date of the first dose change or additional medication was recorded. Time to the addition or modification of PAH medications was defined in study days as: date of the first time a PAH medication was modified or added minus (-) date of randomization. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48
Intervention | Weeks (Mean) |
---|
Rituximab | 21.2 |
Placebo | 26.7 |
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Change in Quality of Life as Measured by the Disability Index of the Scleroderma Health Assessment Questionnaire (HAQ-DI)
The HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) and addresses scleroderma related manifestations that contribute to disability. The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48
Intervention | Units on a Scale (Least Squares Mean) |
---|
| Change from Baseline to Week 24 | Change from Baseline to Week 48 |
---|
Placebo | 0.0 | 0.0 |
,Rituximab | 0.0 | 0.0 |
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Change in Severity of Raynaud's Phenomenon
"Severity of Raynaud's phenomenon was measured by a Visual Analog Scale (VAS) of the Scleroderma Health Assessment Questionnaire (SHAQ). The SHAQ VAS includes a question asking, In the past week, how much has your Raynaud's Phenomenon interfered with your activities? Participants were asked to place a mark on a 15 cm line, scaled from 0 (does not interfere) to 100 (very severe limitation), to describe the severity of their Raynaud's phenomenon in the past week. The distance from the left edge of the line to the vertical line placed by the participant was measured in centimeters; VAS scores were converted to a 0 to 100 scale." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48
Intervention | Score on a Scale (Least Squares Mean) |
---|
| Change from Baseline to Week 24 | Change from Baseline to Week 48 |
---|
Placebo | 0.1 | 0.1 |
,Rituximab | -2.2 | -4.4 |
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Number of Grade 3 or Higher Adverse Events (AEs) Through Week 48
Total number of Grade 3, 4, and 5 AEs. Ref: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48
Intervention | Events (Number) |
---|
| Grade 3 AEs | Grade 4 AEs | Grade 5 AEs |
---|
Placebo | 19 | 2 | 1 |
,Rituximab | 28 | 6 | 3 |
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Oxygen Saturation Levels at Week 24 and Week 48
Oxygen saturation is the amount of oxygen that is in your bloodstream and is measured as the percentage of blood hemoglobin that is carrying oxygen. Normal oxygen saturation levels are considered to be 95-100 percent; low oxygen saturation values indicate worse disease. Room air oxygen saturation by pulse oximetry and/or amount of supplemental oxygen used, if saturation <90%, were recorded. (NCT01086540)
Timeframe: Week 24 , Week 48
Intervention | Percent Oxygen Saturation (Mean) |
---|
| O2 Sat Level: Week 24 | O2 Sat Level: Week 48 |
---|
Placebo | 96.1 | 96.2 |
,Rituximab | 96.5 | 97.7 |
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Percent Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization
"During a right heart catheterization, a catheter is guided to the right side of the heart and then into the pulmonary artery; blood flow through the heart is observed and is used to measure pressures in a participant's heart and lungs. Pulmonary vascular resistance (PVR) is measured in Woods Units. Higher PVR values indicate worse disease status.~Change in PVR is determined by Baseline value minus (-) Week 24 value." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24
Intervention | Percent Change (Least Squares Mean) |
---|
Rituximab | -4.6 |
Placebo | 3.2 |
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Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization at Week 24
During a right heart catheterization, a catheter is guided to the right side of the heart and then into the pulmonary artery; blood flow through the heart is observed and is used to measure pressures in a participant's heart and lungs. The calculation of Pulmonary Vascular Resistance (PVR) is measured in Woods Units. Change is derived by measuring the difference between Baseline and Week 24 PVR (Week 24 minus Baseline). Higher PVR values indicate worse disease status. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24
Intervention | Woods Units (Least Squares Mean) |
---|
Rituximab | -0.5 |
Placebo | 0.1 |
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Number of New Digital Ulcers
The total number of digital ulcers present on the dorsal and palmar surfaces for both the left and right fingers were captured at the Baseline study visit. The number of new digital ulcers since the last study visit (including any ulcers that had appeared and healed since the last study visit) on the dorsal and palmar surfaces for both the left and right fingers were captured at the post-Baseline study visits. The total number of digital ulcers on both hands was summed from the number present on the dorsal and palmar surfaces for both the left and right fingers. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48
Intervention | New Ulcers (Mean) |
---|
| Total Ulcer Count at Baseline | New Ulcers at Week 24 | New Ulcers at Week 48 |
---|
Placebo | 0.4 | 0.1 | 0.2 |
,Rituximab | 0.6 | 0.0 | 0.1 |
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Change From Baseline in Distance Walked During a Six Minute Walk Test at Week 24 and Week 48
The six minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48
Intervention | Meters (Least Squares Mean) |
---|
| Change from Baseline to Week 24 | Change from Baseline to Week 48 |
---|
Placebo | 0.4 | -7.0 |
,Rituximab | 25.5 | 9.5 |
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All-Cause Mortality: From Treatment Initiation to Week 48
Death from any cause occurring after randomization and ≤ Week 48. (NCT01086540)
Timeframe: Day 0 (Treatment Randomization) to Week 48
Intervention | Participants (Count of Participants) |
---|
Rituximab | 4 |
Placebo | 1 |
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Number of Participants With a Positive Surgical Margin at Radical Prostatectomy
The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate. (NCT01088529)
Timeframe: At the end of Cycle 3 (at radical prostatectomy)
Intervention | participants (Number) |
---|
AA+LHRHa | 6 |
LHRHa | 6 |
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Number of Participants With Prostate-Specific Antigen Response
The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL. (NCT01088529)
Timeframe: Cycle 3 Day 1
Intervention | participants (Number) |
---|
AA+LHRHa | 32 |
LHRHa | 0 |
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Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)
The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2. (NCT01088529)
Timeframe: At the end of Cycle 3 (at radical prostatectomy)
Intervention | participants (Number) |
---|
AA+LHRHa | 24 |
LHRHa | 8 |
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Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01092182)
Timeframe: Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.
Intervention | Participants (Count of Participants) |
---|
Group A - Low-risk Burkitt Lymphoma (BL) | 13 |
Group B - High-Risk Burkitt Lymphoma (BL) | 87 |
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 72 |
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Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval
OS was calculated from the enrolment date until date of death or last follow-up using the Kaplan Meier. Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: At 4 years
Intervention | percentage of participants (Number) |
---|
Group A - Low-risk Burkitt Lymphoma (BL) | 100 |
Group B - High-Risk Burkitt Lymphoma (BL) | 84.9 |
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 76.7 |
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Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2
The predictive value of early FDG-PET/CT scans on PFS was assessed after cycle 2. PFS is the time interval from start of treatment to documented evidence of disease progression, assessed by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: After 2 cycles of therapy and prior to cycle 3
Intervention | percentage of participants (Number) |
---|
Group A - Low-risk Burkitt Lymphoma (BL) | 100 |
Group B - High-Risk Burkitt Lymphoma (BL) | 90.0 |
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 78.7 |
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Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval
EFS was determined from the date of enrolment in the study until the date of progression, last documentation of disease at or after the last treatment cycle, death, or last follow-up (whichever occurred first). Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: At 4 years
Intervention | percentage of participants (Number) |
---|
Group A - Low-risk Burkitt Lymphoma (BL) | 100 |
Group B - High-Risk Burkitt Lymphoma (BL) | 82.1 |
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 71.0 |
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Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval
PFS is the time interval from start of treatment to documented evidence of disease progression. Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: Time of progression or death at 4 years
Intervention | percentage of participants (Number) |
---|
Group A - Low-risk Burkitt Lymphoma (BL) | 100 |
Group B - High-Risk Burkitt Lymphoma (BL) | 82.1 |
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 71.0 |
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SF-36 Physical Component Summary
The Medical Outcome Study SF-36 Physical Component Summary (PCS) is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being. (NCT01106833)
Timeframe: Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization
Intervention | score on a scale (Mean) |
---|
| Baseline | 2 Months | 6 Months | 1 Year | 2 Years |
---|
Sirolimus and Prednisone | 38 | 42 | 43 | 43 | 43 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 38 | 39 | 38 | 40 | 44 |
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Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years
The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint. (NCT01106833)
Timeframe: 2 years post-randomization
Intervention | percentage of participants (Number) |
---|
Sirolimus, Calcineurin Inhibitor, and Prednisone | 20 |
Sirolimus and Prednisone | 23.2 |
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Percentage of Participants With Overall Survival
Overall survival is defined as survival of death from any cause. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 6 Months | 24 Months |
---|
Sirolimus and Prednisone | 91.7 | 81.5 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 85.5 | 74.0 |
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Percentage of Participants With Progression-free Survival
Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 6 Months | 24 Months |
---|
Sirolimus and Prednisone | 90.3 | 78.6 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 84.0 | 67.3 |
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Prednisone Dose
Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization. (NCT01106833)
Timeframe: Baseline, 6 months, and 1 year post-randomization
Intervention | mg/kg/day (Median) |
---|
| Baseline | 6 Months | 1 Year |
---|
Sirolimus and Prednisone | 0.9 | 0.2 | 0.1 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 0.9 | 0.2 | 0.2 |
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Provider-reported Chronic GVHD Severity
Each patient's care provider's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe. (NCT01106833)
Timeframe: Baseline, 6 months, 1 year, and 2 years post-randomization
Intervention | Participants (Count of Participants) |
---|
| Baseline72115479 | Baseline72115478 | 6 Months72115479 | 6 Months72115478 | 1 Year72115478 | 1 Year72115479 | 2 Years72115478 | 2 Years72115479 |
---|
| None | Mild | Moderate | Severe | Relapsed | Initiated Secondary Therapy | Dead |
---|
Sirolimus, Calcineurin Inhibitor, and Prednisone | 13 |
Sirolimus and Prednisone | 17 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 46 |
Sirolimus and Prednisone | 48 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 6 |
Sirolimus and Prednisone | 2 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 27 |
Sirolimus and Prednisone | 33 |
Sirolimus and Prednisone | 13 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 3 |
Sirolimus and Prednisone | 14 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 8 |
Sirolimus and Prednisone | 19 |
Sirolimus and Prednisone | 9 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 1 |
Sirolimus and Prednisone | 1 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 5 |
Sirolimus and Prednisone | 3 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 15 |
Sirolimus and Prednisone | 21 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 7 |
Sirolimus and Prednisone | 7 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 10 |
Sirolimus and Prednisone | 11 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 0 |
Sirolimus and Prednisone | 0 |
Sirolimus and Prednisone | 5 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 18 |
Sirolimus and Prednisone | 28 |
Sirolimus and Prednisone | 4 |
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Proportion of Participants With Treatment Success
Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization
Intervention | Participants (Count of Participants) |
---|
| Phase II: 6 Months72115478 | Phase II: 6 Months72115479 | Phase III: 24 Months72115478 | Phase III: 24 Months72115479 |
---|
| Yes | No |
---|
Sirolimus, Calcineurin Inhibitor, and Prednisone | 33 |
Sirolimus and Prednisone | 35 |
Sirolimus and Prednisone | 37 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 9 |
Sirolimus and Prednisone | 10 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 49 |
Sirolimus and Prednisone | 58 |
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Patient-reported Chronic GVHD Severity
Each patient's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe. (NCT01106833)
Timeframe: Baseline, 6 months, 1 year, and 2 years post-randomization
Intervention | Participants (Count of Participants) |
---|
| Baseline72115479 | Baseline72115478 | 6 Months72115478 | 6 Months72115479 | 1 Year72115479 | 1 Year72115478 | 2 Years72115478 | 2 Years72115479 |
---|
| Moderate | Severe | Relapsed | Initiated Secondary Therapy | Dead | Mild | None |
---|
Sirolimus, Calcineurin Inhibitor, and Prednisone | 21 |
Sirolimus and Prednisone | 20 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 23 |
Sirolimus and Prednisone | 32 |
Sirolimus and Prednisone | 10 |
Sirolimus and Prednisone | 0 |
Sirolimus and Prednisone | 6 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 13 |
Sirolimus and Prednisone | 25 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 15 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 3 |
Sirolimus and Prednisone | 1 |
Sirolimus and Prednisone | 14 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 6 |
Sirolimus and Prednisone | 4 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 9 |
Sirolimus and Prednisone | 2 |
Sirolimus and Prednisone | 23 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 4 |
Sirolimus and Prednisone | 3 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 5 |
Sirolimus and Prednisone | 21 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 10 |
Sirolimus and Prednisone | 13 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 2 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 0 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 8 |
Sirolimus and Prednisone | 5 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 18 |
Sirolimus and Prednisone | 28 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 7 |
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NIH Consensus Criteria Chronic GVHD Severity
Chronic GVHD severity was determined at baseline and at 6 months, 1 year, and 2 years post-randomization per the 2005 NIH Consensus Criteria (Filipovich et al. 2005). Severity is categorized as none, mild, moderate, and severe. (NCT01106833)
Timeframe: Baseline, 6 months, 1 year, and 2 years post-randomization
Intervention | Participants (Count of Participants) |
---|
| Baseline72115478 | Baseline72115479 | 6 Months72115478 | 6 Months72115479 | 1 Year72115479 | 1 Year72115478 | 2 Years72115478 | 2 Years72115479 |
---|
| None | Mild | Moderate | Severe | Relapsed | Initiated Secondary Therapy | Dead |
---|
Sirolimus, Calcineurin Inhibitor, and Prednisone | 0 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 1 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 29 |
Sirolimus and Prednisone | 23 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 33 |
Sirolimus and Prednisone | 46 |
Sirolimus and Prednisone | 0 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 25 |
Sirolimus and Prednisone | 27 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 12 |
Sirolimus and Prednisone | 17 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 3 |
Sirolimus and Prednisone | 1 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 7 |
Sirolimus and Prednisone | 14 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 6 |
Sirolimus and Prednisone | 3 |
Sirolimus and Prednisone | 5 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 16 |
Sirolimus and Prednisone | 16 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 9 |
Sirolimus and Prednisone | 10 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 5 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 15 |
Sirolimus and Prednisone | 21 |
Sirolimus and Prednisone | 4 |
Sirolimus and Prednisone | 9 |
Sirolimus and Prednisone | 12 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 8 |
Sirolimus and Prednisone | 8 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 2 |
Sirolimus and Prednisone | 2 |
Sirolimus, Calcineurin Inhibitor, and Prednisone | 18 |
Sirolimus and Prednisone | 28 |
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Percentage of Participants With Relapse
Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 6 Months | 24 Months |
---|
Sirolimus and Prednisone | 1.4 | 10.1 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 4.8 | 14.9 |
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SF-36 Mental Component Summary
The Medical Outcome Study SF-36 Mental Component Summary (MCS) is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being. (NCT01106833)
Timeframe: Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization
Intervention | score on a scale (Mean) |
---|
| Baseline | 2 Months | 6 Months | 1 Year | 2 Years |
---|
Sirolimus and Prednisone | 48 | 50 | 48 | 46 | 50 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 47 | 49 | 50 | 50 | 52 |
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Serum Creatinine Level
Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization. (NCT01106833)
Timeframe: Baseline, 6 months, and 1 year post-randomization
Intervention | mg/dL (Median) |
---|
| Baseline | 6 Months | 1 Year |
---|
Sirolimus and Prednisone | 0.9 | 1.0 | 0.9 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 0.9 | 1.0 | 0.9 |
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Percentage of Participants With Secondary Immunosuppressive Therapy Initiated
The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 6 Months | 24 months |
---|
Sirolimus and Prednisone | 13.9 | 38.5 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 12.9 | 29.4 |
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Change in Prednisone Dose From Baseline
Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization. (NCT01106833)
Timeframe: 6 months and 1 year post-randomization
Intervention | mg/kg/day (Median) |
---|
| 6 Months | 1 Year |
---|
Sirolimus and Prednisone | -0.6 | -0.7 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | -0.6 | -0.6 |
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Change in Serum Creatinine Level From Baseline
Change in creatinine level from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization. (NCT01106833)
Timeframe: 6 months and 1 year post-randomization
Intervention | mg/dL (Median) |
---|
| 6 Months | 1 Year |
---|
Sirolimus and Prednisone | 0.1 | 0.0 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 0.1 | 0.0 |
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Percentage of Participants With Failure-free Survival
Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 6 Months | 24 Months |
---|
Sirolimus and Prednisone | 73.6 | 48.6 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 74.7 | 46.2 |
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FACT-BMT Score
The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being. (NCT01106833)
Timeframe: Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization
Intervention | score on a scale (Mean) |
---|
| Baseline | 2 Months | 6 Months | 1 Year | 2 Years |
---|
Sirolimus and Prednisone | 104 | 110 | 109 | 110 | 113 |
,Sirolimus, Calcineurin Inhibitor, and Prednisone | 103 | 105 | 109 | 114 | 119 |
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Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit
"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up 80 weeks)
Intervention | units on a scale (Mean) |
---|
Main Study: Placebo | 1.24 |
Main Study: Adalimumab | 3.36 |
Integrated Study (Main + Japan Sub-study): Placebo | 1.00 |
Integrated Study (Main + Japan Sub-study): Adalimumab | 2.79 |
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Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit.
Central retinal thickness was measured using OCT and assessed by a central reader. (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up to 80 weeks)
Intervention | percent change (Mean) |
---|
| Left eye (N = 107, 114, 122, 130) | Right eye (N = 108, 113, 124, 129) |
---|
Integrated Study (Main + Japan Sub-study): Adalimumab | 5.2 | 3.9 |
,Integrated Study (Main + Japan Sub-study): Placebo | 6.3 | 9.9 |
,Main Study: Adalimumab | 4.5 | 5.4 |
,Main Study: Placebo | 6.4 | 7.7 |
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Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit
"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:~Grade 0: No evident vitreous haze;~Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;~Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);~Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);~Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;~Grade 4+: Optic nerve head is obscured." (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up to 80 weeks)
Intervention | units on a scale (Mean) |
---|
| Left eye | Right eye |
---|
Integrated Study (Main + Japan Sub-study): Adalimumab | 0.18 | 0.18 |
,Integrated Study (Main + Japan Sub-study): Placebo | 0.35 | 0.36 |
,Main Study: Adalimumab | 0.16 | 0.18 |
,Main Study: Placebo | 0.33 | 0.27 |
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Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit
Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up to 80 weeks)
Intervention | logMAR (Mean) |
---|
| Left eye | Right eye |
---|
Integrated Study (Main + Japan Sub-study): Adalimumab | 0.02 | 0.00 |
,Integrated Study (Main + Japan Sub-study): Placebo | 0.07 | 0.04 |
,Main Study: Adalimumab | 0.01 | -0.01 |
,Main Study: Placebo | 0.06 | 0.02 |
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Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit
"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:~Grade 0 = < 1 cell~Grade 0.5+ = 1 - 5 cells~Grade 1+ = 6 - 15 cells~Grade 2+ = 16 - 25 cells~Grade 3+ = 26 - 50 cells~Grade 4+ = > 50 cells." (NCT01124838)
Timeframe: Baseline and at the Final/Early Termination Visit (up to 80 weeks)
Intervention | units on a scale (Mean) |
---|
| Left eye | Right eye |
---|
Integrated Study (Main + Japan Sub-study): Adalimumab | 0.46 | 0.44 |
,Integrated Study (Main + Japan Sub-study): Placebo | 0.61 | 0.60 |
,Main Study: Adalimumab | 0.41 | 0.40 |
,Main Study: Placebo | 0.57 | 0.53 |
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Time to Treatment Failure on or After Week 2
"Treatment failure was defined by the occurrence of a uveitis flare (the inability to maintain disease control). To be considered treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye at Week 2 or all other visits:~New active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesions relative to Baseline~2-step increase relative to Baseline in anterior chamber cell grade or vitreous haze grade~Worsening of best corrected visual acuity by ≥ 15 letters relative to baseline.~Time to treatment failure was analyzed using the Kaplan-Meier method. Dropouts for reasons other than treatment failure at any time during the study were censored at the drop out date.~Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan." (NCT01124838)
Timeframe: From Baseline until end of study (up to 80 weeks)
Intervention | months (Median) |
---|
Main Study: Placebo | 8.3 |
Main Study: Adalimumab | NA |
Integrated Study (Main + Japan Sub-study): Placebo | 5.6 |
Integrated Study (Main + Japan Sub-study): Adalimumab | NA |
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Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2
"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.~OCT evidence of macular edema on or after Week 2 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out." (NCT01124838)
Timeframe: From Baseline until the Final Visit (up to 80 weeks)
Intervention | months (Median) |
---|
Main Study: Placebo | NA |
Main Study: Adalimumab | NA |
Integrated Study (Main + Japan Sub-study): Placebo | NA |
Integrated Study (Main + Japan Sub-study): Adalimumab | NA |
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Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit
"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The ocular pain subscore is calculated form the answers to 2 eye pain questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain." (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up 80 weeks)
Intervention | units on a scale (Mean) |
---|
Main Study: Placebo | 2.87 |
Main Study: Adalimumab | 3.42 |
Integrated Study (Main + Japan Sub-study): Placebo | 2.60 |
Integrated Study (Main + Japan Sub-study): Adalimumab | 2.15 |
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Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit
"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The near vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up 80 weeks)
Intervention | units on a scale (Mean) |
---|
Main Study: Placebo | 3.98 |
Main Study: Adalimumab | 3.88 |
Integrated Study (Main + Japan Sub-study): Placebo | 3.73 |
Integrated Study (Main + Japan Sub-study): Adalimumab | 2.89 |
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Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit
"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up 80 weeks)
Intervention | units on a scale (Mean) |
---|
Main Study: Placebo | 0.76 |
Main Study: Adalimumab | 2.64 |
Integrated Study (Main + Japan Sub-study): Placebo | 0.60 |
Integrated Study (Main + Japan Sub-study): Adalimumab | 2.96 |
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36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.
All patients received an initial 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15. After the first 2 cycles of ABVD, PET/CT was performed and submitted for central review (cycle 2, days 23-25) and determined whether patients would receive 2 cycles of escalated BEACOPP and involved-field RT (IFRT) or an additional 2 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS rate at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, we compare the PFS rate between patients who received 4 cycles of ABVD and patients who received 2 cycles of ABVD and 2 cycles of IFRT. (NCT01132807)
Timeframe: at 36 months
Intervention | proportion of participants (Number) |
---|
Treatment (ABVD:4 Cycles) | .91 |
Escalated BEACOPP and Involved Field Radiation Therapy | .67 |
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Complete Response Rate
A Complete Response (CR) was defined as having the following conditions: 1. A complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. 2. In patients with a PET scan that was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET-negative. A Complete Response rate was defined as the number of patients who achieved a CR divided by the number of patients that were eligible for analysis in each group. The CR rate was calculated for patients that completed 4 cycles of ABVD and for patients that completed 2 cycles of ABVD and 2 cycles of BEACOPP and IFRT. (NCT01132807)
Timeframe: Up to 5 years
Intervention | proportion of participants (Number) |
---|
Treatment (ABVD: 4 Cycles) | .97 |
Escalated BEACOPP and Involved Field Radiation Therapy | .85 |
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Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD
The primary objective of this trial is to estimate the 3 year PFS in patients who received 4 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, all patients that received 4 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) are included. (NCT01132807)
Timeframe: 36 Months
Intervention | proportion of patients (Number) |
---|
Treatment (ABVD: 4 Cycles) | .91 |
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Number of Participants With Erythroid Response
The rate of erythroid response to treatment with the lenalidomide/prednisone combination in non-del (5q) low and int-1 risk Myelodysplastic Syndrome (MDS) with symptomatic anemia. Hematological improvement erythroid response (HI-E) according to International Working Group (IWG) 2006 criteria. (NCT01133275)
Timeframe: Up to 7 months
Intervention | participants (Number) |
---|
Lenalidomide and Prednisone Therapy | 5 |
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The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment
"Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an other pre-specified outcome." (NCT01133626)
Timeframe: Day 0 (Baseline), Day 42
Intervention | ratio (Geometric Mean) |
---|
BDP HFA 320 µg/Day | 0.90 |
Placebo | 0.95 |
Placebo/Prednisone | 0.31 |
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Time to Treatment Failure on or After Week 6
"Time to treatment failure was analyzed using Kaplan-Meier methods. Treatment failures on or after Week 6 were counted as events. Dropouts for reasons other than treatment failure at any time during the study were censored at the dropout date. To be considered a treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye:~New active, inflammatory chorioretinal or retinal vascular lesions relative to Baseline~Inability to achieve ≤ 0.5+ at Week 6 or a 2-step increase relative to best state achieved at all visits after Week 6 in anterior chamber cell grade or vitreous haze grade~Worsening of best corrected visual acuity by ≥ 15 letters relative to best state achieved.~Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan." (NCT01138657)
Timeframe: From Baseline until end of study (up to 80 weeks)
Intervention | months (Median) |
---|
Main Study: Placebo | 3.0 |
Main Study: Adalimumab | 5.6 |
Integrated Study (Main + Japan Sub-study): Placebo | 3.0 |
Integrated Study (Main + Japan Sub-study): Adalimumab | 4.8 |
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Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:~Grade 0 = < 1 cell;~Grade 0.5+ = 1-5 cells;~Grade 1+ = 6-15 cells;~Grade 2+ = 16-25 cells;~Grade 3+ = 26-50 cells;~Grade 4+ = > 50 cells." (NCT01138657)
Timeframe: From Baseline to Week 6 and at the Final/Early Termination Visit (up to 80 weeks)
Intervention | units on a scale (Mean) |
---|
| Left Eye | Right Eye |
---|
Integrated Study (Main + Japan Sub-study): Adalimumab | 0.35 | 0.36 |
,Integrated Study (Main + Japan Sub-study): Placebo | 0.56 | 0.65 |
,Main Study: Adalimumab | 0.35 | 0.36 |
,Main Study: Placebo | 0.59 | 0.69 |
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Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. (NCT01138657)
Timeframe: From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)
Intervention | logMAR (Mean) |
---|
| Left Eye | Right Eye |
---|
Integrated Study (Main + Japan Sub-study): Adalimumab | 0.07 | 0.05 |
,Integrated Study (Main + Japan Sub-study): Placebo | 0.11 | 0.13 |
,Main Study: Adalimumab | 0.07 | 0.04 |
,Main Study: Placebo | 0.12 | 0.13 |
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Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:~Grade 0: No evident vitreous haze;~Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;~Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);~Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);~Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;~Grade 4+: Optic nerve head is obscured." (NCT01138657)
Timeframe: From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)
Intervention | units on a scale (Mean) |
---|
| Left Eye | Right Eye |
---|
Integrated Study (Main + Japan Sub-study): Adalimumab | 0.11 | 0.16 |
,Integrated Study (Main + Japan Sub-study): Placebo | 0.34 | 0.49 |
,Main Study: Adalimumab | 0.11 | 0.13 |
,Main Study: Placebo | 0.33 | 0.45 |
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Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
Central retinal thickness was measured using optical coherence tomography and assessed by a central reader. (NCT01138657)
Timeframe: Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)
Intervention | percent change (Mean) |
---|
| Left eye (n=100, 100, 107, 108) | Right eye (n=102, 101, 108, 109) |
---|
Integrated Study (Main + Japan Sub-study): Adalimumab | 13.9 | 14.5 |
,Integrated Study (Main + Japan Sub-study): Placebo | 19.0 | 21.7 |
,Main Study: Adalimumab | 9.6 | 8.2 |
,Main Study: Placebo | 20.2 | 22.0 |
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Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6
"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.~OCT evidence of macular edema on or after Week 6 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out." (NCT01138657)
Timeframe: From Baseline until the Final Visit (up to 80 weeks)
Intervention | months (Median) |
---|
Main Study: Placebo | 6.2 |
Main Study: Adalimumab | 11.1 |
Integrated Study (Main + Japan Sub-study): Placebo | 3.7 |
Integrated Study (Main + Japan Sub-study): Adalimumab | 9.2 |
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Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01138657)
Timeframe: Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)
Intervention | units on a scale (Mean) |
---|
Main Study: Placebo | -5.64 |
Main Study: Adalimumab | -3.77 |
Integrated Study (Main + Japan Sub-study): Placebo | -5.72 |
Integrated Study (Main + Japan Sub-study): Adalimumab | -4.42 |
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Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The distance vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01138657)
Timeframe: Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)
Intervention | units on a scale (Mean) |
---|
Main Study: Placebo | -8.09 |
Main Study: Adalimumab | -2.97 |
Integrated Study (Main + Japan Sub-study): Placebo | -7.65 |
Integrated Study (Main + Japan Sub-study): Adalimumab | -3.52 |
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Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The ocular pain subscore is calculated from the answers to 2 ocular pain-related questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain." (NCT01138657)
Timeframe: Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)
Intervention | units on a scale (Mean) |
---|
Main Study: Placebo | -12.62 |
Main Study: Adalimumab | -2.60 |
Integrated Study (Main + Japan Sub-study): Placebo | -12.39 |
Integrated Study (Main + Japan Sub-study): Adalimumab | -3.56 |
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Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01138657)
Timeframe: Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)
Intervention | units on a scale (Mean) |
---|
Main Study: Placebo | -5.50 |
Main Study: Adalimumab | -1.30 |
Integrated Study (Main + Japan Sub-study): Placebo | -5.34 |
Integrated Study (Main + Japan Sub-study): Adalimumab | -1.68 |
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Overall Survival
Overall survival is defined as the time from randomization to death or the date of last known alive. (NCT01145508)
Timeframe: Assessed every 3 months for 2 years, and then every 6 months for 3 years
Intervention | Months (Median) |
---|
Arm A (Vaccine and Chemotherapy) | 20.8 |
Arm B (Chemotherapy) | NA |
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Remission According to DAS28-CRP at Week 16
"Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 16.~DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS).~A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity." (NCT01172639)
Timeframe: week 16
Intervention | Participants (Count of Participants) |
---|
CoBRA Classic High Risk Group | 69 |
CoBRA Slim High Risk Group | 72 |
CoBRA Avant-garde High Risk Group | 61 |
CoBRA Slim Low Risk Group | 25 |
Tight Step Up Low Risk Group | 23 |
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Remission According to DAS28-CRP at Week 104
"Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 104. (co-primary endpoints)~DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS).~A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity." (NCT01172639)
Timeframe: week 104
Intervention | Participants (Count of Participants) |
---|
CoBRA Classic High Risk Group | 64 |
CoBRA Slim High Risk Group | 71 |
CoBRA Avant-garde High Risk Group | 69 |
CoBRA Slim Low Risk Group | 29 |
Tight Step Up Low Risk Group | 34 |
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Clinically Significant Change in HAQ Score
"Number of patients with a change of > 0.22 in the Health Assessment Questionnaire (HAQ) score over the period between baseline and week 104.~A change of > 0.22 in this score is considered as clinical relevant for rheumatoid arthritis patients." (NCT01172639)
Timeframe: Baseline-week104
Intervention | Participants (Count of Participants) |
---|
CoBRA Classic High Risk Group | 71 |
CoBRA Slim High Risk Group | 62 |
CoBRA Avant-garde High Risk Group | 64 |
CoBRA Slim Low Risk Group | 25 |
Tight Step Up Low Risk Group | 26 |
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Remission According to SDAI at Week 52
"Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 52.~SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS.~A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity." (NCT01172639)
Timeframe: week 52
Intervention | Participants (Count of Participants) |
---|
CoBRA Classic High Risk Group | 36 |
CoBRA Slim High Risk Group | 27 |
CoBRA Avant-garde High Risk Group | 39 |
CoBRA Slim Low Risk Group | 20 |
Tight Step Up Low Risk Group | 15 |
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Remission According to SDAI at Week 104
"Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 104.~SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS.~A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity." (NCT01172639)
Timeframe: week 104
Intervention | Participants (Count of Participants) |
---|
CoBRA Classic High Risk Group | 31 |
CoBRA Slim High Risk Group | 28 |
CoBRA Avant-garde High Risk Group | 41 |
CoBRA Slim Low Risk Group | 20 |
Tight Step Up Low Risk Group | 13 |
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Remission According to SDAI (Simple Disease Activity Index) at Week 16
"Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 16.~SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS.~A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity." (NCT01172639)
Timeframe: week 16
Intervention | Participants (Count of Participants) |
---|
CoBRA Classic High Risk Group | 42 |
CoBRA Slim High Risk Group | 33 |
CoBRA Avant-garde High Risk Group | 44 |
CoBRA Slim Low Risk Group | 12 |
Tight Step Up Low Risk Group | 12 |
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Remission According to DAS28-CRP at Week 52
"Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 52. (co-primary end point)~DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS).~A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity." (NCT01172639)
Timeframe: week 52
Intervention | Participants (Count of Participants) |
---|
CoBRA Classic High Risk Group | 63 |
CoBRA Slim High Risk Group | 57 |
CoBRA Avant-garde High Risk Group | 57 |
CoBRA Slim Low Risk Group | 29 |
Tight Step Up Low Risk Group | 29 |
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Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge
Intervention | Fold Change (Geometric Mean) |
---|
| Sputum | Nasal Exudates |
---|
Placebo | 1.34 | 0.39 |
,Prednisone | 0.80 | 0.19 |
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Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of Eotaxin-3 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge
Intervention | Fold Change (Geometric Mean) |
---|
| Sputum | Nasal Exudates |
---|
Placebo | 2.14 | 1.35 |
,Prednisone | 1.30 | 0.86 |
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Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-13 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge
Intervention | Fold Change (Geometric Mean) |
---|
| Sputum | Nasal Exudate |
---|
Placebo | 5.86 | 3.29 |
,Prednisone | 1.57 | 1.02 |
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Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-17 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge
Intervention | Fold Change (Geometric Mean) |
---|
| Sputum | Nasal Exudates |
---|
Placebo | 0.83 | 1.23 |
,Prednisone | 0.68 | 0.84 |
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Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, nasal exudates (NE) and sputum (SP) were collected, then the concentrations of IL-5 were determined from NE and SP collected after 7 hours and previously at baseline (BL), to derive the fold change (FC) from BL for each participant. The geometric mean (GM) was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge
Intervention | Fold Change (Geometric Mean) |
---|
| Sputum | Nasal Exudate |
---|
Placebo | 8.60 | 8.63 |
,Prednisone | 2.16 | 1.69 |
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Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of MIP-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge
Intervention | Fold Change (Geometric Mean) |
---|
| Sputum | Nasal Exudates |
---|
Placebo | 1.92 | 1.19 |
,Prednisone | 1.35 | 0.73 |
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Geometric Mean Fold Change From Baseline in RNA Expression for Genes Encoding IL-5 and IL-13 From Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, SP were collected, then the RNA expression profiles of IL-5 and IL-13 genes were determined from SP collected after 7 hours and previously at baseline, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge
Intervention | Fold Change (Geometric Mean) |
---|
| IL-5 | IL-13 |
---|
Placebo | 7.37 | 3.93 |
,Prednisone | 4.87 | 2.90 |
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Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TARC were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge
Intervention | Fold Change (Geometric Mean) |
---|
| Sputum | Nasal Exudates |
---|
Placebo | 2.04 | 1.22 |
,Prednisone | 1.63 | 1.33 |
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Time to Deterioration in Global Health Status
Global health status deterioration is defined as a drop greater than 16 points from the baseline assessment, confirmed at least 3 weeks later, on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module 30 (EORTC QLQ-C30) index after the score has been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30 consists of 30 questions, where question 1 to 28 can be answered with 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much and question 29 to 30 with 1: Very poor to 7: Excellent. For subscales a high score from 0-100 indicates: high global quality of life, high level of functioning (physical, role, emotional, cognitive, social) or a high level of symptoms (fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). (NCT01193244)
Timeframe: Baseline until EOT (approximately up to 4.7 years)
Intervention | months (Median) |
---|
Placebo + Prednisone 5 mg | 10.7 |
Orteronel 400 mg + Prednisone 5 mg | 8.3 |
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Time to Docetaxel Chemotherapy
Time to docetaxel based chemotherapy is defined as the time from randomization to the start of docetaxel based chemotherapy for prostate cancer, regardless of whether the participant received concurrent orteronel or not. Deaths due to disease progression prior to Docetaxel based chemotherapy were considered as events. (NCT01193244)
Timeframe: Baseline until start of docetaxel chemotherapy (up to 4.7 years)
Intervention | months (Median) |
---|
Placebo + Prednisone 5 mg | 19.0 |
Orteronel 400 mg + Prednisone 5 mg | 23.0 |
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Time to Pain Progression
Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >=4 with a >=2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >=4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <=3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 100 with lower scores being indicative of less pain or pain interference. (NCT01193244)
Timeframe: Baseline until End of treatment (EOT) (approximately up to 4.7 years)
Intervention | months (Median) |
---|
Placebo + Prednisone 5 mg | NA |
Orteronel 400 mg + Prednisone 5 mg | NA |
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Time to PSA Progression
Time to PSA progression was defined as time from randomization to a PSA increase of 25 percent and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, compared to baseline PSA. (NCT01193244)
Timeframe: Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.7 years)
Intervention | months (Median) |
---|
Placebo + Prednisone 5 mg | 5.59 |
Orteronel 400 mg + Prednisone 5 mg | 8.3 |
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Time to SRE
Time to SRE is defined as the time from randomization to SRE, or death due to any cause, whichever comes first. SRE is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence. (NCT01193244)
Timeframe: Baseline up to EOT (Cycle 61 Day 58)
Intervention | months (Median) |
---|
Placebo + Prednisone 5 mg | 9.0 |
Orteronel 400 mg + Prednisone 5 mg | 13.9 |
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Overall Survival
Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier. (NCT01193244)
Timeframe: Baseline until death (up to 4.7 years)
Intervention | months (Median) |
---|
Placebo + Prednisone 5 mg | 29.5 |
Orteronel 400 mg + Prednisone 5 mg | 29.9 |
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Time to Subsequent Antineoplastic Therapy
Time to subsequent antineoplastic therapy is defined as the time from randomization to the start of any alternate antineoplastic therapy for prostate cancer. Deaths due to disease progression prior to antineoplastic therapy for prostate cancer are considered as events. Otherwise, time to next therapy is censored at the date of death or the last date the participant was known to be alive or the data cutoff date, whichever is earlier. (NCT01193244)
Timeframe: Baseline until start of subsequent antineoplastic therapy (up to 4.7 years)
Intervention | months (Median) |
---|
Placebo + Prednisone 5 mg | 13.9 |
Orteronel 400 mg + Prednisone 5 mg | 17.2 |
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Worst Change From Baseline Over Time in Cardiac Ejection Fraction
Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point. (NCT01193244)
Timeframe: Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)
Intervention | percent ejection fraction (Mean) |
---|
Placebo + Prednisone 5 mg | -3.8 |
Orteronel 400 mg + Prednisone 5 mg | -4.8 |
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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
(NCT01193244)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Intervention | participants (Number) |
---|
| TEAE | Serious Adverse Events (SAE) |
---|
Orteronel 400 mg + Prednisone 5 mg | 769 | 380 |
,Placebo + Prednisone 5 mg | 733 | 321 |
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Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings
(NCT01193244)
Timeframe: Baseline up to EOT (Cycle 61 Day 58)
Intervention | participants (Number) |
---|
Placebo + Prednisone 5 mg | 130 |
Orteronel 400 mg + Prednisone 5 mg | 163 |
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Radiographic Progression-free Survival (rPFS)
rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment. (NCT01193244)
Timeframe: Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)
Intervention | months (Median) |
---|
Placebo + Prednisone 5 mg | 8.7 |
Orteronel 400 mg + Prednisone 5 mg | 13.8 |
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Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12
The PSA90 is defined as a decline of PSA by 90 percent from baseline. (NCT01193244)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Placebo + Prednisone 5 mg | 5.4 |
Orteronel 400 mg + Prednisone 5 mg | 16.7 |
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Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12
The PSA50 is defined as a decline of at least 50 percent (%) from baseline. (NCT01193244)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Placebo + Prednisone 5 mg | 24.6 |
Orteronel 400 mg + Prednisone 5 mg | 42.6 |
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Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12
A favorable CTC count was defined as less than <5 counts per 7.5 milliliter (mL) in whole blood. An unfavorable CTC count was defined as greater than or equal to (>=) 5 counts/7.5 mL in whole blood. (NCT01193244)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Placebo + Prednisone 5 mg | 9.1 |
Orteronel 400 mg + Prednisone 5 mg | 15.4 |
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Percentage of Participants With Objective Response
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. A CR was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter or short axis of lymph nodes. (NCT01193244)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years)
Intervention | percentage of participants (Number) |
---|
Placebo + Prednisone 5 mg | 15.2 |
Orteronel 400 mg + Prednisone 5 mg | 34.7 |
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Percentage of Participants Achieving PSA50 Response at Any Time During the Study
The PSA50 is defined as a decline of PSA by 50 percent from baseline. (NCT01193244)
Timeframe: Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37
Intervention | percentage of participants (Number) |
---|
| Cycle 4 (n= 687, 672) | Cycle 7 (n= 541, 540) | Cycle 10 (n= 438, 450) | Cycle 13 (n= 344, 382) | Cycle 16 (n= 286, 303) | Cycle 19 (n= 228, 272) | Cycle 22 (n= 184, 211) | Cycle 25 (n= 109, 119) | Cycle 28 (n= 67, 77) | Cycle 31 (n= 35, 39) | Cycle 34 (n= 22, 18) | Cycle 37 (n= 7, 5) |
---|
Orteronel 400 mg + Prednisone 5 mg | 49.70 | 54.81 | 56.00 | 53.14 | 54.13 | 52.94 | 54.03 | 46.22 | 48.05 | 48.72 | 38.89 | 40.00 |
,Placebo + Prednisone 5 mg | 28.09 | 34.94 | 36.99 | 37.21 | 34.27 | 37.72 | 33.15 | 35.78 | 44.78 | 34.29 | 36.36 | 71.43 |
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Percentage of Participants Achieving PSA90 Response at Any Time During the Study
The PSA90 is defined as a decline of PSA by 90 percent from baseline. (NCT01193244)
Timeframe: Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37
Intervention | percentage of participants (Number) |
---|
| Cycle 4 (n= 687, 672) | Cycle 7 (n= 541, 540) | Cycle 10 (n= 438, 450) | Cycle 13 (n= 344, 382) | Cycle 16 (n= 286, 303) | Cycle 19 (n= 228, 272) | Cycle 22 (n= 184, 211) | Cycle 25 (n= 109, 119) | Cycle 28 (n= 67, 77) | Cycle 31 (n= 35, 39) | Cycle 34 (n= 22, 18) | Cycle 37 (n= 7, 5) |
---|
Orteronel 400 mg + Prednisone 5 mg | 16.67 | 22.22 | 26.44 | 26.18 | 25.74 | 26.10 | 28.44 | 21.01 | 27.27 | 12.82 | 22.22 | 20.00 |
,Placebo + Prednisone 5 mg | 5.39 | 8.69 | 11.64 | 12.79 | 12.24 | 12.72 | 10.87 | 11.01 | 16.42 | 8.57 | 4.55 | 14.29 |
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Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3
Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. (NCT01193244)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Intervention | participants (Number) |
---|
| Grade 3 or higher TEAE | Grade 5 (Death) |
---|
Orteronel 400 mg + Prednisone 5 mg | 537 | 77 |
,Placebo + Prednisone 5 mg | 405 | 78 |
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Time to Pain Progression
Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >= 4 with a >= 2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >= 4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <= 3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. (NCT01193257)
Timeframe: Baseline until EOT visit or until end of short term follow-up, whichever occurred later (approximately up to 4.5 years)
Intervention | months (Median) |
---|
Placebo + Prednisone | 22.0 |
Orteronel + Prednisone | 24.2 |
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Radiographic Progression-free Survival (rPFS)
rPFS was defined as the time from randomization until radiographic disease progression or death due to any cause, whichever occurred first. Radiographic disease progression was defined as the occurrence of 1 or more of the following: The appearance of 2 or more new lesions on radionuclide bone scan as defined by prostate cancer working group (PCWG)2; Should 2 or more new bone lesions be evident at the first assessment (8-week assessment) on treatment, 2 or more additional new lesions must have been evident on a confirmatory assessment at least 6 weeks later; One or more new soft tissue/visceral organ lesions identified by computed tomography (CT)/magnetic resonance imaging (MRI); Progression as defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria. (NCT01193257)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
Intervention | months (Median) |
---|
Placebo + Prednisone | 5.7 |
Orteronel + Prednisone | 8.3 |
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Time to Pain Response
Time to pain response was defined as the time from randomization until first pain response. Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A >= 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. The analysis was performed by Kaplan-Meier method. (NCT01193257)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
Intervention | months (Median) |
---|
Placebo + Prednisone | NA |
Orteronel + Prednisone | NA |
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Time to PSA Progression
Time to PSA progression was defined as time from randomization to a PSA increase of 25% and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, above the baseline PSA. (NCT01193257)
Timeframe: Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.5 years)
Intervention | months (Median) |
---|
Placebo + Prednisone | 2.9 |
Orteronel + Prednisone | 5.5 |
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Percentage of Participants With Pain Response at Week 12
Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A greater than or equal to (>=) 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use; or a 25 percent (%) or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. (NCT01193257)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Placebo + Prednisone | 9.0 |
Orteronel + Prednisone | 12.1 |
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Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)
A favorable CTC count was defined as less than (<) 5 counts per (/) 7.5 mililiter (mL) in whole blood. An unfavorable CTC count was defined as >=5 counts/7.5 mL in whole blood. (NCT01193257)
Timeframe: Baseline and EOT (Cycle 59 Day 58)
Intervention | participants (Number) |
---|
| Baseline: Favorable; EOT: Favorable | Baseline: Favorable; EOT: Unfavorable | Baseline: Unfavorable; EOT: Favorable | Baseline: Unfavorable; EOT: Unfavorable |
---|
Orteronel + Prednisone | 63 | 40 | 23 | 141 |
,Placebo + Prednisone | 27 | 30 | 8 | 92 |
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Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings
(NCT01193257)
Timeframe: Cycle 59 Day 58
Intervention | participants (Number) |
---|
Placebo + Prednisone | 1 |
Orteronel + Prednisone | 3 |
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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
(NCT01193257)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
Intervention | participants (Number) |
---|
Placebo + Prednisone | 345 |
Orteronel + Prednisone | 719 |
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Percentage of Participants With Objective Response
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. The overall objective response was defined as a complete response (CR) or partial response (PR). A complete response (CR) was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes. (NCT01193257)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
Intervention | percentage of participants (Number) |
---|
Placebo + Prednisone | 2.7 |
Orteronel + Prednisone | 17.1 |
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Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12
The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline. (NCT01193257)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Placebo + Prednisone | 2.83 |
Orteronel + Prednisone | 9.66 |
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Number of Participants With Abnormal Physical Examination Findings
(NCT01193257)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
Intervention | participants (Number) |
---|
Placebo + Prednisone | 0 |
Orteronel + Prednisone | 1 |
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Overall Survival
Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier. (NCT01193257)
Timeframe: Baseline until death (approximately up to 4.5 years)
Intervention | months (Median) |
---|
Placebo + Prednisone | 15.3 |
Orteronel + Prednisone | 17.1 |
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Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12
The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline. (NCT01193257)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
Placebo + Prednisone | 9.9 |
Orteronel + Prednisone | 24.9 |
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Percentage of Participants Achieving PSA50 Response at Any Time During the Study
The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline. (NCT01193257)
Timeframe: Cycle: 4, 7, 10, 13, 16, 19, 22, and 25
Intervention | participants (Number) |
---|
| Cycle 4 (n= 283; 559) | Cycle 7 (n= 163; 403) | Cycle 10 (n= 102; 267) | Cycle 13 (n= 55; 171) | Cycle 16 (n= 34; 107) | Cycle 19 (n= 24; 68) | Cycle 22 (n= 14; 36) | Cycle 25 (n= 8; 16) |
---|
Orteronel + Prednisone | 32.74 | 38.21 | 36.70 | 40.94 | 44.86 | 42.65 | 52.78 | 62.50 |
,Placebo + Prednisone | 12.72 | 18.40 | 22.55 | 23.64 | 23.53 | 20.83 | 28.57 | 25.00 |
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Percentage of Participants Achieving PSA90 Response at Any Time During the Study
The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline. (NCT01193257)
Timeframe: Cycle: 7, 10, 13, 16, 19, 22, and 25
Intervention | percentage of participants (Number) |
---|
| Cycle 7 (n=163; 403) | Cycle 10 (n=102; 267) | Cycle 13 (n=55; 171) | Cycle 16 (n=34; 107) | Cycle 19 (n=24; 68) | Cycle 22 (n=14; 36) | Cycle 25 (n=8; 16) |
---|
Orteronel + Prednisone | 14.89 | 14.23 | 15.20 | 19.63 | 23.53 | 27.78 | 43.75 |
,Placebo + Prednisone | 4.91 | 6.86 | 7.27 | 5.88 | 4.17 | 0.00 | 0.00 |
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Number of Participants With Best Pain Response
Best pain response was evaluated in participants who had a pain response across the entire study were summarized by treatment group. The pain response was defined as a >=2-point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. (NCT01193257)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
Intervention | participants (Number) |
---|
Placebo + Prednisone | 72 |
Orteronel + Prednisone | 166 |
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Tumor Response (Phase I)
The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease (NCT01193842)
Timeframe: Up to 2 years post treatment
Intervention | percentage of participants (Number) |
---|
| Complete response | Partial Response |
---|
Phase I: Arm C (VR-CHOP) Dose Level 1 | 100 | 0 |
,Phase I: VR-DA-EPOCH, Dose Level 1 | 83.3 | 16.7 |
,Phase I: VR-DA-EPOCH, Dose Level 2 | 83.3 | 16.7 |
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Pharmacokinetic Clearance (Phase I)
Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points. (NCT01193842)
Timeframe: 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion
Intervention | Liter/hour (Mean) |
---|
| Doxorubicin | Etoposide | Vincristine |
---|
Phase I: VR-DA-EPOCH, Dose Level 1 | 78.6 | 3.0 | 22.4 |
,Phase I: VR-DA-EPOCH, Dose Level 2 | 76.0 | 2.4 | 16.8 |
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Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy. (NCT01193842)
Timeframe: Up to 5 years
Intervention | percentage of participants (Number) |
---|
| Death | Life-threatening | Severe | Moderate | Mild |
---|
Phase II: DA-R-EPOCH | 20.0 | 28.9 | 31.1 | 17.8 | 0 |
,Phase II: VR-DA-EPOCH | 28.9 | 37.8 | 20.0 | 8.9 | 2.2 |
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Changes in Human Immunodeficiency Virus (HIV) Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values. (NCT01193842)
Timeframe: Baseline up to 12 months
Intervention | median change in copies per mL (Median) |
---|
| End of Cycle 2 | At treatment discontinuation | 6-month follow-up | 12-month follow-up |
---|
Phase II: DA-R-EPOCH | -25 | -22.5 | -18 | -20 |
,Phase II: VR-DA-EPOCH | -20 | -87 | -20 | 0 |
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Changes in Absolute CD4 Cell Counts (Phase I)
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts. (NCT01193842)
Timeframe: Baseline up to 12 months
Intervention | cell/mm^3 (Median) |
---|
| End of cycle 2 | Treatment discontinuation | 6-month follow-up | 12-month follow-up |
---|
Phase I: VR-CHOP, Dose Level 1 | -218 | -190 | -175 | -84 |
,Phase I: VR-DA-EPOCH, Dose Level 1 | 92 | -39 | 76 | 169 |
,Phase I: VR-DA-EPOCH, Dose Level 2 | -9 | -29 | 31 | 31 |
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Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values. (NCT01193842)
Timeframe: Baseline up to 12 months
Intervention | copies per milliliter (Median) |
---|
| End of cycle 2 | Treatment discontinuation | 6-month follow-up | 12-month follow-up |
---|
Phase I: VR-CHOP, Dose Level 1 | 28 | 0 | 0 | 0 |
,Phase I: VR-DA-EPOCH, Dose Level 1 | -14518 | -4517 | -55116 | 0 |
,Phase I: VR-DA-EPOCH, Dose Level 2 | -12.5 | 0 | 0 | 0 |
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Change in CD8 Cell Counts (Phase I)
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts. (NCT01193842)
Timeframe: Baseline up to 12 months
Intervention | cells/mm^3 (Median) |
---|
| End of cycle 2 | Treatment discontinuation | 6-month follow-up | 12-month follow-up |
---|
Phase I: VR-CHOP, Dose Level 1 | -172 | -81 | -16 | 128 |
,Phase I: VR-DA-EPOCH, Dose Level 1 | 35.5 | -164.5 | -56 | 604 |
,Phase I: VR-DA-EPOCH, Dose Level 2 | -115 | 211 | 275 | 154 |
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Event-free Survival (EFS) (Phase II)
The percentage of participants surviving without events (relapse or death) one year after starting treatment. (NCT01193842)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Phase II: VR-DA-EPOCH | 75.6 |
Phase II: DA-R-EPOCH | 82.2 |
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Overall Survival (OS) (Phase II)
The percentage of participants surviving one year after starting treatment. (NCT01193842)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Phase II: VR-DA-EPOCH | 77.6 |
Phase II: DA-R-EPOCH | 86.7 |
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Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)
Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle. (NCT01193842)
Timeframe: 21 days
Intervention | Mg per day of Vorinostat (Number) |
---|
Phase I: VR-DA-EPOCH | 300 |
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Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)
"Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study.~In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH)." (NCT01193842)
Timeframe: Up to 6 months
Intervention | percentage of participants (Number) |
---|
Phase II: VR-DA-EPOCH | 67.5 |
Phase II: DA-R-EPOCH | 76.2 |
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Changes in Human Herpes Virus (HHV)-8 Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. (NCT01193842)
Timeframe: Baseline up to 12 months
Intervention | copies per 100uL (Median) |
---|
| At treatment discontinuation | 6-month follow-up | 12-month follow-up |
---|
Phase II: DA-R-EPOCH | 0 | 0 | 0 |
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Changes in Human Herpes Virus (HHV)-8 Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. (NCT01193842)
Timeframe: Baseline up to 12 months
Intervention | copies per 100uL (Median) |
---|
| 12-month follow-up |
---|
Phase II: VR-DA-EPOCH | 0 |
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Changes in Epstein-Barr Virus (EBV) Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load. (NCT01193842)
Timeframe: Baseline up to 12 months
Intervention | IU/mL (Median) |
---|
| End of Cycle 2 | At treatment discontinuation | 6-month follow-up | 12-month follow-up |
---|
Phase I: VR-DA-EPOCH, Dose Level 1 | 0 | 0 | 0 | 0 |
,Phase I: VR-DA-EPOCH, Dose Level 2 | -2436.1 | -1.92 | -1.92 | -1.15 |
,Phase II, DA-R-EPOCH | 0 | -0.28 | 0 | -2.7 |
,Phase II, VR-DA-EPOCH | -0.61 | -2.9 | -1.55 | -0.56 |
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Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL
Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
Intervention | days (Median) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | NA |
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | NA |
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Percentage of Participants Who Died
(NCT01200758)
Timeframe: Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
Intervention | percentage of participants (Number) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 12.7 |
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 8.8 |
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Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death
Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
Intervention | percentage of participants (Number) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 34.6 |
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 31.7 |
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Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
Intervention | percentage of participants (Number) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 57.9 |
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 50.6 |
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Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL
Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
Intervention | percentage of participants (Number) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 36.1 |
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 35.1 |
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Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive. (NCT01200758)
Timeframe: Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
Intervention | days (Median) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | NA |
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | NA |
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Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
Intervention | percentage of participants (Number) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 78.1 |
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 77.9 |
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Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase
Depletion is defined as a CD19 value <80 cells/mm^3. (NCT01200758)
Timeframe: Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])
Intervention | percentage of participants (Number) |
---|
| Cycle 9 Day 1 (n=170, 161) | Cycle 10 Day 1 (n=165, 164) | Cycle 11 Day 1 (n=158, 158) | Cycle 12 Day 1 (n=151, 146) | Cycle 13 Day 1 (n=149, 143) | Cycle 14 Day 1 (n=152, 143) | Cycle 15 Day 1 (n=149, 140) | Cycle 16 Day 1 (n=142, 141) | Cycle 17 Day 1 (n=145, 142) | Cycle 18 Day 1 (n=141, 140) | Cycle 19 Day 1 (n=140, 138) | Cycle 20 Day 1 (n=139, 134) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 99.4 | 99.4 | 99.4 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Intervention | percentage of participants (Number) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 31.7 |
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 32.2 |
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Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
Depletion is defined as a cluster of differentiation (CD) 19 value <80 cells per cubic millimeter (cells/mm^3). (NCT01200758)
Timeframe: Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2
Intervention | percentage of participants (Number) |
---|
| Cycle 1 Day 1 - Baseline (n=188, 168) | Cycle 2 Day 0 (n=183, 180) | Cycle 3 Day 1 (n=175, 175) | Cycle 4 Day 1 (n=178, 180) | Cycle 5 Day 1 (n=179, 176) | Cycle 6 Day 1 (n=173, 175) | Cycle 7 Day 1 (n=178, 173) | Cycle 8 Day 1 (n=175, 174) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 51.6 | 95.1 | 99.4 | 99.4 | 100.0 | 100.0 | 100.0 | 100.0 |
,Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 54.8 | 95.0 | 99.4 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)
Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (≥) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Intervention | percentage of participants (Number) |
---|
Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 85.1 |
Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 80.3 |
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Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Intervention | percentage of participants (Number) |
---|
Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 34.8 |
Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 28.2 |
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Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months]) (NCT01200758)
Timeframe: Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
Intervention | mcg*day/mL (Geometric Mean) |
---|
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 2734.21 |
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 3778.93 |
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Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Intervention | percentage of participants (Number) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 84.9 |
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 84.4 |
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Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab
(NCT01200758)
Timeframe: Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)
Intervention | micrograms per milliliter (mcg/mL) (Geometric Mean) |
---|
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 83.1 |
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 134.6 |
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Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab
Levels of HAHA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years]) (NCT01200758)
Timeframe: Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
Intervention | percentage of participants (Number) |
---|
| Baseline (n=68, 188) | Post-Baseline (n=66, 197) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 10.3 | 7.6 |
,Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 11.2 | 13.2 |
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Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks & 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 & Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 [up to 32 months]) (NCT01200758)
Timeframe: Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)
Intervention | mcg/mL (Geometric Mean) |
---|
| Cycle 1 (n = 198, 193) | Cycle 2 (n = 197, 190) | Cycle 3 (n = 192, 190) | Cycle 4 (n = 186, 185) | Cycle 5 (n = 185, 185) | Cycle 6 (n = 187, 180) | Cycle 7 (n = 183, 172) | Cycle 8 (n = 52, 54) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 14.00 | 30.13 | 45.25 | 54.06 | 64.68 | 71.02 | 78.31 | 77.60 |
,Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 12.88 | 40.00 | 63.83 | 81.71 | 98.00 | 109.56 | 120.75 | 131.48 |
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Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Intervention | percentage of participants (Number) |
---|
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 25.0 |
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 42.9 |
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Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab
Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months]) (NCT01200758)
Timeframe: Stage I (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
Intervention | mcg/mL (Geometric Mean) |
---|
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 250.63 |
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 236.82 |
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Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL
PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. PFS analysis was performed using Kaplan - Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
Intervention | days (Median) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | NA |
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | NA |
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Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in the SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Intervention | percentage of participants (Number) |
---|
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 82.8 |
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 90.5 |
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Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration
(NCT01200758)
Timeframe: 12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])
Intervention | mcg/mL (Median) |
---|
| Week 12: Follow-up Visit 1 (n = 117, 118) | Week 24: Follow-up Visit 2 (n = 88, 96) | Week 36: Follow-up Visit 3 (n = 38, 53) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 15.60 | 2.89 | 1.08 |
,Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 22.35 | 5.19 | 2.02 |
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Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20
All investigator physicians and nurses involved in this study were asked to provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (<) 1 hr, at least 1 hr but <2 hrs, at least 2 hrs but <3 hrs, at least 3 hrs but <4 hrs, >/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV. (NCT01200758)
Timeframe: After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)
Intervention | percentage of responses (Number) |
---|
| After Cy8: <1 hour (n=166) | After Cy8: ≥1 to <2 hours (n=166) | After Cy8: ≥2 to <3 hours (n=166) | After Cy8: ≥3 to <4 hours (n=166) | After Cy8: ≥4 hours (n=166) | After Cy15: <1 hour (n=130) | After Cy15: ≥1 to <2 hours (n=130) | After Cy15: ≥2 to <3 hours (n=126) | After Cy15: ≥3 to <4 hours (n=130) | After Cy15: ≥4 hours (n=130) | After Cy20: <1 hour (n=126) | After Cy20: ≥1 to <2 hours (n=126) | After Cy20: ≥2 to <3 hours (n=126) | After Cy20: ≥3 to <4 hours (n=126) | After Cy20: ≥4 hours (n=126) |
---|
All Participants | 11 | 20 | 35 | 18 | 16 | 13 | 17 | 34 | 14 | 22 | 14 | 32 | 21 | 13 | 19 |
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Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Levels of HACA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years]) (NCT01200758)
Timeframe: Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
Intervention | percentage of participants (Number) |
---|
| Baseline (n=208, 191) | Post-Baseline (n=206, 197) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 5.8 | 1.5 |
,Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 2.6 | 2.0 |
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Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle
Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 [1 Cy=8 weeks]; up to data cutoff of 11 Jan 2016 [up to 6 years]) (NCT01200758)
Timeframe: Stage I and II (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)
Intervention | mcg/mL (Geometric Mean) |
---|
| Cycle 8 (n = 174, 170) | Cycle 9 (n = 171, 168) | Cycle 10 (n = 164, 160) | Cycle 11 (n = 164, 157) | Cycle 12 (n = 160, 150) | Cycle 13 (n = 157, 150) | Cycle 14 (n = 153, 147) | Cycle 15 (n = 148, 143) | Cycle 16 (n = 150, 145) | Cycle 17 (n = 149, 143) | Cycle 18 (n = 143, 132) | Cycle 19 (n = 138, 131) |
---|
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 37.69 | 30.35 | 28.44 | 28.77 | 28.80 | 28.84 | 28.09 | 28.19 | 28.05 | 28.24 | 28.59 | 27.75 |
,Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 61.31 | 49.47 | 47.27 | 46.70 | 44.72 | 44.32 | 43.32 | 44.11 | 42.96 | 42.82 | 44.79 | 43.69 |
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OS Based on Baseline CTC Counts
HE of CTC was defined as having CTC counts ≥5 cells/7.5 mL and LE of CTC was defined as having CTC counts <5 cells/7.5 mL. OS was defined as the time from the date of randomization to the date of death from any cause. (NCT01204710)
Timeframe: Randomization to Death Due to Any Cause Up to 36 Months
Intervention | months (Median) |
---|
Olaratumab + Mitoxantrone (HE) | 12.85 |
Mitoxantrone (HE) | 8.10 |
Olaratumab + Mitoxantrone (LE) | 16.49 |
Mitoxantrone (LE) | 23.00 |
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Progression-Free Survival (PFS)
PFS is measured from randomization to the earliest date of the following events: PD according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1, is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy or were lost to follow-up, PFS was censored at their last tumor assessment. (NCT01204710)
Timeframe: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
Intervention | months (Median) |
---|
Olaratumab + Mitoxantrone | 2.3 |
Mitoxantrone | 2.4 |
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Number of Participants Who Died During Study
(NCT01204710)
Timeframe: From Start of Treatment through Study Completion up to 36 Months
Intervention | participants (Number) |
---|
| Due to PD | Due to AEs | Due to Other reasons |
---|
Mitoxantrone | 27 | 3 | 2 |
,Mitoxantrone: Optional Olaratumab Monotherapy | 12 | 1 | 1 |
,Olaratumab + Mitoxantrone | 43 | 4 | 3 |
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Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC)
"PDGFRα protein expression (pretreatment) by IHC was assessed in tumor cells, and was provided as a dichotomous variable with positive and negative expression. Positive corresponds to weak intensity membranous staining comprising greater than 30% of the tumor and/or moderate to strong intensity membranous staining comprising greater than 5% of the tumor. Negative corresponds to staining that does not meet these requirements." (NCT01204710)
Timeframe: Baseline
Intervention | participants (Number) |
---|
Olaratumab + Mitoxantrone | 14 |
Mitoxantrone | 9 |
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Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE)
Data presented are the number of participants who experienced serious adverse events (SAEs) and other nonserious adverse events (AEs). For participants in mitoxantrone group who had PD and chose optional IMC-3G3 follow-on treatment, the baseline was defined as the last assessment prior to the start of the olaratumab treatment. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section. (NCT01204710)
Timeframe: From Start of Treatment Through Study Completion Up to 36 months
Intervention | participants (Number) |
---|
| SAEs | AEs |
---|
Mitoxantrone | 21 | 51 |
,Mitoxantrone: Optional Olaratumab Monotherapy | 6 | 15 |
,Olaratumab + Mitoxantrone | 26 | 52 |
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Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause. If the participants were alive at the end of the follow-up period or were lost to follow-up, OS time was censored on the last date the participant was known to be alive. (NCT01204710)
Timeframe: Randomization to Death Due to Any Cause Up to 36 Months
Intervention | months (Median) |
---|
Olaratumab + Mitoxantrone | 14.2 |
Mitoxantrone | 12.8 |
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Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Best response is categorized using the RECIST v1.1 guidelines. CR is the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is a ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the pretreatment sum diameter. Percentage of participants = (number of participants who had CR or PR) / (number of participants treated) * 100. (NCT01204710)
Timeframe: Randomization to Objective PD or Death Up to 23 Months
Intervention | percentage of participants (Number) |
---|
Olaratumab + Mitoxantrone | 10.0 |
Mitoxantrone | 3.1 |
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Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity)
Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20. (NCT01204710)
Timeframe: From Start of Treatment up to 9 Months
Intervention | percent of participants (Number) |
---|
Olaratumab + Mitoxantrone | 3.8 |
Mitoxantrone | 0 |
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PFS Based on Baseline Circulating Tumor Cells (CTC) Counts
High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL) and low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 mL. PFS is measured from randomization to the earliest date of the following events: PD according to RECIST criteria v. 1.1, is a ≥20% increase in the sum diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 mm, the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. (NCT01204710)
Timeframe: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
Intervention | months (Median) |
---|
Olaratumab + Mitoxantrone (HE) | 2.32 |
Mitoxantrone (HE) | 2.23 |
Olaratumab + Mitoxantrone (LE) | 2.38 |
Mitoxantrone (LE) | 4.91 |
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Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12
Percentage of participants = (number of participants who had ≥30% decrease in PSA at Week 12) / (number of participants treated) * 100. (NCT01204710)
Timeframe: Pretreatment through Week 12
Intervention | percentage of participants (Number) |
---|
Olaratumab + Mitoxantrone | 22.6 |
Mitoxantrone | 16.9 |
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Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time
Decrease in PSA ≥50% from pretreatment required confirmation no less than 3 weeks after the initial suggestion of response and occurring prior to documentation of PD. Percentage of participants = (number of participants who had ≥50% decrease in PSA at any time) / (number of participants treated) * 100. (NCT01204710)
Timeframe: Pretreatment to PD Up to 23 Months
Intervention | percentage of participants (Number) |
---|
Olaratumab + Mitoxantrone | 22.6 |
Mitoxantrone | 18.6 |
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Inflammatory Cytokine Response to Ablation Procedure
Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery. (NCT01206452)
Timeframe: Immediately Post-Ablation Procedure
Intervention | pg/ml (Mean) |
---|
| IL-1 level | IL-8 level | TNF-α level | IL-6 level |
---|
Ablation Plus Placebo | 11 | 15.3 | 7.9 | 15.78 |
,Ablation Plus Prednisone | 7.94 | 10.54 | 5.45 | 9.03 |
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Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months
Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. (NCT01206452)
Timeframe: From 6 months up to 12 months post-procedure
Intervention | Participants with AF recurrence (Number) |
---|
Ablation Plus Placebo | 4 |
Ablation Plus Prednisone | 6 |
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Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months
Number of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. (NCT01206452)
Timeframe: From 0 months up to 3 months post procedure
Intervention | Participants with AF recurrence (Number) |
---|
Ablation Plus Placebo | 6 |
Ablation Plus Prednisone | 8 |
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Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months
Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. (NCT01206452)
Timeframe: From 3 months up to 6 months post-procedure
Intervention | Participants with AF recurrence (Number) |
---|
Ablation Plus Placebo | 5 |
Ablation Plus Prednisone | 9 |
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Inflammatory Cytokine Response to Ablation Procedure
Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, 24 hours post-ablation to assess interval response to steroid administration. (NCT01206452)
Timeframe: 24 Hours after Ablation Procedure
Intervention | pg/ml (Mean) |
---|
| IL-1 level | IL-8 level | TNF-α level | IL-6 level |
---|
Ablation Plus Placebo | 11.7 | 59.6 | 9.7 | 40.9 |
,Ablation Plus Prednisone | 8.5 | 63.9 | 7.5 | 40.2 |
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Percentage of Participants With Endoscopic Response 48 Weeks After Randomization
"Endoscopic response was defined as a decrease CDEIS > 5 points. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization
Intervention | percentage of participants (Number) |
---|
Clinically Driven Management | 40.2 |
Tight Control Management | 50.8 |
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Change From Baseline in CDAI Over Time
The Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. Participants were asked to record the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI: presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. The CDAI is the sum of the products of each item multiplied by a weighting factor and generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change from Baseline indicates improvement. (NCT01235689)
Timeframe: Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.
Intervention | units on a scale (Mean) |
---|
| Week 4 of Prednisone Run-in | Week 8 of Prednisone Run-in | 2 Weeks After Randomization | 6 Weeks After Randomization | 11 Weeks After Randomization | 14 Weeks After Randomization | 18 Weeks After Randomization | 23 Weeks After Randomization | 26 Weeks After Randomization | 30 Weeks After Randomization | 35 Weeks After Randomization | 38 Weeks After Randomization | 42 Weeks After Randomization | 48 Weeks After Randomization |
---|
Clinically Driven Management | -78.3 | -64.2 | -80.2 | -93.1 | -103.5 | -71.1 | -69.9 | -143.3 | -71.8 | -47.9 | -140.4 | -60.8 | -76.8 | -146.2 |
,Tight Control Management | -90.9 | -105.5 | -110.1 | -130.8 | -141.0 | -101.2 | -112.0 | -154.1 | -135.7 | -143.8 | -166.4 | -132.8 | -107.4 | -175.8 |
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Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Over Time
High sensitivity C-reactive protein was analyzed by a central laboratory. (NCT01235689)
Timeframe: Baseline and 8 weeks during the prednisone run-in, and 11, 23, 35, and 48 weeks after Randomization.
Intervention | mg/L (Mean) |
---|
| Week 8 of Prednisone Run-in | 11 Weeks After Randomization | 23 Weeks After Randomization | 35 Weeks After Randomization | 48 Weeks After Randomization |
---|
Clinically Driven Management | -10.3 | -14.6 | -15.1 | -11.0 | -12.3 |
,Tight Control Management | -9.2 | -15.9 | -14.7 | -14.0 | -13.2 |
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Change From Baseline in Work Productivity Activity Index - Crohn's Disease (WPAI:CD)
"The WPAI:CD questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions.~Work time missed was defined as the percentage of time absent from work due to Crohn's disease in the past week.~Impairment while working is the participant's assessment of the degree to which Crohn's disease affected productivity while working in the past 7 days.~Total work productivity impairment takes into account both hours missed due to Crohn's disease symptoms and the patient's assessment of the degree to which Crohn's disease affected their productivity while working.~Total activity impairment is the percent impairment of non-work related activities due to Crohn's disease.~WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement." (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization
Intervention | percent impairment (Mean) |
---|
| Work time missed | Impairment while working | Overall work impairment | Activity impairment |
---|
Clinically Driven Management | -12.8 | -17.5 | -21.7 | -19.2 |
,Tight Control Management | -17.6 | -25.8 | -29.2 | -27.7 |
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Percentage of Participants in Clinical Remission Over Time
"Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~Participants with missing data at each time point were counted as non-responders." (NCT01235689)
Timeframe: Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.
Intervention | percentage of participants (Number) |
---|
| Week 4 of Prednisone Run-in | Week 8 of Prednisone Run-in | 2 Weeks After Randomization | 6 Weeks After Randomization | 11 Weeks After Randomization | 14 Weeks After Randomization | 18 Weeks After Randomization | 23 Weeks After Randomization | 26 Weeks After Randomization | 30 Weeks After Randomization | 35 Weeks After Randomization | 38 Weeks After Randomization | 42 Weeks After Randomization | 48 Weeks After Randomization |
---|
Clinically Driven Management | 24.6 | 14.8 | 23.8 | 32.8 | 41.8 | 8.2 | 9.0 | 50.8 | 4.1 | 3.3 | 45.1 | 4.1 | 4.1 | 43.4 |
,Tight Control Management | 30.3 | 22.1 | 41.0 | 47.5 | 62.3 | 6.6 | 8.2 | 65.6 | 20.5 | 23.0 | 59.8 | 9.0 | 7.4 | 59.8 |
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Percentage of Participants in Steroid-free Remission Over Time
"Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~Participants with missing data at each time point were counted as non-responders." (NCT01235689)
Timeframe: 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.
Intervention | percentage of participants (Number) |
---|
| 11 Weeks After Randomization | 14 Weeks After Randomization | 18 Weeks After Randomization | 23 Weeks After Randomization | 26 Weeks After Randomization | 30 Weeks After Randomization | 35 Weeks After Randomization | 38 Weeks After Randomization | 42 Weeks After Randomization | 48 Weeks After Randomization |
---|
Clinically Driven Management | 23.8 | 4.1 | 3.3 | 45.1 | 2.5 | 0.8 | 42.6 | 4.1 | 4.1 | 39.3 |
,Tight Control Management | 39.3 | 4.9 | 7.4 | 63.1 | 18.9 | 21.3 | 59.0 | 9.0 | 7.4 | 59.8 |
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Percentage of Participants With Complete Mucosal Healing 48 Weeks After Randomization
"Complete mucosal healing was defined as CDEIS = 0. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization
Intervention | percentage of participants (Number) |
---|
Clinically Driven Management | 16.4 |
Tight Control Management | 18.0 |
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Percentage of Participants in Deep Remission 48 Weeks After Randomization
"Deep remission was defined as CDAI < 150, discontinuation from steroids for at least 8 weeks, absence of draining fistula, CDEIS < 4 and no deep ulcerations.~CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing data 48 weeks after randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization
Intervention | percentage of participants (Number) |
---|
Clinically Driven Management | 23.0 |
Tight Control Management | 36.9 |
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Percentage of Participants in Biologic Remission 48 Weeks After Randomization
"Biologic remission was defined as high sensitivity C-reactive protein (hs-CRP) < 5 mg/L, fecal Calprotectin < 250 μg/g, and CDEIS < 4 at 48 weeks after randomization.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization
Intervention | percentage of participants (Number) |
---|
Clinically Driven Management | 15.6 |
Tight Control Management | 29.5 |
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Percentage of Participants With Mucosal Healing 48 Weeks After Randomization
"Percentage of participants with mucosal healing (defined as a CDEIS < 4) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization
Intervention | percentage of participants (Number) |
---|
Clinically Driven Management | 30.3 |
Tight Control Management | 45.9 |
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Percentage of Participants With Mucosal Healing and CDEIS < 4 in Every Segment 48 Weeks After Randomization
"Percentage of participants with mucosal healing (defined as CDEIS < 4) and CDEIS < 4 in every segment on ileocolonoscopy at 48 weeks after randomization. The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization
Intervention | percentage of participants (Number) |
---|
Clinically Driven Management | 23.8 |
Tight Control Management | 29.5 |
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Percentage of Participants With Mucosal Healing and No Deep Ulcerations
"Percentage of participants with mucosal healing (defined as Crohn's disease endoscopy Index of severity [CDEIS] < 4) and no deep ulcerations on ileocolonoscopy (defined as the absence of all deep ulcerations in all segments explored in CDEIS) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing data 48 weeks after Randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization
Intervention | percentage of participants (Number) |
---|
Clinically Driven Management | 30.3 |
Tight Control Management | 45.9 |
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Number of All-cause Hospitalizations After Randomization
Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. (NCT01235689)
Timeframe: From Randomization through 48 weeks after Randomization
Intervention | hospitalizations (Number) |
---|
Clinically Driven Management | 37 |
Tight Control Management | 25 |
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Change From Baseline in Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease, feeling in general, and mood. Each question is answered on a scale from 1 (all of the time) to 7 ( none of the time); the total score ranges from 7 (worst) to 224 (best). A positive change from baseline indicates improvement. (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization
Intervention | units on a scale (Mean) |
---|
Clinically Driven Management | 31.2 |
Tight Control Management | 41.9 |
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Change From Baseline in Patient Health Questionnaire - 9 (PHQ9)
The PHQ-9 is a 9-item questionnaire for assessing the severity of depression. Each question is answered on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, where higher scores indicate more severe depression. A negative change from Baseline score indicates improvement. (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization
Intervention | units on a scale (Mean) |
---|
Clinically Driven Management | -3.6 |
Tight Control Management | -5.6 |
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, from 0 (not at all) to 4 (very much). The FACIT-Fatigue score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from Baseline score indicates an improvement.~." (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization
Intervention | units on a scale (Mean) |
---|
Clinically Driven Management | 7.6 |
Tight Control Management | 13.0 |
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Change From Baseline in CDEIS at 48 Weeks After Randomization
CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. A negative change from Baseline indicates improvement. (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization
Intervention | units on a scale (Mean) |
---|
Clinically Driven Management | -6.4 |
Tight Control Management | -7.7 |
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Time to All-cause Hospitalization
Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. (NCT01235689)
Timeframe: From Randomization through 48 weeks after Randomization
Intervention | days (Median) |
---|
Clinically Driven Management | NA |
Tight Control Management | NA |
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Time to Clinical Remission
Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI scores generally range from 0 to 600 where higher scores indicate more severe disease. (NCT01235689)
Timeframe: From Randomization through 48 weeks after Randomization
Intervention | days (Median) |
---|
Clinically Driven Management | 78 |
Tight Control Management | 43 |
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Time to Crohn's Disease Flare
Time to Crohn's disease flare, where flare is defined as an increase in CDAI ≥ 70 points compared to Week 8 or Early Randomization CDAI, and a CDAI > 220. (NCT01235689)
Timeframe: From Randomization to 48 weeks after Randomization
Intervention | days (Median) |
---|
Clinically Driven Management | NA |
Tight Control Management | NA |
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Time to Steroid-free Remission
Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. (NCT01235689)
Timeframe: From Randomization through 48 weeks after Randomization
Intervention | days (Median) |
---|
Clinically Driven Management | 162 |
Tight Control Management | 159 |
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Total Dose of Prednisone
The total dose of prednisone each participant received during both the run-in phase and post-randomization treatment phase. (NCT01235689)
Timeframe: From Baseline through 48 weeks after Randomization
Intervention | mg (Mean) |
---|
Clinically Driven Management | 1505.7 |
Tight Control Management | 1369.8 |
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Total Length of Stay in Hospital for All-cause Hospitalizations
(NCT01235689)
Timeframe: From Randomization through 48 weeks after Randomization
Intervention | days (Mean) |
---|
Clinically Driven Management | 40.2 |
Tight Control Management | 50.1 |
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Duration of Response (DOR), Investigator-Assessed
DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%. (NCT01287741)
Timeframe: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Intervention | months (Median) |
---|
Rituximab+Chemotherapy | 71.9 |
Obinutuzumab+Chemotherapy | NA |
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Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab. (NCT01287741)
Timeframe: C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)
Intervention | micrograms per milliliter (μg/mL) (Geometric Mean) |
---|
| Cycle 1, Day 8 pre-infusion | Cycle 1, Day 15 pre-infusion | Cycle 2, Day 1 pre-infusion | Cycle 4, Day 1 pre-infusion | Cycle 6, Day 1 pre-infusion | Cycle 8, Day 1 pre-infusion | Cycle 1, Day 1 post-infusion | Cycle 1, Day 1 20-28 hours after end of infusion | Cycle 1, Day 1 66-80 hours after end of infusion | Cycle 1, Day 8 post-infusion | Cycle 1, Day 15 post-infusion | Cycle 2, Day 1 post-infusion | Cycle 4, Day 1 post-infusion | Cycle 6, Day 1 post-infusion | Cycle 8, Day 1 post-infusion |
---|
Obinutuzumab+Chemotherapy | 174 | 320 | 431 | 352 | 378 | 478 | 435 | 259 | 219 | 578 | 718 | 938 | 817 | 813 | 881 |
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Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants. (NCT01287741)
Timeframe: Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)
Intervention | percentage of participants (Number) |
---|
| Screening | Cycle 4 Day 1 | Study Completion / Early Discontinuation | Follow-Up Month 6 | Follow-Up Month 12 | Follow-Up Month 18 | Follow-Up Month 24 | Follow-Up Month 30 | Follow-Up Completion/ Early Discontinuation | Unscheduled |
---|
Obinutuzumab+Chemotherapy | 2.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Time to Next Anti-Lymphoma Treatment (TTNALT)
Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. (NCT01287741)
Timeframe: Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018)
Intervention | months (Median) |
---|
Rituximab+Chemotherapy | NA |
Obinutuzumab+Chemotherapy | NA |
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Overall Response Rate (ORR), IRC-Assessed
Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants. (NCT01287741)
Timeframe: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Intervention | percentage of participants (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 82.3 | 82.1 |
,Rituximab+Chemotherapy | 80.2 | 81.1 |
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Percentage of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)
Intervention | percentage of participants (Number) |
---|
Rituximab+Chemotherapy | 95.3 |
Obinutuzumab+Chemotherapy | 98.1 |
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Overall Response Rate (ORR), Investigator-Assessed
Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)
Intervention | percentage of participants (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 81.4 | 77.1 |
,Rituximab+Chemotherapy | 80.1 | 77.6 |
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Complete Response (CR) at the End of Treatment, IRC-Assessed
Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants. (NCT01287741)
Timeframe: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Intervention | percentage of participants (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 39.1 | 66.7 |
,Rituximab+Chemotherapy | 34.4 | 65.3 |
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Complete Response (CR) at the End of Treatment, Investigator-Assessed
Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)
Intervention | percentage of participants (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 35.4 | 56.5 |
,Rituximab+Chemotherapy | 33.9 | 59.1 |
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Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)
Intervention | score on a scale (Mean) |
---|
| Baseline | Score Change, Cycle 3 Day 1 | Score Change, Study Compl./Discont. | Score Change, Follow-Up Month 12 | Score Change, Follow-Up Month 24 | Score Change, Follow-Up Month 30 | Score Change, Follow-Up Month 36 | Score Change, Follow-Up Month 48 | Score Change, Follow-Up Term./Compl. |
---|
Obinutuzumab+Chemotherapy | 45.18 | 3.70 | 4.35 | 6.18 | 6.66 | 25.00 | 7.31 | 7.37 | 5.55 |
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)
Intervention | score on a scale (Mean) |
---|
| Baseline | Change Baseline, Cycle 3 Day 1 | Change Baseline, Study Completion | Change Baseline, Follow-Up Month 12 | Change Baseline, Follow-Up Month 24 | Change Baseline, Follow-Up Month 30 | Change Baseline, Follow-Up Month 36 | Change Baseline, Follow-Up Month 48 | Change Baseline, Follow-Up Completion |
---|
Obinutuzumab+Chemotherapy | 58.55 | 7.51 | 10.22 | 13.84 | 15.81 | 58.33 | 17.99 | 17.53 | 8.46 |
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Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)
Intervention | score on a scale (Mean) |
---|
| Baseline | Score Change, Cycle 3 Day 1 | Score Change, Study Compl./Discont. | Score Change, Follow-Up Month 12 | Score Change, Follow-Up Month 24 | Score Change, Follow-Up Month 36 | Score Change, Follow-Up Month 48 | Score Change, Follow-Up Term./Compl. |
---|
Rituximab+Chemotherapy | 45.34 | 3.83 | 5.03 | 6.37 | 7.07 | 7.57 | 8.22 | 5.51 |
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)
Intervention | score on a scale (Mean) |
---|
| Baseline | Change Baseline, Cycle 3 Day 1 | Change Baseline, Study Completion | Change Baseline, Follow-Up Month 12 | Change Baseline, Follow-Up Month 24 | Change Baseline, Follow-Up Month 36 | Change Baseline, Follow-Up Month 48 | Change Baseline, Follow-Up Completion |
---|
Rituximab+Chemotherapy | 59.81 | 6.37 | 9.84 | 12.67 | 14.74 | 15.01 | 16.62 | 8.74 |
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Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)
Time to PSA-PFS: time interval between date of randomization & first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA <10 ng/mL):(a)in participants with baseline PSA>0 ng/mL&<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method. (NCT01308567)
Timeframe: Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
Intervention | months (Median) |
---|
Docetaxel 75 mg/m^2 | 8.3 |
Cabazitaxel 20 mg/m^2 | 8.2 |
Cabazitaxel 25 mg/m^2 | 9.2 |
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Time to Tumor Progression Free Survival
Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method. (NCT01308567)
Timeframe: Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
Intervention | months (Median) |
---|
Docetaxel 75 mg/m^2 | 12.1 |
Cabazitaxel 20 mg/m^2 | 13.4 |
Cabazitaxel 25 mg/m^2 | 13.1 |
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Percentage of Participants With PSA Response
PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL. (NCT01308567)
Timeframe: Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
Intervention | percentage of participants (Number) |
---|
Docetaxel 75 mg/m^2 | 68.4 |
Cabazitaxel 20 mg/m^2 | 60.7 |
Cabazitaxel 25 mg/m^2 | 68.7 |
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Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL
FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms. (NCT01308567)
Timeframe: Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Change at Cycle 1 | Change at Cycle 2 | Change at Cycle 3 | Change at Cycle 4 | Change at Cycle 5 | Change at Cycle 6 | Change at Cycle 7 | Change at Cycle 8 | Change at Cycle 9 | Change at Cycle 10 | Change at Cycle 11 | Change at Cycle 12 | Change at Cycle 13 | Change at Cycle 14 | Change at Cycle 15 | Change at Cycle 16 | Change at Follow-up 1 | Change at Follow-up 2 | Change at Follow-up 3 | Change at Follow-up 4 | Change at Follow-up 5 | Change at Follow-up 6 |
---|
Cabazitaxel 20 mg/m^2 | 6.09 | 5.96 | 5.28 | 4.1 | 4.05 | 3.15 | 3.14 | 2.26 | 2.15 | 1.56 | 2.72 | 3.08 | 1.78 | 1.59 | 1.29 | 1.23 | -1.26 | -1.12 | -1.67 | -2.54 | -5.36 | -5.32 |
,Cabazitaxel 25 mg/m^2 | 5.76 | 4.26 | 3.65 | 3.2 | 3.1 | 2.88 | 2.94 | 1.49 | 1.73 | 1.62 | 2.19 | 0.75 | 0.82 | -0.07 | 1.49 | 1.44 | -1.62 | -1.05 | -1.98 | -1.03 | -0.82 | -2.76 |
,Docetaxel 75 mg/m^2 | 3.31 | 4.37 | 4.31 | 3.39 | 3.41 | 2.76 | 2.29 | 1.67 | 1.75 | 1.52 | 0.35 | 1.04 | 2.13 | -0.13 | -2.1 | -2.26 | -0.96 | -0.07 | -0.32 | -0.91 | -2.15 | -1.77 |
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Time to Pain Progression Free Survival (Pain PFS)
Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method. (NCT01308567)
Timeframe: Baseline until disease progression, death or study cut-off date (maximum duration: 51 months)
Intervention | months (Median) |
---|
Docetaxel 75 mg/m^2 | 10.1 |
Cabazitaxel 20 mg/m^2 | 8.0 |
Cabazitaxel 25 mg/m^2 | 7.3 |
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Percentage of Participants With Pain Response
Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. (NCT01308567)
Timeframe: Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)
Intervention | percentage of participants (Number) |
---|
Docetaxel 75 mg/m^2 | 40.7 |
Cabazitaxel 20 mg/m^2 | 42.4 |
Cabazitaxel 25 mg/m^2 | 39.4 |
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Percentage of Participants With Overall Objective Tumor Response
Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT01308567)
Timeframe: Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
Intervention | percentage of participants (Number) |
---|
Docetaxel 75 mg/m^2 | 30.9 |
Cabazitaxel 20 mg/m^2 | 32.4 |
Cabazitaxel 25 mg/m^2 | 41.6 |
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Overall Survival (OS)
OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method. (NCT01308567)
Timeframe: Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )
Intervention | months (Median) |
---|
Docetaxel 75 mg/m^2 | 24.3 |
Cabazitaxel 20 mg/m^2 | 24.5 |
Cabazitaxel 25 mg/m^2 | 25.2 |
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Progression Free Survival (PFS)
PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method. (NCT01308567)
Timeframe: Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)
Intervention | months (Median) |
---|
Docetaxel 75 mg/m^2 | 5.3 |
Cabazitaxel 20 mg/m^2 | 4.4 |
Cabazitaxel 25 mg/m^2 | 5.1 |
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Percentage of Participants With FACT-P Total Score Response
FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period. (NCT01308580)
Timeframe: From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
Intervention | percentage of participants (Number) |
---|
Cabazitaxel 20 mg/m^2 | 57.2 |
Cabazitaxel 25 mg/m^2 | 59.4 |
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Plasma Clearance (CL) for Cabazitaxel
Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy. (NCT01308580)
Timeframe: Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI
Intervention | Litre/hour (Mean) |
---|
Cabazitaxel 20 mg/m^2 | 44.832 |
Cabazitaxel 25 mg/m^2 | 49.662 |
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Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel
Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy. (NCT01308580)
Timeframe: Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI
Intervention | litre (Mean) |
---|
Cabazitaxel 20 mg/m^2 | 7381.46 |
Cabazitaxel 25 mg/m^2 | 7040.10 |
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Progression Free Survival (PFS)
PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA >0 ng/mL & <10 ng/mL; or post-baseline value of >=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Intervention | months (Median) |
---|
Cabazitaxel 20 mg/m^2 | 2.9 |
Cabazitaxel 25 mg/m^2 | 3.5 |
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Time to Definitive Deterioration of ECOG PS Score From Baseline
The ECOG PS was used to evaluate participant's DP and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for < 50 % of the time; 3= in bed for > 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to ≥2, or from 2 to ≥3. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline until death or study cut-off date (maximum duration: 48 months)
Intervention | months (Median) |
---|
Cabazitaxel 20 mg/m^2 | 14.9 |
Cabazitaxel 25 mg/m^2 | 14.1 |
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Time to First Definitive Consumption of Narcotic Medication
Concomitant medications used were recorded for all participants, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
Intervention | months (Median) |
---|
Cabazitaxel 20 mg/m^2 | 2.2 |
Cabazitaxel 25 mg/m^2 | 0.8 |
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Time to Pain Progression
Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
Intervention | months (Median) |
---|
Cabazitaxel 20 mg/m^2 | 6.2 |
Cabazitaxel 25 mg/m^2 | 6.4 |
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Time to PSA Progression
Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA <10 ng/mL): (a) participants with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Intervention | months (Median) |
---|
Cabazitaxel 20 mg/m^2 | 5.7 |
Cabazitaxel 25 mg/m^2 | 6.8 |
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Time to Tumor Progression
Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Intervention | months (Median) |
---|
Cabazitaxel 20 mg/m^2 | 9.0 |
Cabazitaxel 25 mg/m^2 | 9.3 |
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Percentage of Participants With Pain Response
Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response. (NCT01308580)
Timeframe: From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
Intervention | percentage of participants (Number) |
---|
Cabazitaxel 20 mg/m^2 | 34.7 |
Cabazitaxel 25 mg/m^2 | 37.3 |
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 [severe] and Grade 4 [life-threatening]) was used in this study to grade clinical AEs. (NCT01308580)
Timeframe: From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)
Intervention | percentage of participants (Number) |
---|
| Any Grade TEAE | Any Grade 3-4 TEAE | Grade 3-4 TEAE excluding laboratory TEAE | Grade 3-4 TEAE excluding DP TEAEs | Grade 3-4 TEAE excluding laboratory and DP TEAEs | Any Serious TEAE | Any TEAE leading to permanent discontinuation |
---|
Cabazitaxel 20 mg/m^2 | 91.2 | 39.7 | 35.7 | 39.0 | 35.0 | 30.5 | 16.4 |
,Cabazitaxel 25 mg/m^2 | 93.9 | 54.5 | 48.1 | 53.9 | 47.4 | 43.2 | 19.5 |
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Time to Definitive Weight Loss by 5% and 10% From Baseline
Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline until death or study cut-off date (maximum duration: 48 months)
Intervention | months (Median) |
---|
| Weight Loss by 5% | Weight Loss by 10% |
---|
Cabazitaxel 20 mg/m^2 | 10.6 | NA |
,Cabazitaxel 25 mg/m^2 | 11.1 | 20.3 |
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Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales
The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
Intervention | months (Median) |
---|
| Physical well-being | Social/family well-being | Emotional well-being | Functional well-being | Prostate specific concern |
---|
Cabazitaxel 20 mg/m^2 | 6.6 | 10.8 | 9.7 | 6.6 | 8.7 |
,Cabazitaxel 25 mg/m^2 | 8.3 | 12.4 | 9.9 | 6.7 | 9.7 |
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Overall Survival (OS)
OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Intervention | months (Median) |
---|
Cabazitaxel 20 mg/m^2 | 13.4 |
Cabazitaxel 25 mg/m^2 | 14.5 |
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Change From Baseline in FACT-P:Total Score as a Measure of HRQoL
FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. (NCT01308580)
Timeframe: Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Change from baseline at cycle 1 (n =521, 495) | Change from baseline at cycle 2 (n = 502, 492) | Change from baseline at cycle 3 (n = 459, 452) | Change from baseline at cycle 4 (n = 421, 415) | Change from baseline at cycle 5 (n = 339, 365) | Change from baseline at cycle 6 (n = 275, 320) | Change from baseline at cycle 7 (n = 229, 267) | Change from baseline at cycle 8 (n = 196, 226) | Change from baseline at cycle 9 (n = 164, 172) | Change from baseline at cycle 10 (n = 137, 141) | Change from baseline at Follow-up 1 (n = 137, 153) |
---|
Cabazitaxel 20 mg/m^2 | 5.6 | 5.39 | 4.39 | 2.94 | 1.79 | 2.57 | 2.62 | 1.35 | 1.1 | 0.02 | -3.1 |
,Cabazitaxel 25 mg/m^2 | 5.75 | 6.23 | 6.09 | 4.2 | 3.33 | 2.35 | 2.72 | 1.98 | 1 | 1.33 | -2.09 |
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Percentage of Participants With PSA Response
PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL. (NCT01308580)
Timeframe: From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Intervention | percentage of participants (Number) |
---|
Cabazitaxel 20 mg/m^2 | 29.5 |
Cabazitaxel 25 mg/m^2 | 42.9 |
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Percentage of Participants With Overall Objective Tumor Response
Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT01308580)
Timeframe: From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Intervention | percentage of participants (Number) |
---|
Cabazitaxel 20 mg/m^2 | 18.5 |
Cabazitaxel 25 mg/m^2 | 23.4 |
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Overall Survival
(NCT01309672)
Timeframe: 3 years
Intervention | months (Median) |
---|
Abiraterone Acetate + Prednisone | 25.8 |
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Number of Patients With Toxicity of Abiraterone Acetate
Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT01309672)
Timeframe: Up to 3 years
Intervention | Participants (Number) |
---|
| Alanine aminotransferase increased | Anorexia | Aspartate aminotransferase increased | Hyperglycemia | Hypertension | Hypokalemia | INR increased | Leukocytosis | Lung infection | Nausea | Rectal hemorrhage | Thromboembolic event | Vomiting | Weight gain |
---|
Abiraterone Acetate + Prednisone | 2 | 1 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 2 | 1 | 1 | 2 | 1 |
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Number of Patients With PSA Partial Response
PSA reduction to < 4 ng/ml, but >0.2 ng/ml (NCT01309672)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Abiraterone Acetate + Prednisone | 13 |
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Number of Patients With Undetectable PSA
undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders. (NCT01309672)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Abiraterone Acetate + Prednisone | 5 |
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Objective Progression-free Survival
Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease. (NCT01309672)
Timeframe: 3 years
Intervention | months (Median) |
---|
Abiraterone Acetate + Prednisone | 17.5 |
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Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement. (NCT01314118)
Timeframe: End of Cycle 3 (Approximately Month 3)
Intervention | Percentage of Participants (Number) |
---|
Abiraterone Acetate and Prednisone | 85.2 |
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Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. (NCT01314118)
Timeframe: End of core study visit (Approximately at Month 6)
Intervention | Percentage of participants (Number) |
---|
Abiraterone Acetate and Prednisone | 86.9 |
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Time to Radiographic Evidence of Disease Progression (TTRP)
Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes. (NCT01314118)
Timeframe: Maximum up to Month 30.5
Intervention | Months (Median) |
---|
Abiraterone Acetate and Prednisone | NA |
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Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks. (NCT01314118)
Timeframe: Maximum up to Month 30.5
Intervention | Months (Median) |
---|
Abiraterone Acetate and Prednisone | 28.7 |
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Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO
EXAcerbations of Chronic pulmonary disease tool patient reported outcome (EXACT-PRO) Rolling Average Improvement from Day 1 to Day 29. EXACT-PRO is a 14 point patient reported daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Minimum score is 0 and Maximum score is 14 (higher scores indicate worsening indicative of an exacerbation). Reported value is LS mean improvement from at Day 29 compared to D1 of the study. (NCT01332097)
Timeframe: Up to Day 29
Intervention | score on a scale (Least Squares Mean) |
---|
Treatment A | 5.72 |
Treatment B, E, G & I | 8.89 |
Treatment C | 5.19 |
Treatment D | 5.83 |
Treatment F | 7.89 |
Treatment H | 8.35 |
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Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second
"Change in FEV1 from baseline to Day 5 or baseline to Day 10 measured in mL~Measure: FEV1~Change in Forced Expiry Volume in 1 second" (NCT01332097)
Timeframe: Day 5, Day 10
Intervention | mL (Least Squares Mean) |
---|
| Day 5 | Day 10 |
---|
Treatment A | 155.1 | 164.6 |
,Treatment B, E, G & I | 100.8 | 126.9 |
,Treatment C | 48.9 | 54.9 |
,Treatment D | 106.3 | 54.6 |
,Treatment F | 134.4 | 109.0 |
,Treatment H | 200.6 | 250.5 |
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Overall Survival (Follicular Lymphoma Population)
Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to 10 years
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 14.3 |
Obinutuzumab+Chemotherapy | 12.6 |
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Event-Free Survival (Overall Study Population)
Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 30.6 |
Obinutuzumab+Chemotherapy | 22.6 |
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Overall Survival (Overall Study Population)
Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 10.2 |
Obinutuzumab+Chemotherapy | 8.4 |
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Disease-Free Survival (Follicular Lymphoma Population)
Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 27.9 |
Obinutuzumab+Chemotherapy | 26.3 |
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Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT01332968)
Timeframe: Baseline up to 10 years
Intervention | percentage of participants (Number) |
---|
Rituximab+Chemotherapy | 99.6 |
Obinutuzumab+Chemotherapy | 99.9 |
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Overall Response (Overall Study Population), IRC-Assessed
Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
Intervention | percentage of participants with event (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 89.9 | 87.2 |
,Rituximab+Chemotherapy | 86.7 | 83.3 |
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Overall Response (Overall Study Population), Investigator-Assessed
Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
Intervention | percentage of participants with event (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 87.3 | 85.4 |
,Rituximab+Chemotherapy | 85.7 | 81.8 |
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Overall Response (Follicular Lymphoma Population), IRC-Assessed
Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
Intervention | percentage of participants with event (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 91.3 | 88.6 |
,Rituximab+Chemotherapy | 88.0 | 85.2 |
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Overall Response (Follicular Lymphoma Population), Investigator-Assessed
Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
Intervention | percentage of participants with event (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 88.2 | 85.5 |
,Rituximab+Chemotherapy | 86.4 | 81.2 |
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Complete Response (Overall Study Population), IRC-Assessed
Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)]
Intervention | percentage of participants with event (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 27.1 | 69.5 |
,Rituximab+Chemotherapy | 26.3 | 59.4 |
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Complete Response (Overall Study Population), Investigator-Assessed
Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
Intervention | percentage of participants with event (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 18.4 | 61.1 |
,Rituximab+Chemotherapy | 23.3 | 57.0 |
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Complete Response (Follicular Lymphoma Population), IRC-Assessed
Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
Intervention | percentage of participants with event (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 28.5 | 71.4 |
,Rituximab+Chemotherapy | 26.8 | 59.7 |
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Complete Response (Follicular Lymphoma Population), Investigator-Assessed
Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
Intervention | percentage of participants with event (Number) |
---|
| Without PET | With PET |
---|
Obinutuzumab+Chemotherapy | 18.6 | 62.0 |
,Rituximab+Chemotherapy | 24.1 | 56.7 |
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Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)
The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Intervention | units on a scale (Mean) |
---|
| Total Score, Baseline | Total Score Change, Cycle 3 Day 1 | Total Score Change, End Induction | Total Score Change, Maint Month 2 | Total Score Change, Maint Month 12 | Total Score Change, End Maint |
---|
Obinutuzumab+Chemotherapy | 128.42 | 3.21 | 5.10 | 8.13 | 7.90 | 8.80 |
,Rituximab+Chemotherapy | 127.40 | 1.98 | 4.18 | 8.40 | 8.87 | 7.43 |
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Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)
The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Intervention | units on a scale (Mean) |
---|
| TOI Score, Baseline | TOI Score Change, Cycle 3 Day 1 | TOI Score Change, End Induction | TOI Score Change, Maint M2 | TOI Score Change, Maint M12 | TOI Score Change, End Maint |
---|
Obinutuzumab+Chemotherapy | 86.94 | 2.18 | 4.57 | 7.17 | 7.20 | 7.44 |
,Rituximab+Chemotherapy | 86.61 | 0.46 | 2.91 | 6.22 | 7.61 | 6.23 |
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Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)
The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Intervention | units on a scale (Mean) |
---|
| Lymphoma, Baseline | Lymphoma Change, Cycle 3 Day 1 | Lymphoma Change, End Induction | Lymphoma Change, Maint Month 2 | Lymphoma Change, Maint Month 12 | Lymphoma Change, End Maint |
---|
Obinutuzumab+Chemotherapy | 45.54 | 2.71 | 3.01 | 4.52 | 4.27 | 4.57 |
,Rituximab+Chemotherapy | 45.01 | 2.04 | 2.99 | 4.80 | 4.93 | 4.31 |
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Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase
The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)
Intervention | units on a scale (Mean) |
---|
| Change Baseline, Maint/Obs Month 2 | Change Baseline, Maint/Obs Month 12 | Change Baseline, Maint/Obs Completion |
---|
Obinutuzumab+Chemotherapy | 0.04 | 0.06 | 0.05 |
,Rituximab+Chemotherapy | 0.04 | 0.06 | 0.03 |
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Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)
Intervention | units on a scale (Mean) |
---|
| Baseline Induction | Change Baseline, Cycle 3 Day 1 | Change Baseline, Induction Compl | Change Baseline, Maint/Obs Month 2 | Change from Baseline, Maint/Obs Month 12 | Change Baseline, Maint/Obs Completion |
---|
Obinutuzumab+Chemotherapy | 0.81 | 0.03 | 0.03 | 0.06 | -0.20 | -0.10 |
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Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)
Intervention | units on a scale (Mean) |
---|
| Baseline Induction | Change Baseline, Cycle 3 Day 1 | Change Baseline, Induction Compl | Change Baseline, Maint/Obs Month 2 | Change from Baseline, Maint/Obs Month 12 |
---|
Rituximab+Chemotherapy | 0.80 | 0.03 | 0.04 | 0.05 | 0.00 |
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Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase
The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months)
Intervention | units on a scale (Mean) |
---|
| Change Baseline, Follow-Up Month 36 | Change Baseline, Follow-Up Month 48 |
---|
Obinutuzumab+Chemotherapy | 0.06 | 0.06 |
,Rituximab+Chemotherapy | 0.05 | 0.05 |
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Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)
FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Intervention | units on a scale (Mean) |
---|
| Physical Well-being (PW), Baseline | PW Change, Cycle 3, Day 1 | PW Change, End Induction | PW Change, Maint Month 2 | PW Change, Maint Month 12 | PW Change, End Maint | Social/Family Well-being , Baseline | S/FW Change, Cycle 3 Day 1 | S/FW Change, End Induction | S/FW Change, Maint Month 2 | S/FW Change, Maint Month 12 | S/FW Change, End Maint | Emotional Well-being (EW), Baseline | EW Change, Cycle 3 Day 1 | EW Change, End Induction | EW Change, Maint Month 2 | EW Change, Maint Month 12 | EW Change, End Maint | Functional Well-being (FW), Baseline | FW Change, Cycle 3 Day 1 | FW Change, End Induction | FW Change, Maint Month 2 | FW Change, Maint Month 12 | FW Change, End Maint |
---|
Obinutuzumab+Chemotherapy | 23.14 | -0.21 | 0.56 | 1.42 | 1.34 | 1.33 | 23.28 | -0.67 | -0.56 | -0.67 | -0.97 | -0.71 | 17.87 | 1.35 | 1.14 | 1.49 | 1.46 | 1.49 | 18.76 | -0.07 | 0.93 | 1.25 | 1.65 | 1.72 |
,Rituximab+Chemotherapy | 23.36 | -0.91 | -0.06 | 0.83 | 1.14 | 0.88 | 22.84 | -0.52 | -0.46 | -0.39 | -0.61 | -0.93 | 17.64 | 1.49 | 1.16 | 1.77 | 1.45 | 1.43 | 18.66 | -0.30 | 0.44 | 1.04 | 1.84 | 1.40 |
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Time to Next Anti-Lymphoma Treatment (Overall Study Population)
Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 21.6 |
Obinutuzumab+Chemotherapy | 15.7 |
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Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)
Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to 10 years
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 34.8 |
Obinutuzumab+Chemotherapy | 26.6 |
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Progression-Free Survival in the Overall Study Population, Investigator-Assessed
Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 41.5 |
Obinutuzumab+Chemotherapy | 34.8 |
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Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed
Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 23.5 |
Obinutuzumab+Chemotherapy | 18.0 |
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Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)
Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 24.6 |
Obinutuzumab+Chemotherapy | 18.4 |
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Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 4 years and 7 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 24.0 |
Obinutuzumab+Chemotherapy | 16.8 |
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Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). (NCT01332968)
Timeframe: Baseline up to final analysis (up to 10 years)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 40.6 |
Obinutuzumab+Chemotherapy | 34.3 |
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Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed
DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. (NCT01332968)
Timeframe: From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 39.3 |
Obinutuzumab+Chemotherapy | 33.3 |
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Duration of Response (DOR) (Overall Study Population), Investigator-Assessed
DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. (NCT01332968)
Timeframe: From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 25.5 |
Obinutuzumab+Chemotherapy | 18.7 |
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Event-Free Survival (Follicular Lymphoma Population)
Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event. (NCT01332968)
Timeframe: Baseline up to 10 years
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 42.9 |
Obinutuzumab+Chemotherapy | 35.8 |
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Disease-Free Survival (Overall Study Population)
Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter = 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
Intervention | percentage of participants with event (Number) |
---|
Rituximab+Chemotherapy | 14.9 |
Obinutuzumab+Chemotherapy | 11.2 |
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Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Ixazomib (Phase 1)
The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1). (NCT01335685)
Timeframe: Cycle 1, phase 1 (Up to 42 days)
Intervention | mg (Number) |
---|
Arm A: Ixazomib 3.0 - 3.7 mg | 3 |
Arm B: Ixazomib 3.0 - 5.5 mg | 4 |
Arm C: Ixazomib 3.0 - 4.0 mg | 3 |
Arm D: Ixazomib 4.0 mg | 4 |
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Overall Response Rate (ORR)
ORR is defined as percentage of participants with overall response including CR, VGPR, and partial response (PR). Per IMWG criteria, CR:1)Negative immunofixation on serum and urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. If serum+urine M-protein are unmeasurable and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required. (NCT01335685)
Timeframe: Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) up to 61 cycles, at end of treatment (Up to 5.5 years)
Intervention | percentage of participants (Number) |
---|
Arm A: Ixazomib 3.0 mg | 86 |
Arm A: Ixazomib 3.7 mg | 67 |
Arm B: Ixazomib 3.0 mg | 100 |
Arm B: Ixazomib 4.0 mg | 65 |
Arm B: Ixazomib 5.5 mg | 60 |
Arm C: Ixazomib 3.0 mg | 40 |
Arm C: Ixazomib 4.0 mg | 67 |
Arm D: Ixazomib 4.0 mg | 50 |
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Overall Survival (Phase 2)
Overall Survival is the time in months from start of study treatment to date of death due to any cause. (NCT01335685)
Timeframe: From date of enrollment to date of death, approximately 5.5 years (Approximate median follow-up: 43.6 months)
Intervention | months (Median) |
---|
Arm B: Ixazomib 4.0 mg (RP2D) | NA |
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Progression Free Survival (Phase 2)
Progression Free Survival is defined as time in months from start of study treatment to first documentation of objective tumor progression per investigator assessment or up to death due to any cause, whichever occurs first. Per IMWG criteria, progressive disease requires any 1 or more of following: Increase of ≥25% from nadir in serum M-component and/or (absolute increase must be ≥0.5 g/dL), urine M-component and/or (absolute increase must be ≥200 mg/24 hour. Participants without measurable serum+urine M-protein levels: difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.85 mmol/L) that can be attributed solely to plasma cell proliferative disorder. (NCT01335685)
Timeframe: From the date of enrollment to the date of the first documented disease progression or death due to any cause for up to 5.5 years
Intervention | months (Median) |
---|
Arm B: Ixazomib 4.0 mg (RP2D) | 18.4 |
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Time to First Response (Phase 2)
Response is defined as CR, VGPR and PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required. (NCT01335685)
Timeframe: From the date of enrollment to the date of the first documented response for up to 5.5 years
Intervention | months (Median) |
---|
Arm B: Ixazomib 4.0 mg (RP2D) | 1.9 |
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Time to Progression (TTP) (Phase 2)
TTP is defined as time from date of enrollment to date of first documented disease progression (PD). Per IMWG criteria, progressive disease requires any 1 or more of following: Increase of ≥25% from nadir in serum M-component and/or (absolute increase must be ≥0.5 g/dL), urine M-component and/or (absolute increase must be ≥200 mg/24 hour. Participants without measurable serum+urine M-protein levels: difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.85 mmol/L) that can be attributed solely to plasma cell proliferative disorder. (NCT01335685)
Timeframe: From the date of enrollment to the date of the first documented disease progression for up to 5.5 years
Intervention | months (Median) |
---|
Arm B: Ixazomib 4.0 mg (RP2D) | 22.1 |
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Very Good Partial Response (VGPR) or Better Response Rate (Phase 2)
VGPR or better response rate is defined as percentage of participants with a complete response (CR) and very good partial response (VGPR). Per International Myeloma Working Group Uniform Response Criteria (IMWG), CR: 1) Negative immunofixation on the serum and urine, 2) Disappearance of any soft tissue plasmacytomas and 3) < 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour. (NCT01335685)
Timeframe: Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) until death (Up to 5.5 years)
Intervention | percentage of participants (Number) |
---|
Arm B: Ixazomib 4.0 mg (RP2D) | 48 |
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AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)
(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | hr*ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 11 |
---|
Arm A: Ixazomib 3.0 mg | 319.714 | 1227.143 |
,Arm A: Ixazomib 3.7 mg | 287.000 | 1180.000 |
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AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)
(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | hr*ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 29 |
---|
Arm C: Ixazomib 3.0 mg | 662.833 | 1527.800 |
,Arm C: Ixazomib 4.0 mg | 1037.500 | 2680.000 |
,Arm D: Ixazomib 4.0 mg | 934.800 | 2435.000 |
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Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)
(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 11 |
---|
Arm A: Ixazomib 3.0 mg | 26.791 | 69.214 |
,Arm A: Ixazomib 3.7 mg | 39.300 | 22.000 |
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Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)
(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Arm B: Ixazomib 3.0 mg | 22.950 | 30.267 |
,Arm B: Ixazomib 4.0 mg | 53.278 | 85.636 |
,Arm B: Ixazomib 5.5 mg | 104.225 | 285.000 |
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Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)
(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 29 |
---|
Arm C: Ixazomib 3.0 mg | 55.367 | 59.560 |
,Arm C: Ixazomib 4.0 mg | 50.875 | 109.000 |
,Arm D: Ixazomib 4.0 mg | 72.080 | 146.400 |
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. (NCT01335685)
Timeframe: From first dose of study drug through 30 days after last dose of study drug or until the start of subsequent antineoplastic therapy for up to 5.6 years
Intervention | participants (Number) |
---|
| During Entire Study Any Adverse Event | Grade 3 or Higher Adverse Event | Serious Adverse Event | Adverse Event With Any Study Drug Discontinuation | Adverse Event With Any Study Drug Reduction |
---|
Arm A: Ixazomib 3.0 mg | 7 | 7 | 2 | 0 | 4 |
,Arm A: Ixazomib 3.7 mg | 4 | 4 | 4 | 0 | 2 |
,Arm B: Ixazomib 3.0 mg | 3 | 3 | 3 | 0 | 1 |
,Arm B: Ixazomib 4.0 mg | 26 | 21 | 12 | 8 | 13 |
,Arm B: Ixazomib 5.5 mg | 5 | 5 | 3 | 2 | 3 |
,Arm C: Ixazomib 3.0 mg | 6 | 5 | 4 | 2 | 3 |
,Arm C: Ixazomib 4.0 mg | 4 | 4 | 2 | 1 | 2 |
,Arm D: Ixazomib 4.0 mg | 6 | 5 | 1 | 2 | 4 |
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Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)
Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | ratio (Mean) |
---|
| Cycle 1, Day 11 |
---|
Arm A: Ixazomib 3.0 mg | 4.019 |
,Arm A: Ixazomib 3.7 mg | 4.120 |
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Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)
Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | ratio (Mean) |
---|
| Cycle 1, Day 15 |
---|
Arm B: Ixazomib 3.0 mg | 1.700 |
,Arm B: Ixazomib 4.0 mg | 2.288 |
,Arm B: Ixazomib 5.5 mg | 1.970 |
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Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)
Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | ratio (Mean) |
---|
| Cycle 1, Day 29 |
---|
Arm C: Ixazomib 3.0 mg | 2.632 |
,Arm C: Ixazomib 4.0 mg | 2.560 |
,Arm D: Ixazomib 4.0 mg | 2.540 |
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Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)
Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | 1/hour (Mean) |
---|
| Cycle 1, Day 15 |
---|
Arm B: Ixazomib 3.0 mg | 0.004 |
,Arm B: Ixazomib 4.0 mg | 0.006 |
,Arm B: Ixazomib 5.5 mg | 0.007 |
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Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)
Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | 1/hour (Mean) |
---|
| Cycle 1, Day 29 |
---|
Arm C: Ixazomib 4.0 mg | 0.005 |
,Arm D: Ixazomib 4.0 mg | 0.006 |
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Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)
Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | 1/hour (Mean) |
---|
| Cycle 1, Day 15 | Cycle 1, Day 29 |
---|
Arm C: Ixazomib 3.0 mg | NA | 0.005 |
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Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | hours (Mean) |
---|
| Cycle 1, Day 15 |
---|
Arm B: Ixazomib 3.0 mg | 167.000 |
,Arm B: Ixazomib 4.0 mg | 130.362 |
,Arm B: Ixazomib 5.5 mg | 98.900 |
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Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | hours (Mean) |
---|
| Cycle 1, Day 29 |
---|
Arm C: Ixazomib 4.0 mg | 163.500 |
,Arm D: Ixazomib 4.0 mg | 120.050 |
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Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | hours (Mean) |
---|
| Cycle 1, Day 15 | Cycle 1, Day 29 |
---|
Arm C: Ixazomib 3.0 mg | NA | 140.575 |
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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)
(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | hours (Median) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Arm B: Ixazomib 3.0 mg | 1.750 | 0.833 |
,Arm B: Ixazomib 4.0 mg | 1.000 | 1.000 |
,Arm B: Ixazomib 5.5 mg | 1.302 | 0.500 |
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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)
(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | hours (Median) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 29 |
---|
Arm C: Ixazomib 3.0 mg | 1.560 | 1.500 |
,Arm C: Ixazomib 4.0 mg | 1.282 | 1.275 |
,Arm D: Ixazomib 4.0 mg | 0.567 | 0.760 |
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AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)
(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | hr*ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Arm B: Ixazomib 3.0 mg | 450.000 | 705.667 |
,Arm B: Ixazomib 4.0 mg | 806.824 | 1610.500 |
,Arm B: Ixazomib 5.5 mg | 1612.250 | 1680.000 |
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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)
(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
Intervention | hours (Median) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 11 |
---|
Arm A: Ixazomib 3.0 mg | 1.020 | 1.050 |
,Arm A: Ixazomib 3.7 mg | 0.517 | 8.000 |
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Duration of Response (DOR) (Phase 2)
DOR is defined as time of first documentation of a confirmed PR or better response to first documented PD or start of alternative therapy. DOR was presented for those achieving CR+VGPR+PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required. (NCT01335685)
Timeframe: From the time from the date of first documentation of PR or better to the date of first documented disease progression for up to 5.5 years
Intervention | months (Median) |
---|
Arm B: Ixazomib 4.0 mg (RP2D) | 25.2 |
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Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment
"Complete Response Rate (CR) was reported at the end of the CEOP-P (6 courses for patients not receiving transplant and 4-6 courses for patients receiving transplant). Response assessment was performed by computerized tomography (CT) or positron emission tomography (PET)/CT based on the investigator's preference after cycles 2, 4 and 6. Response was assessed by the treating physician according to the Cheson Revised response criteria (Cheson et al,, 2007) or International Harmonization Project criteria (Cheson, 2007), based on imaging modality used.~Complete Response Definition: Disappearance of all evidence of disease Nodal Masses: (a) [18F]fluorodeoxyglucose(FDG)-avid or PET positive prior to therapy; mass of any size permitted if PETnegative (b) Variably FDG-avid or PET negative; regression to normal size on CT Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative" (NCT01336933)
Timeframe: 168 days - 252 days (4-6 courses; 42 days per course)
Intervention | percentage of participants analyzed (Number) |
---|
Treatment (Chemotherapy and Enzyme Inhibitor Therapy) | 52 |
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Event Free Survival (EFS)
Estimated 2-year Event Free Survival (EFS), as well as plots of EFS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for EFS. Event-free survival is defined as time from therapy until relapse, progression, or death from any cause. (NCT01336933)
Timeframe: 2 years
Intervention | percentage of participants analyzed (Number) |
---|
Treatment (Chemotherapy and Enzyme Inhibitor Therapy) | 39 |
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Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))
"Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete courses of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals.~Complete Response Definition: Defined in Primary Objective Partial Response Definition: Regression of measurable disease and no new sites, Nodal Masses: > 50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT Spleen, Liver:> 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified" (NCT01336933)
Timeframe: 2 years
Intervention | percentage of participants analyzed (Number) |
---|
Treatment (Chemotherapy and Enzyme Inhibitor Therapy) | 70 |
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To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events
Adverse events will be summarized using patient level incidence rates so that a patient contributes once to any adverse event. The number and percentage of patients with any adverse event will be summarized for each course. Serious adverse events will be analyzed similarly. (NCT01336933)
Timeframe: 22 months
Intervention | percentage of participants (Number) |
---|
| Grade 3-4 anaemia | Grade 3-4 thrombocoytopenia | Grade 3-4 febrile neutropenia | Grade 3-4 mucositis | Grade 3-4 sepsis | Grade 3-4 increased creatinine | Grade 3-4 liver transaminases |
---|
Treatment (Chemotherapy and Enzyme Inhibitor Therapy) | 27 | 12 | 18 | 18 | 15 | 12 | 12 |
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Percent of Patients Who Proceeded With Transplant
Percentage of patients who received consolidation with high dose therapy and autologous stem cell rescue (HDT/SCR). (NCT01336933)
Timeframe: 168-252 days (4 courses up to 6 courses of treatment)
Intervention | Participants (Count of Participants) |
---|
Treatment | 15 |
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Overall Survival (OS)
Estimated 2-year Overall Survival (OS), as well as plots of OS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for OS. Overall survival is defined as time from the first chemotherapy administered on trial until death from any cause. (NCT01336933)
Timeframe: 2 years
Intervention | percentage of participants analyzed (Number) |
---|
Treatment (Chemotherapy and Enzyme Inhibitor Therapy) | 60 |
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Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT01359592)
Timeframe: up to 5 years
Intervention | percentage of participants (Number) |
---|
R-CHOP x 3 Followed by PET-directed Therapy | 89 |
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Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
"Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.~Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion >1.5 cm in the longest axis." (NCT01359592)
Timeframe: up to 5 years
Intervention | percentage of participants (Number) |
---|
R-CHOP x 3 Followed by PET-directed Therapy | 87 |
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Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. (NCT01359592)
Timeframe: up to 5 years
Intervention | percentage of participants (Number) |
---|
Interim PET-negative | 89 |
Interim PET-positive | 86 |
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Polymyalgia Rheumatica Activity Score (PMR-AS)
The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient's elevation on upper limbs, patient's assessment of pain, and physician's global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants. (NCT01364389)
Timeframe: Baseline, Day 15
Intervention | Percent reduction (Least Squares Mean) |
---|
ACZ885 | 64.5 |
AIN457 | 51.7 |
Prednisone | 91.9 |
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Mean Steroid Dose Over a 6 Month Period
This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. (NCT01364389)
Timeframe: 6 months
Intervention | Number of doses (Mean) |
---|
ACZ885 | 276.8 |
AIN457 | 256.7 |
Prednisone | 428.9 |
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Number of Flares Over a 6 Month Period
This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. (NCT01364389)
Timeframe: 6 months
Intervention | Participant (Number) |
---|
AIN457 | 1 |
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Pharmacokinetics of AIN457 and ACZ885 - CL
(NCT01364389)
Timeframe: Day 15
Intervention | L/day (Mean) |
---|
ACZ885 | 0.171 |
AIN457 | 0.157 |
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Time to Complete Clinical Response
The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: >70% reduction in patient global assessment VAS compared with baseline, morning stiffness < 30 min, CRP < 1.0 mg/dL and/or ESR < 30 mm/1st hr. (NCT01364389)
Timeframe: Day 15
Intervention | Percentage of participants (Number) |
---|
ACZ885 | 0.0 |
AIN457 | 0.0 |
Prednisone | 25.0 |
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Pharmacokinetics of AIN457 and ACZ885 - T1/2
(NCT01364389)
Timeframe: Day 15
Intervention | Day (Mean) |
---|
ACZ885 | 26.6 |
AIN457 | 40.2 |
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Pharmacokinetics of AIN457 and ACZ885 - Tmax
(NCT01364389)
Timeframe: Day 15
Intervention | days (Median) |
---|
ACZ885 | 0.0868 |
AIN457 | 0.107 |
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Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast
(NCT01364389)
Timeframe: Day 15
Intervention | microg/day/mL (Mean) |
---|
| AUCinf (microg/day/mL) | AUClast (microg/day/mL) |
---|
ACZ885 | 1570 | 1560 |
,AIN457 | 1260 | 1200 |
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Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths
(NCT01364389)
Timeframe: 6 months
Intervention | Participants (Number) |
---|
| Adverse Events (serious and non-serious) | Serious Adverse Events | Deaths |
---|
ACZ885 | 3 | 0 | 0 |
,AIN457 | 2 | 0 | 0 |
,Prednisone | 5 | 0 | 0 |
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Pharmacokinetics of AIN457 and ACZ885 - Vz
(NCT01364389)
Timeframe: Day 15
Intervention | L (Mean) |
---|
ACZ885 | 6.49 |
AIN457 | 9.85 |
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Time to First Flare
This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. Only 1 participant experienced a flare, in the AIN457 treatment group. The flare for this one participant occurred on study day 44 (NCT01364389)
Timeframe: 6 months
Intervention | Days (Number) |
---|
AIN457 | 44 |
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Time to Partial Clinical Response
"The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had:~>50% reduction in patient global assessment visual analogue scale (VAS) compared with baseline and morning stiffness < 60 minutes." (NCT01364389)
Timeframe: Day 15
Intervention | Percentage of participants (Number) |
---|
ACZ885 | 20.0 |
AIN457 | 16.7 |
Prednisone | 75.0 |
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Pharmacokinetics of AIN457 and ACZ885 - Cmax
(NCT01364389)
Timeframe: Day 15
Intervention | microgram/mL (Mean) |
---|
ACZ885 | 69.9 |
AIN457 | 46.8 |
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Change From Baseline in DAS28-CRP at 12 Weeks
"The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores." (NCT01369745)
Timeframe: baseline to week 12
Intervention | units on a scale (Mean) |
---|
Prednisolone | -1.147 |
Dipyridamole | -0.813 |
Prednisone | -1.237 |
Z102 | -0.907 |
Placebo | -0.538 |
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Participants With Objective Response
To determine the efficacy of the combination of Ruxolitinib + Lenalidomide in patients with Myelofibrosis (MF). Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). Objective response rate (ORR), defined as a clinical improvement (CI), partial remission (PR), and complete remission (CR) according to the International Working Group (IWG) Criteria. Complete remission (CR): bone marrow blasts <5%, hemoglobin >/= 10, absolute neutrophil count (ANC) >/= 1000, platelets >/= 100, <2% immature myeloid cell, spleen and liver not palpable. Partial Response (PR): CR plus one or more of the following: ANC >/= 1000, decreased platelets by 50%, hemoglobin >/= 8.5 but < 10, <2% immature myeloid cells. Clinical improvement (CI): hemoglobin increase of 2g/dl, transfusion independence or reduction splenomegaly and/or hepatomegaly >/= 50%, >/=50% reduction in MPN-SAF TSS (NCT01375140)
Timeframe: 3 cycles (28 days each) up to 3 months
Intervention | Participants (Count of Participants) |
---|
Ruxolitinib + Lenalidomide | 7 |
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Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment
Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)
Intervention | Picomoles Per Liter (Pmol/L) (Mean) |
---|
| Estradiol | Estrone |
---|
Abiraterone Acetate + Exemestane + Prednisone | -1.04 | -30.60 |
,Abiraterone Acetate + Prednisone | -3.35 | -28.09 |
,Exemestane | 1.53 | -34.20 |
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Progression-Free Survival (PFS)
Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system. (NCT01381874)
Timeframe: Approximately 2 years
Intervention | Months (Median) |
---|
Exemestane | 3.68 |
Abiraterone Acetate + Prednisone | 3.65 |
Abiraterone Acetate + Exemestane + Prednisone | 4.47 |
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Overall Survival (OS)
OS was calculated as the time from randomization to death from any cause. (NCT01381874)
Timeframe: Approximately 3 years
Intervention | Months (Median) |
---|
Exemestane | NA |
Abiraterone Acetate + Prednisone | 26.41 |
Abiraterone Acetate + Exemestane + Prednisone | NA |
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Overall Response Rate (ORR)
Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years
Intervention | Percentage of participants (Number) |
---|
Exemestane | 6.3 |
Abiraterone Acetate + Prednisone | 5.8 |
Abiraterone Acetate + Exemestane + Prednisone | 12.1 |
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Duration of Response
Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria. (NCT01381874)
Timeframe: Approximately 2 years
Intervention | months (Median) |
---|
Exemestane | 6.47 |
Abiraterone Acetate + Prednisone | 4.86 |
Abiraterone Acetate + Exemestane + Prednisone | 6.93 |
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Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years
Intervention | Percentage of participants (Number) |
---|
Exemestane | 12.7 |
Abiraterone Acetate + Prednisone | 9.6 |
Abiraterone Acetate + Exemestane + Prednisone | 22.7 |
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Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment
Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)
Intervention | Nanomoles Per Liter (nmol/L) (Mean) |
---|
| Progesterone | Testosterone |
---|
Abiraterone Acetate + Exemestane + Prednisone | 12.34 | -0.48 |
,Abiraterone Acetate + Prednisone | 8.98 | -0.51 |
,Exemestane | -4.80 | -0.09 |
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Progression-free Survival Rate
Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. (NCT01390584)
Timeframe: Assessed at 36 months
Intervention | proportion of participants (Number) |
---|
ABVD + INRT | NA |
ABVD + BEACOPP + INRT | NA |
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Overall Survival
Overall survival is defined as the time from study entry to death or date last known alive. (NCT01390584)
Timeframe: Assessed at 36 months
Intervention | months (Median) |
---|
ABVD + INRT | NA |
ABVD + BEACOPP + INRT | NA |
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Proportion of Patients Who Are PET Negative After Induction Treatment
(NCT01390584)
Timeframe: Assessed at end of Cycle 2
Intervention | proportion of participants (Number) |
---|
Step 1: Induction Tx | 0.8 |
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Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment
Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. (NCT01390584)
Timeframe: Assessed at 36 months
Intervention | proportion of participants (Number) |
---|
ABVD + BEACOPP + INRT | NA |
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Complete Response (CR) Rate After Induction Treatment
Complete response (CR) is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. (NCT01390584)
Timeframe: Assessed at end of Cycle 2
Intervention | proportion of participants (Number) |
---|
Step 1: Induction Tx | 1.0 |
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Best Overall Response
Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. (NCT01393730)
Timeframe: Disease was evaluated radiologically at baseline and every 12 weeks cycles on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
Intervention | Participants (Count of Participants) |
---|
Abiraterone + Prednisone + Dutasteride | 6 |
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Change in Serum Androgen Levels
Serum androgen levels measured based on established methods. The change from baseline to progression was calculated for each participant. (NCT01393730)
Timeframe: Pairs of patients' samples for androgen analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.
Intervention | ng/dl (Median) |
---|
Abiraterone + Prednisone + Dutasteride | 1.2 |
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Change in Serum Levels of Testosterone
Serum testosterone levels were estimated based on established methods. The change from baseline to progression was calculated for each participant. (NCT01393730)
Timeframe: Samples for testosterone analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.
Intervention | ng/dL (Median) |
---|
Abiraterone + Prednisone + Dutasteride | 0.25 |
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Presence of AR Amplification
Presence of AR amplification was measured by established methods. (NCT01393730)
Timeframe: Patients' samples were evaluated at baseline and every 12 weeks on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
Intervention | Participants (Count of Participants) |
---|
Abiraterone + Prednisone + Dutasteride | 10 |
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Prostate-Specific Antigen (PSA) Response
PSA response was defined as decline of 50% from baseline confirmed by a PSA at least 4 weeks later based on Prostate-specific Antigen Working Group-2 (PSAWG-2) (2008) criteria. (NCT01393730)
Timeframe: PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
Intervention | Participants (Count of Participants) |
---|
Abiraterone + Prednisone + Dutasteride | 34 |
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Time to Progression (TTP)
TTP based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT01393730)
Timeframe: Disease evaluation occurred every 12 weeks while patients were receiving treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
Intervention | Months (Median) |
---|
Abiraterone + Prednisone + Dutasteride | 11 |
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Time to PSA Progression
Time to PSA progression based on the Kaplan-Meier method was defined as the time between registration and documented PSA progression. PSA progression based on Prostate-Specific Antigen Working Group-2 (PSAWG-2) (2008) criteria was an increase of >/=25% and >/= 2 ng/ml after 12 weeks for patients without a PSA decline from baseline and an increase of >/=25% and >/= 2 ng/ml above the nadir, confirmed by a 2nd value 3 weeks or later for patients with a PSA decline from baseline. PSA progression was reported not duration of response. (NCT01393730)
Timeframe: PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
Intervention | months (Median) |
---|
Abiraterone + Prednisone + Dutasteride | 5 |
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Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab
T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Intervention | days (Mean) |
---|
| Cycle 1 (n = 37) | Cycle 8 (n = 21) |
---|
Obinutuzumab + CHOP | 6.04 | 23 |
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Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab
V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Intervention | mL (Mean) |
---|
| Cycle 1 (n = 54) | Cycle 8 (n = 37) |
---|
Obinutuzumab + CHOP | 4580 | 9210 |
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Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Intervention | percentage of participants (Number) |
---|
Obinutuzumab + CHOP | 55.0 |
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Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Intervention | percentage of participants (Number) |
---|
Obinutuzumab + CHOP | 58.0 |
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Duration of Response (DOR)
DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause. CR: disappearance of all evidence of disease. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites. (NCT01414855)
Timeframe: From the response assessment to relapse, progression, or death (up to 64 months)
Intervention | months (Median) |
---|
Obinutuzumab + CHOP | 45.6 |
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Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Intervention | percentage of participants (Number) |
---|
Obinutuzumab + CHOP | 82.0 |
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Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Intervention | percentage of participants (Number) |
---|
Obinutuzumab + CHOP | 75.0 |
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Percentage of Participants With Adverse Events as a Measure of Safety
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events. (NCT01414855)
Timeframe: From the first dose of study treatment to end of study (up to 5 years 4 months)
Intervention | percentage of participants (Number) |
---|
Obinutuzumab + CHOP | 100.0 |
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Progression-Free Survival (PFS) as Assessed by the Investigator
PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause. (NCT01414855)
Timeframe: From the first dose of study treatment to PFS assessment (up to 64 months)
Intervention | months (Median) |
---|
Obinutuzumab + CHOP | 48.3 |
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Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab
Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Intervention | μg/mL (Mean) |
---|
| Cycle 1 | Cycle 8 (n = 85) |
---|
Obinutuzumab + CHOP | 297 | 574 |
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Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)
Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day*μg/mL). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Intervention | day*μg/mL (Mean) |
---|
| Cycle 1 (n = 59) | Cycle 8 (n = 74) |
---|
Obinutuzumab + CHOP | 1320 | 3300 |
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Pharmacokinetics: Clearance (Cl) for Obinutuzumab
Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Intervention | mL/day (Mean) |
---|
| Cycle 1 (n = 54) | Cycle 8 (n = 37) |
---|
Obinutuzumab + CHOP | 456 | 143 |
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Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. (NCT01424930)
Timeframe: Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1
Intervention | Participants (Number) |
---|
Abiraterone+Prednisone (Low-fat Meal) | 0 |
Abiraterone+Prednisone (High-fat Meal) | 0 |
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Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
The table below shows mean AUC24h. The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. (NCT01424930)
Timeframe: Day 7 and Day 14
Intervention | ng*h/mL (Geometric Mean) |
---|
| Day 7 | Day 14 |
---|
Abiraterone+Prednisone (High-fat Meal) | 973 | 1992 |
,Abiraterone+Prednisone (Low-fat Meal) | 1271 | 1264 |
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone
The table below shows median Tmax of Abiraterone. The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. (NCT01424930)
Timeframe: Day 7 and Day 14
Intervention | hours (Median) |
---|
| Day 7 | Day 14 |
---|
Abiraterone+Prednisone (High-fat Meal) | 2 | 4.0 |
,Abiraterone+Prednisone (Low-fat Meal) | 2 | 2.5 |
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Maximum Observed Plasma Concentration (Cmax) of Abiraterone
The table below shows mean Cmax of Abiraterone. The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. (NCT01424930)
Timeframe: Day 7 and Day 14
Intervention | ng/mL (Geometric Mean) |
---|
| Day 7 | Day 14 |
---|
Abiraterone+Prednisone (High-fat Meal) | 196 | 342 |
,Abiraterone+Prednisone (Low-fat Meal) | 218 | 265 |
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Overall Progression Free Survival (PFS)
Progression was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Progression is defined as ≥50% increase from nadir in the sum of the products of the perpendicular diameters (SPD) of any previously identified abnormal nodes for Partial Response's or non-responders. Progression-free survival (PFS) was determined from the on-study date until date of progression or last follow-up. The probability of PFS as a function of time was estimated by the Kaplan-Meier method. (NCT01445535)
Timeframe: On-study date until date of progression or last follow up, approximately 7 months.
Intervention | Months (Median) |
---|
All Participants | 6.8 |
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Number of Participants With Serious and Non-serious Adverse Events
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01445535)
Timeframe: Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
Intervention | Participants (Count of Participants) |
---|
Cohort 1 - 3.4 mg/kg | 3 |
Cohort 2 - 4.8 mg/kg | 3 |
Cohort 3 - 8.5 mg/kg | 3 |
Cohort 4 - 15 mg/kg | 5 |
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Number of Dose-Limiting Toxicities (DLT)
DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an EBV-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) and grade 3 laboratory AEs were not considered to be DLTs. (NCT01445535)
Timeframe: First 30 days after treatment initiation.
Intervention | Dose Limiting Toxicities (Number) |
---|
Cohort 1 - 3.4 mg/kg | 0 |
Cohort 2 - 4.8 mg/kg | 0 |
Cohort 3 - 8.5 mg/kg | 0 |
Cohort 4 - 15 mg/kg | 0 |
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Number of Participants With a Response to Therapy
Response was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete Remission was defined as the disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (for example lactate dehydrogenase (LDH)) definitely assignable to the lymphoma. Complete response unconfirmed was defined as a residual node greater than 1.5 cm, with a decrease by greater than 75 percent in the sum of the products of the perpendicular diameters (SPD) of all measured lymph nodes. Partial Response was defined as a ≥ 50% decreased in SPD of 6 largest dominant nodes or nodal masses. Relapsed disease was defined as the appearance of any new lesion or increase by ≥50% in the size of the previously identified sites. Progressive disease was defined as a ≥50% increase from nadir in the SPD. (NCT01445535)
Timeframe: Response assessments were performed after the fourth and sixth cycle of therapy, at therapy completion, and every 3 months for year 1, four months for year 2, 6 months for years 3-5, and annually thereafter, up to 5 years.
Intervention | Participants (Count of Participants) |
---|
| Complete Remission | Complete Response Unconfirmed | Partial Response | Relapsed Disease | Progressive Disease | Stable Disease | Not Evaluable |
---|
Cohort 1 - 3.4 mg/kg | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
,Cohort 2 - 4.8 mg/kg | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
,Cohort 3 - 8.5 mg/kg | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
,Cohort 4 - 15 mg/kg | 4 | 0 | 0 | 0 | 0 | 0 | 2 |
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Maximum Tolerated Dose (MTD) of Siplizumab
A classic 3+3 dose-escalation design was used to assess the MTD of siplizumab in combination with dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). If 2 of 6 patients experienced a dose-limiting toxicity (DLT) at a particular dose level, the MTD has been exceeded. The preceding dose level will be the MTD, provided 6 patients have been entered at this level and no more than one has experienced a DLT. DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an Epstein Barr Virus (EBV)-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted EPOCH-R and grade 3 laboratory adverse events (AEs) were not considered to be DLTs. (NCT01445535)
Timeframe: First 30 days after treatment initiation.
Intervention | mg/kg (Number) |
---|
All Participants | 15 |
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Overall Survival (OS)
Overall survival was determined from the on-study date until date of progression or last follow up. The probability of OS as a function of time was estimated by the Kaplan-Meier method. (NCT01445535)
Timeframe: On study date until date of death or last follow up, approximately 12 months.
Intervention | Months (Median) |
---|
All Participants | 12.1 |
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Probability of Event-free Survival (EFS)
"For EFS, relapse and second malignancies are considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. Kaplan-Meier estimates of the OS and EFS curves are computed, along with estimates of standard errors by Peto's method.~Please note the unit of measurement of probabilities are percentages." (NCT01451515)
Timeframe: Two years post therapy.
Intervention | percentage of event-free patients (Number) |
---|
Stratum 1 | 91.7 |
Stratum 2 | 71.4 |
Stratum 3 | 100 |
All Enrollments | 86.96 |
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Probability of Overall Survival (OS)
"For OS, only deaths are considered failures for OS. Kaplan-Meier estimates of the OS curves are computed along with estimates of standard errors by Peto's method.~Please note the unit of measurement of probabilities are percentages." (NCT01451515)
Timeframe: Two years post therapy.
Intervention | percentage of patients alive (Number) |
---|
Stratum 1 | 91.7 |
Stratum 2 | 71.4 |
Stratum 3 | 100 |
All Enrollments | 86.96 |
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Minimal Residual Disease (MRD)
Detectable disease in bone marrow or blood: A binary measure, positive (detectable), negative (non-detectable) (NCT01451515)
Timeframe: Day 8
Intervention | participants (Number) |
---|
| Negative | Positive |
---|
Stratum 1 | 8 | 0 |
,Stratum 2 | 4 | 1 |
,Stratum 3 | 0 | 4 |
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Minimal Disseminated Disease (MDD)
Detectable disease in bone marrow or blood: A binary measure, positive (detectable), negative (non-detectable) (NCT01451515)
Timeframe: At Diagnosis
Intervention | participants (Number) |
---|
| Negative | Positive |
---|
Stratum 1 | 4 | 1 |
,Stratum 2 | 2 | 3 |
,Stratum 3 | 0 | 4 |
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Number of Participants With Complete Response and Partial Response
Complete response is transfusion independence with hemoglobin >9 gm/dl; partial response is transfusion dependence with hemoglobin < 9gm/dl with an increase in reticulocyte count over baseline (NCT01464164)
Timeframe: 9 months
Intervention | Participants (Count of Participants) |
---|
Sotatercept Cohort 1 | 0 |
Sotatercept Cohort 2 | 0 |
Sotatercept Cohort 3 | 0 |
Sotatercept With Prednisone Boost Cohort 4a | 0 |
Sotatercept Cohort 4b | 0 |
Sotatercept With Prednisone Boost Cohort 5a | 0 |
Sotatercept Cohort 5b | 0 |
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Severe Adverse Events Attributable to Study Drug
Assess severity of adverse events and relationship to sotatercept according to the currently active minor version of the NCI Common Terminology for Adverse Events version 4.0 (NCT01464164)
Timeframe: 9 months
Intervention | Participants (Count of Participants) |
---|
Sotatercept Cohort 1 | 0 |
Sotatercept Cohort 2 | 0 |
Sotatercept Cohort 3 | 0 |
Sotatercept With Prednisone Boost Cohort 4a | 0 |
Sotatercept Cohort 4b | 0 |
Sotatercept With Prednisone Boost Cohort 5a | 0 |
Sotatercept Cohort 5b | 0 |
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Maximum Tolerated Dose (MTD) of Pasireotide in Combination With Docetaxel and Prednisone by the Occurrence of Adverse Events and the Associated Grade Per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
To identify the maximum tolerated dose (MTD) of pasireotide, The occurrence rate of binary endpoints (eg, specific types of toxicity at a certain dose level and severity grade, response, etc) will be described by point estimates and exact 90% confidence intervals (CIs) for proportions using Wilson's method. (NCT01468532)
Timeframe: Up to day 57
Intervention | mg (Number) |
---|
Treatment (Chemotherapy, Receptor Agonist) | 60 |
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The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
The count of patients who experience a given type and grade of toxicity as assessed via NCI CTCAE version 4.0 (NCT01468532)
Timeframe: On days 1, 8, 15, 22, 29, 36 43, 50 and 57
Intervention | Participants (Count of Participants) |
---|
| Abdominal pain grade 1 | Agitation grade 1 | Alkaline phosphatase increased grade 3 | Allergic reaction grade 1 | Alopecia grade 1 | Alopecia grade 2 | Anemia grade 1 | Anemia grade 3 | Anorexia grade 1 | Anorexia grade 2 | Arthritis grade 1 | Aspartate aminotransferase increased grade 2 | Aspartate aminotransferase increased grade 3 | Back pain grade 1 | Back pain grade 2 | Bladder infection grade 2 | Blood and lymphatic system disorders-Other grade 1 | Bruising grade 1 | Cardiac disorders - Other, specify grade 1 | Cataract grade 1 | Chills grade 1 | Cholesterol high grade 1 | Conjunctivitis grade 2 | Constipation grade 1 | Cough grade 1 | Cough grade 2 | Creatinine increased grade 1 | Dehydration grade 2 | Dehydration grade 3 | Depression grade 1 | Diarrhea grade 1 | Diarrhea grade 2 | Diarrhea grade 3 | Dizziness grade 1 | Dry mouth grade 1 | Dry skin grade 1 | Dysgeusia grade 1 | Dysgeusia grade 2 | Dyspnea grade 1 | Ear and labyrinth disorders-Other, specify grade 1 | Edema limbs grade 1 | Edema limbs grade 2 | EKG QT corrected interval prolong grade 1 | EKG QT corrected interval prolong grade 2 | EKG QT corrected interval prolong grade 3 | Eye disorders - Other, specify grade 1 | Fatigue grade 1 | Fatigue grade 2 | Fatigue grade 3 | Fever grade 1 | Flank pain grade 1 | Flu like symptoms grade 1 | Flushing grade 1 | Gastroesophageal reflux disease grade 1 | Gastroesophageal reflux disease grade 2 | Gastrointestinal disorders -Other, specify grade 1 | Generalized muscle weakness grade 1 | Generalized muscle weakness grade 2 | Headache grade 1 | Hearing impaired grade 1 | Heart failure grade 1 | Hematuria grade 1 | Hematuria grade 2 | Hoarseness grade 1 | Hot flashes grade 1 | Hyperglycemia grade 1 | Hyperglycemia grade 2 | Hyperglycemia grade 3 | Hyperkalemia grade 2 | Hypertension grade 2 | Hypertension grade 3 | Hypertriglyceridemia grade 1 | Hypertriglyceridemia grade 3 | Hypoalbuminemia grade 3 | Hypocalcemia grade 1 | Hypocalcemia grade 3 | Hypokalemia grade 2 | Hypomagnesemia grade 1 | Hypomagnesemia grade 2 | Hyponatremia grade 3 | Hypophosphatemia grade 3 | Hypotension grade 3 | Hypothyroidism grade 1 | Infusion related reaction grade 2 | Infusion site extravasation grade 2 | Injection site reaction grade 1 | Insomnia grade 1 | Localized edema grade 1 | Lymphedema grade 1 | Lymphocyte count decreased grade 1 | Lymphocyte count decreased grade 3 | Lymphocyte count decreased grade 4 | Mucositis oral grade 2 | Muscle weakness lower limb grade 1 | Musculoskeletal and connective tissue dis. grade 1 | Myalgia grade 1 | Nail discoloration grade 1 | Nail discoloration grade 2 | Nail loss grade 1 | Nail ridging grade 1 | Nasal congestion grade 1 | Nausea grade 1 | Nausea grade 2 | Nervous system disorders - Other grade 1 | Neutrophil count decreased grade 3 | Neutrophil count decreased grade 4 | Otitis externa grade 2 | Pain grade 1 | Pain in extremity grade 2 | Pelvic pain grade 1 | Penile infection grade 1 | Penile pain grade 1 | Peripheral sensory neuropathy grade 1 | Peripheral sensory neuropathy grade 2 | Platelet count decreased grade 1 | Rash acneiform grade 1 | Rash acneiform grade 2 | Rectal pain grade 1 | Renal and urinary disorders - Other grade 1 | Renal and urinary disorders - Other grade 2 | Respiratory, thoracic and mediastinal dis. grade 3 | Serum amylase increased grade 4 | Sinus disorder grade 1 | Sinusitis grade 2 | Skin and subcutaneous tissue disorders grade 1 | Skin and subcutaneous tissue disorders grade 2 | Skin infection grade 4 | Sore throat grade 1 | Thromboembolic event grade 3 | Toothache grade 1 | Tremor grade 1 | Upper respiratory infection grade 1 | Upper respiratory infection grade 2 | Upper respiratory infection grade 3 | Urinary frequency grade 1 | Urinary tract infection grade 2 | Urinary tract infection grade 3 | Urinary tract obstruction grade 2 | Vomiting grade 1 | Watering eyes grade 1 | Weight loss grade 1 | Weight loss grade 2 | Weight loss grade 3 | Wheezing grade 1 | White blood cell decreased grade 3 | White blood cell decreased grade 4 |
---|
Treatment (Chemotherapy, Receptor Agonist) | 1 | 1 | 3 | 1 | 1 | 1 | 4 | 4 | 6 | 1 | 2 | 1 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 4 | 5 | 1 | 4 | 2 | 1 | 1 | 2 | 1 | 2 | 10 | 2 | 1 | 8 | 2 | 2 | 1 | 4 | 6 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 6 | 7 | 1 | 1 | 1 | 2 | 2 | 3 | 1 | 7 | 5 | 2 | 1 | 1 | 1 | 2 | 1 | 1 | 3 | 3 | 1 | 10 | 1 | 5 | 5 | 3 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 4 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 7 | 1 | 1 | 2 | 5 | 1 | 2 | 1 | 1 | 2 | 1 | 10 | 1 | 1 | 10 | 6 | 1 | 2 | 1 | 1 | 1 | 1 | 7 | 4 | 1 | 6 | 1 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | 9 | 1 | 1 | 3 | 1 | 1 | 1 | 2 | 1 | 1 | 4 | 4 | 1 | 1 | 4 | 1 | 1 | 6 | 1 | 1 | 11 | 3 |
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Pharmacokinetics (PK) of SOM230
Pharmacokinetics (PK) of SOM230 measured in the bloodstream (in ng/ml) at days 29, 57, and 85. (NCT01468532)
Timeframe: Predosing/end of infusion/2, 3, 4 ,7, 24 and 48 hours after start of docetaxel; Day 43; predosing for docetaxel and pasireotide/end of infusion/2, 3, 4, 7, 24 hours day 44/48 hours day 45 after start of infusion; days 29, 57, and 85 prior to pasireotide
Intervention | ng/ml (Median) |
---|
| Level at day 29 | Level at day 57 | Level at day 85 |
---|
Treatment (Chemotherapy, Receptor Agonist) | 15.4 | 14.9 | 14.5 |
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Percentage Prostate-specific Antigen (PSA) Change Noted
Percentage change of prostate-specific antigen (PSA) decline or increase noted (NCT01468532)
Timeframe: On days 1, 22, 43
Intervention | percentage change of PSA from day 1 (Median) |
---|
| from day 1 to day 22 | from day 1 to day 43 |
---|
Treatment (Chemotherapy, Receptor Agonist) | -18.52 | -31.49 |
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Measurements of CTC Counts, the Change Between Time-points Pre-therapy, Post-therapy
Measurements of CTC counts, the change between time-points (day 22 and day 43) from day 1 as measured in percent change. (NCT01468532)
Timeframe: Baseline and days 22 and 43
Intervention | percent change of CTC from day 1 (Median) |
---|
| CTC from day 1 to day 22 | CTC from day 1 to day 43 |
---|
Treatment (Chemotherapy, Receptor Agonist) | -5.50 | -29.50 |
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Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy
Measurement of levels of IGF-1, serum chromogranin A (SCA), and neuron specific enolase (NSE), the change between time points (day 22 and day 43) from day 1 as measured in percent change. (NCT01468532)
Timeframe: Baseline and days 22 and 43
Intervention | percent change of biomarker from day 1 (Median) |
---|
| IGF-1 day 1 to day 22 | IGF-1 day 1 to day 43 | SCA day 1 to day 22 | SCA day 1 to day 43 | NSE day 1 to day 22 | NSE day 1 to day 43 |
---|
Treatment (Chemotherapy, Receptor Agonist) | -47.74 | -65.64 | -25.36 | -21.43 | -17.00 | 8.00 |
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Time to Progression (TTP)
Time from Treatment start date to Progression (TTP) Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT01468532)
Timeframe: Every 3 months for the first 9 months on study then every 4 months after the first 9 months on study, up to 2 years
Intervention | months (Median) |
---|
Treatment (Chemotherapy, Receptor Agonist) | 7.2 |
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Overall Survival (OS)
Time from Treatment start date to date of death or last follow-up. (NCT01468532)
Timeframe: Every 3 months for the first 9 months on study then every 4 months after the first 9 months on study
Intervention | months (Median) |
---|
Treatment (Chemotherapy, Receptor Agonist) | 18.3 |
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Measurements of Tumor Using Response Evaluation Criteria In Solid Tumors (RECIST) Criteria Before and After Treatment With the Combination of Pasireotide in Combination With Docetaxel
Percentage of participants responding to treatment by measurements of tumor using Response Evaluation Criteria In Solid Tumors (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, before and after treatment with the combination of pasireotide in combination with docetaxel (NCT01468532)
Timeframe: Every 12 weeks for the first 36 weeks and then every 16 weeks thereafter up to 100 weeks
Intervention | percentage of participants (Number) |
---|
Treatment (Chemotherapy, Receptor Agonist) | 44.4 |
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Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms
The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant. (NCT01471340)
Timeframe: 26 weeks, plus 7 days after the last treatment
Intervention | Asthma exacerbations (Number) |
---|
MF/F MDI BID | 708 |
MF MDI BID | 779 |
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Number of SAO Components in MF/F Participants vs MF Participants
To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of >= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only. (NCT01471340)
Timeframe: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
Intervention | SAO components (Number) |
---|
| First SAO | Asthma-related hospitalizations | Asthma-related intubations | Asthma-related deaths |
---|
MF MDI BID | 32 | 32 | 0 | 0 |
,MF/F MDI BID | 39 | 39 | 0 | 0 |
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Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms
The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant. (NCT01471340)
Timeframe: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
Intervention | Serious asthma outcomes (Number) |
---|
MF/F MDI BID | 39 |
MF MDI BID | 32 |
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Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss
Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method. (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Intervention | months (Median) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 8.77 |
Phase II: Ipatasertib 200 mg + Abiraterone | NA |
Phase II: Placebo + Abiraterone | NA |
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Phase II: Overall Survival (ITT Population)
Overall survival was defined as the interval between the date of screening and death due to any cause. Overall survival was estimated using Kaplan Meier method. (NCT01485861)
Timeframe: Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)
Intervention | Months (Median) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 18.27 |
Phase II: Ipatasertib 200 mg + Abiraterone | 17.31 |
Phase II: Placebo + Abiraterone | 18.37 |
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Phase II: Overall Survival in Participants With ICR IHC PTEN Loss
"Overall survival was defined as the interval between the date of randomization and death from any cause. Overall survival was estimated using Kaplan Meier method. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)
Intervention | months (Median) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 17.12 |
Phase II: Ipatasertib 200 mg + Abiraterone | 28.45 |
Phase II: Placebo + Abiraterone | 17.28 |
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Phase II: Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01485861)
Timeframe: Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 8.9 years)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 98.8 |
Phase II: Ipatasertib 200 mg + Abiraterone | 96.6 |
Phase II: Placebo + Abiraterone | 93.8 |
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Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population)
CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline. (NCT01485861)
Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 67.2 |
Phase II: Ipatasertib 200 mg + Abiraterone | 71.0 |
Phase II: Placebo + Abiraterone | 63.5 |
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Phase II: Percentage of Participants With CTC Conversion (ITT Population)
CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline. (NCT01485861)
Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 43.9 |
Phase II: Ipatasertib 200 mg + Abiraterone | 46.8 |
Phase II: Placebo + Abiraterone | 41.7 |
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Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss
"CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 66.7 |
Phase II: Ipatasertib 200 mg + Abiraterone | 22.2 |
Phase II: Placebo + Abiraterone | 31.8 |
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Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss
"CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 75.0 |
Phase II: Ipatasertib 200 mg + Abiraterone | 75.0 |
Phase II: Placebo + Abiraterone | 70.6 |
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Phase II: Percentage of Participants With Objective Response (ITT Population)
Objective response was defined as having a confirm response (CR) or partial response (PR) according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 32.4 |
Phase II: Ipatasertib 200 mg + Abiraterone | 23.1 |
Phase II: Placebo + Abiraterone | 22.9 |
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Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss
"Objective response was defined as having a CR or PR according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss. Number of participants analyzed=participants with PTEN loss and evaluable for this endpoint." (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 11.1 |
Phase II: Ipatasertib 200 mg + Abiraterone | 26.7 |
Phase II: Placebo + Abiraterone | 14.3 |
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Phase II: Percentage of Participants With Pain Progression (ITT Population)
Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). (NCT01485861)
Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 33.3 |
Phase II: Ipatasertib 200 mg + Abiraterone | 34.9 |
Phase II: Placebo + Abiraterone | 34.9 |
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Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss
"Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 40.0 |
Phase II: Ipatasertib 200 mg + Abiraterone | 28.0 |
Phase II: Placebo + Abiraterone | 33.3 |
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Phase II: Percentage of Participants With PSA Progression (ITT Population)
PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 nanogram per milliliter (ng/mL) from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. (NCT01485861)
Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 57.1 |
Phase II: Ipatasertib 200 mg + Abiraterone | 69.8 |
Phase II: Placebo + Abiraterone | 72.3 |
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Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss
"PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 72.0 |
Phase II: Ipatasertib 200 mg + Abiraterone | 64.0 |
Phase II: Placebo + Abiraterone | 66.7 |
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Phase II: Percentage of Participants With PSA Response (ITT Population)
PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement. (NCT01485861)
Timeframe: Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)
Intervention | Percentage of Participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 36.9 |
Phase II: Ipatasertib 200 mg + Abiraterone | 33.7 |
Phase II: Placebo + Abiraterone | 34.9 |
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Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss
"PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)
Intervention | percentage of participants (Number) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 40.0 |
Phase II: Ipatasertib 200 mg + Abiraterone | 44.0 |
Phase II: Placebo + Abiraterone | 28.6 |
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Phase II: Radiographic Progression Free Survival (rPFS) (Intent-To-Treat [ITT] Population)
rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on a second bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Intervention | months (Median) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 8.18 |
Phase II: Ipatasertib 200 mg + Abiraterone | 8.31 |
Phase II: Placebo + Abiraterone | 6.37 |
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Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss
"rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (RECIST 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on 2nd bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss. Number of participants analyzed=participants with PTEN loss." (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Intervention | months (Median) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 11.53 |
Phase II: Ipatasertib 200 mg + Abiraterone | 11.10 |
Phase II: Placebo + Abiraterone | 4.60 |
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Phase II: Time to Pain Progression (ITT Population)
Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). (NCT01485861)
Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
Intervention | months (Median) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 13.90 |
Phase II: Ipatasertib 200 mg + Abiraterone | 16.16 |
Phase II: Placebo + Abiraterone | 15.15 |
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Phase II: Time to Pain Progression in Participants With ICR PTEN Loss
"Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression: ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of 4questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)
Intervention | months (Median) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 16.49 |
Phase II: Ipatasertib 200 mg + Abiraterone | NA |
Phase II: Placebo + Abiraterone | 6.93 |
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Phase II: Time to PSA Progression (ITT Population)
Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. (NCT01485861)
Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Intervention | months (Median) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 5.55 |
Phase II: Ipatasertib 200 mg + Abiraterone | 3.78 |
Phase II: Placebo + Abiraterone | 3.71 |
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Phase II: Time to PSA Progression in Participants With ICR PTEN Loss
"Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Intervention | Months (Median) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 3.71 |
Phase II: Ipatasertib 200 mg + Abiraterone | 2.92 |
Phase II: Placebo + Abiraterone | 2.79 |
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Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone
(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | ng/mL*hours (Geometric Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Phase Ib: Ipatasertib 400 mg | 1710 | 3290 |
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Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | ng/mL*hr (Geometric Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Phase Ib: Apitolisib 30 mg | 475 | 220 |
,Phase Ib: Ipatasertib 400 mg | 749 | 961 |
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Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone
(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | ng/mL*hours (Geometric Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Phase Ib: Apitolisib 30 mg | 1600 | 1640 |
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Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | ng/mL (Geometric Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Phase Ib: Apitolisib 30 mg | 88.2 | 52.7 |
,Phase Ib: Ipatasertib 400 mg | 151 | 140 |
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Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone
(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | ng/mL (Geometric Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Phase Ib: Apitolisib 30 mg | 190 | 193 |
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Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone
(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | ng/mL (Geometric Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Phase Ib: Ipatasertib 400 mg | 269 | 466 |
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Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | hours (Geometric Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Phase Ib: Apitolisib 30 mg | 7.68 | 14.70 |
,Phase Ib: Ipatasertib 400 mg | 5.25 | 6.92 |
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Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib
RP2D is a dose of a drug which would be used in Phase II stage of the study. RP2D was to be determined based on maximum tolerated dose (MTD) in Phase Ib stage of the study. The highest dose level (in 3+3 escalation scheme) with an acceptable safety profile and with a minimum of 6 participants at which fewer than one-third of participants experienced a DLT was declared the MTD and RP2D. (NCT01485861)
Timeframe: Days 1 to 28 of Cycle 1 (Cycle length = 28 days)
Intervention | milligrams (mg) (Number) |
---|
| Apitolisib |
---|
Phase Ib: Apitolisib 30 mg | NA |
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Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib
RP2D is a dose of a drug which would be used in Phase II stage of the study. RP2D was to be determined based on maximum tolerated dose (MTD) in Phase Ib stage of the study. The highest dose level (in 3+3 escalation scheme) with an acceptable safety profile and with a minimum of 6 participants at which fewer than one-third of participants experienced a DLT was declared the MTD and RP2D. (NCT01485861)
Timeframe: Days 1 to 28 of Cycle 1 (Cycle length = 28 days)
Intervention | milligrams (mg) (Number) |
---|
| Ipatasertib |
---|
Phase Ib: Ipatasertib 400 mg | 400 |
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Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone
(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | hours (Median) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Phase Ib: Ipatasertib 400 mg | 2.00 | 2.02 |
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Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | hours (Median) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Phase Ib: Apitolisib 30 mg | 2.01 | 3.04 |
,Phase Ib: Ipatasertib 400 mg | 2.05 | 2.17 |
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Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone
(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | hours (Median) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 15 |
---|
Phase Ib: Apitolisib 30 mg | 2.02 | 2.04 |
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Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
(NCT01485861)
Timeframe: Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length = 28 days)
Intervention | ng/mL (Geometric Mean) |
---|
| Cycle 1, Day 1: 1 hour postdose | Cycle 1, Day 1: 4 hours postdose | Cycle 1, Day 15: predose | Cycle 1, Day 15: 2 hours postdose | Cycle 1, Day 15: 4 hours postdose | Cycle 2, Day 1: predose | Cycle 2, Day 1: 1-4 hours postdose |
---|
Phase II: Ipatasertib 200 mg + Abiraterone | 63.4 | 87.0 | 24.5 | 140 | 139 | 25.3 | 145 |
,Phase II: Ipatasertib 400 mg + Abiraterone | 101 | 180 | 53.1 | 213 | 272 | 46.7 | 243 |
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Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs)
DLT: 1 of the following toxicities, at least possibly related to ipatasertib or apitolisib. 1) Grade ≥ 3 non-hematologic, non-hepatic major organ AE; 2) Grade ≥ 3 febrile neutropenia; 3) Grade ≥ 4 neutropenia (absolute neutrophils less than [<] 500 per microliter) lasting greater than (>) 7 days; 4) Grade ≥3 thrombocytopenia associated with acute hemorrhage; 5) Grade ≥4 thrombocytopenia; 6) Grade ≥4 anemia; 7) 1 episode of fasting Grade ≥4 hyperglycemia or 3 episodes of fasting Grade 3 hyperglycemia on separate days within 7 days, as determined by laboratory blood glucose evaluation; 8) Grade ≥3 elevation lasting for > 48 hours for hepatic transaminase or liver-specific alkaline phosphatase or total bilirubin. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0. (NCT01485861)
Timeframe: Days 1 to 28 of Cycle 1 (Cycle length = 28 days)
Intervention | percentage of participants (Number) |
---|
Phase Ib: Ipatasertib 400 mg | 0 |
Phase Ib: Apitolisib 30 mg | 0 |
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Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. (NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 15 of Cycle 1 (cycle length = 28 days)
Intervention | milliliter per hour (mL/h) (Geometric Mean) |
---|
Phase Ib: Ipatasertib 400 mg | 99600 |
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Phase II: Duration of Tumor Response (ITT Population)
Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method. (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)
Intervention | months (Median) |
---|
Phase II: Ipatasertib 400 mg + Abiraterone | 8.77 |
Phase II: Ipatasertib 200 mg + Abiraterone | NA |
Phase II: Placebo + Abiraterone | NA |
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Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Accumulation Ratio was caculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1). (NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | ratio (Geometric Mean) |
---|
Phase Ib: Ipatasertib 400 mg | 0.823 |
Phase Ib: Apitolisib 30 mg | 0.882 |
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Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone
Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1). (NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)
Intervention | ratio (Geometric Mean) |
---|
Phase Ib: Ipatasertib 400 mg | 1.82 |
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Phase Ib: Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01485861)
Timeframe: Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 10 months).
Intervention | percentage of participants (Number) |
---|
Phase Ib: Ipatasertib 400 mg | 100.0 |
Phase Ib: Apitolisib 30 mg | 100.0 |
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Change in Tissue Testosterone and Dihydrotestosterone
Tissue testosterone will be measured in biopsy tissues (NCT01503229)
Timeframe: From baseline to week 4
Intervention | pg/mg (Median) |
---|
Treatment (Abiraterone Acetate and Prednisone) | 0.156 |
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Phase 2: PSA Progression Free Survival
"Prostate-specific antigen progression-free survival was defined as the time interval between the date of treatment start and the date of either first documented PSA progression or death due to any cause, whichever was earlier. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.~Analysis was performed by Kaplan Meire method." (NCT01511536)
Timeframe: Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)
Intervention | months (Median) |
---|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | 6.93 |
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Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate
MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting >7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03. (NCT01511536)
Timeframe: Up to Cycle 2 of Phase 1 (up to 42 days)
Intervention | mg/m^2 (Number) |
---|
Phase 1: Overall Population | 25 |
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Phase 2: Objective Progression Free Survival (PFS)
"Objective PFS was defined as the time interval between the date of enrollment and the first occurrence of any of the events:~1) Radiological tumor progression (assessed using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. in case of progressive disease (PD) diagnosed only on non target bone lesions on bone scan, PD was to be considered only in case of appearance of at least 2 new lesions on bone scan confirmed 6 weeks later by another bone scan, and at least the appearance of 2 new additional lesions. 2) Death due to any cause.~Analysis was performed by Kaplan-Meier method." (NCT01511536)
Timeframe: From baseline until radiological tumor or disease progression or death due to any cause, assessed up to Month 5
Intervention | months (Median) |
---|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | NA |
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Phase 2: Overall Survival
Overall survival was defined as the time interval from the date of treatment start to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method. (NCT01511536)
Timeframe: From baseline up to death or study cut-off (maximum duration: 603 days)
Intervention | months (Median) |
---|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | NA |
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Phase 2: Percentage of Participants With Objective Response
Objective response was defined as having complete response (CR) or Partial Response (PR) assessed by RECIST 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). (NCT01511536)
Timeframe: Baseline, every 12 weeks there after until disease progression (maximum duration: 603 days)
Intervention | percentage of participants (Number) |
---|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | 21.4 |
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Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response
Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA. (NCT01511536)
Timeframe: Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)
Intervention | percentage of participants (Number) |
---|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | 46.2 |
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Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24)
Area under the plasma concentration-time curve calculated using the trapezoidal method from time zero to 24 hours corresponding to abiraterone acetate dosing interval. (NCT01511536)
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1
Intervention | ng*h/mL (Mean) |
---|
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 928 |
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Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss)
(NCT01511536)
Timeframe: Pre abiraterone dose on Day 1 of Cycle 1
Intervention | ng/mL (Mean) |
---|
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 9.99 |
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Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax)
(NCT01511536)
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1
Intervention | hour (Median) |
---|
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 2.00 |
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Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax)
(NCT01511536)
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1
Intervention | ng/mL (Mean) |
---|
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 216 |
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Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC)
Area under the concentration-time curve calculated using the following equation: AUC = Plasma clearance (CL)/dose (NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
Intervention | ng*h/mL (Mean) |
---|
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 817 |
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Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax)
(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
Intervention | ng/mL (Mean) |
---|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | 330 |
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Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z)
(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
Intervention | hour (Mean) |
---|
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 91.6 |
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Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL)
(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
Intervention | L/h/m^2 (Mean) |
---|
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 31.4 |
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Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss)
(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
Intervention | L/m^2 (Mean) |
---|
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 2711 |
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Number of Participants With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. (NCT01517802)
Timeframe: Up to 9 years
Intervention | Participants (Count of Participants) |
---|
Abiraterone Acetate + Prednisone/Prednisolone | 16 |
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Percentage of Participants With New Donor Specific Antibodies (DSAs)
Donor specific antibodies are antibodies that are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT01517984)
Timeframe: 6 to 18 months post-randomization
Intervention | percentage of participants (Number) |
---|
Randomized to Tacrolimus Withdrawal | 36 |
Randomized to Control Group | 14 |
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Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation
Estimated glomerular filtration rate (eGFR) is a test to measure the level of kidney function. In this measure, the effects of tacrolimus withdrawal on long-term kidney function was assessed by comparing absolute 24 month eGFR (18 months post-randomization) and change in eGFR from 6 to 24 months (randomization to 18 months randomization). Lower numbers indicate poorer kidney function (NCT01517984)
Timeframe: 6 months post-transplantation, 24 months post-transplantation
Intervention | mL/min (Mean) |
---|
| 6 Month eGFR | 24 Month eGFR | Change in eGFR from 6 to 24 months |
---|
Randomized to Control Group | 62.3 | 68.6 | 6.3 |
,Randomized to Tacrolimus Withdrawal | 56.2 | 61.7 | 5.5 |
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Incidence of Acute Rejection
Acute renal allograft rejection is defined as histological reading of borderline or greater determined by the local pathology laboratory. Participants suspected of having a rejection episode on the basis of clinical signs, symptoms, or on the basis of laboratory tests, had a renal ultrasound and underwent a renal transplant biopsy. Any detection of acute cellular rejection or acute humoral rejection resulted in participants in the 'Randomized to Tacrolimus Withdrawal' group to be restarted on tacrolimus and followed per the reduced follow-up schedule of events. (NCT01517984)
Timeframe: 6 to 18 months post-randomization
Intervention | participants (Number) |
---|
Randomized to Tacrolimus Withdrawal | 6 |
Randomized to Control Group | 0 |
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Percentage of Participants in the Experimental Arm Off Tacrolimus
Participants in the 'Randomized to Tacrolimus Withdrawal' group were considered fully withdrawn once they no longer received any doses of tacrolimus. Participants met this endpoint if they did not resume taking tacrolimus as of 18 months post randomization with stable allograft function and without rejection of donor-specific antibodies. (NCT01517984)
Timeframe: 18 months post-randomization
Intervention | percentage of participants (Number) |
---|
Randomized to Tacrolimus Withdrawal | 43 |
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Participant Survival Rate
Number of participants who did not die within the course of this study. (NCT01517984)
Timeframe: 6 to 18 months post-transplantation
Intervention | participants (Number) |
---|
Randomized to Tacrolimus Withdrawal | 14 |
Randomized to Control Group | 7 |
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Allograft Survival Rate
Allograft survival is defined as participants who did not need to be re-transplanted or placed on dialysis due to the failure of their allograft transplantation during the course of this study. (NCT01517984)
Timeframe: 6 to 18 months post-randomization
Intervention | participants (Number) |
---|
Randomized to Tacrolimus Withdrawal | 14 |
Randomized to Control Group | 7 |
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Bone Scan Response (BSR)
BSR is defined as >=30% in the bone scan lesion area (BSLA) compared with baseline. Bones scans were evaluated by an independent radiology facility (IRF) for response. (NCT01522443)
Timeframe: BSR was measured at the end of Week 12 as determined by the IRF
Intervention | percentage of responders (Number) |
---|
Cabozantinib | 31 |
Mitoxantrone/Prednisone | 5.2 |
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Overall Survival (OS)
OS was defined as the time from randomization to the date of death (due to any cause). Participants that had not died were censored at last known date alive. The analyses for OS occurred after 78/196 deaths (40% of the total required for the pre-specified primary analysis of OS). The data cut-off date was 06 October 2014. Median OS was calculated using Kaplan-Meier estimates. (NCT01522443)
Timeframe: OS was measured at the time of randomization until 78 deaths
Intervention | months (Median) |
---|
Cabozantinib | 9.0 |
Mitoxantrone/Prednisone | 7.9 |
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Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported
The pre-specified primary analysis of Pain Response at Week 6 confirmed at Week 12 was defined as ≥ 30% from baseline in the average daily worst pain intensity score during a 7-day reporting period, with neither a concomitant increase in average daily use of any opioid narcotic type, nor addition of any new opioid narcotic type, relative to baseline. Pain Progression at a given time point is defined as ≥ 30% increase compared with baseline in the average daily worst pain intensity score during a 7-day reporting period or either an increase in the average daily use of any type of opioid narcotic or addition of a new opioid narcotic type compared with baseline. (NCT01522443)
Timeframe: Pain response was measured at Week 6 and Week 12 by self-reports of subjects
Intervention | percentage of responders (Number) |
---|
Cabozantinib | 15 |
Mitoxantrone/Prednisone | 17 |
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Participants With Glucocorticoid Responsiveness - Cardiac Involvement
Cardiac involvement in participants with hypereosinophilic syndromes (HES) (NCT01524536)
Timeframe: Baseline (Day 1)
Intervention | Participants (Count of Participants) |
---|
Steroid Challenge - Glucocorticoid Responsiveness | 1 |
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness | 0 |
Steroid Challenge - Glucocorticoid Unresponsiveness | 4 |
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Participants With Glucocorticoid Responsiveness - LHES Variant
Participants with lymphoid hypereosinophilic syndromes (LHES) that achieved glucocorticoid responsiveness, suboptimal responsiveness, or without response. (NCT01524536)
Timeframe: Baseline (Day 1)
Intervention | Participants (Count of Participants) |
---|
Steroid Challenge - Glucocorticoid Responsiveness | 2 |
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness | 1 |
Steroid Challenge - Glucocorticoid Unresponsiveness | 2 |
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Participants With Glucocorticoid Responsiveness - Overlap HES Subtypes
Participants with overlap hypereosinophilic syndromes that achieved glucocorticoid responsiveness, suboptimal responsiveness, or without response. (NCT01524536)
Timeframe: Baseline (Day 1)
Intervention | Participants (Count of Participants) |
---|
Steroid Challenge - Glucocorticoid Responsiveness | 3 |
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness | 2 |
Steroid Challenge - Glucocorticoid Unresponsiveness | 1 |
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Participants With Glucocorticoid Responsiveness - Pulmonary Involvement
Pulmonary involvement in participants with hypereosinophilic syndromes (HES) (NCT01524536)
Timeframe: Baseline (Day 1)
Intervention | Participants (Count of Participants) |
---|
Steroid Challenge - Glucocorticoid Responsiveness | 4 |
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness | 3 |
Steroid Challenge - Glucocorticoid Unresponsiveness | 3 |
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Participants With Glucocorticoid Responsiveness - MHES Variant
Participants with myeloid hypereosinophilic syndromes (MHES) that achieved glucocorticoid responsiveness, suboptimal responsiveness, or without response. (NCT01524536)
Timeframe: Baseline (Day 1)
Intervention | Participants (Count of Participants) |
---|
Steroid Challenge - Glucocorticoid Responsiveness | 0 |
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness | 0 |
Steroid Challenge - Glucocorticoid Unresponsiveness | 1 |
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Mean Baseline Absolute Eosinophil Count
Mean baseline absolute eosinophil count in participants prior to initiation of glucocorticoids (NCT01524536)
Timeframe: Baseline (Day 1)
Intervention | 10^3 cells per microliter (Geometric Mean) |
---|
Steroid Challenge - Glucocorticoid Responsiveness | 2.81 |
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness | 3.85 |
Steroid Challenge - Glucocorticoid Unresponsiveness | 5.90 |
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Participants With Glucocorticoid Responsiveness - IHES Variant
Participants with idiopathic hypereosinophilic syndromes (IHES) that achieved glucocorticoid responsiveness, suboptimal responsiveness, or without response. (NCT01524536)
Timeframe: Baseline (Day 1)
Intervention | Participants (Count of Participants) |
---|
Steroid Challenge - Glucocorticoid Responsiveness | 6 |
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness | 2 |
Steroid Challenge - Glucocorticoid Unresponsiveness | 2 |
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Mean Percent Change in Eosinophil Count After Glucocorticoid Challenge
"Response to glucocorticoid challenge as assessed by the percentage of the eosinophil count 24 hours post-glucocorticoid challenge relative to the Baseline AEC for each participant.~Measure Description (%): Percent of baseline AEC is defined as the Absolute Eosinophil Count at 24 hours divided by the Absolute Eosinophil Count at Baseline *100." (NCT01524536)
Timeframe: 24 hours
Intervention | percentage of eosinophil count (Mean) |
---|
Steroid Challenge - Responders | -69.6 |
Steroid Challenge - Non-responders | -13.6 |
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Mean Baseline IgE Level
Mean baseline immunoglobulin E (IgE) level in participants prior to initiation of glucocorticoid (NCT01524536)
Timeframe: Baseline (Day 1)
Intervention | IU/mL (Geometric Mean) |
---|
Steroid Challenge - Glucocorticoid Responsiveness | 285.2 |
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness | 1171.5 |
Steroid Challenge - Glucocorticoid Unresponsiveness | 434.8 |
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Number of Participants Who Needed Additional Therapy or Colectomy
Number of participants who needed additional therapy or colectomy. Additional therapy included Anti-Tumour Necrosis Factor alpha (TNFα), Calcineurin inhibitor, Immunomodulator (NCT01536535)
Timeframe: Within 52 weeks
Intervention | Participants (Count of Participants) |
---|
Mild UC Disease | 46 |
Moderate to Severe UC | 151 |
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Number of Participants With Corticosteroid Free Remission (SFR)
"Week 52 CS-free remission: Number of participants with a PUCAI < 10 and no corticosteroids (CS) for 28 days without additional therapy or colectomy. Participants in both groups received corticosteroids, biologics, or colectomies, if symptomatic.~The Pediatric Ulcerative Colitis Activity Index (PUCAI) is a non-invasive disease activity index. The index measures include abdominal pain, rectal bleeding, stool consistency, number of stools per 24 hours, nocturnal stools, and activity level. A total score less than 10 indicates remission, Mild disease activity is 10-30, Moderate 35-60, Severe disease activity 65-85." (NCT01536535)
Timeframe: 52 weeks
Intervention | Participants (Count of Participants) |
---|
Mild UC | 80 |
Moderate to Severe UC | 70 |
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Number of Participants Receiving a Colectomy
Number of participants who received a colectomy within 52 weeks (NCT01536535)
Timeframe: Within 52 weeks
Intervention | Participants (Count of Participants) |
---|
Mild UC Disease | 2 |
Moderate to Severe UC | 23 |
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Number of Participants Reporting Change From Baseline in ECG Morphology
Participants with incidence of ECG morphology abnormalities were observed. Types of abnormalities included appearance of abnormal U waves, T waves inversion, elevation of ST segment, depression of ST segment, second or third degree heart block, right or left bundle branch block, atrial fibrillation/flutter, and myocardial infarction. New morphological changes were observed in abnormal U waves, depression of ST segment, and T waves inversion. Here, 'new' refers to change not present at baseline, ie, at any evaluation predose, and only seen postbaseline. Results of change in ECG morphology analyzed from 12-lead ECGs at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
Intervention | participant (Number) |
---|
| Abnormal U waves | ST segment depression | T-wave inversion |
---|
Orteronel + Prednisone | 1 | 8 | 3 |
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Number of Participants Reporting One or More Treatment-emergent Adverse Events
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. (NCT01549951)
Timeframe: Baseline up to 30 days after last dose of study drug (Day 86)
Intervention | participants (Number) |
---|
Orteronel + Prednisone | 48 |
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AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite
AUC(0-6) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 6 hours in this study). Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
Intervention | nanogram hours per milliliter (ng*hr/mL) (Mean) |
---|
| Cycle 1 Day 1 (n=50) | Cycle 2 Day 1 (n=44) |
---|
Orteronel + Prednisone | 7570.4 | 12971.6 |
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Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval
Triplicate 12-lead ECG measurements (each recording separated by approximately 1 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Bazette's formula (QTcB = QT divided by square root of RR). Results of change in QTcB, PR, QRS and uncorrected QT analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
Intervention | msec (Mean) |
---|
| QTcB Interval (N=43) | PR Interval (N=48) | QRS Interval (N=48) | Uncorrected QT Interval (N=48) |
---|
Orteronel + Prednisone | 9.7 | -4.2 | -1.0 | -12.5 |
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Number of Participants Reporting Clinically Significant Abnormalities in ECG
The number of participants who reported clinically significant abnormalities in ECG were measured throughout study. ECGs were performed after the participant had been supine for at least 10 minutes. (NCT01549951)
Timeframe: Baseline up to 30 days after last dose of study drug (Day 86)
Intervention | participants (Number) |
---|
Orteronel + Prednisone | 0 |
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Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 1 minute) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Results of change in QTcF analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
Intervention | millisecond (msec) (Mean) |
---|
Orteronel + Prednisone | -1.4 |
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Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings
Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). (NCT01549951)
Timeframe: Baseline up to 30 days after last dose of study drug (Day 86)
Intervention | participants (Number) |
---|
Orteronel + Prednisone | 0 |
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Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs
The number of participants with any clinically significant abnormalities in vital signs collected throughout study. Vital signs included body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). (NCT01549951)
Timeframe: Baseline up to 30 days after last dose of study drug (Day 86)
Intervention | participants (Number) |
---|
Orteronel + Prednisone | 0 |
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Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values
The number of participants with any clinically significant abnormalities in safety laboratory values collected throughout study. (NCT01549951)
Timeframe: Baseline up to 30 days after last dose of study drug (Day 86)
Intervention | participants (Number) |
---|
Orteronel + Prednisone | 5 |
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Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel
Coefficient of correlation was measured using linear mixed effects model for the association between two variables; change from baseline versus the plasma concentration. Participant's effects on the intercept and plasma concentration slope were included in the model as random effects terms. Plasma concentrations were re scaled for model convergence. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
Intervention | correlation coefficient (Least Squares Mean) |
---|
Orteronel + Prednisone | -0.002603 |
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Changes From Baseline in Heart Rate
Triplicate 12-lead Electrocardiogram (ECG) measurements were performed and average was calculated. Supine heart rate was measured as beats per minute (bpm). Results of change in heart rate analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
Intervention | bpm (Mean) |
---|
Orteronel + Prednisone | 5.7 |
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Radiographic Progression Free Survival
Radiographic progression free survival is defined as the duration of time from start of treatment to time of radiographic progression by computed tomography (CT) scan (or magnetic resonance imaging (MRI)) or bone scan. Progression is a minimum of two new lesions observed on bone scan. The minimum size for a measurable lesion on CY and MRI should be twice the slice thickness based on the assumption that CT slice thickness is 500 or less. (NCT01553188)
Timeframe: Median potential follow-up of 50.3 months
Intervention | Months (Median) |
---|
DL 1 Run in - 15mg/kg | 2.7 |
DL 2 Run in - 30mg/kg | 9.0 |
Abiraterone, Prednisone and AMG | 13.7 |
Abiraterone and Prednisone Only | 10.6 |
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Progression Free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Clinical progression is assessed by the Response Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). (NCT01553188)
Timeframe: Median potential follow-up of 50.3 months
Intervention | Months (Median) |
---|
DL 1 Run in - 15mg/kg | 2.8 |
DL 2 Run in - 30mg/kg | 9.0 |
Abiraterone, Prednisone and AMG | 11.5 |
Abiraterone and Prednisone Only | 10.1 |
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Overall Survival
Overall Survival is the time between the first day of treatment to the day of death. (NCT01553188)
Timeframe: Time between the first day of treatment to the day of death, approximately 50.3 months.
Intervention | Months (Median) |
---|
DL 1 Run in - 15mg/kg | 11.1 |
DL 2 Run in - 30mg/kg | 27.9 |
Abiraterone, Prednisone and AMG | 31.1 |
Abiraterone and Prednisone Only | 25.5 |
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Dose Limiting Toxicity (DLT)
DLTs are defined as any grade 3 or higher hematologic (excluding anemia) or non-hematologic toxicity considered to be possible related to AMG 386. Any treatment related adverse events that lead tor reduction of dose exposure of either agent (duration or dose) by >50% in cycle 1 will be considered a DLT. (NCT01553188)
Timeframe: First 28 days of treatment
Intervention | Participants (Count of Participants) |
---|
DL 1 Run in - 15mg/kg | 0 |
DL 2 Run in - 30mg/kg | 1 |
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Count of Participants With Serious and Non-serious Adverse Events
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01553188)
Timeframe: Date treatment consent signed to date off study, approximately 65 months and 7 days
Intervention | Participants (Count of Participants) |
---|
DL 1 Run in - 15mg/kg | 3 |
DL 2 Run in - 30mg/kg | 6 |
Abiraterone, Prednisone and AMG | 16 |
Abiraterone and Prednisone Only | 11 |
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Maximum Tolerated Dose (MTD)
The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity was less than 33%. (NCT01553188)
Timeframe: First 28 days of treatment
Intervention | mg/kg (Number) |
---|
All Participants | 30 |
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Rates of PSA Decline
Change in PSA from baseline to 12 weeks (NCT01576172)
Timeframe: 12 weeks
Intervention | ng/ml (Mean) |
---|
Arm I (Abiraterone Acetate and Prednisone) | -41.1 |
Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | -52.9 |
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Progression-free Survival (PFS)
Time from randomization to disease progression or death. (NCT01576172)
Timeframe: Up to 42 months
Intervention | months (Median) |
---|
Arm I (Abiraterone Acetate and Prednisone) | 10.1 |
Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 11.0 |
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Objective Response Rates in Patients With Measurable Disease.
Overall response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01576172)
Timeframe: Up to 3 years
Intervention | Participants (Count of Participants) |
---|
Arm I (Abiraterone Acetate and Prednisone) | 18 |
Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 24 |
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Confirmed Prostate-specific Antigen (PSA) Response Rate
50% or greater decline in PSA from baseline. (NCT01576172)
Timeframe: Up to 3 years
Intervention | Participants (Count of Participants) |
---|
Arm I (Abiraterone Acetate and Prednisone) | 46 |
Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 55 |
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Grade 4 or 5 Adverse Events
Grade 4 or greater toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 at least possibly related to treatment. (NCT01576172)
Timeframe: 30 days after completion of study treatment
Intervention | Participants (Count of Participants) |
---|
Arm I (Abiraterone Acetate and Prednisone) | 1 |
Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 3 |
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Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction With Treatment Score
The TSQM Global Satisfaction with Treatment is a 14-item questionnaire that ranges from 0 - 100 with higher scores indicating better outcomes. (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits
Intervention | score on a scale (Least Squares Mean) |
---|
Daily Prednisone | 71.2 |
Daily Deflazacort | 67.8 |
Intermittent Prednisone | 65.1 |
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Rise From the Floor Velocity
Reciprocal of time to rise from the floor (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits
Intervention | rise/sec (Least Squares Mean) |
---|
Daily Prednisone | 0.24 |
Daily Deflazacort | 0.24 |
Intermittent Prednisone | 0.18 |
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Range of Motion (Goniometry) of Right Ankle
Range of motion at the ankle joint in dorsiflexion measured in degrees from plantigrade averaged over all post-baseline visits. (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits
Intervention | degrees (Mean) |
---|
Daily Prednisone | 4.05 |
Daily Deflazacort | 2.81 |
Intermittent Prednisone | 2.29 |
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Range of Motion (Goniometry) of Left Ankle
Range of motion at the ankle joint in dorsiflexion measured in degrees from plantigrade averaged over all post-baseline visits. (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits
Intervention | degrees (Mean) |
---|
Daily Prednisone | 4.39 |
Daily Deflazacort | 3.29 |
Intermittent Prednisone | 2.67 |
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Quality of Life- Child
Quality of life was measured by child self-report in children age 5 and older utilizing the PEDSQL measurement tool. This is a 23-question tool. Scores can range from 0 to 100, with higher scores indicating better quality of life. (NCT01603407)
Timeframe: Average of Months 12, 24, and 36 visits
Intervention | score on a scale (Least Squares Mean) |
---|
Daily Prednisone | 67.39 |
Daily Deflazacort | 64.96 |
Intermittent Prednisone | 65.07 |
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Quality of Life - Parent
Quality of life was measured by parent/guardian self-report for all children utilizing the PEDSQL measurement tool. This is a 23-question tool. Scores can range from 0 to 100, with higher scores indicating better quality of life for the child. (NCT01603407)
Timeframe: Average of Months 12, 24, and 36 visits
Intervention | score on a scale (Least Squares Mean) |
---|
Daily Prednisone | 64.88 |
Daily Deflazacort | 63.71 |
Intermittent Prednisone | 61.33 |
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PR Interval
Measured by trans-thoracic echocardiogram and 12-lead ECG. (NCT01603407)
Timeframe: 36 months
Intervention | milliseconds (Least Squares Mean) |
---|
Daily Prednisone | 115.59 |
Daily Deflazacort | 116.87 |
Intermittent Prednisone | 117.90 |
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Participant Weight
(NCT01603407)
Timeframe: 36 months
Intervention | kilograms (Least Squares Mean) |
---|
Daily Prednisone | 26.3 |
Daily Deflazacort | 24.9 |
Intermittent Prednisone | 26.3 |
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Participant Height
(NCT01603407)
Timeframe: 36 months
Intervention | centimeters (Least Squares Mean) |
---|
Daily Prednisone | 116.8 |
Daily Deflazacort | 115.3 |
Intermittent Prednisone | 119.9 |
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Participant Body Mass Index
(NCT01603407)
Timeframe: 36 months
Intervention | kilograms/square meter (Least Squares Mean) |
---|
Daily Prednisone | 18.9 |
Daily Deflazacort | 18.3 |
Intermittent Prednisone | 18.1 |
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Number of Participants Who Tolerated the Regimen
The number of participants who completed 36 months of follow-up on the originally assigned dosage (for weight) of study medication. (NCT01603407)
Timeframe: 3 years
Intervention | Participants (Count of Participants) |
---|
Daily Prednisone | 36 |
Daily Deflazacort | 36 |
Intermittent Prednisone | 37 |
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North Star Ambulatory Assessment (NSAA) Score
"The North Star Ambulatory Assessment (NSAA) is a 17-item rating scale that is used to measure functional motor abilities in ambulant children with Duchenne Muscular Dystrophy (DMD). It is usually used to monitor the progression of the disease and treatment effects.~The activities are graded as follows:~2 - Normal - no obvious modification of activity~1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently This scale is ordinal with 34 as the maximum score indicating fully-independent function." (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits
Intervention | score on a scale (Least Squares Mean) |
---|
Daily Prednisone | 23.7 |
Daily Deflazacort | 24.0 |
Intermittent Prednisone | 20.7 |
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Left Ventricular Ejection Fraction Percent
Measured by trans-thoracic echocardiogram and 12-lead ECG. (NCT01603407)
Timeframe: 36 months
Intervention | percentage of ejection fraction (Least Squares Mean) |
---|
Daily Prednisone | 61.88 |
Daily Deflazacort | 62.65 |
Intermittent Prednisone | 62.45 |
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Heart Rate
Measured by trans-thoracic echocardiogram and 12-lead ECG. (NCT01603407)
Timeframe: 36 months
Intervention | bpm (Least Squares Mean) |
---|
Daily Prednisone | 94.10 |
Daily Deflazacort | 93.52 |
Intermittent Prednisone | 91.65 |
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Forced Vital Capacity
Forced vital capacity was measured during a spirometry test. Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits
Intervention | liters (Least Squares Mean) |
---|
Daily Prednisone | 1.4 |
Daily Deflazacort | 1.4 |
Intermittent Prednisone | 1.5 |
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6 Minute Walk Test
Measures the total distance walked in 6 minutes averaged over all post-baseline follow-up visits through Month 36. (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits
Intervention | meters (Least Squares Mean) |
---|
Daily Prednisone | 384.95 |
Daily Deflazacort | 384.17 |
Intermittent Prednisone | 346.81 |
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Fractional Shortening Percent
Measured by trans-thoracic echocardiogram and 12-lead ECG. (NCT01603407)
Timeframe: 36 months
Intervention | percentage of fractional shortening (Least Squares Mean) |
---|
Daily Prednisone | 33.74 |
Daily Deflazacort | 34.01 |
Intermittent Prednisone | 34.33 |
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Progression-free Survival (PFS)
The exploratory analysis of PFS is the time from randomization to date of first documented radiographic progression (bone and/or soft tissue) according to the investigator's assessment or death. PFS was defined per mRECIST 1.1 and included evaluation of measurable, nonmeasurable, target and nontarget lesions. A Kaplan-Meier analysis was performed to estimate the median duration. (NCT01605227)
Timeframe: Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months
Intervention | months (Median) |
---|
Cabozantinib | 5.6 |
Prednisone | 2.8 |
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Bone Scan Response (BSR)
BSR is defined as >=30% reduction in the bone scan lesion area (BSLA) compared with baseline. Confirmation of bone scan was not required for response or progression. Bone scans were evaluated by an independent radiology facility (IRF) for response. (NCT01605227)
Timeframe: BSR was measured at the end of Week 12 as determined by the IRF
Intervention | percentage of participants (Number) |
---|
Cabozantinib | 42 |
Prednisone | 3 |
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Overall Survival (OS)
The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred. (NCT01605227)
Timeframe: OS was measured from the time of randomization until 614 events, approximately 24 months after study start
Intervention | months (Median) |
---|
Cabozantinib | 11.0 |
Prednisone | 9.8 |
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Comparison of Circulating Androstenedione Levels Between Primary-Resistant Patients and Responders
The distribution of the baseline androstenedione levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12
Intervention | ng/dL (Mean) |
---|
Androstenedione in Primary Resistant (STD) | NA |
Androstenedione in Responders (STD) | NA |
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Comparison of Circulating DHEA-S Levels Between Primary-Resistant Patients and Responders
The distribution of the baseline DHEA-S levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12
Intervention | microgram per deciliter (µg/dL) (Mean) |
---|
DHEA-S in Primary Resistant (STD) | NA |
DHEA-S in Responders (STD) | NA |
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Comparison of Circulating Testosterone Levels Between Primary-Resistant Patients and Responders
The distribution of the baseline testosterone levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12
Intervention | Nanograms per decilitre (ng/dL) (Mean) |
---|
Testosterone in Primary Resistant (STD) | NA |
Testosterone in Responders (STD) | NA |
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Correlation of Circulating Dehydroepiandrosterone (DHEA) Levels From Baseline to Week 12
"Pearson's correlation coefficients (r) will be calculated to summarize the relationship between DHEA values at baseline and at 12 weeks. DHEA labs will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of DHEA levels between the 2 time points, a value of 0 indicating no association between DHEA levels between the two time points, and a value of +1 indicating a positive linear association of DHEA levels between the two time points." (NCT01637402)
Timeframe: Baseline and Week 12
Intervention | correlation coefficient (r) (Number) |
---|
Standard Dose | 0 |
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Number of Patients With PSA Response From Dose Escalation
A PSA response for the dose escalation group is defined as a participant with a documented PSA decline after 12 weeks of therapy with standard-dose, then had disease progression, and then achieved a ≥30% PSA decline after 12 weeks from the start of dose escalation therapy. (NCT01637402)
Timeframe: Up to 12 weeks from start of dose escalation
Intervention | Participants (Count of Participants) |
---|
Dose Escalation | 0 |
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Serum Concentration Levels of Abiraterone Acetate Over Time
Pharmacokinetic assessment at the initiation of standard dose therapy, at the time of initial disease progression, at the time of a response to increased dose of abiraterone acetate and at the time of disease progression on increased-dose therapy. (NCT01637402)
Timeframe: Up to 24 months
Intervention | nanograms per millilitre (ng/mL) (Median) |
---|
Concentration at First Draw on Standard Dose Therapy (4 Weeks) | 5.5 |
Concentration at Time of Disease Progression on Standard Dose | 14.2 |
Concentration at Time of Disease Progression on Increased Dose | 31.5 |
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Time to PSA Progression for Dose Escalation Cohort
Time to PSA progression as defined by RECIST criteria or by the Prostate Cancer Working Group 2 (PCWG) criteria for patients whom were treated with increased dose Abiraterone Acetate. (NCT01637402)
Timeframe: up to 24 months
Intervention | months (Median) |
---|
Dose Escalation | 12 |
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Comparison of Circulating DHEA Levels Between Primary-Resistant and Responders
The distribution of the baseline DHEA levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12
Intervention | ng/dL (Mean) |
---|
| Initial draw | Progression / Week 12 |
---|
DHEA in Primary Resistant (STD) | 56.2 | 28.5 |
,DHEA in Responders (STD) | 79.4 | 13.5 |
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Change From Baseline to EoT in Bone Specific Alkaline Phosphatase
Bone metabolism marker bone specific alkaline phosphatase levels were derived from blood samples collected. (NCT01650194)
Timeframe: Baseline and EoT; the median duration of treatment was 10.1 months.
Intervention | ug/L (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | -5.18 |
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Change From Baseline in Progesterone Concentration in Blood
Progesterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | nmol/L (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | 1.43 |
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Change From Baseline in Pregnenolone in Bone Marrow Aspirate
Pregnenolone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | pg/ml (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | 1381.44 |
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Change From Baseline in Pregnenolone Concentration in Blood
Pregnenolone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | pg/ml (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | 1507.42 |
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Percentage of Participants With Objective Response for Soft Tissue Lesions According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST)
Objective response was based on RECIST version 1.1 for soft tissue lesion on Magnetic resonance imaging (MRI) / Computerized tomography (CT) and the PCWG2 guidelines for bone lesions on bone scans and was defined as partial response (PR) or complete response (CR) based on the investigators' assessments of target, non-target and new lesions while on study treatment. The 95% for objective response rate was based on exact binomial 95% confidence interval (Clopper-Pearson). (NCT01650194)
Timeframe: Up to 1849 days
Intervention | percentage of participants (Median) |
---|
Enzalutamide + Abiraterone + Prednisone | 68.8 |
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Progression Free Survival (PFS)
PFS was measured as the time from the date of first dose of any drug of the study combination treatment until the first evidence of documented progression (a composite endpoint consisting of radiographic progression or PSA progression by PCWG2 or clinical deterioration) or death in the absence of progression (whichever came first) or the date last known to be progression free. The Kaplan-Meier (KM) 95% CI was based on Brookmeyer and Crowley robust non-parametric method. (NCT01650194)
Timeframe: Up to 1849 days
Intervention | days (Median) |
---|
Enzalutamide + Abiraterone + Prednisone | 251 |
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Bone Scan Response at EoT
PD: ≥1 of 3 criteria: PSA progression: ≥2 rising PSA levels, interval of ≥1 week between each determination. Soft tissue disease progression: RECIST 1.1. Bone disease progression: PCWG2 criteria (≥2 or new lesions on bone scan compared with prior scan). Target lesion CR: disappearance of all target lesions, PR as ≥30% decrease in sum of longest diameter (LD) of target lesions, referencing baseline sum LD, SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing smallest sum LD since treatment start, PD ≥20% increase in sum of LD of target lesions, referencing smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Non-target lesions CR: disappearance of all non-target lesions and normalization of tumor marker level, SD: persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits, PD: appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. (NCT01650194)
Timeframe: EoT; the median duration of treatment was 10.1 months.
Intervention | Participants (Count of Participants) |
---|
| Complete Response (CR) | Progressive Disease (PD) | Non-CR/Non-PD | Not Evaluable |
---|
Enzalutamide + Abiraterone + Prednisone | 1 | 15 | 35 | 1 |
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Change From Baseline in Cortisol in Bone Marrow Aspirate
Cortisol in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | nmol/L (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | -46.86 |
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Change From Baseline in Androstenedione Concentration in Blood
Androstenedione concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | nmol/L (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | -0.24 |
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Change From Baseline in Cortisol Concentration in Blood
Cortisol concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | nmol/L (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | -48.81 |
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Change From Baseline to End-of-Treatment (EoT) in Prostate-Specific Antigen (PSA) Levels
Prostate-specific antigen progression by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) was defined as a PSA increase ≥25% and ≥2 ng/ml above the post-baseline nadir, and which was confirmed by the first subsequent value of 3 or more weeks later. (NCT01650194)
Timeframe: Baseline and EoT; the median duration of treatment was 10.1 months.
Intervention | ug/L (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | 36.35 |
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Change From Baseline in Progesterone in Bone Marrow Aspirate
Progesterone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | nmol/L (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | 1.16 |
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Change From Baseline in Testosterone Concentration in Blood
Testosterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | nmol/L (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | -0.06 |
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Change From Baseline in Testosterone Concentration in Bone Marrow Aspirate
Testosterone concentration in bone marrow aspirate was measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | pmol/L (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | -19.48 |
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Change From Baseline in Urine N-Telopeptide
Bone metabolism marker urine N-telopeptide levels were derived from urine samples collected. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | nmolBCE/mmolcreat (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | 29.35 |
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Number of Participants With Adverse Events (AEs)
A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03). (NCT01650194)
Timeframe: From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Enzalutamide-related TEAEs | Abiraterone-related TEAEs | Prednisone-related TEAEs | Deaths | Serious TEAEs | Enzalutamide-related serious TEAEs | Abiraterone-related serious TEAEs | Prednisone-related serious TEAEs | TEAEs leading to discontinuation of enzalutamide | Enza-related TEAEs leading to disc. of enza | Abiraterone-related TEAEs leading to disc. of enza | Prednisone-related TEAEs leading to disc. of enza | TEAEs leading to discontinuation of abiraterone | Abiraterone-related TEAEs leading to disc. of abi |
---|
Enzalutamide + Abiraterone + Prednisone | 60 | 56 | 58 | 16 | 0 | 10 | 0 | 2 | 0 | 3 | 0 | 0 | 0 | 1 | 1 |
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Change From Baseline in Androstenedione in Bone Marrow Aspirate
Androstenedione in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9
Intervention | nmol/L (Geometric Mean) |
---|
Enzalutamide + Abiraterone + Prednisone | -0.32 |
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Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. (NCT01666314)
Timeframe: Baseline and Week 4
Intervention | percent change (Mean) |
---|
Placebo (Japan) | -87.666 |
Orteronel 200 mg (Japan) | -97.245 |
Orteronel 300 mg (Japan) | -96.812 |
Placebo (Ex-Japan) | -63.702 |
Orteronel 200 mg (Ex-Japan) | -86.268 |
Orteronel 400 mg (Ex-Japan) | -53.954 |
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Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline. (NCT01666314)
Timeframe: Baseline and Week 4
Intervention | percentage of participants (Number) |
---|
Placebo (Japan) | 48.0 |
Orteronel 200 mg (Japan) | 50.0 |
Orteronel 300 mg (Japan) | 41.0 |
Placebo (Ex-Japan) | 17.0 |
Orteronel 200 mg (Ex-Japan) | 48.0 |
Orteronel 400 mg (Ex-Japan) | 46.0 |
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Absolute Values for Prostate-Specific Antigen (PSA)
Serum PSA was measured at the central laboratory. (NCT01666314)
Timeframe: Baseline and Cycle 2 Day 1
Intervention | ng/mL (Mean) |
---|
| Baseline | Cycle 2 Day 1 |
---|
Orteronel 200 mg (Ex-Japan) | 165.992 | 117.257 |
,Orteronel 200 mg (Japan) | 27.227 | 18.005 |
,Orteronel 300 mg (Japan) | 97.504 | 38.892 |
,Orteronel 400 mg (Ex-Japan) | 100.237 | 56.437 |
,Placebo (Ex-Japan) | 133.238 | 152.940 |
,Placebo (Japan) | 37.588 | 24.325 |
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AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite
AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study. (NCT01666314)
Timeframe: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Intervention | h*ng/mL (Geometric Mean) |
---|
| Orteronel | Orteronel Metabolite M-I |
---|
Orteronel 200 mg (Ex-Japan) | 7830 | 1570 |
,Orteronel 200 mg (Japan) | 8810 | 2130 |
,Orteronel 300 mg (Japan) | 12800 | 3290 |
,Orteronel 400 mg (Ex-Japan) | 10200 | 2080 |
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Absolute Values for Testosterone
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. (NCT01666314)
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Intervention | ng/dL (Mean) |
---|
| Baseline | Cycle 1 Day 8 | Cycle 2 Day 1 |
---|
Orteronel 200 mg (Ex-Japan) | 9.263 | 0.345 | 0.266 |
,Orteronel 200 mg (Japan) | 9.079 | 0.213 | 0.203 |
,Orteronel 300 mg (Japan) | 10.148 | 0.251 | 0.270 |
,Orteronel 400 mg (Ex-Japan) | 14.588 | 6.658 | 11.720 |
,Placebo (Ex-Japan) | 9.173 | 3.509 | 3.095 |
,Placebo (Japan) | 9.749 | 1.957 | 1.096 |
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Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory. (NCT01666314)
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Intervention | nmol/L (Mean) |
---|
| Baseline | Cycle 1 Day 8 | Cycle 2 Day 1 |
---|
Orteronel 200 mg (Ex-Japan) | 1783.0 | 116.9 | 21.5 |
,Orteronel 200 mg (Japan) | 2529.0 | 63.4 | 14.5 |
,Orteronel 300 mg (Japan) | 2340.9 | 71.8 | 36.3 |
,Orteronel 400 mg (Ex-Japan) | 2155.7 | 226.6 | 180.6 |
,Placebo (Ex-Japan) | 2601.7 | 973.8 | 815.7 |
,Placebo (Japan) | 1928.0 | 414.9 | 268.9 |
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Absolute Values for Cortisol
Serum Cortisol was measured by immunometric assay at the central laboratory. (NCT01666314)
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Intervention | nmol/L (Mean) |
---|
| Baseline | Cycle 1 Day 8 | Cycle 2 Day 1 |
---|
Orteronel 200 mg (Ex-Japan) | 449.0 | 100.9 | 97.2 |
,Orteronel 200 mg (Japan) | 371.3 | 49.5 | 49.2 |
,Orteronel 300 mg (Japan) | 383.4 | 55.5 | 54.3 |
,Orteronel 400 mg (Ex-Japan) | 446.8 | 122.0 | 109.1 |
,Placebo (Ex-Japan) | 384.8 | 175.8 | 149.6 |
,Placebo (Japan) | 366.5 | 82.3 | 53.9 |
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Absolute Values for Corticosterone
Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory. (NCT01666314)
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Intervention | nmol/L (Mean) |
---|
| Baseline | Cycle 1 Day 8 | Cycle 2 Day 1 |
---|
Orteronel 200 mg (Ex-Japan) | 10.030 | 48.668 | 29.929 |
,Orteronel 200 mg (Japan) | 6.515 | 11.067 | 11.108 |
,Orteronel 300 mg (Japan) | 7.768 | 9.709 | 14.654 |
,Orteronel 400 mg (Ex-Japan) | 17.975 | 60.301 | 47.204 |
,Placebo (Ex-Japan) | 6.317 | 5.598 | 4.321 |
,Placebo (Japan) | 5.946 | 1.530 | 0.758 |
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Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. (NCT01666314)
Timeframe: Baseline and Week 12
Intervention | percent change (Mean) |
---|
Orteronel 200 mg (Japan) | -95.804 |
Orteronel 300 mg (Japan) | -95.703 |
Orteronel 200 mg (Ex-Japan) | -91.311 |
Orteronel 400 mg (Ex-Japan) | -14.442 |
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Absolute Values for Adrenocorticotropic Hormone (ACTH)
Serum ACTH was measured by immunometric assay at the central laboratory. (NCT01666314)
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Intervention | pmol/L (Mean) |
---|
| Baseline | Cycle 1 Day 8 | Cycle 2 Day 1 |
---|
Orteronel 200 mg (Ex-Japan) | 6.0 | 3.8 | 3.7 |
,Orteronel 200 mg (Japan) | 5.5 | 2.3 | 1.7 |
,Orteronel 300 mg (Japan) | 8.3 | 3.0 | 2.7 |
,Orteronel 400 mg (Ex-Japan) | 6.4 | 3.2 | 3.6 |
,Placebo (Ex-Japan) | 4.7 | 3.1 | 3.0 |
,Placebo (Japan) | 5.0 | 3.1 | 1.7 |
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Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. (NCT01666314)
Timeframe: Baseline and Week 4
Intervention | percentage of participants (Number) |
---|
Placebo (Ex-Japan) | 48.0 |
Orteronel 400 mg (Ex-Japan) | 79.0 |
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Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. (NCT01666314)
Timeframe: Baseline and Week 4
Intervention | percentage of participants (Number) |
---|
Placebo (Japan) | 86.0 |
Orteronel 300 mg (Japan) | 100.0 |
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Percentage of Participants With PSA50 After 12 Weeks of Treatment
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline. (NCT01666314)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Orteronel 200 mg (Japan) | 55.0 |
Orteronel 300 mg (Japan) | 47.0 |
Orteronel 200 mg (Ex-Japan) | 56.0 |
Orteronel 400 mg (Ex-Japan) | 44.0 |
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. (NCT01666314)
Timeframe: From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years
Intervention | participants (Number) |
---|
| AE | SAE |
---|
Orteronel 200 mg (Ex-Japan) | 36 | 16 |
,Orteronel 200 mg (Japan) | 33 | 8 |
,Orteronel 300 mg (Japan) | 32 | 18 |
,Orteronel 400 mg (Ex-Japan) | 36 | 12 |
,Placebo (Ex-Japan) | 18 | 1 |
,Placebo (Japan) | 7 | 0 |
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Amount of Pain Medication - Day 1 to 48 Hours
Number of times the subject needed to use pain medication between day 1 and the 48 hour follow-up (NCT01671423)
Timeframe: Assessed once during the 48 hour follow-up
Intervention | medications taken (Median) |
---|
Prednisone | 7 |
Placebo | 2 |
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Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours
The level of pain as measured by a Visual Analog Scale(VAS) measured once at day 1 and once during the 48th hour follow-up visit. Minimum value 0, maximum value 100mm, higher scores corresponds to more pain/worse outcomes. (NCT01671423)
Timeframe: Assessed once at day 1 and then once during the 48 hour follow-up
Intervention | score on a scale (Mean) |
---|
| VAS at Day 1 | VAS at 48 hrs |
---|
Placebo | 56.45 | 25.91 |
,Prednisone | 79.64 | 39.71 |
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SNOT-22 Questionnaire
"The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (nasal obstruction and loss of smell and taste) ranked from 0 (not a problem) to 5 (problem as bad as it can be).~Min score= 0, Max score= 110 (worst possible problem on all symptoms)~Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis." (NCT01676415)
Timeframe: 4-6 weeks and 3 months after initiation of treatment
Intervention | units on a scale (Mean) |
---|
| 4-6 WEEKS | 3 MONTHS |
---|
Prednisone | 45.75 | 49 |
,Topical Mometasone | 34.4 | 34.4 |
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Medication Side-effect and Compliance Inventory
The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study. (NCT01676415)
Timeframe: 4-6 weeks and 3 months after initiation of treatment
Intervention | Participants (Count of Participants) |
---|
Prednisone | 0 |
Topical Mometasone | 0 |
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Taskforce Symptom Inventory
Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS. (NCT01676415)
Timeframe: 4-6 weeks and 3 months after initiation of treatment
Intervention | Participants (Count of Participants) |
---|
Prednisone | 0 |
Topical Mometasone | 0 |
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Time to Disease Progression
Compare arms to determine the time to disease progression of study patients (NCT01681433)
Timeframe: 60 days
Intervention | months (Median) |
---|
Experimental: Arm A | 1.9055 |
Control Arm: Arm B | 1.0842 |
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PSA Response
Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization. (NCT01681433)
Timeframe: 60 days
Intervention | participants (Number) |
---|
| PSA DECLINE >= 30% | PSA DELCINE >=50 % | ANY DECLINE |
---|
Control Arm: Arm B | 2 | 1 | 11 |
,Experimental: Arm A | 2 | 2 | 13 |
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Objective Response
Compare arms to determine the objective response of study patients, per RECIST 1.1 (NCT01681433)
Timeframe: 60 days
Intervention | participants (Number) |
---|
| Partial Response | Stable Disease | Progressive Disease |
---|
Control Arm: Arm B | 0 | 5 | 25 |
,Experimental: Arm A | 1 | 6 | 26 |
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Circulating Tumor Cell (CTC) Counts
Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study (NCT01681433)
Timeframe: Every 4 weeks
Intervention | participants (Number) |
---|
| Best CTC Change from Baseline >=5 to <5 | Best CTC Change from Baseline <5 to <5 | Best CTC Change from Baseline >=5 to >=5 | Best CTC Change from Baseline<5 to >=5 |
---|
Control Arm: Arm B | 4 | 15 | 10 | 1 |
,Experimental: Arm A | 8 | 16 | 7 | 1 |
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Progression-Free Survival
To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B. (NCT01681433)
Timeframe: 60 days
Intervention | participants (Number) |
---|
Experimental: Arm A | 12 |
Control Arm: Arm B | 6 |
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Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01683994)
Timeframe: Adverse events were assessed from the date treatment consent signed to date off study, approximately 45 months and 14 days for Arm A; 43 months and 14 days for Arm B; 9 months and 11 days for DL1; 27 months and 1 day for DL2; & 11 months & 25 days for DL3
Intervention | Participants (Count of Participants) |
---|
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone | 4 |
Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone | 8 |
Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone | 7 |
Ph II Arm A: Docetaxel + Prednisone | 12 |
Ph II Arm B: Cabozantinib + Docetaxel + Prednisone | 13 |
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Progression Free Survival (PFS) of Cabozantinib + Docetaxel + Prednisone Compared to Docetaxel + Prednisone Alone
PFS is the time interval from start of treatment to documented evidence of disease progression or death. Disease progression was assessed by the Response Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions as referenced by the smallest sum on study. Appearance of one or more new lesions on bone scan and/or two consecutive rising prostatic-specific antigen values above the baseline at a minimum of one week intervals. A normal PSA value is 4.0 ng/ml and lower. (NCT01683994)
Timeframe: From start date of treatment until the date of first documented progression, date of death from any cause and up to 40 months, whichever occurred first.
Intervention | months (Median) |
---|
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone | 8 |
Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone | 13 |
Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone | 6 |
Ph II Arm A: Docetaxel + Prednisone | 10 |
Ph II Arm B: Cabozantinib + Docetaxel + Prednisone | 6.5 |
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Number of Participants Achieving Prostatic-Specific Antigen (PSA) Decline of 30% or 50% From Baseline
PSA normal range is 4 ng/ml or lower. Participants with PSA decline of 30% or 50% is the measures for prostate cancer based on conventional reporting metrics. (NCT01683994)
Timeframe: up to 38 months
Intervention | Participants (Count of Participants) |
---|
| Decline in PSA>30% from baseline | Decline in PSA>50% from baseline |
---|
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone | 0 | 0 |
,Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone | 5 | 5 |
,Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone | 5 | 4 |
,Ph II Arm A Docetaxel + Prednisone | 5 | 3 |
,Ph II Arm B: Cabozantinib + Docetaxel + Prednisone | 10 | 9 |
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Number of Participants With a Dose Limiting Toxicities (DLTs)
A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding. (NCT01683994)
Timeframe: First two cycles of treatment (each cycle is 21 days), approximately 42 days.
Intervention | Participants (Count of Participants) |
---|
| Neutropenic fever | Palmar plantar erythroderma |
---|
Ph I Dose Level 1: Cabozantinib + Docetaxel + Prednisone | 0 | 0 |
,Ph I Dose Level 2: Cabozantinib + Docetaxel + Prednisone | 0 | 0 |
,Ph I Dose Level 3: Cabozantinib + Docetaxel + Prednisone | 1 | 1 |
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Maximum Tolerated Dose (MTD)
MTD is defined as the dose level at which no more than 1 of 6 patients experiences a dose limiting toxicity (DLT) at the level below that which had two instances of DLT. A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding. (NCT01683994)
Timeframe: First two cycles of treatment (each cycle is 21 days), approximately 42 days.
Intervention | mg (Number) |
---|
Ph I Cabozantinib + Docetaxel + Prednisone | 40 |
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Mean Global Evaluation for Efficacy by Participant/Parent and Investigator
At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis. (NCT01687296)
Timeframe: Day 8
Intervention | Scores on a scale (Mean) |
---|
| Participant/parent global evaluation | Investigator global evaluation |
---|
Fluticasone Propionate | 1.5 | 1.5 |
,Prednisone | 1.5 | 1.5 |
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Mean Evening PEF on Diary Card Over the Treatment Assessment Period
PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem [PM]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considered missing if less than 2 days was recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using an ANCOVA model with effects due to gender, age, centre and treatment group. (NCT01687296)
Timeframe: Days 1/2 to 8
Intervention | L/min (Least Squares Mean) |
---|
Fluticasone Propionate | 195.79 |
Prednisone | 194.63 |
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Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population
PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group. (NCT01687296)
Timeframe: Days 2 to 8
Intervention | Litres per minute (L/min) (Least Squares Mean) |
---|
Fluticasone Propionate | 188.77 |
Prednisone | 188.31 |
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Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population
PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group. (NCT01687296)
Timeframe: Days 2 to 8
Intervention | L/min (Least Squares Mean) |
---|
Fluticasone Propionate | 189.46 |
Prednisone | 188.96 |
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Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period
Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, centre, age and treatment. (NCT01687296)
Timeframe: During the treatment period at Day 5, Day 8
Intervention | Litres (Least Squares Mean) |
---|
| FEV1, Day 5 | FEV1, Day 8 | FVC, Day 5 | FVC, Day 8 |
---|
Fluticasone Propionate | 1.288 | 1.400 | 1.476 | 1.544 |
,Prednisone | 1.331 | 1.396 | 1.543 | 1.582 |
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Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8
The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. A negative value of change in score from Baseline indicated improvement in severity of symptoms. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3 (NCT01687296)
Timeframe: Baseline, Day 5 and Day 8
Intervention | Scores on a scale (Mean) |
---|
| Day 5 | Day 8 |
---|
Fluticasone Propionate | -2.7 | -3.4 |
,Prednisone | -2.6 | -3.4 |
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Number of Participants Who Achieved a Reduction of Their Daily OCS Dose to <=5.0 mg During Weeks 20 to 24 While Maintaining Asthma Control
Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Number of participants who achieved a reduction of their daily OCS dose to <=5.0 mg was based on the value of the MN dose. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose. (NCT01691508)
Timeframe: Weeks 20 to 24
Intervention | Participants (Number) |
---|
| <=5 mg/day | >5 mg/day or lack of asthma control or WD |
---|
Mepolizumab 100 mg SC | 37 | 32 |
,Placebo | 21 | 45 |
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Median Percentage Change From Baseline in Daily OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control
BL dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent change of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (MN dose minus BL dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. For participants who withdrew from the study prior to the Maintenance Phase, and for participants with a lack of asthma control during the Maintenance Phase, a value equal to the minimum percent reduction in OCS use across all subjects was imputed for the analysis. (NCT01691508)
Timeframe: Baseline; Weeks 20 to 24
Intervention | Percentage reduction in OCS dose (Median) |
---|
Placebo | 0.0 |
Mepolizumab 100 mg SC | -50.0 |
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Number of Participants Who Achieved a Reduction of >=50% in Their Daily Oral Corticosteroid (OCS) Dose Compared With Baseline Dose, During Weeks 20 to 24 While Maintaining Asthma Control
Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose. (NCT01691508)
Timeframe: Baseline; Weeks 20 to 24
Intervention | Participants (Number) |
---|
| 50 to 100% | <50% or no decrease/lack of asthma control/WD |
---|
Mepolizumab 100 mg SC | 37 | 32 |
,Placebo | 22 | 44 |
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Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control
Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The percent reduction of OCS was categorized as: 90 to 100%; 75 to <90%; 50 to <75%; >0 to <50%; no decrease in prednisone dose, or lack of asthma control, or withdrawal (WD) from treatment. Analysis was performed using a proportional odds model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose. (NCT01691508)
Timeframe: Baseline; Weeks 20 to 24
Intervention | Participants (Number) |
---|
| 90 to 100% | 75 to <90% | 50 to <75% | >0 to <50% | No decrease /lack of asthma control/early WD |
---|
Mepolizumab 100 mg SC | 16 | 12 | 9 | 7 | 25 |
,Placebo | 7 | 5 | 10 | 7 | 37 |
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Number of Participants Who Achieved a Total Reduction of OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control
MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The number of participants who achieved a total reduction of OCS dose was based on the value of the MN dose. Total reduction implied no OCS use during the entire MN phase. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose. (NCT01691508)
Timeframe: Weeks 20 to 24
Intervention | Participants (Number) |
---|
| 0 mg/day | OCS taken or lack of asthma control or WD |
---|
Mepolizumab 100 mg SC | 10 | 59 |
,Placebo | 5 | 61 |
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DB Phase: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT01695135)
Timeframe: Approximately up to 3.8 years
Intervention | Percentage of Participants (Number) |
---|
Placebo + Prednisone (Double-blind) | 4.2 |
Abiraterone Acetate + Prednisone (Double-blind) | 17.5 |
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DB Phase: Overall Survival
Overall survival was defined as the time interval from the date of randomization to the date of death from any cause. (NCT01695135)
Timeframe: From randomization to the date of death due to any cause (up to approximately 3.8 years)
Intervention | Days (Median) |
---|
Placebo + Prednisone (Double-blind) | 561.00 |
Abiraterone Acetate + Prednisone (Double-blind) | 579.00 |
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DB Phase: Percentage of Participants Experiencing Pain Palliation
Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced >=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. (NCT01695135)
Timeframe: Approximately up to 3.8 years
Intervention | Percentage of Participants (Number) |
---|
Placebo + Prednisone (Double-blind) | 31.8 |
Abiraterone Acetate + Prednisone (Double-blind) | 54.5 |
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DB Phase: Percentage of Participants Who Achieved PSA Response
Percentage of participants who achieved PSA response (defined as >= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: >= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later. (NCT01695135)
Timeframe: Approximately up to 3.8 years
Intervention | Percentage of Participants (Number) |
---|
Placebo + Prednisone (Double-blind) | 18.3 |
Abiraterone Acetate + Prednisone (Double-blind) | 54.5 |
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DB Phase: Time to Pain Progression
Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of >=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score >=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. (NCT01695135)
Timeframe: Approximately up to 3.8 years
Intervention | Days (Median) |
---|
Placebo + Prednisone (Double-blind) | 169.00 |
Abiraterone Acetate + Prednisone (Double-blind) | 505.00 |
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DB Phase: Time to Prostate-Specific Antigen Progression (PSA)
Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later. (NCT01695135)
Timeframe: Up to 1.8 years
Intervention | Days (Median) |
---|
Placebo + Prednisone (Double-blind) | 84.00 |
Abiraterone Acetate + Prednisone (Double-blind) | 169.00 |
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DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
"The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its worst, usual, and now during normal waking hours, with 0 being no fatigue and 10 being fatigue as bad as you can imagine. Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being does not interfere and 10 being completely interferes. BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue)." (NCT01695135)
Timeframe: Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])
Intervention | Units on a scale (Mean) |
---|
| Fatigue Now | Usual Fatigue | Worst Fatigue | General Activity | Mood | Walking Ability | Normal Work | Relations with Other People | Enjoyment of Life |
---|
Abiraterone Acetate + Prednisone (Double-blind) | 1.7 | 1.5 | 1.6 | 1.7 | 1.8 | 1.8 | 2.0 | 1.6 | 1.9 |
,Placebo + Prednisone (Double-blind) | 2.4 | 2.4 | 2.6 | 2.3 | 2.7 | 2.4 | 2.2 | 2.0 | 2.5 |
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DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). (NCT01695135)
Timeframe: Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])
Intervention | Units on a scale (Mean) |
---|
| Total Score | Physical Well-being | Functional Well-being | Emotional Well-being | Social Well-being | FACT-G Total Score | Prostate Cancer Subscale (PCS) | Treatment Outcome Index (FACT-TOI) |
---|
Abiraterone Acetate + Prednisone (Double-blind) | -16.1 | -4.9 | -2.7 | -2.4 | -1.2 | -11.2 | -4.9 | -12.5 |
,Placebo + Prednisone (Double-blind) | -19.9 | -6.7 | -5.1 | -2.1 | -0.8 | -14.6 | -5.3 | -17.1 |
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AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval
AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365. (NCT01714817)
Timeframe: Days 337 to 365
Intervention | ug*h/mL (Geometric Mean) |
---|
Abatacept IV | 36480.24 |
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Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants
Adjusted Mean Change from Baseline in UPCR at Day 365 of the double-blind period in nephrotic participants (NCT01714817)
Timeframe: Baseline and Day 365
Intervention | UPCR (mg/mg) (Mean) |
---|
Abatacept IV | -5.01 |
Placebo IV | -4.84 |
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Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population
Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population (NCT01714817)
Timeframe: Day 1 and Day 365
Intervention | UPCR (mg/mg) (Mean) |
---|
Abatacept IV | -2.99 |
Placebo IV | -2.90 |
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Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period
"Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG A represents the presence of serious features of lupus. BILAG B represents more moderate features of the disease. BILAG C includes only mild symptomatic features. BILAG D represents prior activity with no current symptoms due to active lupus. BILAG E represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome." (NCT01714817)
Timeframe: Day 1 to Day 365
Intervention | Scores on a Scale (Mean) |
---|
Abatacept IV | -8.22 |
Placebo IV | -7.60 |
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)
"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729
Intervention | Percentage (Mean) |
---|
Abatacept IV | 0.0328 |
Placebo IV | 0.0325 |
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Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period
"BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG A represents the presence of one or more serious features of lupus. A BILAG B represents more moderate features of the disease. A BILAG C includes only mild symptomatic features. A BILAG D represents only prior activity with no current symptoms due to active lupus. A BILAG E represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome." (NCT01714817)
Timeframe: Day 1 to Day 729; Day 365 to Day 729
Intervention | Scores on a Scale (Mean) |
---|
| Day 1 to Day 729 | Day 365 to Day 729 |
---|
Abatacept IV | -9.31 | -0.95 |
,Placebo IV | -8.53 | -0.40 |
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Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX1.25X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 729
Intervention | participants (Number) |
---|
| HEMOGLOBIN, low | HEMOGLOBIN, high | HEMATOCRIT, low | HEMATOCRIT, high | ERYTHROCYTES, low | ERYTHROCYTES, high | PLATELET COUNT, low | PLATELET COUNT, high | LEUKOCYTES, low | LEUKOCYTES, high | EOSINOPHILS (ABSOLUTE), low | EOSINOPHILS (ABSOLUTE), high | BASOPHILS (ABSOLUTE), low | BASOPHILS (ABSOLUTE), high | MONOCYTES (ABSOLUTE), low | MONOCYTES (ABSOLUTE), high | LYMPHOCYTES (ABSOLUTE), low | LYMPHOCYTES (ABSOLUTE), high |
---|
Abatacept IV | 8 | NA | 6 | NA | 4 | NA | 2 | 1 | 19 | 3 | NA | 11 | NA | 0 | NA | 0 | 43 | 0 |
,Placebo IV | 9 | NA | 2 | NA | 2 | NA | 4 | 0 | 24 | 5 | NA | 6 | NA | 0 | NA | 0 | 62 | 0 |
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Summary Statistics for Systolic Blood Pressure
Summary statistics for systolic blood pressure (NCT01714817)
Timeframe: Day 1 to Day 729
Intervention | mmHg (Mean) |
---|
| Day 1, end of observation | Day 365, end of observation | Day 729, end of observation |
---|
Abatacept IV | 122.0 | 112.3 | 108.6 |
,Placebo IV | 122.6 | 115.0 | 114.2 |
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Summary Statistics for Heart Rate
Summary statistics for Heart Rate (NCT01714817)
Timeframe: Day 1 to Day 729
Intervention | beats per minute (Mean) |
---|
| Day 1, end of observation | Day 365, end of observation | Day 729, end of observation |
---|
Abatacept IV | 80.6 | 78.5 | 76.2 |
,Placebo IV | 81.4 | 70.0 | 76.7 |
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Summary Statistics for Diastolic Blood Pressure
Summary statistics for diastolic blood pressure (NCT01714817)
Timeframe: Day 1 to Day 729
Intervention | mmHg (Mean) |
---|
| Day 1, end of observation | Day 365, end of observation | Day 729, end of observation |
---|
Abatacept IV | 76.5 | 73.5 | 67.5 |
,Placebo IV | 77.0 | 77.5 | 72.7 |
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Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
Complete Renal Response or Complete Response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; UPCR < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial Renal Response or Partial Response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment. No Renal Response or No Response (NR): defined as not meeting criteria for CR or PR or withdrawn (NCT01714817)
Timeframe: Day 365, Day 729
Intervention | Percentage (Number) |
---|
| CR - Day 365 | PR - Day 365 | NR - Day 365 | CR - Day 729 | PR - Day 729 | NR - Day 729 |
---|
Abatacept IV | 35.1 | 20.8 | 44.1 | 60.7 | 25.9 | 13.4 |
,Placebo IV | 33.5 | 21.7 | 44.8 | 53.6 | 22.7 | 23.6 |
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Percentage of Participants in Treatment Failure Over Time During the Double-blind Period
"Lupus treatment failure is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.~Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor." (NCT01714817)
Timeframe: Day 365, Day 729
Intervention | Percentage (Number) |
---|
| Lupus treatment failure (LTF) - Day 365 | Overall treatment failure (OTF) - Day 365 | LTF - Day 729 | OTF - Day 729 |
---|
Abatacept IV | 3.5 | 4.5 | 4.5 | 5.2 |
,Placebo IV | 4.4 | 4.9 | 5.3 | 8.4 |
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Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period
Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit. (NCT01714817)
Timeframe: Day 365, Day 729
Intervention | Participants (Number) |
---|
| Day 365 | Day 729 |
---|
Abatacept IV | 5 | 52 |
,Placebo IV | 3 | 56 |
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Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR 1.25X ULN, OR IF PRE RXULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR 2X PRE R~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 729
Intervention | participants (Number) |
---|
| GLUCOSE, SERUM, low | GLUCOSE, SERUM, high | GLUCOSE, FASTING SERUM, low | GLUCOSE, FASTING SERUM, high | PROTEIN, TOTAL, low | PROTEIN, TOTAL, high | ALBUMIN, low | ALBUMIN, high |
---|
Abatacept IV | 15 | 3 | 3 | 3 | 10 | 2 | 4 | NA |
,Placebo IV | 24 | 2 | 1 | 1 | 7 | 3 | 5 | NA |
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Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR 1.25X ULN, OR IF PRE RXULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR 2X PRE R~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
Intervention | participants (Number) |
---|
| GLUCOSE, SERUM, low | GLUCOSE, SERUM, high | PROTEIN, TOTAL, low | PROTEIN, TOTAL, high | ALBUMIN, low | ALBUMIN, high |
---|
Abatacept IV | 33 | 10 | 44 | 0 | 10 | NA |
,Placebo IV | 29 | 5 | 26 | 1 | 11 | NA |
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Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 (NCT01714817)
Timeframe: Day 1 to Day 729
Intervention | participants (Number) |
---|
| PROTEIN, URINE, low | PROTEIN, URINE, high | GLUCOSE, URINE, low | GLUCOSE, URINE, high | BLOOD, URINE, low | BLOOD, URINE, high | Red blood cells (RBC), URINE, low | Red blood cells (RBC), URINE, high | White blood cells (WBC), URINE, low | White blood cells (WBC), URINE, high |
---|
Abatacept IV | NA | 0 | NA | 0 | NA | 0 | NA | 58 | NA | 46 |
,Placebo IV | NA | 0 | NA | 0 | NA | 0 | NA | 55 | NA | 59 |
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Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 (NCT01714817)
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
Intervention | participants (Number) |
---|
| PROTEIN, URINE, low | PROTEIN, URINE, high | GLUCOSE, URINE, low | GLUCOSE, URINE, high | BLOOD, URINE, low | BLOOD, URINE, high | Red blood cells (RBC), URINE, low | Red blood cells (RBC), URINE, high | White blood cells (WBC), URINE, low | White blood cells (WBC), URINE, high |
---|
Abatacept IV | NA | 0 | NA | 0 | NA | 0 | NA | 93 | NA | 91 |
,Placebo IV | NA | 0 | NA | 0 | NA | 0 | NA | 103 | NA | 98 |
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Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 729
Intervention | participants (Number) |
---|
| ALKALINE PHOSPHATASE (ALP), low | ALKALINE PHOSPHATASE (ALP), high | ASPARTATE AMINOTRANSFERASE (AST), low | ASPARTATE AMINOTRANSFERASE (AST), high | ALANINE AMINOTRANSFERASE (ALT), low | ALANINE AMINOTRANSFERASE (ALT), high | G-GLUTAMYL TRANSFERASE (GGT), low | G-GLUTAMYL TRANSFERASE (GGT), high | BILIRUBIN, TOTAL, low | BILIRUBIN, TOTAL, high | BILIRUBIN, DIRECT, low | BILIRUBIN, DIRECT, high | BLOOD UREA NITROGEN, low | BLOOD UREA NITROGEN, high | CREATININE, low | CREATININE, high |
---|
Abatacept IV | NA | 4 | NA | 2 | NA | 4 | NA | 17 | NA | 0 | NA | 1 | NA | 10 | NA | 17 |
,Placebo IV | NA | 0 | NA | 3 | NA | 3 | NA | 11 | NA | 0 | NA | 0 | NA | 9 | NA | 16 |
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Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
Intervention | participants (Number) |
---|
| ALKALINE PHOSPHATASE (ALP), low | ALKALINE PHOSPHATASE (ALP), high | ASPARTATE AMINOTRANSFERASE (AST), low | ASPARTATE AMINOTRANSFERASE (AST), high | ALANINE AMINOTRANSFERASE (ALT), low | ALANINE AMINOTRANSFERASE (ALT), high | G-GLUTAMYL TRANSFERASE (GGT), low | G-GLUTAMYL TRANSFERASE (GGT), high | BILIRUBIN, TOTAL, low | BILIRUBIN, TOTAL, high | BILIRUBIN, DIRECT, low | BILIRUBIN, DIRECT, high | BLOOD UREA NITROGEN, low | BLOOD UREA NITROGEN, high | CREATININE, low | CREATININE, high |
---|
Abatacept IV | NA | 1 | NA | 5 | NA | 8 | NA | 17 | NA | 0 | NA | 0 | NA | 20 | NA | 24 |
,Placebo IV | NA | 1 | NA | 0 | NA | 2 | NA | 15 | NA | 0 | NA | 0 | NA | 12 | NA | 20 |
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Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX1.25X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
Intervention | participants (Number) |
---|
| HEMOGLOBIN, low | HEMOGLOBIN, high | HEMATOCRIT, low | HEMATOCRIT, high | ERYTHROCYTES, low | ERYTHROCYTES, high | PLATELET COUNT, low | PLATELET COUNT, high | LEUKOCYTES, low | LEUKOCYTES, high | EOSINOPHILS (ABSOLUTE), low | EOSINOPHILS (ABSOLUTE), high | BASOPHILS (ABSOLUTE), low | BASOPHILS (ABSOLUTE), high | MONOCYTES (ABSOLUTE), low | MONOCYTES (ABSOLUTE), high | LYMPHOCYTES (ABSOLUTE), low | LYMPHOCYTES (ABSOLUTE), high |
---|
Abatacept IV | 6 | NA | 12 | NA | 7 | NA | 4 | 0 | 35 | 29 | NA | 2 | NA | 1 | NA | 0 | 81 | 1 |
,Placebo IV | 10 | NA | 12 | NA | 10 | NA | 3 | 0 | 21 | 25 | NA | 6 | NA | 1 | NA | 1 | 104 | 2 |
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Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR 1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR 1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR NCT01714817)
Timeframe: Day 1 to Day 729
Intervention | participants (Number) |
---|
| SODIUM, SERUM, low | SODIUM, SERUM, high | POTASSIUM, SERUM, low | POTASSIUM, SERUM, high | CHLORIDE, SERUM, low | CHLORIDE, SERUM, high | CALCIUM, TOTAL, low | CALCIUM, TOTAL, high | PHOSPHORUS, INORGANIC, low | PHOSPHORUS, INORGANIC, high |
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Abatacept IV | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 1 | 3 | 6 |
,Placebo IV | 0 | 1 | 2 | 2 | 1 | 0 | 0 | 0 | 4 | 3 |
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Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR 1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR 1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR NCT01714817)
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
Intervention | participants (Number) |
---|
| SODIUM, SERUM, low | SODIUM, SERUM, high | POTASSIUM, SERUM, low | POTASSIUM, SERUM, high | CHLORIDE, SERUM, low | CHLORIDE, SERUM, high | CALCIUM, TOTAL, low | CALCIUM, TOTAL, high | PHOSPHORUS, INORGANIC, low | PHOSPHORUS, INORGANIC, high |
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Abatacept IV | 1 | 2 | 3 | 7 | 0 | 0 | 1 | 2 | 9 | 13 |
,Placebo IV | 1 | 2 | 5 | 7 | 1 | 0 | 1 | 0 | 7 | 13 |
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Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension
All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug. (NCT01714817)
Timeframe: From the first dose in Year 2 of the double-blind period up to 56 days post last dose
Intervention | Participants (Number) |
---|
| Participants with Adverse Events | Participants with Serious Adverse Events | Participants with infection Adverse Events | Participants with malignancies | Participants with autoimmune events |
---|
Abatacept IV | 127 | 15 | 100 | 0 | 7 |
,Placebo IV | 137 | 25 | 107 | 1 | 11 |
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Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug. (NCT01714817)
Timeframe: From Day 1 up to 56 days post last dose in Year 1 of the double-blind period
Intervention | Participants (Number) |
---|
| Participants with Adverse Events | Participants with Serious Adverse Events | Participants with infection Adverse Events | Participants with malignancies | Participants with autoimmune events | Participants with peri-infusional Adverse Events | Participants with acute infusional Adverse Events |
---|
Abatacept IV | 188 | 49 | 150 | 2 | 10 | 7 | 2 |
,Placebo IV | 194 | 39 | 147 | 1 | 9 | 9 | 4 |
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Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period
Participants who experienced a positive antibody response relative to baseline (ECL Assay) (NCT01714817)
Timeframe: Day 365, Day 729
Intervention | Participants (Number) |
---|
| Day 365, overall |
---|
Abatacept IV | 7 |
,Placebo IV | 9 |
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)
"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729
Intervention | x10^9 cells/L (Mean) |
---|
| EOSINOPHILS (ABSOLUTE) (x10^9 cells/L) | LYMPHOCYTES (ABSOLUTE) (x10^9 cells/L) | MONOCYTES (ABSOLUTE) (x10^9 cells/L) | NEUTROPHILS (ABSOLUTE) (x10^9 cells/L) | PLATELET COUNT (x10^9 cells/L) |
---|
Abatacept IV | 0.034 | 0.141 | -0.018 | -2.259 | -4.9 |
,Placebo IV | 0.010 | -0.149 | -0.050 | -2.289 | -9.1 |
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)
"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729
Intervention | umol/L (Mean) |
---|
| BILIRUBIN, TOTAL (umol/L) | CREATININE (umol/L) |
---|
Abatacept IV | 1.77 | -5.6 |
,Placebo IV | 1.00 | -6.2 |
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729
Intervention | mmol/L (Mean) |
---|
| BLOOD UREA NITROGEN (mmol/L) | CALCIUM, TOTAL (mmol/L) | CHLORIDE, SERUM (mmol/L) | GLUCOSE, SERUM (mmol/L) | PHOSPHORUS, INORGANIC (mmol/L) | POTASSIUM, SERUM (mmol/L) | SODIUM, SERUM (mmol/L) |
---|
Abatacept IV | -2.31 | 0.097 | -1.1 | -0.23 | -0.077 | -0.02 | -0.2 |
,Placebo IV | -2.25 | 0.108 | -0.5 | -0.58 | -0.037 | -0.10 | -0.5 |
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)
"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729
Intervention | g/L (Mean) |
---|
| ALBUMIN (g/L) | HEMOGLOBIN (g/L) | PROTEIN, TOTAL (g/L) |
---|
Abatacept IV | 9.2 | 8.8 | 9.9 |
,Placebo IV | 8.1 | 9.0 | 10.1 |
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Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365 (NCT01714817)
Timeframe: Days 1 to 365
Intervention | ug/mL (Geometric Mean) |
---|
| Day 15 | Day 29 | Day 57 | Day 85 | Day 113 | Day 169 | Day 281 | Day 337 | Day 365 |
---|
Abatacept IV | 69.97 | 90.46 | 36.43 | 34.46 | 16.42 | 13.98 | 14.44 | 14.99 | 13.62 |
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Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV
Cmax: Maximum observed serum concentration following participants receiving active abatacept IV (NCT01714817)
Timeframe: at 1 hour post Day 1 dose and 30 minutes post Day 337 dose
Intervention | ug/mL (Geometric Mean) |
---|
| Day 1 | Day 337 |
---|
Abatacept IV | 527.43 | 203.51 |
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Adjusted Mean Change From Baseline in UPCR Over Time
A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used. (NCT01714817)
Timeframe: Day 365; Day 729, includes data up to July 1st 2017 when double-blind therapy ended
Intervention | UPCR (mg/mg) (Mean) |
---|
| Day 365 | Day 729 |
---|
Abatacept IV | -2.95 | -3.13 |
,Placebo IV | -2.68 | -2.72 |
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Adjusted Mean Change From Baseline in eGFR Over Time
Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)α X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 [if female]) X (1.159 [if black]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years. (NCT01714817)
Timeframe: Day 365, Day 729
Intervention | mL/min per 1.73m2 (Mean) |
---|
| Day 365 | Day 729 |
---|
Abatacept IV | 6.85 | 7.20 |
,Placebo IV | 5.85 | 7.91 |
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Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable. (NCT01714817)
Timeframe: Day 729
Intervention | Percentage (Number) |
---|
Abatacept IV | 61.9 |
Placebo IV | 52.7 |
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Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no <85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable. (NCT01714817)
Timeframe: Day 365
Intervention | Percentage (Number) |
---|
Abatacept IV | 35.1 |
Placebo IV | 33.5 |
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Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable. (NCT01714817)
Timeframe: Day 729
Intervention | Percentage (Number) |
---|
Abatacept IV | 50.0 |
Placebo IV | 49.0 |
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Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable. (NCT01714817)
Timeframe: Day 365
Intervention | Percentage (Number) |
---|
Abatacept IV | 27 |
Placebo IV | 29.5 |
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)
"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729
Intervention | U/L (Mean) |
---|
| ALANINE AMINOTRANSFERASE (ALT) (U/L) | ALKALINE PHOSPHATASE (ALP) (U/L) | ASPARTATE AMINOTRANSFERASE (AST) (U/L) | G-GLUTAMYL TRANSFERASE (GGT) (U/L) |
---|
Abatacept IV | -2.2 | 8.2 | 0.3 | -5.3 |
,Placebo IV | -3.4 | 11.7 | 0.3 | -4.1 |
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Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. (NCT01715285)
Timeframe: Up to 66 months
Intervention | Months (Median) |
---|
Abiraterone Acetate+Prednisone+ADT | 33.31 |
Placebo + ADT | 7.43 |
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Time to Subsequent Therapy for Prostate Cancer
Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer. (NCT01715285)
Timeframe: Up to 66 months
Intervention | Months (Median) |
---|
Abiraterone Acetate+Prednisone+ADT | 54.87 |
Placebo + ADT | 21.22 |
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Time to Pain Progression
"Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing no pain and 10 representing pain as bad as you can imagine." (NCT01715285)
Timeframe: Up to 66 months
Intervention | Months (Median) |
---|
Abiraterone Acetate+Prednisone+ADT | 47.41 |
Placebo + ADT | 16.62 |
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Overall Survival (OS)
Overall survival was defined as the time from randomization to date of death from any cause. (NCT01715285)
Timeframe: Up to 66 months
Intervention | months (Median) |
---|
Abiraterone Acetate+Prednisone+ADT | 53.32 |
Placebo + ADT | 36.53 |
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Radiographic Progression-Free Survival (PFS)
Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter. (NCT01715285)
Timeframe: Up to 44 months
Intervention | Months (Median) |
---|
Abiraterone Acetate+Prednisone+ADT | 33.02 |
Placebo + ADT | 14.78 |
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Time to Initiation of Chemotherapy
Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. (NCT01715285)
Timeframe: Up to 66 months
Intervention | months (Median) |
---|
Abiraterone Acetate+Prednisone+ADT | NA |
Placebo + ADT | 57.59 |
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Safety and Tolerability
The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0. (NCT01717053)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Abiraterone+Radiotherapy+ADT | 12 |
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Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year
The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of <0.1 ng/mL. (NCT01717053)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Abiraterone+Radiotherapy+ADT | 54.54 |
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Testosterone Recovery
Time to testosterone recovery (NCT01717053)
Timeframe: up to 5 years
Intervention | months (Median) |
---|
Abiraterone Acetate | 9.2 |
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Time to PSA Nadir
The median time in months to the lowest PSA value from the start of study therapy. (NCT01717053)
Timeframe: 1 year
Intervention | months (Median) |
---|
Abiraterone+Radiotherapy+ADT | 8.9 |
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Percentage of Participants With Biochemical Progression-free Survival (BPFS)
Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case. (NCT01717053)
Timeframe: 36 and 48 months
Intervention | percentage of participants (Number) |
---|
| 36 months | 48 months |
---|
Abiraterone Acetate | 96.96 | 96.96 |
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PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
Percentage of men with 1, 2, 3, 4 and 5 year PSA < 1.5ng/ml in setting of non-castrate testosterone. (NCT01717053)
Timeframe: 1 year, 2 years, 3 years, 4 years, 5 years
Intervention | percentage of patients (Number) |
---|
| 1 year | 2 years | 3 years | 4 years | 5 years |
---|
Abiraterone+Radiotherapy+ADT | 100 | 100 | 90.91 | 90.91 | 90.91 |
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PSA Nadir Value
The lowest PSA value from the start of study therapy. (NCT01717053)
Timeframe: 1 year, 2 years
Intervention | ng/mL (Median) |
---|
| Year 1 | Year 2 |
---|
Abiraterone+Radiotherapy+ADT | 0.03 | 0.03 |
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Number of Reported Dose Limiting Toxicities When Combining BEZ235 With Abiraterone Acetate (Phase I).
(NCT01717898)
Timeframe: Beginning of study up to 15 months
Intervention | Participants (Count of Participants) |
---|
Phase I: BEZ235 200 mg | 3 |
Phase I: BEZ235 300 mg | 0 |
Phase I: BEZ235 400 mg | 0 |
Phase II | 0 |
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Maximum Tolerated Dose for BEZ235 + Abiraterone Acetate (Phase I).
Maximum Tolerated Dose (MTD) for BEZ235 + Abiraterone Acetate (to be determined during Phase I). The MTD of BEZ235 will be the dose when given in combination results in less than 33% dose limiting toxicities (DLT). (NCT01717898)
Timeframe: Beginning of study up to 15 months
Intervention | Participants (Count of Participants) |
---|
Phase I: BEZ235 200 mg | 0 |
Phase I: BEZ235 300 mg | 0 |
Phase I: BEZ235 400 mg | 0 |
Phase II | 0 |
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Anti-tumor Responses as Defined by a Decline in PSA of > 50%
Anti-tumor responses as defined by a decline in PSA of > 50% following 12 weeks of therapy to the combination of Abiraterone Acetate plus BEZ-235 occur in a cohort of patients who have received prior therapy with Abiraterone Acetate therapy (NCT01717898)
Timeframe: From day 1 of therapy initiation up to 12 weeks
Intervention | Participants (Count of Participants) |
---|
Phase I: BEZ235 200 mg | 0 |
Phase I: BEZ235 300 mg | 0 |
Phase I: BEZ235 400 mg | 0 |
Phase II | 0 |
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Radiographic Progression-free Survival (rPFS)
(NCT01718353)
Timeframe: From baseline, every 12 weeks until radiological tumor progression or study cut-off, whichever was earlier (Maximum duration: 60 weeks)
Intervention | months (Median) |
---|
Overall Population (Treatment A or Treatment B) | NA |
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Clinical Progression-free Survival (cPFS)
cPFS was assessed before switch and during the study including skeletal-related events (SRE), increasing pain requiring escalation of narcotic analgesics, urinary obstruction, etc. SRE included pathological fractures and/or spinal cord compression, need for bone irradiation (including radioisotopes or bone surgery), change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the face of increase in pain) to treat bone pain. Pain was assessed using present pain intensity (PPI) scale (0=no pain, up to 5=excruciating pain) and analgesics used for cancer pain (1 point for non-narcotic medications and 4 points for narcotic medications). (NCT01718353)
Timeframe: Baseline, Pre-dose every 3 weeks, EOT, every 3 months (for 1 year) until first SRE occurrence or death or study cut-off, whichever was earlier (Maximum duration: 60 weeks)
Intervention | months (Median) |
---|
| Before switch | Whole treatment continuum |
---|
Overall Population (Treatment A or Treatment B) | NA | NA |
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Drug-target Engagement in Circulating Tumor Cells (CTCs): Change From Baseline at Cycle 1 Day 8 in Percent Androgen Receptor Nuclear Localization (%ARNL) by Categories of PSA Decrease From Baseline (≥50%, Not ≥50%) After Cycle 4
Analysis of CTCs is a co-primary endpoint. Growth of prostate cancer cells is dependent on sustained androgen receptor (AR) nuclear signaling. Taxanes (e.g., docetaxel and cabazitaxel) may mediate some of their activity in prostate cancer by impairing AR trafficking along the microtubules from the tumor cell cytoplasm into the nucleus, as a result of taxane-induced microtubule bundling (MTB). Blood samples were collected at baseline and post-treatment to allow isolation of CTCs, which were evaluated for tumor cell biomarker measures %ARNL and MTB score. %ARNL was assessed by quantitative analysis of images of CTCs captured by geometrically enhanced differential immunocapture (GEDI). Reduction from baseline in %ARNL (percentage of total cellular AR that is located in the nucleus) may indicate inhibition of AR signaling. Change from baseline in %ARNL at Cycle 1 Day 8 is summarized by categories of participants with PSA decrease from baseline (≥50%, Not ≥50%) after Cycle 4. (NCT01718353)
Timeframe: Baseline and Cycle 1 Day 8, Cycle 4
Intervention | percentage ARNL (Mean) |
---|
| PSA decreased ≥50% at Cycle 4 | PSA not decreased ≥50% at Cycle 4 |
---|
Overall Population (Treatment A or Treatment B) | -17.58 | 2.30 |
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Drug-target Engagement in CTCs: Change From Baseline at Cycle 1 Day 8 in MTB by Categories of PSA Decrease From Baseline (≥30%, Not ≥30%) After Cycle 4
Analysis of CTCs is a co-primary endpoint. Growth of prostate cancer cells is dependent on sustained AR nuclear signaling. Taxanes (e.g., docetaxel and cabazitaxel) may mediate some of their activity in prostate cancer by impairing AR trafficking along the microtubules from the tumor cell cytoplasm into the nucleus, as a result of taxane-induced MTB. Blood samples were collected at baseline and post-treatment to allow isolation of CTCs, which were evaluated for tumor cell biomarker measures %ARNL and MTB score. MTB in images of CTCs captured by GEDI was qualitatively assessed by three independent operators for increase compared with baseline on a scale of 0 to 3 from no to most MTB increase. Increase from baseline in MTB may indicate inhibition of AR signaling. Change from baseline in MTB at Cycle 1 Day 8 is summarized by categories of participants with PSA decrease from baseline (≥30%, Not ≥30%) after Cycle 4. (NCT01718353)
Timeframe: Baseline and Cycle 1 Day 8, Cycle 4
Intervention | units on a scale (Mean) |
---|
| PSA decreased ≥30% at Cycle 4 | PSA not decreased ≥30% at Cycle 4 |
---|
Overall Population (Treatment A or Treatment B) | 0.69 | 0.09 |
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Overall Survival
Overall survival before switch and overall survival during the study was defined as the time interval from the date of random allocation to the date of death due to any cause until study cut-off date. (NCT01718353)
Timeframe: From baseline until death due to any cause or study cut-off, whichever was earlier (Maximum duration: 60 weeks)
Intervention | Months (Median) |
---|
| Before switch | whole treatment continuum |
---|
Overall Population (Treatment A or Treatment B) | 8.8 | NA |
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Percentage of Participants With ≥30% and ≥50% Reduction in PSA Response
Participants with ≥30% and ≥50% reduction in PSA response from base line were evaluated in participants who were previously treated with a high potency androgen receptor (AR)-targeted agent (AR signaling inhibitor or cytochrome P450 17 alphahydroxylase/17,20lyase [CYP 17] inhibitor). (NCT01718353)
Timeframe: From baseline until DP or study cut-off, whichever was earlier (Maximum duration: 60 weeks)
Intervention | percentage of participants (Number) |
---|
| ≥30% reduction | ≥50% reduction |
---|
Overall Population (AR-target Agent Treated) | 52.0 | 44.0 |
,Overall Population (Non AR-target Agent Treated) | 74.3 | 68.6 |
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Percentage of Participants With PSA Response
PSA response was defined as ≥50% decrease in PSA levels in both treatment arms from baseline, during the whole treatment, before treatment switch and after treatment switch. PSA progression was defined as decline of PSA from baseline (an increase of ≥25% [at least 2ng/ml] over the nadir value, confirmed by a second PSA value at least 3 weeks apart) and no decline of PSA from baseline (an increase of ≥25% [at least 2ng/ml] over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart). Because the purpose of this study is to explore the benefit of a regimen in which participants are switched to a different taxane if PSA does not decrease ≥30% after 4 cycles, irrespective of which agent (docetaxel or cabazitaxel) is administered initially, the data for participants who began treatment with docetaxel and for those who began treatment with cabazitaxel were combined for the efficacy analyses. (NCT01718353)
Timeframe: Baseline, Pre-dose every 3 weeks, 30 days after last treatment administration (End of treatment [EOT]), every 3 months (for 1 year) then every 6 months until PSA progression or study cut-off, whichever was earlier (Maximum duration: 60 weeks)
Intervention | percentage of participants (Number) |
---|
| PSA response before switch | PSA response after switch | Overall PSA response |
---|
Overall Population (Treatment A or Treatment B) | 39.7 | 15.9 | 55.6 |
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Progression Free Survival (PFS)
PFS was defined as the time interval between the date of random allocation of the treatment and the date of first documentation of any of the following: radiographic tumor progression (using Modified Response Evaluation Criteria in Solid Tumors [RECIST1.1] before any switch and during the study), clinical progression (including skeletal-related events, increasing pain requiring escalation of narcotic analgesics, urinary obstruction), PSA progression or death from any cause. Analysis was performed by Kaplan Meier method. (NCT01718353)
Timeframe: From Baseline until DP or death due to any cause or study cut off, whichever was earlier (Maximum duration: 60 weeks)
Intervention | months (Median) |
---|
| Before switch | Whole treatment continuum |
---|
Overall Population (Treatment A or Treatment B) | 4.1 | 9.1 |
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PSA Progression Free Survival
PSA progression-free survival before any switch and PSA progression free survival during the study was defined as the time interval between the date of Day 1 of Cycle 1 to the date of either first PSA progression or death due to any cause whichever came first. PSA progression was defined as decline of PSA from baseline (an increase of ≥25% [at least 2ng/mL] over the nadir value, confirmed by a second PSA value at least 3 weeks apart) and no decline of PSA from baseline (an increase of ≥25% [at least 2ng/mL] over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart). (NCT01718353)
Timeframe: From Baseline until DP or death due to any cause or study cut off date, whichever was earlier (Maximum duration: 60 weeks)
Intervention | months (Median) |
---|
| Before switch | whole treatment continuum |
---|
Overall Population (Treatment A or Treatment B) | NA | 12.4 |
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Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion (NCT01724021)
Timeframe: Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)
Intervention | minutes (Median) |
---|
Rituximab Intravenous (IV) | 840 |
Rituximab Subcutaneous (SC) | 22 |
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Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)
Intervention | units on a scale (Mean) |
---|
| Expectations of therapy domain | Feelings about side effects domain | Satisfaction with therapy domain |
---|
Rituximab Intravenous (IV) | 80.88 | 60.63 | 84.59 |
,Rituximab Subcutaneous (SC) | 82.07 | 61.64 | 85.42 |
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Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Intervention | percentage of participants (Number) |
---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Interim staging | Cycle 5 | Cycle 6 | Cycle 7 | Cycle 8 | Final staging | Follow-up, 6 months | Follow-up, 12 months | End of study/early treatment termination |
---|
Arm A | 11.4 | 7.0 | 7.1 | 7.0 | 9.0 | 12.5 | 16.0 | 23.8 | 13.3 | 10.0 | 6.5 | 7.7 | 3.5 |
,Arm B | 15.6 | 18.2 | 23.5 | 14.7 | 9.7 | 10.2 | 11.6 | 10.9 | 11.0 | 12.6 | 13.4 | 8.7 | 6.3 |
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Percentage of Participants With Anti-Rituximab Antibodies Over Time
(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Intervention | percentage of participants (Number) |
---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Interim staging | Cycle 5 | Cycle 6 | Cycle 7 | Cycle 8 | Final staging | Follow-up, 6 months | Follow-up, 12 months | End of study/early treatment termination |
---|
Arm A | 2.0 | 2.1 | 0.3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.8 | 2.1 | 0.6 |
,Arm B | 3.0 | 2.2 | 0.9 | 0.3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.6 | 0.6 |
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Rituximab Administration Satisfaction Questionnaire (RASQ) Score
The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)
Intervention | units on a scale (Mean) |
---|
| Physical impact domain | Psychological Impact domain | Impact on activitiesf daily living | Convenience domain | Satisfaction domain |
---|
Rituximab Intravenous (IV) | 82.14 | 77.73 | 59.49 | 59.05 | 74.88 |
,Rituximab Subcutaneous (SC) | 82.08 | 84.00 | 81.86 | 81.05 | 87.26 |
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Summary of Observed Serum Rituximab Concentration
(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Intervention | microgram per milliter (Mean) |
---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Interim staging | Cycle 5 | Cycle 6 | Cycle 7 | Cycle 8 | Final staging | Follow-up, 6 months | Follow-up, 12 months | End of study/early treatment termination |
---|
Arm A | 3355.9 | 25053.1 | 62977.0 | 87956.6 | 117273.6 | 108030.9 | 100927.7 | 95614.0 | 104873.0 | 86806.6 | 7802.9 | 2380.1 | 9302.0 |
,Arm B | 970.1 | 24541.1 | 46093.9 | 59485.5 | 77665.3 | 70387.3 | 98679.7 | 117172.0 | 137048.1 | 120995.7 | 8042.9 | 1685.3 | 9553.9 |
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Number of Participants With Treatment Emergent Adverse Events (AEs)
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01724021)
Timeframe: Randomization of first participant to clinical cutoff date (Up to 4 years)
Intervention | participants (Number) |
---|
Arm A | 352 |
Arm B | 347 |
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Event-free Survival (EFS)
EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Intervention | months (Median) |
---|
Arm A | NA |
Arm B | NA |
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Disease-free Survival (DFS)
DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Intervention | months (Median) |
---|
Arm A | NA |
Arm B | NA |
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Complete Response (CR) Rate
CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study. (NCT01724021)
Timeframe: 28 days (± 3 days) after Day 1 of the last dose of induction treatment
Intervention | percentage of participants (Number) |
---|
Arm A | 49.2 |
Arm B | 52.7 |
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Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Intervention | months (Median) |
---|
Arm A | NA |
Arm B | NA |
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Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6. (NCT01724021)
Timeframe: Cycle 6 (Up to 24 weeks)
Intervention | percentage of participants (Number) |
---|
Arm A | 79.1 |
Arm B | 80.6 |
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Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8. (NCT01724021)
Timeframe: Cycle 8 (Up to 32 weeks)
Intervention | percentage of participants (Number) |
---|
Arm A | 77.1 |
Arm B | 84.2 |
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Progression-free Survival (PFS)
PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Intervention | months (Median) |
---|
Arm A | NA |
Arm B | NA |
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Steroid Therapy
Number of patients on treatment with corticosteroids at 2 years (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 16 |
Group B | 14 |
Group C | 9 |
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eGFR (MRDRD) < 45 ml/Min/1.73m2
Patients with reduced Renal function measured by estimated GFR MDRD < 45 ml/min at 24 months (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 9 |
Group B | 8 |
Group C | 20 |
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New Onset Diabetes After Transplantation (NODAT)
Number of patients developing New Onset Diabetes Mellitus after Transplant by one of 5 definitions; only patients without preexisting diabetes were included (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 11 |
Group B | 5 |
Group C | 12 |
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Delayed Graft Function
Number of patients experiencing Delayed graft function (DGF) within first week after transplant. DGF is defined as need for dialysis within the first week after transplant. (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 3 |
Group B | 1 |
Group C | 5 |
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Discontinuation of Mycophenolate
Number of patients who were discontinued from mycophenolate treatment at 2 years (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 11 |
Group B | 9 |
Group C | 13 |
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Requirement of T-cell Depleting Therapy for Biopsy Proven Acute Rejection (BPAR)
Number of patients requiring anti-lymphocyte therapy for the treatment of BPAR rejection (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 8 |
Group B | 15 |
Group C | 0 |
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Time to First BPAR
Mean Time to first episode of BPAR (days) (NCT01729494)
Timeframe: 24 months
Intervention | days (Mean) |
---|
Group A | 229 |
Group B | 131.6 |
Group C | 159.6 |
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Mean eGFR (MDRD) (ml/Min/1.73m2)
Mean eGFR (MDRD) (ml/min/1.73m2) measured for all patients reaching 2 year endpoint (NCT01729494)
Timeframe: 24 months
Intervention | ml/min/1.73m2 (Mean) |
---|
Group A | 65.5 |
Group B | 65.3 |
Group C | 63.4 |
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Discontinuation of Study Treatment (Belatacept or Tacrolimus)
Number of patients who had to Discontinue study treatment (belatacept or tacrolimus) at 2 years (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 11 |
Group B | 9 |
Group C | 5 |
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Leukopenia (WBC < 2000/mm3)
Number of patients developing leukopenia defined as WBC < 2000/mm3 (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 22 |
Group B | 14 |
Group C | 15 |
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Proteinuria UPC Ratio > 0.8
Number of Patients with a Urine protein/creatinine (UPC) ratio > 0.8 (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 11 |
Group B | 5 |
Group C | 21 |
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Patient Death
Number of Patients who experienced death, all causes (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 2 |
Group B | 4 |
Group C | 1 |
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Biopsy Proven Mixed Acute Rejection
Incidence of patients experiencing a Biopsy proven acute cellular rejection with either DSA positive or C4d staining positive indicating antibody rejection (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 4 |
Group B | 2 |
Group C | 2 |
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Biopsy Proven Acute Rejection
Incidence of all biopsy proven acute rejection whether clinically relevant or clinically silent. (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 20 |
Group B | 26 |
Group C | 7 |
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# of Patients Developing Denovo Donor Specific Antibody (DSA) Post-transplant
Number of patients (%) with development of denovo DSA after transplant (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 5 |
Group B | 1 |
Group C | 5 |
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# Patients Experiencing a First Biopsy-proven ACR With Severity Banff > or = 2a Grade
Number of patients with their First BPACR with a Banff grade >= Banff 2a using the Banff 2007 classification system for biopsy grading. Banff grade 2a and above is considered severe cellular rejection and includes grades of Banff 2a, Banff 2b, and Banff 3. (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 5 |
Group B | 12 |
Group C | 0 |
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# Patients Experiencing a Graft Loss But Not Including Patients Who Died With Functioning Graft (Death-censored Graft Loss)
Number of patient who experienced Graft loss, not including (censored) patients who lost graft due to death (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 0 |
Group B | 1 |
Group C | 1 |
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# Patients With Composite Endpoint of Either Experiencing Death, Graft Loss, or eGFR < 45ml/Min at 24 Months
Composite Endpoint of number of patients who experienced either patient death, allograft loss, or had an eGFR < 45 ml/min/1.73m2 (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 11 |
Group B | 13 |
Group C | 21 |
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# Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min
Number of Patients that experienced patient Death or Graft Loss or had an estimated GFR (eGFR) (MDRD) < 45 mL/min (NCT01729494)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Group A | 9 |
Group B | 15 |
Group C | 14 |
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Biopsy Proven Acute Antibody Mediated Rejection
Incidence of patients experiencing a Biopsy proven acute antibody mediated rejection (BPAMR) (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 2 |
Group B | 2 |
Group C | 3 |
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Biopsy Proven Acute Cellular Rejection
Biopsy proven acute cellular rejection (BPACR) (NCT01729494)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Group A | 14 |
Group B | 22 |
Group C | 2 |
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Induction Response
Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Response was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks. (NCT01746173)
Timeframe: Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).
Intervention | proportion of patients (Number) |
---|
CHOEP + High Dose Therapy + Auto SCT | .60 |
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24-month Progression-Free Survival Rate
24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). (NCT01746173)
Timeframe: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.
Intervention | proportion of patients (Number) |
---|
CHOEP + High Dose Therapy + Auto SCT | 0.0 |
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Krupp Fatigue Severity Score (FSS) Within 8 Weeks
"The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 (completely disagree) to 7 (completely agree) to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from no fatigue to fatigue as bad as could be. Higher scores on the scale are indicative of more severe fatigue.~This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue).~Rows: at Baseline, at Week 4, at Week 8" (NCT01753401)
Timeframe: at Baseline, Week 4 and Week 8 (within 8 weeks)
Intervention | score on a scale (Mean) |
---|
| at Baseline | at Week 4 | at Week 8 |
---|
Acthar | 5.648 | 5.298 | 5.152 |
,Placebo | 5.374 | 5.379 | 5.404 |
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Number of Participants Who Meet the Definition of a Responder Within 4 Weeks
"Participants are counted as responders based on two SLE indices: the Systemic Lupus Erythematosus Disease Activity Index amended by the SELENA group (SELENA-SLEDAI) and the British Isles Lupus Assessment Group (BILAG) Index.~decrease in SELENA-SLEDAI score from 4 to 0 for the arthritis descriptor (highest possible score is 4) and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash (highest possible score is 2) and no worsening in other organ systems based on BILAG~The BILAG is a transitional index that captures changing severity of clinical manifestations. It has an ordinal scale scoring system by design that produces an overview of disease activity across eight systems. The individual system scores were not intended to be summated into a global score." (NCT01753401)
Timeframe: within 4 weeks
Intervention | Participants (Count of Participants) |
---|
Placebo | 3 |
Acthar | 4 |
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Number of Participants Who Meet the Definition of a Responder Within 8 Weeks
"Participants are counted as responders based on:~decrease in SELENA-SLEDAI score from 4 to 0 for arthritis and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash and no worsening in other organ systems based on BILAG" (NCT01753401)
Timeframe: within 8 weeks
Intervention | Participants (Count of Participants) |
---|
Placebo | 3 |
Acthar | 11 |
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Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Within 8 Weeks
"The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease.~Rows: at Baseline, at Week 4, at Week 8" (NCT01753401)
Timeframe: at Baseline, Week 4 and Week 8 (within 8 weeks)
Intervention | score on a scale (Mean) |
---|
| at Baseline | at Week 4 | at Week 8 |
---|
Acthar | 6.4 | 4.8 | 3.7 |
,Placebo | 6.1 | 6.3 | 5.7 |
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Number of Participants With a Relapse Within 52 Weeks
(NCT01753401)
Timeframe: within 52 weeks
Intervention | Participants (Count of Participants) |
---|
Placebo/Acthar | 1 |
Acthar/Acthar | 6 |
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Number of Tender or Swollen Joints at Week 52
The doctor counted the number of tender or swollen joints at Week 52. (NCT01753401)
Timeframe: at Week 52
Intervention | Tender or Swollen Joints (Mean) |
---|
Placebo/Acthar | 1.1 |
Acthar/Acthar | 0.7 |
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Score on the SELENA-SLEDAI at Week 52
"SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI).~The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity." (NCT01753401)
Timeframe: at Week 52
Intervention | score on a scale (Median) |
---|
Placebo/Acthar | 3 |
Acthar/Acthar | 4 |
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BILAG Total Score Within 8 Weeks
"The BILAG is a transitional index that captures changing severity of clinical manifestations that produces an overview of disease activity across eight systems.~The 8 systems are scored on a scale from 0=not present to 4=worse, for the 4 week period before the assessment. The lowest possible score is 0, and the highest possible score is 32. A higher score means the symptoms are worse.~Rows: Baseline, Week 4, Week 8" (NCT01753401)
Timeframe: within 8 weeks
Intervention | score on a scale (Mean) |
---|
| at Baseline | at Week 4 | at Week 8 |
---|
Acthar | 15.7 | 9.2 | 6.8 |
,Placebo | 15.4 | 10.3 | 13.5 |
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Krupp Fatigue Severity Score (FSS) at Week 52
"The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 (completely disagree) to 7 (completely agree) to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from no fatigue to fatigue as bad as could be. Higher scores on the scale are indicative of more severe fatigue.~This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue)." (NCT01753401)
Timeframe: at Week 52
Intervention | score on a scale (Mean) |
---|
Placebo/Acthar | 4.523 |
Acthar/Acthar | 4.743 |
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Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) at Week 52
The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease. (NCT01753401)
Timeframe: at Week 52
Intervention | score on a scale (Mean) |
---|
Placebo/Acthar | 0.4 |
Acthar/Acthar | 1.3 |
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Number of Participants Who Meet the Definition of a Responder at Week 52
"Participants are counted as responders based on:~decrease in SELENA-SLEDAI score from 4 to 0 for arthritis and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash and no worsening in other organ systems based on BILAG" (NCT01753401)
Timeframe: at Week 52
Intervention | Participants (Count of Participants) |
---|
Placebo/Acthar | 4 |
Acthar/Acthar | 3 |
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Number of Tender or Swollen Joints Within 8 Weeks
The doctor counted the number of tender or swollen joints at Baseline, at Week 4, and at Week 8 (NCT01753401)
Timeframe: at Baseline, Week 4, and Week 8 (within 8 weeks)
Intervention | Tender or Swollen Joints (Mean) |
---|
| at Baseline | at Week 4 | at Week 8 |
---|
Acthar | 9.6 | 4.5 | 3.5 |
,Placebo | 6.2 | 3.8 | 4.0 |
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Score on the SELENA-SLEDAI Within 8 Weeks
"SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI).~The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.~Rows: Week 2, Week 4, Week 6, Week 8" (NCT01753401)
Timeframe: within 8 weeks
Intervention | score on a scale (Median) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 |
---|
Acthar | 8.0 | 8.0 | 6.0 | 6.0 |
,Placebo | 10.0 | 9.0 | 8.0 | 9.0 |
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Change in Absolute CD4 Count From Baseline to Post-treatment
Change in absolute CD4 count from baseline to post-treatment (visit 6) (NCT01775475)
Timeframe: From baseline to 18 weeks
Intervention | cells per mm^3 (Mean) |
---|
Arm I (CHOP) | -41.3 |
Arm II (Oral Chemotherapy) | 203.3 |
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Participants Who Experienced an Adverse Event
Number of participants who experienced an adverse event (NCT01775475)
Timeframe: Up to 24 months
Intervention | Participants (Count of Participants) |
---|
Arm I (CHOP) | 4 |
Arm II (Oral Chemotherapy) | 3 |
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Progression-free Survival
Proportion of participants who survived without disease progression at 2 years (NCT01775475)
Timeframe: Up to 24 months
Intervention | proportion (Number) |
---|
Arm I (CHOP) | 0 |
Arm II (Oral Chemotherapy) | 0 |
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Proportion of Patients Who Are Adherent to Chemotherapy
Patients who did not miss any doses of chemotherapy (NCT01775475)
Timeframe: Up to 18 weeks
Intervention | Participants (Count of Participants) |
---|
Arm I (CHOP) | 4 |
Arm II (Oral Chemotherapy) | 3 |
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Proportion of Patients Who Are Adherent to Antiretroviral Therapy
Number of patients who did not miss any of their doses of antiretroviral therapy (NCT01775475)
Timeframe: Up to 24 months
Intervention | Participants (Count of Participants) |
---|
Arm I (CHOP) | 3 |
Arm II (Oral Chemotherapy) | 3 |
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Overall Response Rate
Overall response is complete or partial response as defined by response definitions of the 2014 International Conference on Malignant Lymphoma Imaging Working Group (i.e. Lugano classification). Complete response is the disappearance of all lesions with no new lesions detected. Partial response is >=50% decrease in the sum of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites and no new sites of disease. (NCT01775475)
Timeframe: Up to 24 months
Intervention | Participants (Count of Participants) |
---|
Arm I (CHOP) | 3 |
Arm II (Oral Chemotherapy) | 1 |
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Overall Survival
Proportion of participants who survived 2 years (NCT01775475)
Timeframe: Up to 24 months
Intervention | Proportion of participants (Number) |
---|
Arm I (CHOP) | 0 |
Arm II (Oral Chemotherapy) | 0 |
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Number of Patients Who Complete Treatment
Number of patients who complete chemotherapy treatment. (NCT01775475)
Timeframe: Up to 18 weeks
Intervention | Participants (Count of Participants) |
---|
Arm I (CHOP) | 3 |
Arm II (Oral Chemotherapy) | 1 |
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Objective Response Rate (ORR) Per IRF at End of Treatment
The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. (NCT01777152)
Timeframe: Up to 8.34 months
Intervention | Participants (Count of Participants) |
---|
A+CHP | 188 |
CHOP | 163 |
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Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. (NCT01777152)
Timeframe: Up to 8.34 months
Intervention | Participants (Count of Participants) |
---|
A+CHP | 153 |
CHOP | 126 |
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Overall Survival (OS)
The time from randomization to death due to any cause. (NCT01777152)
Timeframe: Up to 90 months
Intervention | Months (Median) |
---|
A+CHP | NA |
CHOP | NA |
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Progression-free Survival Per Independent Review Facility (IRF)
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. (NCT01777152)
Timeframe: Up to 60 months
Intervention | months (Median) |
---|
A+CHP | 48.20 |
CHOP | 20.80 |
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Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. (NCT01777152)
Timeframe: Up to 60 months
Intervention | months (Median) |
---|
A+CHP | 55.66 |
CHOP | 32.03 |
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Incidence of Adverse Events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. (NCT01777152)
Timeframe: Up to 8.28 months
Intervention | Participants (Count of Participants) |
---|
| Any treatment-emergent AE | Blinded study treatment-related AE | CHP treatment-related AE | Any serious adverse event (SAE) | Blinded study treatment-related SAE | CHP treatment-related SAE | Treatment discontinuations due to AE | Treatment discontinuations due to blinded study treatment-related AE | Treatment discontinuations due to CHP treatment-related AE |
---|
A+CHP | 221 | 201 | 198 | 87 | 58 | 62 | 14 | 10 | 8 |
,CHOP | 221 | 193 | 205 | 87 | 45 | 53 | 15 | 10 | 7 |
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Incidence of Laboratory Abnormalities
Number of participants who experienced a Grade 3 or higher laboratory toxicity. (NCT01777152)
Timeframe: Up to 8.28 months
Intervention | Participants (Count of Participants) |
---|
| Any Chemistry Test | Alanine Aminotransferase High | Albumin Low | Alkaline Phosphatase High | Calcium Low | Glucose High | Phosphate Low | Potassium High | Potassium Low | Sodium High | Sodium Low | Urate High | Any Hematology Test | Absolute Neutrophil Count Low | Hemoglobin High | Hemoglobin Low | Leukocytes Low | Lymphocytes High | Lymphocytes Low | Neutrophils Low | Platelets Low |
---|
A+CHP | 25 | 3 | 2 | 1 | 1 | 8 | 4 | 0 | 3 | 1 | 4 | 5 | 68 | 17 | 1 | 9 | 12 | 0 | 52 | 17 | 1 |
,CHOP | 23 | 1 | 3 | 0 | 1 | 6 | 3 | 2 | 2 | 0 | 6 | 2 | 78 | 19 | 0 | 13 | 21 | 1 | 61 | 19 | 1 |
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Serum Prothrombin Fragment 1 and 2 (PF 1.2)
(NCT01782859)
Timeframe: First 24 hours after surgery
Intervention | pmol/mL (Mean) |
---|
| Baseline | Wound Closure | 4 hours postoperatively | 6 hours postoperatively | 24 hours postoperatively |
---|
Placebo | 334.15 | 778.33 | 1306.76 | 1175.71 | 356.79 |
,Prednisone/Hydrocortisone | 298.12 | 619.21 | 1138.65 | 1032.52 | 422.61 |
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Plasmin-a 2 Antiplasmin Complex (PAP)
(NCT01782859)
Timeframe: First 24 hours after surgery
Intervention | mcg/L (Mean) |
---|
| Baseline | Wound Closure | 4 hours postoperatively | 6 hours postoperatively | 24 hours postoperatively |
---|
Placebo | 924.67 | 1361.23 | 2251.33 | 2283.18 | 996.39 |
,Prednisone/Hydrocortisone | 1011.17 | 2251.33 | 2455.71 | 2379.57 | 914.16 |
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Pain at 3 Months Post-op
At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain. (NCT01782859)
Timeframe: 3 months postoperatively
Intervention | units on a scale (Mean) |
---|
Placebo | 0.92 |
Prednisone/Hydrocortisone | 0.54 |
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Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. (NCT01782859)
Timeframe: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
Intervention | picograms/milliliter (Mean) |
---|
| Baseline | Wound closure | 4 hours postoperatively | 6 hours postoperatively | 24 hours postoperatively |
---|
Placebo | 2.98 | 4.46 | 89.21 | 115.17 | 176.79 |
,Prednisone/Hydrocortisone | 5.69 | 4.47 | 56.72 | 64.4 | 68.51 |
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Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab
Cmin,ss is minimum model-predicted serum steady state concentration of tocilizumab measured in mcg/mL. (NCT01791153)
Timeframe: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])
Intervention | mcg/mL (Mean) |
---|
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 68.1 |
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 11.1 |
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Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper)
Remission was defined as the absence of flare and normalization of the C-reactive protein (CRP) (less than [<] 1 milligram per deciliter [mg/dL]). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit. (NCT01791153)
Timeframe: Week 52
Intervention | percentage of participants (Number) |
---|
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 56.0 |
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 53.1 |
Part 1: Placebo + 26 Weeks Prednisone Taper | 14.0 |
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Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper)
Remission was defined as the absence of flare and normalization of the CRP (<1 mg/dL). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit. (NCT01791153)
Timeframe: Week 52
Intervention | percentage of participants (Number) |
---|
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 56.0 |
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 53.1 |
Part 1: Placebo + 52 Weeks Prednisone Taper | 17.6 |
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Percentage of Participants With Anti-Tocilizumab Antibodies
All samples were tested by screening assay, and those samples that were positive were further analyzed by a confirmation assay to confirm specificity. Percentage of participants who has a positive confirmation assay result any time after the initial drug administration with a negative confirmation assay result at baseline was reported. (NCT01791153)
Timeframe: Baseline up to Week 52
Intervention | percentage of participants (Number) |
---|
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 1.1 |
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 6.5 |
Part 1: Placebo + 26 Weeks Prednisone Taper | 2.0 |
Part 1: Placebo + 52 Weeks Prednisone Taper | 2.1 |
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Serum Interleukin-6 (IL-6) Level
(NCT01791153)
Timeframe: Baseline and Week 52
Intervention | picograms per milliliter (pg/mL) (Mean) |
---|
| Baseline (n=91,44,50,47) | Week 52 (n=69,32,28,30) |
---|
Part 1: Placebo + 26 Weeks Prednisone Taper | 12.73 | 35.96 |
,Part 1: Placebo + 52 Weeks Prednisone Taper | 8.31 | 10.85 |
,Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 16.29 | 52.70 |
,Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 8.79 | 65.99 |
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Serum Soluble IL-6 Receptor (sIL-6R) Level
(NCT01791153)
Timeframe: Baseline and Week 52
Intervention | nanograms per milliliter (ng/mL) (Mean) |
---|
| Baseline (n=99,48,50,50) | Week 52 (n=73,33,33,31) |
---|
Part 1: Placebo + 26 Weeks Prednisone Taper | 42.07 | 76.44 |
,Part 1: Placebo + 52 Weeks Prednisone Taper | 40.37 | 64.80 |
,Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 50.82 | 464.30 |
,Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 51.34 | 600.53 |
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Minimum Observed Serum Concentration (Ctrough) of Tocilizumab
Ctrough is minimum observed serum concentration of tocilizumab measured in mcg/mL. (NCT01791153)
Timeframe: Predose (Hour 0) at Baseline and Week 52
Intervention | mcg/mL (Mean) |
---|
| Baseline (n= 99, 48) | Week 52 (n= 72, 33) |
---|
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 0.00 | 12.22 |
,Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 0.07 | 67.93 |
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Erythrocyte Sedimentation Rate (ESR)
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. (NCT01791153)
Timeframe: Baseline and Week 52
Intervention | mm/hr (Median) |
---|
| Baseline (n=99,49,50,51) | Week 52 (n=76,35,35,33) |
---|
Part 1: Placebo + 26 Weeks Prednisone Taper | 23.00 | 20.00 |
,Part 1: Placebo + 52 Weeks Prednisone Taper | 20.00 | 24.00 |
,Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 15.00 | 5.00 |
,Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 19.00 | 3.00 |
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Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52
Participants assessed their current disease activity on a 0-100 millimeter (mm) VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity. A negative change from baseline indicates improvement. (NCT01791153)
Timeframe: Baseline, Week 52
Intervention | mm (Mean) |
---|
| Baseline (n=100,49,49,51) | Change at Week 52 (n=60,26,11,18) |
---|
Part 1: Placebo + 26 Weeks Prednisone Taper | 35.73 | -8.45 |
,Part 1: Placebo + 52 Weeks Prednisone Taper | 47.78 | -10.00 |
,Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 46.65 | -22.69 |
,Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 43.61 | -19.68 |
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C-Reactive Protein (CRP) Level
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. (NCT01791153)
Timeframe: Baseline and Week 52
Intervention | milligrams per liter (mg/L) (Median) |
---|
| Baseline (n=100,49,50,51) | Week 52 (n=76,35,35,33) |
---|
Part 1: Placebo + 26 Weeks Prednisone Taper | 3.64 | 4.90 |
,Part 1: Placebo + 52 Weeks Prednisone Taper | 3.56 | 8.12 |
,Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 4.52 | 0.33 |
,Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 3.67 | 0.30 |
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Total Cumulative Prednisone Dose
The median total cumulative prednisone dose over the 52 weeks for each treatment group and the corresponding 95% confidence intervals are presented. (NCT01791153)
Timeframe: Up to 52 weeks
Intervention | milligrams (mg) (Median) |
---|
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 1862.00 |
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 1862.00 |
Part 1: Placebo + 26 Weeks Prednisone Taper | 3296.00 |
Part 1: Placebo + 52 Weeks Prednisone Taper | 3817.50 |
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Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab
AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval. AUCtau is measured in microgram*day per milliliter (mcg*day/mL). (NCT01791153)
Timeframe: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])
Intervention | mcg*day/mL (Mean) |
---|
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 499.2 |
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 227.2 |
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Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab
Cmax,ss is maximum model-predicted serum steady state concentration of tocilizumab measured in micrograms per milliliter (mcg/mL). (NCT01791153)
Timeframe: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])
Intervention | mcg/mL (Mean) |
---|
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 73 |
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 19.3 |
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Time to First GCA Disease Flare
Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. Participants who withdrew from the study prior to Week 52 were censored from the time of withdrawal. (NCT01791153)
Timeframe: Up to 52 weeks
Intervention | days (Median) |
---|
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | NA |
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | NA |
Part 1: Placebo + 26 Weeks Prednisone Taper | 165.0 |
Part 1: Placebo + 52 Weeks Prednisone Taper | 295.0 |
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Overall Survival (OS)
"Overall survival (OS) was defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored on the date the patient was last known to be alive.~Median overall survival was estimated using the Kaplan-Meier method." (NCT01818752)
Timeframe: From randomization until the data cut-off date of 15 July 2016; median follow-up time for OS was 22.2 and 22.5 months in the bortezomib and carfilzomib arms respectively.
Intervention | months (Median) |
---|
Bortezomib, Melphalan, Prednisone | NA |
Carfilzomib, Melphalan, Prednisone | NA |
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Complete Response Rate
"Complete response rate was defined as the percentage of participants in each treatment group who achieved a sCR or CR per the IMWG-URC as their best response.~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy." (NCT01818752)
Timeframe: Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
Intervention | percentage of participants (Number) |
---|
Bortezomib, Melphalan, Prednisone | 23.1 |
Carfilzomib, Melphalan, Prednisone | 25.9 |
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Overall Response Rate
"Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline." (NCT01818752)
Timeframe: Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
Intervention | percentage of participants (Number) |
---|
Bortezomib, Melphalan, Prednisone | 78.8 |
Carfilzomib, Melphalan, Prednisone | 84.3 |
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Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy
"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.~Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:~Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death." (NCT01818752)
Timeframe: From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
Intervention | percentage of participants (Number) |
---|
Bortezomib, Melphalan, Prednisone | 35.1 |
Carfilzomib, Melphalan, Prednisone | 2.5 |
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Progression-Free Survival (PFS)
"Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression.~Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner." (NCT01818752)
Timeframe: From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
Intervention | months (Median) |
---|
Bortezomib, Melphalan, Prednisone | 22.1 |
Carfilzomib, Melphalan, Prednisone | 22.3 |
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European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores
"The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients.~It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL." (NCT01818752)
Timeframe: Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48
Intervention | units on a scale (Mean) |
---|
| Baseline (n = 425, 425) | Week 6 (n = 412, 407) | Week 12 (n = 376, 389) | Week 18 (n = 341, 369) | Week 24 (n = 320, 345) | Week 30 (n = 298, 317) | Week 36 (n = 285, 308) | Week 42 (n = 275, 288) | Week 48 (n = 261, 265) |
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Bortezomib, Melphalan, Prednisone | 53.3 | 56.2 | 55.3 | 55.7 | 57.3 | 61.6 | 61.9 | 63.3 | 62.9 |
,Carfilzomib, Melphalan, Prednisone | 53.9 | 61.1 | 62.4 | 63.2 | 63.3 | 63.0 | 64.0 | 65.0 | 65.1 |
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Number of Participants With Adverse Events
"Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal.~A serious adverse event is an adverse event that met 1 or more of the following criteria:~Death~Life-threatening~Required inpatient hospitalization or prolongation of an existing hospitalization~Resulted in persistent or significant disability/incapacity~Congenital anomaly/birth defect~Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above.~Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship." (NCT01818752)
Timeframe: From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
Intervention | participants (Number) |
---|
| All adverse events | AEs ≥ grade 3 | Serious adverse events | Leading to discontinuation of study drug | Fatal adverse events | Treatment-related adverse events (TRAEs) | TRAEs ≥ grade 3 | Treatment-related serious adverse events | TRAE leading to discontinuation of study drug | Treatment-related fatal adverse events |
---|
Bortezomib, Melphalan, Prednisone | 454 | 358 | 198 | 73 | 20 | 431 | 285 | 102 | 51 | 5 |
,Carfilzomib, Melphalan, Prednisone | 460 | 354 | 235 | 83 | 31 | 408 | 268 | 136 | 54 | 10 |
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Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months)
Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate. (NCT01829295)
Timeframe: 6 Months
Intervention | Participants (Count of Participants) |
---|
Methotrexate | 64 |
Mycophenolate Mofetil | 56 |
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Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months)
Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate in patients who were a treatment success at the primary outcome of 6 months. (NCT01829295)
Timeframe: 12 Months
Intervention | Participants (Count of Participants) |
---|
Methotrexate | 48 |
Mycophenolate Mofetil | 40 |
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Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months)
Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate for patients who crossed over to other medication following treatment failure at 6 months (or earlier). (NCT01829295)
Timeframe: 6 Months
Intervention | Participants (Count of Participants) |
---|
Switched Over to Methotrexate | 20 |
Switched Over to Mycophenolate Mofetil | 7 |
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Number of Participants With a PSA Value Equal to or Greater Than 25%
Compared between the two patient subsets using the nonparametric Mann-Whitney test. A comparison of CTC counts between baseline and at progression for those who have progressed will be carried out using either a paired t test or the nonparameteric Wilcoxon matched pairs test. (NCT01848067)
Timeframe: Baseline up to 3 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Alisertib, Abiraterone Acetate, Prednisone) | 3 |
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Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1
Summarized with descriptive statistics. (NCT01848067)
Timeframe: Up to 21 days
Intervention | Participants (Count of Participants) |
---|
Treatment (Alisertib, Abiraterone Acetate, Prednisone) | 2 |
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Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population
EFS: duration from randomization date to disease progression(PD) date, relapse from complete response(CR) assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either positron emission tomography(PET)-positive/ biopsy-proven residual disease upon completion of >=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in sum of product of diameters(SPD) of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to 5.5 years
Intervention | Months (Median) |
---|
Treatment Arm B: Ibrutinib+R-CHOP | 49.64 |
Treatment Arm A: Placebo+R-CHOP | 54.77 |
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Event-Free Survival (EFS) - Activated B-Cell (ABC) Population
EFS: duration from randomization date to PD date, relapse from CR assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either PET-positive/ biopsy-proven residual disease upon completion of >=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to approximately 4.5 years
Intervention | Months (Median) |
---|
Treatment Arm B: Ibrutinib+R-CHOP | 48.56 |
Treatment Arm A: Placebo+R-CHOP | 48.16 |
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Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. (NCT01855750)
Timeframe: Up to approximately 4.5 years
Intervention | Months (Median) |
---|
Treatment Arm B: Ibrutinib+R-CHOP | 11.7 |
Treatment Arm A: Placebo+R-CHOP | 35.0 |
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Progression-Free Survival (PFS)
PFS was defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD): any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 centimeter (cm) in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to approximately 4.5 years
Intervention | Months (Median) |
---|
Treatment Arm B: Ibrutinib+R-CHOP | 48.56 |
Treatment Arm A: Placebo+R-CHOP | NA |
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Percentage of Participants Who Achieved Complete Response (CR)
Percentage of participants with measurable disease who achieved CR were reported. CR: disappearance of all evidence of disease. CR Criteria: Complete disappearance of all disease-related symptoms; all lymph nodes and nodal masses regressed to normal size (less than or equal to [<=]1.5 cm in greatest transverse diameter [GTD] for nodes greater than [>]1.5 cm before therapy). Previous nodes of 1.1 to 1.5 cm in long axis and greater than (>)1.0 cm in short axis before treatment decreased to <=1.0 cm in short axis after treatment. Disappearance of all splenic and hepatic nodules and other extranodal disease; a negative positron emission tomography (PET) scan. A posttreatment residual mass of any size but PET-negative; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to approximately 4.5 years
Intervention | Percentage of participants (Number) |
---|
Treatment Arm B: Ibrutinib+R-CHOP | 67.3 |
Treatment Arm A: Placebo+R-CHOP | 68.0 |
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Overall Survival
Overall survival was defined as the duration from the date of randomization to the date of the participant's death. Median Overall Survival was estimated by using the Kaplan-Meier method. (NCT01855750)
Timeframe: Up to 5.5 years
Intervention | Months (Median) |
---|
Treatment Arm B: Ibrutinib+R-CHOP | NA |
Treatment Arm A: Placebo+R-CHOP | NA |
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Proportion of Patients With Complete Response
Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10
Intervention | proportion of participants (Number) |
---|
Arm A (R2CHOP) | 0.73 |
Arm B (RCHOP) | 0.68 |
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Overall Survival Rate at 3 Years
Overall survival is defined as time from randomization to death or date last known alive. Overall survival rate at 3 years was calculated using the method of Kaplan Meier. (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10
Intervention | proportion of participants (Number) |
---|
Arm A (R2CHOP) | 0.826 |
Arm B (RCHOP) | 0.751 |
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3-year Progression-free Survival Rate
"Progression-free survival is defined as the time from randomization to disease progression, new primary of the same type or death, whichever occurs first. Progressive disease is defined as:~Appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.~>= 50% increase from nadir in the sum of the product of the diameters of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions.~>= 50% increase in the longest diameter of any single previously identified node or extranodal mass > 1 cm in its short axis.~Lesions should be PET positive unless the lesion is too small to be detected with current PET systems.~Measurable extranodal disease should be assessed in a manner similar to that for nodal disease.~3-year progression-free survival rate was calculated using Kaplan-Meier method." (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10, 3-year PFS rate reported
Intervention | proportion of participants (Number) |
---|
Arm A (R2CHOP) | 0.727 |
Arm B (RCHOP) | 0.615 |
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Proportion of Patients With Response
"Response is defined as complete response (CR) or partial response (PR) CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms~PR:~>=50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses~No increase in the size of other nodes, liver or spleen~Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified~No new sites of disease~The post-treatment PET should be positive at any previously involved sites~For variably FDG-avid lymphomas/FDG-avidity unknown, without a pretreatment PET scan, or if a pretreatment PET scan was negative, CT scan criteria should be used~Patients with a CR and persistent morphologic bone marrow involvement~Patients with bone marrow involved before therapy and a clinical CR but no bone marrow assessment after treatment" (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10
Intervention | proportion of participants (Number) |
---|
Arm A (R2CHOP) | 0.97 |
Arm B (RCHOP) | 0.92 |
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Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS
EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed. (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
Intervention | Units on a scale (Mean) |
---|
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | -4.5 |
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | -5.0 |
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | -6.6 |
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | -3.1 |
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Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment
No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension. (NCT01867710)
Timeframe: Week 24
Intervention | Percentage of Participants (Number) |
---|
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 70.6 |
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 36.8 |
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 60.0 |
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 70.3 |
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Progression-Free Survival (PFS)
PFS: Time from randomization to one of following: radiographic progression (RP), clinical progression (CP) or death. RP- per PCWG2 criteria and modified RECIST as time from randomization to one of following: 1) considered to have progressed by bone scan if: a) first scan with >=2 new lesions compared to baseline at <12 weeks from randomization and confirmed by second scan >=6 weeks later with >=2 additional new lesions, b) first scan with >=2 new lesions compared to baseline at >=12 weeks from randomization and new lesions on next bone scan >=6 weeks later; 2) Progression of soft tissue lesions per modified RECIST; CP: cancer pain requiring initiation of chronic use of opiate analgesia (oral use for >=3 weeks; parenteral use for >=7 days), Or immediate need to initiate cytotoxic chemotherapy or either radiation therapy or surgical intervention for complications due to tumor progression, even in absence of RP, Or deterioration in ECOG performance status to grade 3 or above. (NCT01867710)
Timeframe: Up to 4.9 years
Intervention | Months (Median) |
---|
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 16.16 |
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 12.68 |
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 8.51 |
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 21.22 |
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Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12
The PSA response is defined as a >= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show >=50% decline from baseline. (NCT01867710)
Timeframe: Week 12
Intervention | Percentage of Participants (Number) |
---|
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 57.1 |
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 70.6 |
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 47.2 |
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 79.5 |
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Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score
FACT-P is a 39-item participant rated questionnaire which consists of 5 subscales assessing physical well-being (7 items; score range 0-28), social/family well-being (7 items; score range 0-28), emotional well-being (6 items; score range 0-24), functional well-being (7 items; score range 0-28), prostate-specific concerns (12 items; score range 0-48). Each item rated on 0 to 4 Likert type scale, then combined to produce subscale scores for each domain, as well as global quality of life (QoL) score that ranges from 0 to 156. Higher scores represent better QoL. Additional Concerns subscale has 12 items, each with a score 0-6 making a total subscale range 0-72 (higher scores are better). Missing data imputed as per FACT-P Ver4 scoring system (sum of item scores*number of items in subscale/number of items answered). (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
Intervention | Units on a scale (Mean) |
---|
| Physical Well-Being | Social/Family Well-Being | Emotional Well-Being | Functional Well-Being | Global Score | Additional Concerns |
---|
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | -1.04 | -1.97 | -0.02 | -2.95 | -5.77 | -0.72 |
,Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | -2.46 | -0.78 | -1.66 | -2.67 | -10.39 | -3.96 |
,Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | -0.98 | -0.01 | -1.46 | -1.13 | -4.73 | -1.29 |
,Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | -2.20 | 0.61 | -0.89 | -2.19 | -6.62 | -2.35 |
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Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression was defined as time interval from the date of randomization to the date of the first prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group 2 (PSAWG2) criteria during the main study treatment period. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. (NCT01867710)
Timeframe: Up to 156 weeks
Intervention | Months (Median) |
---|
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 10.38 |
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 10.22 |
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 4.83 |
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 18.56 |
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Overall Survival
Overall survival was defined as the time interval from the date of randomization to the date of death from any cause. (NCT01867710)
Timeframe: Up to 156 weeks
Intervention | Months (Median) |
---|
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 34.07 |
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 48.43 |
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 27.96 |
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 42.81 |
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Objective Response Rate (ORR)
ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions , any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 millimetre [mm] short axis). PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT01867710)
Timeframe: Up to 4.9 years
Intervention | Percentage of participants (Number) |
---|
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 42.1 |
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 38.9 |
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 60.0 |
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 56.3 |
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Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score
"EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed." (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
Intervention | Units on a scale (Mean) |
---|
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | -0.0694 |
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | -0.0638 |
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | -0.0728 |
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | -0.0359 |
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Time to Next Prostate Cancer Therapy
Time to next prostate cancer therapy is defined as the time interval from the date of randomization to the date of initiation of first next therapy for prostate cancer. (NCT01867710)
Timeframe: Up to 4.9 years
Intervention | Months (Median) |
---|
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 20.14 |
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 19.48 |
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 16.66 |
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 28.29 |
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Mean Rate of Change in Grip Strength Treatment Compared to Pre-Treatment
Hand grip was measured using a study approved dynamometer to test the maximum isometric strength of the hand and forearm muscles. The grip strength of the left and right hands were analyzed together. Grip strength was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. Grip strength is a measurement of muscle strength and declines as ALS progresses. A positive value means that scores during treatment were higher than pre-treatment scores, indicating an increase in grip strength over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)
Intervention | pounds change per month (Mean) |
---|
Immunosuppression Regimen | 1.38 |
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Mean Rate of Change of ALSFRS-R Scores During Treatment Compared to Pre-Treatment
The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability). ALSFRS-R was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in ability over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)
Intervention | units on a scale change per month (Mean) |
---|
Immunosuppression Regimen | -0.24 |
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Collection of Cerebrospinal Fluid for Future Analysis of Cytokine Levels
Lumbar punctures (LPs) were performed to collect cerebrospinal fluid (CSF). CSF is banked for future use to characterize immune system markers and to further the understanding of the immune factors that contribute to disease progression in ALS. Cytokines are markers of neuroinflammation and can be categorized as neurotoxic or neuroprotective. The role that cytokines play in in ALS progression is still not yet fully understood. (NCT01884571)
Timeframe: Pre-Treatment Period (two months prior to the start of treatment), Treatment Period (Months 2 and 6), Post-Treatment Period (Month 12)
Intervention | Participants (Count of Participants) |
---|
Immunosuppression Regimen | 29 |
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Mean Rate of Change of Hand-Held Dynamometry (HHD) During Treatment Compared to Pre-Treatment
Hand held dynamometry (HHD) is a measure of muscle strength and scores decrease as ALS progresses. Six proximal muscle groups were examined bilaterally in both upper and lower extremities. Mean and standard deviation for each muscle group are established from the initial values for each participant. Strength determinations were converted to Z scores and averaged to provide an HHD megascore. The Z-score indicates the number of standard deviations away from the mean of 0. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. HHD was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in strength over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)
Intervention | z-score change per month (Mean) |
---|
Immunosuppression Regimen | -0.05 |
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Mean Rate of Change of Slow Vital Capacity (SVC) During Treatment Compared to Pre-Treatment
Vital capacity (VC), percent of predicted normal, was determined using the slow VC method. SVC measures the amount of air exhaled following a deep breath. For this test, participants hold a mouthpiece in their mouth, breathe in deeply, and breathe out as much air as they can. The test was done seated in a chair and then repeated while lying on an exam table at the Screening Visit. For all other visits, this test was done while seated in a chair. This test takes 15-20 minutes. SVC was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. SVC is a way to measure respiratory insufficiency in persons with ALS and SVC decreases as ALS progresses. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)
Intervention | percent predicted change per month (Mean) |
---|
Immunosuppression Regimen | -0.18 |
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Mean Rate of Change of T-cell Subsets in Blood Treatment Compared to Pre-Treatment
Blood was collected for ribonucleic acid (RNA) and the mean rate of decline of T-cells during the 6 month treatment period compared to the pre-treatment period was assessed (blood was collected twice during the 3-month long lead in period). The precise role that T-cells have in ALS is unknown and this study aims to further the understanding of how T-cells operate in persons with ALS. T-cell measurement is a ratio where the relative expression levels of FOXP3 messenger ribonucleic acid (mRNA) was calculated using the Comparative CT Method (ΔΔCT Method), normalizing to β-actin. Samples were obtained during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in T-cells over time. (NCT01884571)
Timeframe: Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6)
Intervention | fold change per month (Mean) |
---|
Immunosuppression Regimen | -0.04 |
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Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month
The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score (best of 48) from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). A clinical response is defined as a rate of change of ALSFRS-R of +6 points over 6 months (mean of +1 point per month), where typically patients with ALS have a decline in ALSFRS-R by an average of -1/month. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)
Intervention | Participants (Count of Participants) |
---|
Immunosuppression Regimen | 0 |
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Collection of Blood for Future Analysis of Peripheral Blood Mononuclear Cells (PBMCs)
Blood was drawn and banked for future use in order to characterize immune system markers and further the understanding of the immune factors that contribute to disease progression in ALS. (NCT01884571)
Timeframe: Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6), Post-Treatment Period (Months 8 and 12)
Intervention | Participants (Count of Participants) |
---|
Immunosuppression Regimen | 31 |
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Total Number of Adverse Events.
Adverse events were listed using CTCAE Version 4.03 (Common Terminology Criteria for Adverse Events) toxicity grade. (NCT01888952)
Timeframe: Average of 21 days.
Intervention | Adverse events (Number) |
---|
Roflumilast and Prednisone | 2 |
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DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21
Plasma concentrations of rituximab in participants with DLBCL by chemotherapy regimen cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 14 days (R-CHOP-14) or cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 21 days (R-CHOP-21) in the PK) population.DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
Intervention | micrograms per millilitre (ug/mL) (Mean) |
---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 7 Predose | Cycle 7 Day 7 | Cycle 7 Day 14 | Cycle 8 Predose |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) R-CHOP-21 | 28.37 | 88.92 | 110.50 | 94.00 | 74.25 | 150.13 | 398.76 | 272.50 | 123.76 |
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DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21
Plasma concentrations of rituximab in participants with DLBCL by chemotherapy regimen cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 14 days (R-CHOP-14) or cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 21 days (R-CHOP-21) in the PK) population.DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
Intervention | micrograms per millilitre (ug/mL) (Mean) |
---|
| Cycle 2 Predose | Cycle 5 Predose | Baseline | Cycle 7 Predose | Cycle 7 Day 7 | Cycle 7 Day 14 | Cycle 8 Predose |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) R-CHOP-14 | 170.00 | 125.00 | 214.25 | 93.50 | 71.55 | 42.00 | 78.50 |
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Percentage of Participants With Progression-Free Survival (PFS) According to IWG Response Criteria
PFS was defined as the time from first dose of rituximab to the first occurrence of disease progression or relapse, according to the International Working Group (IWG) response criteria or other country standards, or death from any cause, whichever occurred first. (NCT01889069)
Timeframe: Day 1 up to first occurrence of progression or relapse, or death, whichever occurs first (up to maximum 54 months)
Intervention | Percentage of Participants (Number) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 29.2 |
Follicular Lymphoma (FL) | 22.1 |
Subcutaneous (SC) Rituximab | 25.3 |
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Percentage of Participants With Overall Survival (OS)
OS was defined as the time from first dose of rituximab to death from any cause. (NCT01889069)
Timeframe: Day 1 until death (up to maximum 54 months)
Intervention | Percentage of Participants (Number) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 19.4 |
Follicular Lymphoma (FL) | 4.7 |
Subcutaneous (SC) Rituximab | 11.4 |
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Percentage of Participants With Event-Free Survival (EFS) According to IWG Response Criteria
EFS was defined as the time from first dose of rituximab to first occurrence of progression or relapse, according to the International Working Group (IWG) response criteria or other country standards, or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurred first. (NCT01889069)
Timeframe: Day 1 up to first occurrence of progression or relapse, or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first (up to maximum 54 months)
Intervention | Percentage of Participants (Number) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 29.2 |
Follicular Lymphoma (FL) | 22.1 |
Subcutaneous (SC) Rituximab | 25.3 |
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Percentage of Participants With Disease-Free Survival (DFS) According to IWG Response Criteria
DFS assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from 4 to 8 weeks after end of Induction period up to relapse or death from any cause, whichever occured first. (NCT01889069)
Timeframe: From 4 to 8 weeks after end of Induction period up to relapse or death from any cause, whichever occurs first (up to maximum 54 months) (end of Induction period = up to 8 months)
Intervention | Percentage of Participants (Number) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 21.7 |
Follicular Lymphoma (FL) | 25.6 |
Subcutaneous (SC) Rituximab | 23.5 |
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Percentage of Participants With Complete Response (CR) According to IWG Response Criteria
Complete response required: 1) the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities, 2) all lymph nodes and nodal masses had regressed to normal size, 3) the spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and not be palpable on physical examination and 4) if the bone marrow was involved by lymphoma before treatment, the infiltrate was cleared on repeat bone marrow aspirate and biopsy of the same site. CR/unconfirmed (CRu) included those patients who fulfilled criteria 1 and 3 above as well as 1) a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that regressed by more than 75% in the SPD and 2) indeterminate bone marrow. Response was assessed according to the IWG response criteria. (NCT01889069)
Timeframe: At 4 to 8 weeks after end of Induction period (end of Induction period = up to 8 months)
Intervention | Percentage of Participants (Number) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 65.2 |
Follicular Lymphoma (FL) | 67.9 |
Subcutaneous (SC) Rituximab | 66.4 |
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Percentage of Participants With At Least One Treatment-Emergent Serious Adverse Events
SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. (NCT01889069)
Timeframe: Baseline up to 54 months
Intervention | Percentage of Participants (Number) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 36.1 |
Follicular Lymphoma (FL) | 26.7 |
Subcutaneous (SC) Rituximab | 31.0 |
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Percentage of Participants With At Least One Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study were also considered as adverse events. Grading was completed according to the CTCAE, version 4.0. (NCT01889069)
Timeframe: Baseline up to 54 months
Intervention | Percentage of Participants (Number) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 51.4 |
Follicular Lymphoma (FL) | 43.0 |
Subcutaneous (SC) Rituximab | 46.8 |
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FL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab
FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. PK data only collected for participants enrolled during Induction. During the induction phase each Cycle is 21 days. (NCT01889069)
Timeframe: Induction collection: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, and Cycle 8 Predose on Day 1
Intervention | micrograms per millilitre (ug/mL) (Geometric Least Squares Mean) |
---|
Follicular Lymphoma (FL) | 61.01 |
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DLBCL: Maximum Plasma Concentration (Cmax) of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
Intervention | micrograms per millilitre (ug/mL) (Mean) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | NA |
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DLBCL: Apparent Total Clearance (CL/F) of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
Intervention | liter per hour (L/h) (Mean) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | NA |
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DLBCL: Area Under the Plasma Concentration-Time Curve (AUC) of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
Intervention | mcg*hr/mL (Mean) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | NA |
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Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores
Patient-assessed satisfaction was evaluated using RASQ. Participants were asked questions regarding convenience and satisfaction for rituximab SC. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. DLBCL participants could be enrolled at cycle 2, cycle 3, or cycle 4. FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must be able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. Each Cycle is 21 days for DLBCL. Each Cycle 21 days during the Induction phase and 2 months during Maintenance phase for FL. (NCT01889069)
Timeframe: DLBCL: Cycle (C) 2, C3, C4, C5, C6, End of C8; FL: Induction: C3, C4, C5, C6, C8, Maintenance: C2, C3, C4, C5, C6, C7, C8, C10, C12, End of treatment (4-8 weeks after last dose)
Intervention | Units on a Scale (Mean) |
---|
| Convenience domain Cycle 3 Induction | Convenience domain Cycle 4 Induction | Convenience domain Cycle 5 Induction | Convenience domain Cycle 6 Induction | Convenience domain Cycle 8 Induction | Convenience domain Cycle 2 Maintenance | Convenience domain Cycle 3 Maintenance | Convenience domain Cycle 4 Maintenance | Convenience domain Cycle 5 Maintenance | Convenience domain Cycle 6 Maintenance | Convenience domain Cycle 7 Maintenance | Convenience domain Cycle 8 Maintenance | Convenience domain Cycle 10 Maintenance | Convenience domain Cycle 12 Maintenance | Convenience domain End of Treatment | Satisfaction domain Cycle 3 Induction | Satisfaction domain Cycle 4 Induction | Satisfaction domain Cycle 5 Induction | Satisfaction domain Cycle 6 Induction | Satisfaction domain Cycle 8 Induction | Satisfaction domain Cycle 2 Maintenance | Satisfaction domain Cycle 3 Maintenance | Satisfaction domain Cycle 4 Maintenance | Satisfaction domain Cycle 5 Maintenance | Satisfaction domain Cycle 6 Maintenance | Satisfaction domain Cycle 7 Maintenance | Satisfaction domain Cycle 8 Maintenance | Satisfaction domain Cycle 10 Maintenance | Satisfaction domain Cycle 12 Maintenance | Satisfaction domain End of Treatment |
---|
Follicular Lymphoma (FL) | 81.8 | 76.5 | 79.6 | 95.8 | 83.1 | 83.6 | 87.5 | 100.0 | 80.2 | 83.3 | 82.7 | 93.8 | 91.7 | 86.3 | 75.0 | 89.4 | 84.1 | 91.7 | 93.8 | 91.3 | 92.0 | 79.2 | 100.0 | 79.7 | 87.5 | 94.2 | 93.8 | 50.0 | 91.0 | 75.0 |
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DLBCL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
Intervention | micrograms per millilitre (ug/mL) (Geometric Least Squares Mean) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 70.50 |
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FL: Plasma Trough Concentrations of Rituximab
FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. Pharmacokinetic (PK) data only collected for participants enrolled during Induction. During the induction phase each Cycle is 21 days. (NCT01889069)
Timeframe: Induction collection: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, and Cycle 8 Predose on Day 1
Intervention | micrograms per millilitre (ug/mL) (Mean) |
---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 8 Predose |
---|
Follicular Lymphoma (FL) | 55.49 | 119.50 | 157.25 | 7.60 | 90.88 | 201.56 |
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Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores
Patient-assessed satisfaction was evaluated using RASQ. Participants were asked questions regarding convenience and satisfaction for rituximab SC. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. DLBCL participants could be enrolled at cycle 2, cycle 3, or cycle 4. FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must be able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. Each Cycle is 21 days for DLBCL. Each Cycle 21 days during the Induction phase and 2 months during Maintenance phase for FL. (NCT01889069)
Timeframe: DLBCL: Cycle (C) 2, C3, C4, C5, C6, End of C8; FL: Induction: C3, C4, C5, C6, C8, Maintenance: C2, C3, C4, C5, C6, C7, C8, C10, C12, End of treatment (4-8 weeks after last dose)
Intervention | Units on a Scale (Mean) |
---|
| Convenience domain Cycle 2 Treatment | Convenience domain Cycle 3 Treatment | Convenience domain Cycle 4 Treatment | Convenience domain Cycle 5 Treatment | Convenience domain Cycle 6 Treatment | Convenience domain Cycle 8 Treatment | Satisfaction domain Cycle 2 Treatment | Satisfaction domain Cycle 3 Treatment | Satisfaction domain Cycle 4 Treatment | Satisfaction domain Cycle 5 Treatment | Satisfaction domain Cycle 6 Treatment | Satisfaction domain Cycle 8 Treatment |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 75.0 | 81.9 | 82.1 | 83.3 | 80.8 | 83.8 | 87.5 | 83.3 | 85.6 | 83.3 | 84.6 | 91.2 |
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Percentage of Participants With Administration-Associated Reactions (AAR)
AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01889069)
Timeframe: Baseline up to 54 months
Intervention | Percentage of Participants (Number) |
---|
| At least One AAR | At Least One AAR Grade ≥3 | Cutaneous and Soft Tissue AARs (Localized) | Cutaneous and Soft Tissue AARs (Non-Localized) |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 4.2 | 0 | 1.4 | 2.8 |
,Follicular Lymphoma (FL) | 8.1 | 0 | 8.1 | 0 |
,Subcutaneous (SC) Rituximab | 6.3 | 0 | 5.1 | 1.3 |
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FL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu)
FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. PK data only collected for participants enrolled during Induction. During the induction phase each Cycle is 21 days. (NCT01889069)
Timeframe: Induction collection: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, and Cycle 8 Predose on Day 1
Intervention | micrograms per millilitre (ug/mL) (Mean) |
---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 8 Predose |
---|
Follicular Lymphoma (FL) | 48.86 | 156.33 | 200.33 | 7.60 | 97.90 | 284.08 |
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DLBCL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu)
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
Intervention | micrograms per millilitre (ug/mL) (Mean) |
---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 7 Predose | Cycle 8 Predose |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 53.97 | 101.79 | 110.50 | 121.67 | 109.40 | 157.93 | 132.57 |
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DLBCL: Plasma Trough Concentrations of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 pre-dose on Day 1
Intervention | micrograms per millilitre (ug/mL) (Mean) |
---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 7 Predose | Cycle 8 Predose |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 42.53 | 88.92 | 110.50 | 100.20 | 92.92 | 141.44 | 117.61 |
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DLBCL: Plasma Concentrations of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
Intervention | micrograms per millilitre (ug/mL) (Mean) |
---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 7 Predose | Cycle 7 Day 7 | Cycle 7 Day 14 | Cycle 8 Predose |
---|
Diffuse Large B-Cell Lymphoma (DLBCL) | 42.53 | 88.92 | 110.50 | 100.20 | 92.92 | 141.44 | 348.81 | 226.40 | 117.61 |
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Change From Baseline in Central Retinal Thickness (CRT) At Week 16
CRT was measured by spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT. (NCT01900431)
Timeframe: Baseline to Week 16
Intervention | µm (microns) (Least Squares Mean) |
---|
Placebo (Part A) | -8.9 |
Sarilumab 200 mg q2w (Part A) | -35.4 |
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Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16
Participants with AC cell score = 0 or with ≥2 step reduction from baseline at Week 16 were evaluated. Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: grade 0 = no cells; grade +0.5 = 1 - 5 cells; grade +1 = 6 - 25 cells; grade +2= 26 - 50 cells; grade +3 = too many to count. (NCT01900431)
Timeframe: Week 16
Intervention | Percentage of participants (Number) |
---|
Placebo (Part A) | 86.7 |
Sarilumab 200 mg q2w (Part A) | 86.2 |
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Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16
BCVA score is based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters, and then at 1 meter. The range of ETDRS is 0 to 100 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA. (NCT01900431)
Timeframe: Baseline to Week 16
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (Part A) | 3.5 |
Sarilumab 200 mg q2w (Part A) | 9.3 |
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Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16
At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose <10 mg/day (or equivalent oral corticosteroid) were also evaluated. (NCT01900431)
Timeframe: Week 16
Intervention | Percentage of participants (Number) |
---|
Placebo (Part A) | 30.0 |
Sarilumab 200 mg q2w (Part A) | 46.1 |
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Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16
Participants with prednisone dose ≤5 mg/day (or equivalent oral corticosteroid) at Week 16 were evaluated. (NCT01900431)
Timeframe: Week 16
Intervention | Percentage of participants (Number) |
---|
Placebo (Part A) | 40.0 |
Sarilumab 200 mg q2w (Part A) | 41.4 |
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Percent Change From Baseline in CRT at Week 16
CRT was measured by SD-OCT, a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT. (NCT01900431)
Timeframe: Baseline to Week 16
Intervention | percent change (Least Squares Mean) |
---|
Placebo (Part A) | 0.0 |
Sarilumab 200 mg q2w (Part A) | -6.4 |
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Change From Baseline in VH Scale at Week 16
Change from baseline in VH scale was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) were equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Least squares (LS) mean was calculated using mixed model for repeated measurements (MMRM) model with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects as well as fixed continuous covariate of baseline adjudicated VH. (NCT01900431)
Timeframe: Baseline to Week 16
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (Part A) | -0.1 |
Sarilumab 200 mg q2w (Part A) | -0.9 |
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Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
Serum functional (unbound) sarilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method with a lower limit of quantification (LLOQ) of 294 ng/mL. Concentrations below LLOQ were set to zero for samples at predose. Post-treatment concentrations below LLOQ were replaced by LLOQ/2. The samples were considered non-eligible for the analysis if the previous dosing time was <11 days or >17 days before the sampling time for every other week regimens. (NCT01900431)
Timeframe: Predose on Day 1 (Baseline), Week 2, 4, 8, 12, 16, 24, 36, 52, and end of study (EOS) (Week 56)
Intervention | ng/mL (Mean) |
---|
| At Baseline | At Week 2 | At Week 4 | At Week 8 | At Week 12 | At Week 16 | At Week 24 | At Week 36 | At Week 52 | EOS (Week 56) |
---|
Sarilumab 200 mg q2w (Part A + Part B) | 0.0 | 7383.3 | 9876.6 | 15958.9 | 19705.2 | 19598.4 | 22406.8 | 24375.4 | 25046.0 | 1730.0 |
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Descriptive of Hematological Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01920932)
Timeframe: From enrollment to end of therapy (approximately 8 months)
Intervention | Participants (Count of Participants) |
---|
| Leukopenia | Neutropenia | Lymphopenia | Anemia | Thrombocytopenia |
---|
Cycle 1 - Grade 2 | 15 | 5 | 15 | 23 | 3 |
,Cycle 1 - Grade 3-4 | 49 | 62 | 36 | 12 | 3 |
,Cycle 2 - Grade 2 | 28 | 13 | 18 | 28 | 2 |
,Cycle 2 - Grade 3-4 | 23 | 51 | 15 | 5 | 1 |
,Cycle 3 - Grade 2 | 8 | 7 | 9 | 6 | 0 |
,Cycle 3 - Grade 3-4 | 4 | 10 | 7 | 1 | 2 |
,Cycle 4 - Grade 2 | 5 | 5 | 16 | 6 | 0 |
,Cycle 4 - Grade 3-4 | 5 | 3 | 15 | 0 | 1 |
,Cycle 5 - Grade 2 | 7 | 4 | 13 | 4 | 0 |
,Cycle 5 - Grade 3-4 | 2 | 3 | 22 | 1 | 1 |
,Cycle 6 - Grade 2 | 14 | 8 | 20 | 2 | 1 |
,Cycle 6 - Grade 3-4 | 5 | 6 | 31 | 1 | 2 |
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Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients. (NCT01920932)
Timeframe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Intervention | percentage of participants (Number) |
---|
AEPA Chemotherapy | 31.25 |
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Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients. (NCT01920932)
Timeframe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Intervention | percentage of participants (Number) |
---|
AEPA Chemotherapy | 31.25 |
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Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac.
The local failure rate within the high-risk HL participants treated with AEPA/CAPDac will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). (NCT01920932)
Timeframe: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
Intervention | Probability (Number) |
---|
AEPA/CAPDac | 0.013 |
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Descriptive of Infectious Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01920932)
Timeframe: From enrollment to end of therapy (approximately 8 months)
Intervention | Participants (Count of Participants) |
---|
| Febrile neutropenia | Mucositis | Upper respiratory infection | Genitourinary infection |
---|
Cycle 1 - Grade 2 | 0 | 10 | 5 | 1 |
,Cycle 1 - Grade 3-4 | 6 | 2 | 2 | 0 |
,Cycle 2 - Grade 2 | 0 | 6 | 3 | 1 |
,Cycle 2 - Grade 3-4 | 3 | 4 | 0 | 0 |
,Cycle 3 - Grade 2 | 0 | 0 | 0 | 2 |
,Cycle 3 - Grade 3-4 | 0 | 0 | 0 | 0 |
,Cycle 4 - Grade 2 | 0 | 1 | 0 | 1 |
,Cycle 4 - Grade 3-4 | 2 | 0 | 2 | 0 |
,Cycle 5 - Grade 2 | 0 | 1 | 0 | 2 |
,Cycle 5 - Grade 3-4 | 1 | 0 | 0 | 0 |
,Cycle 6 - Grade 2 | 0 | 1 | 0 | 0 |
,Cycle 6 - Grade 3-4 | 0 | 0 | 0 | 0 |
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Complete Response Rate Estimate for All Evaluable Participants
To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL). (NCT01920932)
Timeframe: After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)
Intervention | percentage of participants (Number) |
---|
AEPA/CAPDac | 35 |
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Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2). (NCT01920932)
Timeframe: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
Intervention | probability (Number) |
---|
AEPA/CAPDac | 0.974 |
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Descriptive of Neuropathic Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01920932)
Timeframe: From enrollment to end of therapy (approximately 8 months)
Intervention | Participants (Count of Participants) |
---|
| Peripheral sensory neuropathy | Pain in extremity | Neuralgia | Pain NOS |
---|
Cycle 1 - Grade 2 | 0 | 3 | 1 | 1 |
,Cycle 1 - Grade 3-4 | 0 | 1 | 0 | 0 |
,Cycle 2 - Grade 2 | 1 | 4 | 0 | 1 |
,Cycle 2 - Grade 3-4 | 0 | 0 | 0 | 0 |
,Cycle 3 - Grade 2 | 2 | 1 | 0 | 0 |
,Cycle 3 - Grade 3-4 | 0 | 0 | 0 | 0 |
,Cycle 4 - Grade 2 | 3 | 1 | 0 | 0 |
,Cycle 4 - Grade 3-4 | 0 | 0 | 0 | 0 |
,Cycle 5 - Grade 2 | 1 | 2 | 1 | 0 |
,Cycle 5 - Grade 3-4 | 0 | 0 | 0 | 0 |
,Cycle 6 - Grade 2 | 1 | 0 | 0 | 1 |
,Cycle 6 - Grade 3-4 | 0 | 0 | 0 | 1 |
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Number of Infectious Complications
The number of infections complications occurring among study participants is presented here. (NCT01921218)
Timeframe: Baseline up to Month 36
Intervention | complications (Number) |
---|
Belatacept Treatment Group | 12 |
Control Group | 18 |
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Number of Participants With Donor-specific Antibody Formation
The number of participants in each group with donor-specific antibody formation at 36 months following randomization. (NCT01921218)
Timeframe: Month 36
Intervention | Participants (Count of Participants) |
---|
Belatacept Treatment Group | 3 |
Control Group | 4 |
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Glomerular Filtration Rate (GFR)
The glomerular filtration rate (GFR) assesses kidney function. GFR uses values for serum creatinine (SCr) measured in mg/dL, age in years, blood urea nitrogen (BUN) measures in mg/dL, and serum albumin (Alb) measured in g/dL. GFR is calculated as 170 x (SCr/0.95)^(-0.999) x (Age)^(-0.176) x (0.762 if the patient is female) x (1.180 if the patient is black) x (BUN)^(-0.170) x (Alb)^(0.318). A value of 90 or above is considered normal while values between 15 and 29 indicate severely decreased kidney function and values below 15 indicate kidney failure. The GFR in participants who do not require dialysis will be followed for two years. (NCT01921218)
Timeframe: Baseline up to Month 24
Intervention | mL/min/1.73 m^2 (Mean) |
---|
| Baseline | Month 1 | Month 2 | Month 3 | Month 6 | Month 9 | Month 12 |
---|
Control Group | 14.5 | 11 | 10.5 | 16.5 | 14.5 | 13.5 | 20 |
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Glomerular Filtration Rate (GFR)
The glomerular filtration rate (GFR) assesses kidney function. GFR uses values for serum creatinine (SCr) measured in mg/dL, age in years, blood urea nitrogen (BUN) measures in mg/dL, and serum albumin (Alb) measured in g/dL. GFR is calculated as 170 x (SCr/0.95)^(-0.999) x (Age)^(-0.176) x (0.762 if the patient is female) x (1.180 if the patient is black) x (BUN)^(-0.170) x (Alb)^(0.318). A value of 90 or above is considered normal while values between 15 and 29 indicate severely decreased kidney function and values below 15 indicate kidney failure. The GFR in participants who do not require dialysis will be followed for two years. (NCT01921218)
Timeframe: Baseline up to Month 24
Intervention | mL/min/1.73 m^2 (Mean) |
---|
| Baseline | Month 1 | Month 2 | Month 3 | Month 6 | Month 9 | Month 12 | Month 18 |
---|
Belatacept Treatment Group | 14.25 | 14.25 | 19.33 | 16.33 | 14.67 | 14.67 | 13.67 | 7 |
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Time to Initiation of Dialysis
Time to dialysis is measured as the time of randomization to initiation of dialysis. Participants already requiring dialysis at the time of enrollment were excluded from this endpoint analysis. (NCT01921218)
Timeframe: Up to Year 2
Intervention | months (Mean) |
---|
Belatacept Treatment Group | 11.75 |
Control Group | 10.5 |
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Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies
The presence of anti-HLA Class I and Class II alloantibodies is categorized as being negative (absent for both classes of alloantibodies), positive for Class I, positive for Class II, and positive for both Class I and Class II alloantibodies. (NCT01921218)
Timeframe: Baseline up to Month 36
Intervention | Participants (Count of Participants) |
---|
| Baseline - Negative | Baseline - Positive Class I | Baseline - Positive Class II | Baseline - Positive Class I and II | Month 12 - Negative | Month 12 - Positive Class I | Month 12 - Positive Class II | Month 12 - Positive Class I and II | Month 24 - Negative | Month 24 - Positive Class I | Month 24 - Positive Class II | Month 24 - Positive Class I and II | Month 36 - Negative | Month 36 - Positive Class I | Month 36 - Positive Class II | Month 36 - Positive Class I and II |
---|
Belatacept Treatment Group | 6 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 2 | 0 |
,Control Group | 5 | 2 | 0 | 0 | 2 | 4 | 3 | 3 | 1 | 2 | 1 | 1 | 1 | 2 | 1 | 1 |
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MTD of Inotuzumab Ozogamicin With CVP for Patients With Relapsed or Refractory CD22+ Acute Leukemia
To determine the maximum tolerated dose (MTD) of inotuzumab ozogamicin in this regimen for patients with relapsed or refractory CD22+ acute leukemia (B-cell acute lymphoblastic leukemia [B-ALL], mixed phenotype, and Burkitt's). The MTD is defined as the highest dose studied in which the incidence of dose-limiting toxicities is < 33% using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. (NCT01925131)
Timeframe: 28 days
Intervention | mg/m^2 (Number) |
---|
| Day 1 Dose | Day 8 Dose | Day 15 Dose |
---|
CVP + Inotuzumab | 0.8 | 0.5 | 0.5 |
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Frequency and Severity of Toxicities
Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported by given type of adverse event. (NCT01925131)
Timeframe: Up to 3 years
Intervention | Participants (Number) |
---|
| Anemia | Ascites | Dysphagia | Encephalopathy | Enterocolitis | Fatigue | Febrile neutropenia | Fever | Gastric hemorrhage | Gastrointestinal disorders - Other, specify | Headache | Hyperglycemia | Hypertension | Hypoalbuminemia | Hypocalcemia | Hypokalemia | Infections and infestations - Other, specify | Intracranial hemorrhage | Lipase increased | Lung infection | Lymphocyte count decreased | Mucositis oral | Neutrophil count decreased | Platelet count decreased | Renal and urinary disorders - Other, specify | Sepsis | Skin infection | White blood cell decreased |
---|
CVP + Inotuzumab Dose Level 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 3 | 2 | 0 | 0 | 0 | 3 |
,CVP + Inotuzumab Dose Level 2 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 2 | 0 | 0 | 0 | 4 |
,CVP + Inotuzumab Dose Level 3 | 7 | 0 | 1 | 1 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 4 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 9 | 7 | 0 | 0 | 1 | 10 |
,CVP + Inotuzumab Dose Level 4 | 3 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 3 | 0 | 4 | 4 | 0 | 0 | 0 | 5 |
,CVP + Inotuzumab Dose Level 5 | 5 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 6 | 0 | 8 | 5 | 0 | 0 | 0 | 7 |
,CVP + Inotuzumab MTD | 5 | 1 | 0 | 0 | 0 | 1 | 7 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 4 | 0 | 1 | 0 | 6 | 1 | 8 | 10 | 1 | 2 | 0 | 9 |
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Response Rate (CR+CRi) Among Expansion Cohort
The response rate (CR + CRi) is defined as the rate of complete remission (CR) + complete remission with incomplete count recovery (CRi). Complete remission (CR) is defined as < 5% marrow aspirate blasts, neutrophils ≥ 1000/uL, platelets > 100,000/uL, no blasts in peripheral blood, and C1 Extramedullary disease status. C1 Extramedullary disease status is characterized by complete disappearance of all measurable and non-measurable extramedullary disease with the exception of lesions for which the following must be true: for participants with at least one measurable lesion, all lesions must have reduced by 75% in sum of products of greatest diameters (SPD), have no new lesions, and the spleen and other previously enlarged organs must have regressed in size. Complete remission with incomplete platelet recovery (CRi) is defined the same as CR, except absolute neutrophil count may be <1000/uL and/or platelet count may be ≤ 100,000/uL. (NCT01925131)
Timeframe: Up to 3 years
Intervention | percentage of participants (Number) |
---|
CVP + Inotuzumab MTD | 83.33 |
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Complete Remission Rate
Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). (NCT01925612)
Timeframe: Up to 6 months
Intervention | Participants (Count of Participants) |
---|
Part 1: BV(1.2 mg/kg) + RCHOP | 20 |
Part 1: BV(1.8 mg/kg) + RCHOP | 16 |
Part 2: BV(1.8 mg/kg) + RCHP | 9 |
Part 3: BV(1.8 mg/kg) + RCHP | 6 |
Part 3: RCHOP | 8 |
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Incidence of Adverse Events
Number (count) of participants that experienced at least 1 adverse event. (NCT01925612)
Timeframe: Up to 6 months
Intervention | Participants (Count of Participants) |
---|
Part 1: BV(1.2 mg/kg) + RCHOP | 29 |
Part 1: BV(1.8 mg/kg) + RCHOP | 22 |
Part 2: BV(1.8 mg/kg) + RCHP | 11 |
Part 3: BV(1.8 mg/kg) + RCHP | 11 |
Part 3: RCHOP | 12 |
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Objective Response Rate
Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007) (NCT01925612)
Timeframe: Up to 6 months
Intervention | Participants (Count of Participants) |
---|
Part 1: BV(1.2 mg/kg) + RCHOP | 23 |
Part 1: BV(1.8 mg/kg) + RCHOP | 19 |
Part 2: BV(1.8 mg/kg) + RCHP | 10 |
Part 3: BV(1.8 mg/kg) + RCHP | 10 |
Part 3: RCHOP | 9 |
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Incidence of Laboratory Abnormalities
Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. (NCT01925612)
Timeframe: Up to 6 months
Intervention | Participants (Count of Participants) |
---|
| Any Hematology Test | Lymphocytes (x10^3/uL) | Absolute Neutrophil Count (x10^3/uL) | Neutrophils (x10^3/uL) | Leukocytes (x10^3/uL) | Hemoglobin (x10^3/uL) | Platelets (x10^3/uL) | Any Chemistry Test | Glucose (mg/dL) | Potassium (mEq)/L | Calcium (mg/dL) | Sodium (mEq/L) | Alanine Aminotransferase (IU/L) |
---|
Part 1: BV(1.2 mg/kg) + RCHOP | 10 | 8 | 4 | 4 | 3 | 0 | 1 | 4 | 3 | 0 | 1 | 0 | 0 |
,Part 1: BV(1.8 mg/kg) + RCHOP | 16 | 15 | 4 | 4 | 2 | 1 | 1 | 7 | 5 | 2 | 1 | 2 | 0 |
,Part 2: BV(1.8 mg/kg) + RCHP | 4 | 3 | 1 | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 1 |
,Part 3: BV(1.8 mg/kg) + RCHP | 6 | 4 | 2 | 2 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
,Part 3: RCHOP | 4 | 4 | 0 | 0 | 1 | 0 | 0 | 3 | 1 | 2 | 0 | 0 | 0 |
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Progression-free Survival
Median progression-free survival (in months) and observed minimum-maximum range. (NCT01925612)
Timeframe: Up to approximately 4 years
Intervention | Months (Median) |
---|
Part 1: BV(1.2 mg/kg) + RCHOP | NA |
Part 1: BV(1.8 mg/kg) + RCHOP | NA |
Part 2: BV(1.8 mg/kg) + RCHP | NA |
Part 3: BV(1.8 mg/kg) + RCHP | NA |
Part 3: RCHOP | NA |
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Overall Survival
Median overall survival (in months) and observed minimum-maximum range. (NCT01925612)
Timeframe: Up to approximately 4 years
Intervention | Months (Median) |
---|
Part 1: BV(1.2 mg/kg) + RCHOP | NA |
Part 1: BV(1.8 mg/kg) + RCHOP | NA |
Part 2: BV(1.8 mg/kg) + RCHP | NA |
Part 3: BV(1.8 mg/kg) + RCHP | NA |
Part 3: RCHOP | NA |
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Change in PSA Response
Percent of men with Prostate Specific Antigen (PSA) declines > 30%, > 50% and > 90% (NCT01940276)
Timeframe: Baseline and up to 2 years
Intervention | percentage of participants (Number) |
---|
| Percent of men with PSA declines > 30% | Percent of men with PSA declines > 50% | Percent of men with PSA declines > 90% |
---|
Abiraterone Acetate and Prednisone: African American Men | 82 | 74 | 48 |
,Abiraterone Acetate and Prednisone: White Men | 78 | 66 | 38 |
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Overall Survival
Length of patient's life after starting study (NCT01940276)
Timeframe: up to 3 years
Intervention | months (Median) |
---|
Abiraterone Acetate and Prednisone: White Men | 35.7 |
Abiraterone Acetate and Prednisone: African American Men | 35.9 |
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Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml
Number of men who achieve a PSA decline to < 0.1 and < 0.2 ng/ml (NCT01940276)
Timeframe: up to 2 years
Intervention | Participants (Count of Participants) |
---|
| PSA decline to < 0.1 | PSA decline to < 0.2 |
---|
Abiraterone Acetate and Prednisone: African American Men | 9 | 13 |
,Abiraterone Acetate and Prednisone: White Men | 4 | 5 |
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Percent of Subjects Experiencing Hypertension
Incidence and grade of hypertension in the two populations. (Grade 1: Systolic BP 120 to 139 mmHg or diastolic BP 80 to 89 mmHg, Grade 2: Systolic BP 140 to 159 mmHg or diastolic BP 90 to 99 mmHg, Grade 3: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, Grade 4: Life-threatening consequences, urgent intervention indicated) (NCT01940276)
Timeframe: up to 2 years
Intervention | Participants (Count of Participants) |
---|
| All grades | Grades 3 and 4 |
---|
Abiraterone Acetate and Prednisone: African American Men | 23 | 12 |
,Abiraterone Acetate and Prednisone: White Men | 20 | 8 |
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Proportion of Participants With Pathologic Stage Less Than or Equal to ypT2N0
The proportion of participants with pathologic stage less than or equal to ypT2N0 will be descriptively summarized and compared between the two treatment arms. The proportion will be calculated as the number of patients with less than or equal to ypT2N0 in each treatment arm divided by the total number of patients who underwent surgery in the same arm. (NCT01946165)
Timeframe: For all participants who underwent surgery, from start of treatment until surgery is completed
Intervention | Participants (Count of Participants) |
---|
Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone. | 13 |
Group B: Abiraterone + LHRHa + Prednisone | 11 |
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Proportion of Participants With Positive Surgical Margins
The difference in the rate of positive surgical margins between the two groups will be descriptively summarized. (NCT01946165)
Timeframe: For both groups, tumor samples collected at baseline and during surgery.
Intervention | Participants (Count of Participants) |
---|
Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone | 9 |
Group B: Abiraterone + LHRHa + Prednisone | 2 |
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Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs).
The number of Grade 3, 4, or 5 hematological AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Adverse Events (Number) |
---|
| Grade 3 | Grade 4 | Grade 5 |
---|
MMF Maintenance | 3 | 0 | 0 |
,MMF Withdrawal | 0 | 0 | 0 |
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Number of Grade 3, 4, or 5 Adverse Events (AEs)
The number of Grade 3, 4, or 5 AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Adverse Events (Number) |
---|
| Grade 3 | Grade 4 | Grade 5 |
---|
MMF Maintenance | 18 | 2 | 0 |
,MMF Withdrawal | 15 | 0 | 0 |
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Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score
The SLICC/DI measures accumulated damage that has occurred since the onset of systemic lupus erythematosus (SLE), regardless of cause, in 12 organ systems. SLE damage is defined as an irreversible change in an organ or system that has been present for at least 6 months. The SLICC/DI includes 39 areas of damage in 12 domains, where each item is rated as present or absent; if evidence of damage is present for a particular item, it is given a score of 1. Some items are scored with 2 or 3 points in the case of recurring events or end stage renal disease. The SLICC/DI total score will be computed as the sum of all scores for items indicated as present; scores can range from 0 to 45. Higher scores indicate more damage. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60
Intervention | Scores on a Scale (Mean) |
---|
| Week 24 | Week 48 | Week 60 |
---|
MMF Maintenance | 0.0 | 0.0 | 0.0 |
,MMF Withdrawal | 0.0 | 0.0 | 0.0 |
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Change From Baseline in the Lupus Quality of Life (QoL)Score
The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life over the preceding 4 weeks. Scores range from 0 (worst QoL) to 100 (best QoL). Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60
Intervention | Scores on a Scale (Mean) |
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| Change in Physical Health at Week 24 | Change in Physical Health at Week 48 | Change in Physical Health at Week 60 | Change in Pain at Week 24 | Change in Pain at Week 48 | Change in Pain at Week 60 | Change in Planning at Week 24 | Change in Planning at Week 48 | Change in Planning at Week 60 | Change in Intimate Relationships at Week 24 | Change in Intimate Relationships at Week 48 | Change in Intimate Relationships at Week 60 | Change in Burden to Others at Week 24 | Change in Burden to Others at Week 48 | Change in Burden to Others at Week 60 | Change in Emotional Health at Week 24 | Change in Emotional Health at Week 48 | Change in Emotional Health at Week 60 | Change in Body Image at Week 24 | Change in Body Image at Week 48 | Change in Body Image at Week 60 | Change in Fatigue at Week 24 | Change in Fatigue at Week 48 | Change in Fatigue at Week 60 |
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MMF Maintenance | -1.11 | -2.83 | 0.00 | -0.17 | -3.10 | -0.19 | 0.35 | -5.43 | -3.03 | -1.47 | -0.81 | -2.08 | 1.56 | -0.58 | -1.33 | -0.87 | -2.03 | -1.52 | 2.94 | -0.17 | 3.22 | 3.78 | -2.18 | -0.57 |
,MMF Withdrawal | 1.04 | 0.46 | 1.56 | 1.77 | 1.60 | 1.42 | 3.90 | -0.18 | 0.18 | 4.29 | -1.10 | 2.86 | 0.18 | -4.43 | -3.55 | 0.09 | -1.22 | -0.87 | -1.09 | -0.56 | -4.45 | -1.17 | -1.56 | -1.95 |
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Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score
FACIT-Fatigue scale (FS) is a 13-item questionnaire completed by the patient (participant), that provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. A decrease in the FACIT-FS score reflects worse fatigue/quality of life. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60
Intervention | units on a scale (Mean) |
---|
| Week 24 | Week 48 | Week 60 |
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MMF Maintenance | -2.41 | -3.39 | -3.13 |
,MMF Withdrawal | -0.81 | -0.85 | 0.42 |
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Time to First Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare
The time to first severe SELENA-SLEDAI flare was defined as the time from Baseline/Day 0 to the date of the first severe SELENA-SLEDAI flare. Time to severe SELENA-SLEDAI flare was defined in study weeks as: date of SELENA-SLEDAI flare minus (-) baseline date. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Weeks (Mean) |
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MMF Maintenance | 43.5 |
MMF Withdrawal | 41.5 |
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Time to First Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare
The time to first mild/moderate or severe SELENA-SLEDAI flare was defined as the time from Baseline/Day 0 to the date of the first mild/moderate or severe SELENA-SLEDAI flare. Time to SELENA-SLEDAI flare was defined in study weeks as: date of SELENA-SLEDAI flare minus (-) baseline date. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Weeks (Mean) |
---|
MMF Maintenance | 20.5 |
MMF Withdrawal | 27.5 |
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Time to Clinically Significant Disease Reactivation
The time to clinically significant disease reactivation was defined as the time from Baseline/Day 0 to the date of the first Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) assessment that met (or went on to meet) the criteria for clinically significant disease reactivation. Time to clinically significant disease reactivation was defined in study weeks as: date of SELENA-SLEDAI assessment that met reactivation criteria minus (-) baseline date. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Weeks (Mean) |
---|
MMF Maintenance | 38.0 |
MMF Withdrawal | 38.5 |
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Time From Clinically Significant Disease Reactivation to Return to Pre-Flare Steroid Dose
For each participant who experienced disease reactivation, time from clinically significant disease reactivation to recovery to pre-flare steroid dose was calculated in study days as: date of clinically significant disease reactivation minus (-) date of return to pre-flare steroid dose. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Days (Mean) |
---|
MMF Maintenance | NA |
MMF Withdrawal | 37 |
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Time From Clinically Significant Disease Reactivation to Recovery to Baseline British Isles Lupus Assessment Group (BILAG) Score or BILAG C
For each participant who experienced disease reactivation, time from clinically significant disease reactivation to recovery to baseline BILAG scores or BILAG C, whichever is worse, was calculated in study days as: date of clinically significant disease reactivation minus (-) date of BILAG recovery. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Days (Mean) |
---|
MMF Maintenance | 114.5 |
MMF Withdrawal | 77.7 |
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Time From Clinically Significant Disease Reactivation to Improvement in British Isles Lupus Assessment Group (BILAG) From Maximum Level During Flare
For each participant who experienced disease reactivation, time from clinically significant disease reactivation to improvement in BILAG from maximum level (at least an A or B) during the flare was calculated in study days as: date of clinically significant disease reactivation minus (-) date of BILAG improvement. If multiple body systems had a BILAG flare at the visit, then the body system with the most severe score was tracked for improvement; if multiple body systems had the same score (at least an A or B), then just one needed to show improvement. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Days (Mean) |
---|
MMF Maintenance | 114.5 |
MMF Withdrawal | 40.5 |
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The Addition of Aggressive Adjunctive Therapy to Mycophenolate Mofetil (MMF) or Change in MMF Therapy to Cytotoxic Drug Due to Flare by Week 60
The addition of aggressive adjunctive therapy could include intravenous (IV) immunoglobulin or rituximab at any point during the participant's study participation. A change in therapy to cytotoxic drug due to flare could include drugs such as cyclophosphamide, etc. A blinded list of study medications was reviewed to identify the addition of aggressive adjunctive therapy or cytotoxic drugs. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 0 |
MMF Withdrawal | 1 |
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Number of Serious Adverse Events (SAEs).
The number of SAEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Serious Adverse Events (Number) |
---|
MMF Maintenance | 12 |
MMF Withdrawal | 6 |
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Number of Participants in the Lupus Nephritis Subgroup Experiencing a British Isles Lupus Assessment Group (BILAG) A Renal Flare by Week 60
The BILAG assesses participants on a variety of disease activity criteria in nine body system categories (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each category is scored as an A, B, C, or D/E, where A indicates most severe disease activity and D/E indicates inactive/no disease activity. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 0 |
MMF Withdrawal | 2 |
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Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF <2000 mg/Day Subgroup
"The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.~MMF: mycophenolate mofetil" (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 3 |
MMF Withdrawal | 6 |
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Number of Participants Experiencing Clinically Significant Disease Reactivation by Week 60
Disease reactivation requires:1) SELENA-SLEDAI mild/moderate or severe flare,and 2) Increased immunosuppressive therapy on a sustained basis,defined by one of the following criteria:a) Sustained activity:Significant prolonged SLE flare requiring steroid increase/burst to ≥15 mg/day prednisone (or equivalent) for >4 weeks.b) Frequent relapsing/remitting:Participant flares requiring an increase/burst of steroids and is successfully tapered to <15 mg/day within 4 weeks, but this occurs on >2 occasions, or IA, IM or IV steroids on more than1 occasion.c)Clinical activity of sufficient severity to warrant resumption of/increased dose of MMF or addition of other major immunosuppressive including AZA or MTX.Regardless of steroid use, if the investigator observes disease activity of sufficient severity to warrant resumption, addition or increase in dosage of major immunosuppressant in the setting of a SELENA-SLEDAI flare, participant has met the primary endpoint.Risk difference also included (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 5 |
MMF Withdrawal | 9 |
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Number of Participants Experiencing Any British Isles Lupus Assessment Group (BILAG) A Flare by Week 60
The BILAG assesses participants on a variety of disease activity criteria in nine body system categories (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each category is scored as an A, B, C, or D/E, where A indicates most severe disease activity and D/E indicates inactive/no disease activity. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 1 |
MMF Withdrawal | 4 |
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Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 1 |
MMF Withdrawal | 1 |
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Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 3 |
MMF Withdrawal | 7 |
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Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 4 |
MMF Withdrawal | 8 |
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Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 5 |
MMF Withdrawal | 6 |
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Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup
"The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.~MMF: mycophenolate mofetil" (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 9 |
MMF Withdrawal | 12 |
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Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 20 |
MMF Withdrawal | 25 |
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Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 15 |
MMF Withdrawal | 19 |
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Number of Malignancies Reported as Adverse Events (AEs).
The number of malignancies reported as AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Adverse Events (Number) |
---|
MMF Maintenance | 2 |
MMF Withdrawal | 3 |
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Cumulative Systemic Steroid Dose by Week 60
"Steroids include medications that code to a medication class which includes the terms glucocorticoid or corticosteroid. Systemic steroids will include any of these steroids that are taken by mouth (PO), intravenous (IV), or intramuscular (IM). Total cumulative systemic steroid dose, in milligrams, was summarized over the 60 week study period, or until early study termination, for each participant." (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | steroid dose (mg) (Mean) |
---|
MMF Maintenance | 851 |
MMF Withdrawal | 912 |
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Cumulative Excess Systemic Steroid Dose From Time of Clinically Significant Disease Reactivation to Return to Pre-Flare Dose or End of Trial Participation
"For each participant who experienced disease reactivation, excess systemic steroid dose was summed from the time of clinically significant disease reactivation until the dose returns to pre-flare levels or the end of study participation, whichever occurred first. Excess systemic steroid dose was defined as the total dose given for the flare minus (-) a participant's pre-flare steroid dose. Participants who do not have an increase in their steroid use due to the flare had their excess dose set to zero. Steroids include medications that code to a medication class which includes the terms glucocorticoid or corticosteroid. Systemic steroids will include any of these steroids that are taken by mouth (PO), intravenous (IV), or intramuscular (IM)." (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Steroid dose (mg) (Mean) |
---|
MMF Maintenance | 812.8 |
MMF Withdrawal | 1750.7 |
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All-Cause Mortality
All-cause mortality is defined as death from any cause occurring after randomization. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 0 |
MMF Withdrawal | 0 |
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Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF<2000 mg/Day Subgroup
"The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.~MMF: mycophenolate mofetil" (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 11 |
MMF Withdrawal | 13 |
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Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup
"The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.~MMF: mycophenolate mofetil" (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60
Intervention | Participants (Count of Participants) |
---|
MMF Maintenance | 1 |
MMF Withdrawal | 2 |
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Overall Survival (OS)
Overall survival is defined as the time from study registration to death due to any cause. (NCT01949337)
Timeframe: Up to 5 years post treatment
Intervention | months (Median) |
---|
Arm A: (Enzalutamide) | 32.5 |
Arm B: (Enzalutamide, Abiraterone, Prednisone) | 34.2 |
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Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.
Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates. (NCT01950819)
Timeframe: Month 12 and 24
Intervention | mL / min / 1.73m2 / day (Mean) |
---|
EVR+rCNI | 0.0001 |
MPA+sCNI | 0.0047 |
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Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.
Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation. (NCT01950819)
Timeframe: Month 24
Intervention | Participants (Count of Participants) |
---|
EVR+rCNI | 276 |
MPA+sCNI | 152 |
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Incidence of Major Cardiovascular Events.
Incidence of major cardiovascular events by Preferred Term (NCT01950819)
Timeframe: Month 24
Intervention | Participants (Count of Participants) |
---|
EVR+rCNI | 66 |
MPA+sCNI | 86 |
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Incidence of Malignancies.
Incidence of malignancies. (NCT01950819)
Timeframe: Month 24
Intervention | Participants (Count of Participants) |
---|
EVR+rCNI | 41 |
MPA+sCNI | 39 |
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Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup
Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| month 12 | month 24 |
---|
EVR+rCNI | 489 | 489 |
,MPA+sCNI | 456 | 443 |
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Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.
Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events. (NCT01950819)
Timeframe: Month 24
Intervention | Participants (Count of Participants) |
---|
| clinical signs of CMV infection | any BKV infection | new onset of diabetes mellitus | at least one event of interest |
---|
EVR+rCNI | 53 | 103 | 144 | 871 |
,MPA+sCNI | 132 | 154 | 138 | 764 |
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Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection
Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection) (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| deaths month 12 | deaths month 24 | graft loss month 12 | graft loss month 24 | tBPAR month 12 | tBPAR month 24 | BPAR month 12 | BPAR month 24 | tAR month 12 | tAR month 24 | AR month 12 | AR month 24 | aAMR month 12 | aAMR month 24 | cAMR month 12 | cAMR month 24 |
---|
EVR+rCNI | 20 | 32 | 33 | 37 | 107 | 118 | 114 | 127 | 129 | 145 | 147 | 167 | 73 | 84 | 9 | 13 |
,MPA+sCNI | 28 | 36 | 28 | 32 | 91 | 98 | 95 | 104 | 117 | 126 | 133 | 144 | 61 | 69 | 14 | 18 |
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Incidence of Failure on the Composite Endpoint of Graft Loss or Death.
Incidence of failure on the composite endpoint of graft loss or death. (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| month 12 | month 24 |
---|
EVR+rCNI | 51 | 67 |
,MPA+sCNI | 54 | 65 |
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Incidence of eGFR < 50 mL/Min/1.73m2
Incidence of eGFR < 50 mL/min/1.73m2 (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| month 12 | month 24 |
---|
EVR+rCNI | 456 | 474 |
,MPA+sCNI | 424 | 423 |
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Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.
Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios. (NCT01950819)
Timeframe: Baseline, Month 12 and 24
Intervention | mg/g (Mean) |
---|
| albumine /creatinine ratio baseline | albumine /creatinine ratio month 12 | albumine /creatinine ratio month 24 | protein /creatinine ratio baseline | protein /creatinine ratio month 12 | protein /creatinine ratio month 24 |
---|
EVR+rCNI | 1019.75 | 150.061 | 149.049 | 1648.10 | 298.557 | 290.242 |
,MPA+sCNI | 646.111 | 111.322 | 116.618 | 1142.59 | 234.698 | 233.009 |
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Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2
Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2 (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| month 12 | month 24 |
---|
EVR+rCNI | 497 | 497 |
,MPA+sCNI | 466 | 457 |
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Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death
Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| month 12 | month 24 |
---|
EVR+rCNI | 146 | 169 |
,MPA+sCNI | 131 | 147 |
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Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.
Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2. (NCT01950819)
Timeframe: Month 12 is Primary, Month 24 secondary
Intervention | Participants (Count of Participants) |
---|
| month 12 | month 24 |
---|
EVR+rCNI | 489 | 489 |
,MPA+sCNI | 456 | 443 |
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Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up
Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| month 12 | month 24 |
---|
EVR+rCNI | 181 | 218 |
,MPA+sCNI | 170 | 201 |
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Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.
Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 among compliant subjects. (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| month 12 | month 24 |
---|
EVR+rCNI | 60 | 62 |
,MPA+sCNI | 106 | 102 |
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Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)
"Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)" (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| Patient's maximum tBPAR grade : no grade (missing) | Patient's maximum tBPAR grade : grade IA | Patient's maximum tBPAR grade : grade IB | Patient's maximum tBPAR grade : grade IIA | Patient's maximum tBPAR grade : grade IIB | Patient's maximum tBPAR grade : grade III |
---|
EVR+rCNI | 25 | 34 | 23 | 21 | 9 | 6 |
,MPA+sCNI | 18 | 36 | 17 | 24 | 3 | 0 |
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Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2
Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2 (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| month 12 | month 24 |
---|
EVR+rCNI | 475 | 475 |
,MPA+sCNI | 441 | 426 |
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Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections
"Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)" (NCT01950819)
Timeframe: Month 12 and 24
Intervention | Participants (Count of Participants) |
---|
| month 12 | month 24 |
---|
EVR+rCNI | 66 | 74 |
,MPA+sCNI | 53 | 55 |
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Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)
"Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)" (NCT01950819)
Timeframe: Month 12 and 24
Intervention | events (Number) |
---|
| overall number of tBPAR regardless of grade | number of tBPAR regardless of grade days 1-90 | number of tBPAR regardless of grade days 91-180 | number of tBPAR regardless of grade days 181-360 | number of tBPAR regardless of grade days 361-540 | number of tBPAR regardless of grade days 541-720 | number of tBPAR regardless of grade days 721-810 |
---|
EVR+rCNI | 146 | 72 | 24 | 25 | 12 | 11 | 2 |
,MPA+sCNI | 116 | 63 | 14 | 20 | 15 | 2 | 2 |
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Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR
Renal allograft function : mean estimated glomerular filtration rate, eGFR (NCT01950819)
Timeframe: Baseline (week 4), Month 12 and 24
Intervention | mL/min/1.73m2 (Mean) |
---|
| baseline (week 4) | month 12 | month 24 |
---|
EVR+rCNI | 53.13 | 53.29 | 52.63 |
,MPA+sCNI | 52.25 | 54.49 | 54.91 |
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Renal Function Assessed by Creatinine Lab Values
Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis. (NCT01950819)
Timeframe: Month 12 and 24
Intervention | micromol/L (Mean) |
---|
| screening baseline (creatinine, micromol/L) | month 12 (creatinine, micromol/L) | month 24 (creatinine, micromol/L) |
---|
EVR+rCNI | 590.1 | 129.8 | 130.1 |
,MPA+sCNI | 601.8 | 128.6 | 127.6 |
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Part A: Percentage of Patients Experiencing Adverse Events (AEs)
"The safety and tolerability of olaparib in combination with abiraterone was assessed during Part A of the study. The percentage of patients experiencing AEs, including information on seriousness, severity, study treatment relationship and those leading to discontinuation for all doses of olaparib and for abiraterone are presented.~Severity of AEs was assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) v4.0. AEs were assigned to a Grade from 1 through 5 as follows:~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalisation; Grade 4: Life-threatening consequences; Grade 5: Death related to AE.~'c-r' = causally related 'discont' = discontinuation." (NCT01972217)
Timeframe: Cohort 1 and 2: From baseline in Part A (Day 1 for each cohort) up to 30 days following last dose of study treatment.
Intervention | Percentage of patients (Number) |
---|
| Any AE c-r to olaparib + abiraterone | Any AE c-r to olaparib only | Any AE c-r to abiraterone only | Any AE CTCAE Grade 3 or higher | Any AE CTCAE Grade 3 or higher c-r to olaparib | Any AE CTCAE Grade 3 or higher c-r to abiraterone | Any AE with outcome = death | Any serious AE (SAE) | Any SAE c-r to olaparib | Any SAE c-r to abiraterone | Any AE causing discont of olaparib | Any AE causing discont of olaparib c-r to olaparib | Any AE causing discont olaparib c-r to abiraterone |
---|
Part A Cohort 1: Olaparib 200 mg + Abiraterone | 66.7 | 33.3 | 0 | 66.7 | 0 | 0 | 0 | 66.7 | 0 | 0 | 0 | 0 | 0 |
,Part A Cohort 2: Olaparib 300 mg + Abiraterone | 46.2 | 7.7 | 15.4 | 23.1 | 7.7 | 7.7 | 0 | 23.1 | 0 | 0 | 7.7 | 0 | 0 |
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Part A PK: Abiraterone Tmax,ss
"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone tmax,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | Hours (Median) |
---|
| Abiraterone alone | Olaparib + abiraterone |
---|
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone | 2.525 | 2.500 |
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Part A PK: Abiraterone Tmax,ss
"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone tmax,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | Hours (Median) |
---|
| Olaparib + abiraterone |
---|
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone | 3.000 |
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Part A PK: Abiraterone Cmin,ss
"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone Cmin,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | ng/mL (Geometric Mean) |
---|
| Abiraterone alone | Olaparib + abiraterone |
---|
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone | 8.376 | 6.358 |
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Part A PK: Abiraterone Cmin,ss
"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone Cmin,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | ng/mL (Geometric Mean) |
---|
| Olaparib + abiraterone |
---|
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone | 7.983 |
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Part A PK: Abiraterone Cmax,ss
"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone Cmax,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | nanograms per millilitre (ng/mL) (Geometric Mean) |
---|
| Abiraterone alone | Olaparib + abiraterone |
---|
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone | 145.8 | 86.12 |
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Part A PK: Abiraterone Cmax,ss
"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone Cmax,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | nanograms per millilitre (ng/mL) (Geometric Mean) |
---|
| Olaparib + abiraterone |
---|
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone | 130.7 |
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Part A PK: Abiraterone AUCss
"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone AUCss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | ng*h/mL (Geometric Mean) |
---|
| Abiraterone alone | Olaparib + abiraterone |
---|
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone | 825.5 | 524.6 |
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Part A PK Analysis: Olaparib Time to Reach Maximum Plasma Concentration at Steady State (Tmax,ss)
"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib tmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | Hours (h) (Median) |
---|
| Olaparib alone | Olaparib + abiraterone |
---|
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone | 2.000 | 2.080 |
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Part A PK Analysis: Olaparib Time to Reach Maximum Plasma Concentration at Steady State (Tmax,ss)
"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib tmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | Hours (h) (Median) |
---|
| Olaparib + abiraterone |
---|
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone | 2.000 |
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Part A PK Analysis: Olaparib Minimum Plasma Concentration at Steady State (Cmin,ss)
"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmin,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | mcg/mL (Geometric Mean) |
---|
| Olaparib alone | Olaparib + abiraterone |
---|
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone | 1.264 | 0.9170 |
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Part A PK Analysis: Olaparib Minimum Plasma Concentration at Steady State (Cmin,ss)
"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmin,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | mcg/mL (Geometric Mean) |
---|
| Olaparib + abiraterone |
---|
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone | 1.279 |
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Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)
"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib AUCss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | mcg*h/mL (Geometric Mean) |
---|
| Olaparib alone | Olaparib + abiraterone |
---|
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone | 45.27 | 40.83 |
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Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)
"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib AUCss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | mcg*h/mL (Geometric Mean) |
---|
| Olaparib + abiraterone |
---|
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone | 49.51 |
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Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss)
"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | micrograms per millilitre (mcg/mL) (Geometric Mean) |
---|
| Olaparib alone | Olaparib + abiraterone |
---|
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone | 7.781 | 6.504 |
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Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss)
"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | micrograms per millilitre (mcg/mL) (Geometric Mean) |
---|
| Olaparib + abiraterone |
---|
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone | 7.724 |
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Part B: Percentage of Patients With Progression Events or Death (rPFS)
"The efficacy of olaparib when given in combination with abiraterone was assessed by rPFS, defined as the time from randomisation to disease progression using RECIST version 1.1 (for soft tissue disease) and PCWG-2 (for bone disease) criteria, or death.~Progression using RECIST 1.1 criteria was defined as at least 20% increase from baseline in the sum of diameters of target lesions, progression of existing non-target lesions, or the appearance of at least 1 new lesion.~Progression using PCWG-2 criteria was determined if 2 or more new metastatic bone lesions were observed (with a total of at least 4 new lesions since baseline assessment if observed at the 12 week scan, or persistence of or increase in number of lesions if observed after the 12 week scan as determined by a confirmatory scan at least 6 weeks later or at next scheduled visit).~The percentage of patients with progression events is presented overall and according to RECIST 1.1 and/or PCWG-2 criteria, or death." (NCT01972217)
Timeframe: From baseline, every 12 weeks up to Week 72, then every 24 weeks up to 24 months.
Intervention | Percentage of patients (Number) |
---|
Part B: Olaparib + Abiraterone | 64.8 |
Part B: Placebo + Abiraterone | 76.1 |
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Part A PK: Abiraterone AUCss
"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone AUCss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.
Intervention | ng*h/mL (Geometric Mean) |
---|
| Olaparib + abiraterone |
---|
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone | 718.9 |
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Part B: Percentage of Patients With PSA Responses
"The percentages of patients with single visit responses and with confirmed responses are presented to assess the anti-tumour activity of olaparib when given in addition to abiraterone, compared with placebo given in addition to abiraterone.~A single visit response was defined as any post-dose visit PSA level reduced by 50% or more compared with baseline.~A confirmed response was defined as a reduction in PSA level of 50% or more on 2 consecutive occasions at least 4 weeks apart compared with baseline.~Patients may have had more than 1 single visit response or confirmed response but were counted once." (NCT01972217)
Timeframe: From baseline, then every 4 weeks up to Week 24, and then every 12 weeks.
Intervention | Percentage of patients (Number) |
---|
| Single visit response | Confirmed response |
---|
Part B: Olaparib + Abiraterone | 50.7 | 47.9 |
,Part B: Placebo + Abiraterone | 47.9 | 42.3 |
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Part B: Percentage of Patients Experiencing AEs
"The safety and tolerability of olaparib when given in combination with abiraterone was assessed during Part B of the study. The percentage of patients experiencing AEs, including information on seriousness, severity, study treatment relationship and those leading to discontinuation for all doses of olaparib and for abiraterone are presented.~Severity of AEs was assessed using the NCI Common Terminology CTCAE v4.0. AEs were assigned to a Grade from 1 through 5 as follows:~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalisation; Grade 4: Life-threatening consequences; Grade 5: Death related to AE.~'c-r' = causally related. 'discont' = discontinuation. 'ola/pla' = olaparib/placebo." (NCT01972217)
Timeframe: From first dose of study treatment following randomisation in Part B up to 30 days following last dose of study treatment (up to approximately 3 years).
Intervention | Percentage of patients (Number) |
---|
| Any AE c-r to ola/pla + abiraterone | Any AE c-r to ola/pla only | Any AE c-r to abiraterone only | Any AE CTCAE Grade 3 or higher | Any AE CTCAE Grade 3 or higher c-r to ola/pla | Any AE CTCAE Grade 3 or higher c-r to abiraterone | Any AE with outcome = death | Any AE with outcome = death c-r to ola/pla | Any AE with outcome = death c-r to abiraterone | Any SAE | Any SAE c-r to ola/pla | Any SAE c-r to abiraterone | Any AE causing discont of ola/pla | Any AE causing discont of treatment c-r to ola/pla | Any AE causing discont treatment c-r abiraterone |
---|
Part B: Olaparib + Abiraterone | 45.1 | 18.3 | 1.4 | 53.5 | 23.9 | 16.9 | 5.6 | 1.4 | 0 | 35.2 | 9.9 | 5.6 | 29.6 | 16.9 | 8.5 |
,Part B: Placebo + Abiraterone | 12.7 | 9.9 | 7.0 | 28.2 | 5.6 | 1.4 | 1.4 | 0 | 0 | 19.7 | 1.4 | 0 | 9.9 | 5.6 | 1.4 |
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Part B: Percentage of Patients With at Least One Objective Response (Objective Response Rate [ORR])
"The overall radiological ORR was calculated to assess the anti-tumour activity of olaparib in combination with abiraterone, compared with placebo in combination with abiraterone.~The best overall ORR was defined as the percentage of patients with at least 1 visit response of complete response (CR) or partial response (PR) in soft tissue disease assessed by RECIST 1.1 and also bone scan status of non-progressive disease or non-evaluable for their bone scans assessed by PCWG-2.~CR: Disappearance of all target lesions. Reduction of pathological lymph nodes to <10 millimetres.~PR: At least a 30% decrease in the sum of diameters of target lesions from baseline.~The percentage of patients with a response is presented." (NCT01972217)
Timeframe: From baseline, then every 4 weeks up to Week 52, and then every 12 weeks.
Intervention | Percentage of patients (Number) |
---|
Part B: Olaparib + Abiraterone | 27.3 |
Part B: Placebo + Abiraterone | 31.6 |
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Part A: Number of Patients With Dose Limiting Toxicities (DLTs)
"DLTs were assessed by a Safety Review Committee (SRC) after a minimum of 3 patients had received at least 14 days of treatment in Part A.~A DLT was defined as any toxicity which was not a recognised AE of abiraterone or prednisolone, and was not attributable to the disease or disease-related processes under investigation, which occurred during a minimum period of 14 days treatment and which included: 1. haematological toxicity CTCAE v4.0 Grade 4 or higher present for more than 4 days (except anaemia); 2. non-haematological toxicity CTCAE v4.0 Grade 3 or higher including infection, corrected QT interval prolongation; 3. any other toxicity that was greater than that at baseline, was clinically significant and/or unacceptable, did not respond to supportive care, resulted in a disruption of dosing schedule of 7 days or more, or was judged to be a DLT by the SRC.~A DLT excluded alopecia and isolated laboratory changes of any grade without clinical sequelae or clinical significance." (NCT01972217)
Timeframe: From Day 1 for Cohort 1 and from Day 4 for Cohort 2 up to 14 days treatment with olaparib + abiraterone for 3 patients.
Intervention | Patients (Number) |
---|
Part A Cohort 1: Olaparib 200 mg + Abiraterone | 2 |
Part A Cohort 2: Olaparib 300 mg + Abiraterone | 4 |
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Primary Analysis: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication. (NCT01974440)
Timeframe: Up to 8 years
Intervention | Participants (Count of Participants) |
---|
Placebo + Chemoimmunotherapy (CIT) | 197 |
Ibrutinib + CIT | 199 |
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Primary Analysis: Overall Response Rate (ORR): Stratified Analysis
ORR was defined as the percentage of participants who achieved a CR or partial response (PR). Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years
Intervention | percentage of participants (Number) |
---|
Placebo + Chemoimmunotherapy (CIT) | 90.5 |
Ibrutinib + CIT | 91.6 |
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Primary Analysis: Overall Survival (OS): Stratified Analysis
OS was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years
Intervention | months (Median) |
---|
Placebo + Chemoimmunotherapy (CIT) | NA |
Ibrutinib + CIT | NA |
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Primary Analysis: Progression Free Survival (PFS): Stratified Analysis
PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 centimeters (cm) in any axis, 50% increase in sum of product of diameters (SPD) of greater than (>) 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years
Intervention | months (Median) |
---|
Placebo + Chemoimmunotherapy (CIT) | 23.75 |
Ibrutinib + CIT | 40.51 |
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Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL
DOR in MZL participants was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years
Intervention | months (Median) |
---|
Placebo + Chemoimmunotherapy (CIT) | 89.17 |
Ibrutinib + CIT | NA |
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Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire
Time-to-worsening in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. (NCT01974440)
Timeframe: Up to 8 years
Intervention | months (Median) |
---|
Placebo + Chemoimmunotherapy (CIT) | 37.03 |
Ibrutinib + CIT | 24.84 |
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Supplementary Analysis: Number of Participants With TEAEs: Participants With MZL
Number of MZL participants with TEAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication. (NCT01974440)
Timeframe: Up to 8 years
Intervention | Participants (Count of Participants) |
---|
Placebo + Chemoimmunotherapy (CIT) | 28 |
Ibrutinib + CIT | 28 |
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Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL
ORR in MZL participants was defined as the percentage of participants who achieved a CR or PR. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years
Intervention | percentage of participants (Number) |
---|
Placebo + Chemoimmunotherapy (CIT) | 82.1 |
Ibrutinib + CIT | 89.3 |
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Primary Analysis: Complete Response Rate (CRR): Stratified Analysis
CRR was defined as the percentage of participants who achieved a complete response (CR); (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years
Intervention | percentage of participants (Number) |
---|
Placebo + Chemoimmunotherapy (CIT) | 50.2 |
Ibrutinib + CIT | 55 |
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Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL)
PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by >=50% of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years
Intervention | months (Median) |
---|
Placebo + Chemoimmunotherapy (CIT) | 91.63 |
Ibrutinib + CIT | NA |
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Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL
TTW in MZL participants in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. (NCT01974440)
Timeframe: Up to 8 years
Intervention | months (Median) |
---|
Placebo + Chemoimmunotherapy (CIT) | 36.83 |
Ibrutinib + CIT | 58.91 |
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Primary Analysis: Duration of Response (DOR): Stratified Analysis
DOR was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years
Intervention | months (Median) |
---|
Placebo + Chemoimmunotherapy (CIT) | 21.68 |
Ibrutinib + CIT | 44.32 |
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Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL
CRR in MZL participants was defined as the percentage of participants who achieved a CR (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years
Intervention | percentage of participants (Number) |
---|
Placebo + Chemoimmunotherapy (CIT) | 60.7 |
Ibrutinib + CIT | 64.3 |
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Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL
OS in MZL participants was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years
Intervention | months (Median) |
---|
Placebo + Chemoimmunotherapy (CIT) | NA |
Ibrutinib + CIT | NA |
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Number of Participants With DLTs in Non-DLBCL Population
All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD. (NCT01992653)
Timeframe: Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)
Intervention | Participants (Count of Participants) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 0 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
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Number of Participants With Anti-Polatuzumab Vedotin Antibodies
The Anti-Drug Antibody (ADA) screening assay was optimized to tolerate drug interference and was able to detect 90 and 500 ng/mL of the positive control sample in the presence of 20 μg/mL of polatuzumab vedotin. Polatuzumab vedotin total antibody concentrations were determined for each ADA sample. Out of a total of 186 ADA samples that were measured for polatuzumab vedotin total antibody, 184 samples had levels less than 20 μg/mL. Polatuzumab vedotin total antibody concentrations ranged from <0.050 μg/mL to 52.1 μg/mL with a median concentration of 3.38 μg/mL. (NCT01992653)
Timeframe: Baseline up to Month 9 (assessed prior to polatuzumab vedotin infusion [0 hour; Hr] on Day 2 [D2] of Cy 1 and 2, D1 of Cy 4, treatment completion/early termination [Month 6], and at 3 months post-treatment [Month 9]; cycle length=21 days)
Intervention | Participants (Count of Participants) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 0 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
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Number of Participants With Anti-Obinutuzumab Antibodies
The ADA screening assay was optimized to tolerate drug interference and was able to detect 500 ng/mL of the ADA-positive control sample in the presence of 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations were determined for each ADA sample. Out of a total of 48 ADA samples that were measured for obinutuzumab, 9 samples had levels less than 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations in ADA samples ranged from 0.282 micrograms/mL to 522 micrograms/mL with a median concentration of 210 micrograms/mL. Therefore, it is possible that samples with obinutuzumab concentrations greater than 50 micrograms/mL might be false negative for ADA. (NCT01992653)
Timeframe: Baseline up to Month 9 (assessed prior to obinutuzumab infusion [0 Hr] on D1 of Cy 1, 2, 4 and at 3 months post-treatment [Month 9]; cycle length=21 days)
Intervention | Participants (Count of Participants) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 0 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
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Number of Participants With Adverse Events in Non-DLBCL Population
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs). (NCT01992653)
Timeframe: Baseline up to 5 years
Intervention | Participants (Count of Participants) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 1 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 1 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 1 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 2 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 2 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
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Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs). (NCT01992653)
Timeframe: Baseline up to 5 years
Intervention | Participants (Count of Participants) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 2 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 3 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 5 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 4 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 4 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 40 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 17 |
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Maximum Concentration (Cmax) of Polatuzumab Vedotin
Cmax for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Intervention | ng/mL (Mean) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 373 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 537 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 781 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 1400 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 537 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 557 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 532 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 530 |
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Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Intervention | Months (Median) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
Polatuzumab Vedotin (1.8mg) + R-CHP | 6.87 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 6.70 |
Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
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Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Intervention | Months (Median) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + R-CHP | NA |
Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 35.45 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
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Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Intervention | Months (Median) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
Polatuzumab Vedotin (1.8mg) + R-CHP | 4.11 |
Polatuzumab Vedotin (2.4mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
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Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Intervention | Months (Median) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + R-CHP | NA |
Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
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Clearance (CL) of Polatuzumab Vedotin
CL for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Intervention | mL/day/kg (Mean) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 14.0 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 17.3 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 12.8 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 10.5 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 13.2 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 18.7 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 18.9 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 17.7 |
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Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin
AUC information for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 minutes (min) post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Intervention | ng day/mL (Mean) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 1300 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 1510 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 2600 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 4090 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 1940 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 1850 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 1870 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 1940 |
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Plasma Levels of Cyclophosphamide
Plasma levels of cyclophosphamide will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin. (NCT01992653)
Timeframe: End of cyclophosphamide infusion (infusion time=1-24 Hr), 3 and 23 hours post end of cyclophosphamide infusion on D1 of Cy 1 and 3 (cycle length=21 days)
Intervention | ug/mL (Mean) |
---|
| C1D1 0.5hr POSTDOSE | C1D1 3.5hr POSTDOSE | C1D1 23.5hr POSTDOSE | C3D1 0.5hr POSTDOSE | C3D1 3.5hr POSTDOSE | C3D1 23.5hr POSTDOSE |
---|
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 32.3 | 22.5 | 3.32 | 35.2 | 22.5 | 3.16 |
,Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 37.5 | 23.2 | 2.98 | 34.8 | 24.2 | 3.17 |
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Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
Intervention | Score of a Questionnaire (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 22 |
---|
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0.32 | 0.91 | 0.07 | 0.22 | 0.26 | 0.17 | 0.25 | 0.35 | 0.31 | 0.38 | 0.53 | 0.39 | 0.65 | 0.78 | 0.62 | 0.70 | 1.12 | 0.91 | 0.64 | 0.45 | 0.09 |
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Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
Intervention | Score of a Questionnaire (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 |
---|
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 | 0 | 0.02 | 0.06 | 0.18 | 0.16 | 0.16 | 0.14 | 0.17 | 0.25 | 0.30 | 0.26 | 0.30 | 0.25 | 0.49 | 0.48 | 0.66 | 0.25 |
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Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
Intervention | Score of a Questionnaire (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 22 |
---|
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 | 1 | 0 | 0.40 | 0.50 | 0.17 | 0.40 | 0.60 | 0.25 | 0.50 | 1.14 | 0.57 | 0.71 | 1.12 | 0.88 | 0.75 | 1.50 | 1.14 | 2 | 2 | 1 |
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Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
Intervention | Score of a Questionnaire (Mean) |
---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 |
---|
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 | 0 | 0.25 | 0.33 | 0.40 | 0.40 | 0.40 | 0.29 | 0.33 | 0.40 | 0.86 | 0.86 | 1.14 | 0.86 | 1.12 | 1.12 | 1.56 | 0.40 |
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Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET. (NCT01992653)
Timeframe: At the end of treatment (Month 6)
Intervention | Percentage of Participants (Number) |
---|
| Complete Response (CR) | Partial Response (PR) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 100.0 | 0 |
,Polatuzumab Vedotin (1.4mg) + G-CHP | 100.0 | 0 |
,Polatuzumab Vedotin (1.8mg) + G-CHP | 100.0 | 0 |
,Polatuzumab Vedotin (1.8mg) + R-CHP | 100.0 | 0 |
,Polatuzumab Vedotin (2.4mg) + R-CHP | 100.0 | 0 |
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Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET. (NCT01992653)
Timeframe: At the end of treatment (Month 6)
Intervention | Percentage of Participants (Number) |
---|
| Complete Response (CR) | Partial Response (PR) |
---|
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 76.5 | 11.8 |
,Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 75.0 | 15.0 |
,Polatuzumab Vedotin (1.0mg) + R-CHP | 50.0 | 50.0 |
,Polatuzumab Vedotin (1.4mg) + G-CHP | 75.0 | 0 |
,Polatuzumab Vedotin (1.4mg) + R-CHP | 100.0 | 0 |
,Polatuzumab Vedotin (1.8mg) + G-CHP | 100.0 | 0 |
,Polatuzumab Vedotin (1.8mg) + R-CHP | 100.0 | 0 |
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Terminal Half-Life (t1/2) of Polatuzumab Vedotin
t1/2 for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Intervention | days (Mean) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 5.03 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 4.85 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 4.79 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 4.42 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 5.19 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 4.89 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 5.03 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 5.50 |
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Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin
Vss for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Intervention | mL/kg (Mean) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 58.2 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 80.0 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 57.7 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 41.9 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 67.9 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 87.5 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 96.5 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 99.3 |
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Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population
Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage. (NCT01992653)
Timeframe: 6 months
Intervention | Percentage (Mean) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 100.00 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 100.94 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 132.22 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 99.72 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 100.17 |
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Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population
Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage. (NCT01992653)
Timeframe: 6 months
Intervention | Percentage (Mean) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 100.70 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 99.97 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 96.04 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 99.35 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 99.95 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 96.71 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 98.92 |
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Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Intervention | Months (Median) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
Polatuzumab Vedotin (1.8mg) + R-CHP | 6.87 |
Polatuzumab Vedotin (2.4mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
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Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Intervention | Months (Median) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + R-CHP | NA |
Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
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Overall Survival for Non-DLBCL Population
The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive. (NCT01992653)
Timeframe: Screening up to death due to any cause (up to approximately 6 years)
Intervention | Months (Median) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
Polatuzumab Vedotin (1.8mg) + R-CHP | 15.24 |
Polatuzumab Vedotin (2.4mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
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Overall Survival for DLBCL Population
The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive. (NCT01992653)
Timeframe: Screening up to death due to any cause (up to approximately 6 years)
Intervention | Months (Median) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + R-CHP | NA |
Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
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Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population
All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD. (NCT01992653)
Timeframe: Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)
Intervention | Participants (Count of Participants) |
---|
Polatuzumab Vedotin (1.0mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.4mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.8mg) + R-CHP | 1 |
Polatuzumab Vedotin (2.4mg) + R-CHP | 0 |
Polatuzumab Vedotin (1.4mg) + G-CHP | 1 |
Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
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Plasma Levels of Doxorubicin
Plasma levels of doxorubicin will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin. (NCT01992653)
Timeframe: 2, 24 hours post end of doxorubicin infusion (infusion time=15 min) on D1 of Cy 1 and 3 (cycle length=21 days)
Intervention | ug/mL (Mean) |
---|
| C1D1 2hr POSTDOSE | C1D1 24hr POSTDOSE | C3D1 2hr POSTDOSE | C3D1 24hr POSTDOSE |
---|
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 30.2 | 11.7 | 29.6 | 9.14 |
,Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 35.4 | 9.13 | 29.3 | 8.68 |
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Safety and Tolerability
Number of Participants with Adverse Events (NCT01994590)
Timeframe: Participants are followed while actively taking study drug and for at least 30 days post last dose.
Intervention | Participants (Count of Participants) |
---|
All Patients | 4 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
---|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 33.2 | -0.7 | -1.9 | -1.0 | -0.4 | -0.8 | -1.3 | -1.4 | -1.5 | -1.0 | -0.8 | -0.8 | -1.1 | -0.5 | -2.1 | -2.0 | -1.5 | -0.2 | -1.0 | 3.1 | -0.5 | 0.0 |
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Percentage of Participants With Adverse Events (AEs) Leading to Death
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
Intervention | percentage of participants (Number) |
---|
Enzalutamide 160 mg | 5.9 |
Enzalutamide Crossing Over to Abiraterone + Prednisone | 0 |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 3.2 |
Placebo+Abiraterone 1000mg+ Prednisone 10mg | 2.4 |
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Progression Free Survival (PFS)
PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date. (NCT01995513)
Timeframe: From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (maximum up to 20.3 months)
Intervention | months (Median) |
---|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 5.7 |
Placebo+Abiraterone 1000mg+ Prednisone 10mg | 5.6 |
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Rate of Pain Progression
Rate of pain progression was defined as percentage of participants with an increase of >=30% from baseline in the mean Brief Pain Inventory-Short Form (BPI-SF) pain intensity item scores of 4 items assessing average, worst, least, and intermediate pain severity. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf score range for each item was from 0=no pain to 10=worst possible pain. Total score was reported as average of individual questions ranges from 0 to 10, where lower scores indicated less pain or less pain interference. (NCT01995513)
Timeframe: Month 6
Intervention | percentage of participants (Number) |
---|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 36.2 |
Placebo+Abiraterone 1000mg+ Prednisone 10mg | 27.1 |
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Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation. (NCT01995513)
Timeframe: From randomization up to maximum of 18.4 months
Intervention | months (Median) |
---|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 4.6 |
Placebo+Abiraterone 1000mg+ Prednisone 10mg | 6.4 |
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Time to First Use of New Antineoplastic Therapy for Prostate Cancer
It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment. (NCT01995513)
Timeframe: From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months
Intervention | months (Median) |
---|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 10.3 |
Placebo+Abiraterone 1000mg+ Prednisone 10mg | 8.6 |
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Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
Intervention | percentage of participants (Number) |
---|
| AEs | SAEs |
---|
Enzalutamide 160 mg | 93.5 | 32.0 |
,Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 91.2 | 37.6 |
,Enzalutamide Crossing Over to Abiraterone + Prednisone | 100 | 30.8 |
,Placebo+Abiraterone 1000mg+ Prednisone 10mg | 92.7 | 29.8 |
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Prostate Specific Antigen (PSA) Response Rate
PSA response rate was defined as percentage of participants with >=30% and >=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well. (NCT01995513)
Timeframe: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Intervention | percentage of participants (Number) |
---|
| >= 50% | >= 30% |
---|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 0.8 | 2.4 |
,Placebo+Abiraterone 1000mg+ Prednisone 10mg | 2.5 | 2.5 |
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Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
Intervention | percentage of participants (Number) |
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| Drug Discontinuation with Abiraterone | Drug Discontinuation with Prednisone |
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Enzalutamide Crossing Over to Abiraterone + Prednisone | 7.7 | 7.7 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
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| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
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Placebo+Abiraterone 1000mg+ Prednisone 10mg | 34.2 | -0.9 | -0.1 | -1.4 | -0.6 | -0.8 | -0.3 | -0.6 | -0.8 | -0.7 | -1.7 | -0.9 | -1.8 | -3.3 | -3.1 | -2.6 | 1.1 | -6.4 | -1.5 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
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| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
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Placebo+Abiraterone 1000mg+ Prednisone 10mg | 20.3 | -0.7 | -0.4 | -0.5 | -0.7 | -0.3 | -0.2 | -0.7 | 0.2 | 0.8 | -0.3 | 1.5 | 1.3 | 2.0 | 2.9 | 1.7 | 2.3 | 4.0 | 2.5 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
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Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 22.9 | -0.8 | -1.0 | -1.1 | -0.8 | -1.7 | -2.5 | -2.5 | -1.8 | -1.5 | -2.0 | -0.9 | -0.2 | -0.4 | -0.8 | -1.9 | -0.3 | -0.3 | -0.7 | 1.5 | -1.0 | 0.0 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
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| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
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Placebo+Abiraterone 1000mg+ Prednisone 10mg | 23.6 | 0.1 | 0.0 | -0.3 | -0.8 | -0.4 | 0.3 | 0.1 | 0.4 | 0.4 | -0.4 | 0.6 | 0.7 | 0.4 | 0.4 | 0.4 | -0.5 | -3.0 | 4.0 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
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| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 (n =17, 13) | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
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Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 116.4 | -3.3 | -4.4 | -3.7 | -2.5 | -3.1 | -6.8 | -5.9 | -6.1 | -5.7 | -6.0 | -4.2 | -4.8 | -4.3 | -5.5 | -7.0 | -3.5 | -0.7 | -4.0 | 10.8 | -5.5 | -2.0 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
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| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
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Placebo+Abiraterone 1000mg+ Prednisone 10mg | 22.4 | -0.8 | -0.4 | -0.6 | -1.2 | -1.0 | -0.2 | 0.0 | 0.8 | -0.1 | -0.8 | 0.0 | 0.4 | 0.2 | -0.2 | -0.5 | -0.5 | -1.0 | -0.5 |
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Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
Intervention | percentage of participants (Number) |
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| Drug Discontinuation with Enzalutamide or Placebo | Drug Discontinuation with Abiraterone | Drug Discontinuation with Prednisone |
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Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 23.2 | 23.2 | 16.0 |
,Placebo+Abiraterone 1000mg+ Prednisone 10mg | 11.3 | 12.9 | 12.1 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
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Placebo+Abiraterone 1000mg+ Prednisone 10mg | 18.5 | 0.1 | 0.2 | 0.4 | 0.1 | 0.3 | 0.3 | 0.9 | 0.9 | 1.4 | 1.2 | 1.3 | 1.2 | 1.6 | 1.1 | 2.9 | 1.5 | -5.0 | 2.0 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
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Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 18.1 | -0.1 | -0.1 | -0.2 | 0.3 | 0.3 | -0.5 | 0.1 | -0.7 | 0.1 | -0.5 | 0.0 | 0.1 | -0.4 | -0.3 | -0.9 | -0.5 | 1.0 | 0.1 | 1.5 | -1.5 | -3.0 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 (n =17, 13) | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
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Placebo+Abiraterone 1000mg+ Prednisone 10mg | 119.0 | -2.2 | -0.5 | -2.3 | -2.7 | -2.1 | 0.3 | -0.2 | 0.9 | 1.3 | -2.6 | 1.8 | 1.8 | 0.1 | 0.6 | 1.9 | 4.4 | -35.0 | 6.5 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
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Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 22.1 | -0.5 | -0.4 | -0.1 | -0.5 | 0.1 | -0.1 | -0.2 | -0.8 | -1.4 | -0.9 | -0.6 | -1.0 | -2.0 | -1.5 | -1.5 | -1.4 | -0.6 | -0.9 | 6.2 | -1.0 | 0.0 |
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Intervention | units on a scale (Mean) |
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| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
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Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 20.2 | -1.0 | -1.2 | -1.3 | -1.2 | -1.0 | -2.4 | -2.0 | -1.5 | -2.1 | -2.0 | -2.1 | -1.6 | -1.4 | -0.8 | -1.2 | 0.2 | -0.6 | -1.6 | -1.5 | -1.5 | 1.0 |
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Objective Response Rate (ORR)
Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: >= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. (NCT01995513)
Timeframe: From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
Intervention | percentage of participants (Number) |
---|
| CR + PR | CR + PR + SD |
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Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 0.0 | 68.4 |
,Placebo+Abiraterone 1000mg+ Prednisone 10mg | 5.0 | 57.5 |
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Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
Intervention | percentage of participants (Number) |
---|
| Drug Discontinuation with Enzalutamide or Placebo |
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Enzalutamide 160 mg | 11.8 |
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Time to Prostate Specific Antigen (PSA) Progression
Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of >=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date. (NCT01995513)
Timeframe: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Intervention | months (Median) |
---|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 2.8 |
Placebo+Abiraterone 1000mg+ Prednisone 10mg | 2.8 |
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Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment
Number of days post-transplant to the first episode of acute rejection that required treatment. This includes acute rejection episodes requiring treatment that were not biopsy proven. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
Intervention | Days (Mean) |
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Enrolled, Transplanted | 23 |
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Number of Days From Transplant to Platelet Count Recovery
Time (in days) from transplant to the first day of a platelet count of ≥20,000 per μL without a prior platelet transfusion in the preceding seven days. Low platelet numbers is associated with increased risk of bleeding and bruising. A healthy person has a platelet count ranging from 150,000 to 450,000 platelets per microliter of blood. (NCT02029638)
Timeframe: Transplant to Platelet Count Recovery
Intervention | Days (Mean) |
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Enrolled, Transplanted | 36 |
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Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery
Time (in days) from neutrophil nadir, the first day post-transplant on which the absolute neutrophil count (ANC) is below 500 per µL, to the first day after three consecutive daily ANCs ≥ 500 per µL. ANC is a measure of the number of neutrophils present in the blood. Neutrophils are a type of white blood cell that fight against infection. A healthy person has an ANC between 2,500 and 6,000 per µL. A value below 500 per µL means the risk of infection is higher. (NCT02029638)
Timeframe: Post-Transplant Neutrophil Nadir to Neutrophil Recover
Intervention | Days (Mean) |
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Enrolled, Transplanted | 15 |
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Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Time (in days) from the start date of the AE until the end date of the AE. Two events contributed to this calculation. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)
Intervention | Days (Mean) |
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Enrolled, Transplanted | 9.5 |
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Percent of Participants Who Achieved Operational Tolerance
Operational tolerance is defined as remaining off all immunosuppression 52 weeks after completion of immunosuppression withdrawal, with no evidence of biopsy-proven allograft rejection and, with acceptable renal function defined as a serum creatinine that has increased no more than 25% above baseline at the primary endpoint visit. Baseline creatinine is defined as the average of the lowest three creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval. (NCT02029638)
Timeframe: Transplantation through 52 Weeks after Discontinuation of All Immunosuppression
Intervention | Percent of participants (Number) |
---|
Enrolled, Transplanted | 0 |
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Duration in Days of Graft-versus-Host Disease in Transplanted Participants
Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Duration (in days) is measured as the time from the start of the GVHD event to the end of the GVHD event. (NCT02029638)
Timeframe: Transplant to Two Years Post-Transplant
Intervention | Days (Mean) |
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Enrolled, Transplanted | 7 |
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Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology
This outcome includes results from biopsies with proven acute renal allograft rejection according to the 2007 Banff Classification Renal Allograft Pathology. A Banff result of indeterminate is not classified as rejection. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
Intervention | participants (Number) |
---|
| Acute Cellular Rejection Banff Grade IA | Acute Cellular Rejection Banff Grade IB | Acute Cellular Rejection Banff Grade IIA | Acute Cellular Rejection Banff Grade IIB | Acute Cellular Rejection Banff Grade III | Acute Antibody Mediated Rejection |
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Enrolled, Transplanted | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)
Intervention | Events (Number) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
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Enrolled, Not Transplanted | 0 | 0 | 0 | 0 | 0 |
,Enrolled, Transplanted | 0 | 0 | 2 | 0 | 0 |
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Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation
Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months)
Intervention | Participants (Count of Participants) |
---|
Enrolled, Transplanted | 0 |
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Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal
Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT02029638)
Timeframe: Initiation of Immunosuppression Withdrawal to End of Study (to 25 months)
Intervention | Participants (Count of Participants) |
---|
Enrolled, Transplanted | 0 |
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Number of Participants Free From Return to Immunosuppression for the Duration of the Study
Participants who were able to withdrawal successfully from all immunosuppression medication and remained off all immunosuppression medication for the remainder of the study. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 Months)
Intervention | Participants (Count of Participants) |
---|
Enrolled, Transplanted | 0 |
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Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant
Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. (NCT02029638)
Timeframe: Transplant to Two Years Post-Transplant
Intervention | Participants (Count of Participants) |
---|
Enrolled, Transplanted | 1 |
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Number of Transplanted Participants With Engraftment Syndrome
Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil counts ≥ 500 per µL), without apparent other cause. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
Intervention | Participants (Count of Participants) |
---|
Enrolled, Transplanted | 0 |
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Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection
Outcome includes participants who experienced chronic T cell-mediated rejection, antibody-mediated rejection and progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy, without an alternative, non-rejection related cause. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
Intervention | Participants (Count of Participants) |
---|
Enrolled, Transplanted | 1 |
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Number of Transplanted Participants With Acute Renal Allograft Rejection
Acute renal allograft rejection demonstrated either by biopsy or clinically (when a biopsy could not be performed). This measure includes participants with biopsy proven acute renal allograft rejection and those that have creatinine values 25% or greater relative to baseline for over 72 hours. Baseline serum creatinine is defined as the average of the lowest three serum creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
Intervention | Participants (Count of Participants) |
---|
Enrolled, Transplanted | 1 |
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Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)
Intervention | Events (Number) |
---|
| Infection | Wound complications | Post-transplant diabetes | Hemorrhagic cystitis | Malignancy |
---|
Enrolled, Not Transplanted | 0 | 0 | 0 | 0 | 0 |
,Enrolled, Transplanted | 2 | 0 | 0 | 0 | 0 |
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Number of Transplanted Participants Who Died
Number of participant deaths after receiving a transplant per protocol. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
Intervention | Participants (Count of Participants) |
---|
Enrolled, Transplanted | 1 |
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Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed
Number of transplanted participants who remained off immunosuppression for ≥52 weeks, including those in whom the 52 week biopsy was not performed. This outcome included participants who were able to withdrawal successfully from all immunosuppression medication and remain off all immunosuppression for 52 weeks after the completion of withdrawal. (NCT02029638)
Timeframe: Transplant to 52 Weeks after Discontinuation of All Immunosuppression
Intervention | Participants (Count of Participants) |
---|
Enrolled, Transplanted | 0 |
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Time to Radiological Progression
(NCT02034552)
Timeframe: From the randomization date to the date of radiological disease progression (about 30.82months)
Intervention | Months (Median) |
---|
Radium-223 Dichloride (Xofigo, BAY88-8223) | 4.40 |
Radium-223 With Abiraterone & Prednision | NA |
Radium-223 With Enzalutamide | NA |
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Time to Radiological Bone Progression
(NCT02034552)
Timeframe: From the randomization date to the date of radiological bone progression (about 30.82 months)
Intervention | Months (Median) |
---|
Radium-223 Dichloride (Xofigo, BAY88-8223) | 11.5 |
Radium-223 With Abiraterone & Prednision | NA |
Radium-223 With Enzalutamide | NA |
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Time to First Symptomatic Skeletal Event
(NCT02034552)
Timeframe: From the randomization date to the first SSE on or following the randomization date (about 30.82 months)
Intervention | Months (Median) |
---|
Radium-223 Dichloride (Xofigo, BAY88-8223) | NA |
Radium-223 With Abiraterone & Prednision | NA |
Radium-223 With Enzalutamide | NA |
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Symptomatic Skeletal Event-free Survival
(NCT02034552)
Timeframe: From the randomization date to the first SSE on or following the randomization date or death, whichever occurred first (about 32.39 months)
Intervention | Months (Median) |
---|
Radium-223 Dichloride (Xofigo, BAY88-8223) | 11.93 |
Radium-223 With Abiraterone & Prednision | NA |
Radium-223 With Enzalutamide | 19.91 |
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Radiological Progression Free Survival
(NCT02034552)
Timeframe: From randomization to radiological disease progression or death from any cause (about 30.82 months )
Intervention | Months (Median) |
---|
Radium-223 Dichloride (Xofigo, BAY88-8223) | 4.40 |
Radium-223 With Abiraterone & Prednision | NA |
Radium-223 With Enzalutamide | NA |
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Overall Survival
(NCT02034552)
Timeframe: From the randomization date to the date of death due to any cause (about 42.94 months)
Intervention | Months (Median) |
---|
Radium-223 Dichloride (Xofigo, BAY88-8223) | 35.81 |
Radium-223 With Abiraterone & Prednision | 37.55 |
Radium-223 With Enzalutamide | 29.86 |
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Bone Scan Lesion Area
Bone scan lesion area was defined as the sum of the pixel areas (cm2) of the set of the whole body technetium-99 bone scan imaging pixels identified as bone lesion. (NCT02034552)
Timeframe: At 24 weeks
Intervention | cm^2 (Mean) |
---|
Radium-223 Dichloride (Xofigo, BAY88-8223) | 30227.13 |
Radium-223 With Abiraterone & Prednision | 10185.58 |
Radium-223 With Enzalutamide | 17321.45 |
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Patient Bone Scan Response Rate
Radiological bone scan response based on change from baseline of digitized technetium-99 bone scans using computer-aided detection software. Responder (R): 30% or greater resolution of the BSLA compared to baseline. Stable Disease (SD): Not meeting the criteria for R, PD, or UE. Progressive Disease (PD): Two or more new areas of radiotracer uptake attributable to metastatic disease in regions of bone that had not previously shown radiotracer uptake or greater than 30% increase from baseline in BSLA attributable to metastatic disease. Unable to Evaluate (UE): Assigned if bone scan results cannot be interpreted due to inconsistent image acquisition parameters compared to the reference scan, incomplete imaging, or other similar technical deficiencies. (NCT02034552)
Timeframe: At 24 weeks
Intervention | Percentage (Number) |
---|
| Responder (R) | Stable Disease (SD) | Progressive Disease (PD) | Missing |
---|
Radium-223 Dichloride (Xofigo, BAY88-8223) | 22.2 | 0 | 27.8 | 50.0 |
,Radium-223 With Abiraterone & Prednision | 57.9 | 21.1 | 5.3 | 15.8 |
,Radium-223 With Enzalutamide | 50.0 | 18.8 | 12.5 | 18.8 |
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Number of Participants With Treatment-emergent Bone Fractures
Treatment-emergent fractures were adverse events identified as fractures that occurred after start of study treatment until the end of the treatment period. All bone fractures and bone-associated events (e.g., osteoporosis) were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator's causality assessment. (NCT02043678)
Timeframe: From start of study treatment until 4 weeks after last study treatment, up to 65 months
Intervention | Participants (Count of Participants) |
---|
Radium-223 Dichloride + Abi/Pred | 107 |
Placebo + Abi/Pred | 49 |
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Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity
"An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with reasonable causal relationship to the study treatment decided by the investigators." (NCT02043678)
Timeframe: After the treatment period, up to 46 months
Intervention | Participants (Count of Participants) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|
Placebo + Abi/Pred | 3 | 3 | 3 | 0 |
,Radium-223 Dichloride + Abi/Pred | 3 | 9 | 5 | 1 |
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Time to Pain Progression
Time to pain progression was defined as the interval from randomization to the first date a subject experienced pain progression, assessed by BPI-SF (see Baseline Characteristics) and defined as: an increase of 2 or more points in the average worst pain score (WPS) from baseline observed at 2 consecutive evaluations >= 4 weeks apart or initiation of short- or long-acting opioid use for pain for subjects with WPS 0 at baseline; an increase of 2 or more points in the average WPS from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart and an average WPS of ≥ 4 OR initiation of short- or long-acting opioid use for pain for subjects with WPS 1 to 3 at baseline. Subjects without pain progression at the end of study are censored at the last date known to have not progressed: the last evaluation date for pain scores or last visit when recorded opiate use, whichever is last. Subjects with no on-study assessment or no baseline assessment are censored at the date of randomization. (NCT02043678)
Timeframe: From randomization until the date of pain progression based on pain score, up to 47 months
Intervention | Months (Median) |
---|
Radium-223 Dichloride + Abi/Pred | 14.4 |
Placebo + Abi/Pred | 18.7 |
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Time to Opiate Use for Cancer Pain
Time to opiate use for cancer pain was defined as the interval from the date of randomization to the date of opiate use. (NCT02043678)
Timeframe: From randomization until the date of opiate use, up to 47 months
Intervention | Months (Median) |
---|
Radium-223 Dichloride + Abi/Pred | 19.0 |
Placebo + Abi/Pred | 22.6 |
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Symptomatic Skeletal Event Free Survival (SSE-FS)
SSE-FS was defined as time (months) from randomization to the earliest of onset date of skeletal symptoms treated with external beam radiotherapy (EBRT), onset date of pathological bone fracture, onset date of spinal cord compression, procedure date of tumor-related orthopedic surgery, or death from any cause. Subjects who died without prior SSE and ≥ 13 weeks after the last SSE assessment are censored at the last SSE assessment date. Subjects alive at the survival cut-off date are censored at the last date known to be alive. Subjects with multiple events are only counted for the category in which the first event occurred. If multiple SSE (component events) occur on the same date for 1 subject, the subject is only counted into 1 category in the order of: spinal cord compression > bone fracture > orthopedic surgery > EBRT. (NCT02043678)
Timeframe: From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 months
Intervention | Months (Median) |
---|
Radium-223 Dichloride + Abi/Pred | 22.3 |
Placebo + Abi/Pred | 26.0 |
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Radiological Progression Free Survival (rPFS)
rPFS was defined as the time (months) from the date of randomization to the date of confirmed radiological progression or death (if death occurred before progression) based on independent assessment. (NCT02043678)
Timeframe: From randomization until the date of confirmed radiological progression or death, up to 47 months
Intervention | Months (Median) |
---|
Radium-223 Dichloride + Abi/Pred | 11.2 |
Placebo + Abi/Pred | 12.4 |
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Overall Survival (OS)
OS was defined as the time (months) from the date of randomization to the date of death due to any cause. Subjects alive at the survival cut-off date were censored at the last date known to be alive. (NCT02043678)
Timeframe: From randomization until death from any cause, up to 67 months
Intervention | Months (Median) |
---|
Radium-223 Dichloride + Abi/Pred | 30.1 |
Placebo + Abi/Pred | 34.8 |
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Number of Participants With Any Treatment-emergent Additional Primary Malignancies
Treatment-emergent additional primary malignancies were adverse events identified as additional primary malignancies that occurred after start of study treatment until the end of the treatment period. (NCT02043678)
Timeframe: From start of study treatment until 4 weeks after last study treatment, up to 65 months
Intervention | Participants (Count of Participants) |
---|
Radium-223 Dichloride + Abi/Pred | 26 |
Placebo + Abi/Pred | 25 |
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Time to Cytotoxic Chemotherapy
Time to cytotoxic chemotherapy is time (months) from randomization to the earliest date of the first cytotoxic chemotherapy. Participants who have not started cytotoxic chemotherapy during the study were censored at the last assessment date. (NCT02043678)
Timeframe: From randomization until the date of first cytotoxic chemotherapy, up to 47 months
Intervention | Months (Median) |
---|
Radium-223 Dichloride + Abi/Pred | 29.5 |
Placebo + Abi/Pred | 28.5 |
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Number of Participants With Post-treatment Adverse Events
"An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with reasonable causal relationship to the study treatment decided by the investigators." (NCT02043678)
Timeframe: After the treatment period, up to 46 months
Intervention | Participants (Count of Participants) |
---|
| Any events | Any drug-related events | Any chemotherapy-related events | Any additional primary malignancies |
---|
Placebo + Abi/Pred | 133 | 9 | 34 | 7 |
,Radium-223 Dichloride + Abi/Pred | 138 | 18 | 31 | 6 |
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Number of Participants With Treatment-emergent Adverse Events
"An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was lifethreatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. AEs or SAEs occurring after start of study treatment until the end of the treatment period were defined as treatment-emergent AEs (TEAEs) or serious TEAEs. Drug-related TEAEs or serious TEAEs were those with reasonable causal relationship to the study treatment decided by the investigators." (NCT02043678)
Timeframe: From start of study treatment until the end of the treatment period, up to 65 months
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Any drug-related TEAE | Radium-223/Placebo-related TEAE | Any serious TEAE | Any drug-related serious TEAE | Radium-223/Placebo-related serious TEAE |
---|
Placebo + Abi/Pred | 387 | 271 | 92 | 172 | 29 | 7 |
,Radium-223 Dichloride + Abi/Pred | 382 | 265 | 92 | 175 | 32 | 11 |
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Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
Post-treatment blood and lymphatic system disorders were adverse events identified as blood and lymphatic system disorders that occurred after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study. (NCT02043678)
Timeframe: After the treatment period, up to 46 months
Intervention | Participants (Count of Participants) |
---|
| Anaemia | Bone marrow failure | Febrile neutropenia | Leukopenia | Neutropenia | Pancytopenia | Thrombocytopenia |
---|
Placebo + Abi/Pred | 4 | 0 | 8 | 0 | 3 | 1 | 2 |
,Radium-223 Dichloride + Abi/Pred | 5 | 1 | 5 | 1 | 8 | 0 | 2 |
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Number of Participants With Post-treatment Bone Fractures
Post-treatment fractures were adverse events identified as fractures that occured after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study. All bone fractures and bone-associated events (e.g., osteoporosis), were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator's causality assessment. (NCT02043678)
Timeframe: After the treatment period, up to 46 months
Intervention | Participants (Count of Participants) |
---|
| Lumbar vertebral fracture | Rib fracture | Spinal compression fracture | Thoracic vertebral fracture | Traumatic fracture | Osteoporotic fracture | Pathological fracture |
---|
Placebo + Abi/Pred | 1 | 1 | 1 | 1 | 2 | 0 | 13 |
,Radium-223 Dichloride + Abi/Pred | 0 | 0 | 0 | 0 | 6 | 6 | 12 |
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Cyclophosphamide PK: Cmax
Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Intervention | mcg/mL (Mean) |
---|
Venetoclax PK Popluation | 32.1 |
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Doxorubicin PK: Cmax
Cmax was determined using the post-dose Doxorubicin plasma concentrations. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Intervention | mcg/mL (Mean) |
---|
Venetoclax PK Popluation | 1260 |
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Prednisone Plasma PK: Cmax
Cmax was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Intervention | Ng/ML (Mean) |
---|
| Cycle 1, Day 1 | Cycle 2, Day 1 |
---|
Venetoclax PK Popluation | 49.9 | 43.2 |
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Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy
Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%. (NCT02055820)
Timeframe: Baseline up to Cycle 6 (cycle length = 21 days)
Intervention | Percentage of participants (Number) |
---|
| Cyclophosphamide | Doxorubicin | Vincristine | Prednisone |
---|
Venetoclax + R-CHOP Arm | 89.5 | 88.6 | 86.6 | 87.4 |
,Venetoclax 600mg + G-CHOP | 77.4 | 77.4 | 78.1 | 81.3 |
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Relative Dose Intensity of Venetoclax
Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%. (NCT02055820)
Timeframe: Baseline up to Cycle 6 (cycle length = 21 days)
Intervention | Percentage of Partcipants (Number) |
---|
| <80% | 80-<85% | 85-<90% | >=90% |
---|
Venetoclax + G-CHOP 800 mg | 83.3 | 0.00 | 16.7 | 0.00 |
,Venetoclax + G-CHOP 800mg B | 100.0 | 0.00 | 0.00 | 0.00 |
,Venetoclax + R-CHOP 800 mg Phase II | 26.0 | 3.4 | 2.9 | 67.6 |
,Venetoclax 200 mg + R-CHOP | 71.4 | 0.00 | 0.00 | 28.6 |
,Venetoclax 200mg + G-CHOP | 100.00 | 0.00 | 0.00 | 0.00 |
,Venetoclax 400 mg + R-CHOP | 0.00 | 0.00 | 0.00 | 100.00 |
,Venetoclax 400mg + G-CHOP | 14.3 | 14.3 | 0.00 | 71.4 |
,Venetoclax 600 mg + R-CHOP | 12.5 | 12.5 | 12.5 | 62.5 |
,Venetoclax 600mg + G-CHOP | 50.0 | 16.7 | 0.00 | 33.3 |
,Venetoclax 800mg + R-CHOP | 0.00 | 0.00 | 0.00 | 100.00 |
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Prednisone Plasma PK: Tmax
Tmax was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Intervention | Hour (Mean) |
---|
| Cycle 1, Day 1 | Cycle 2, Day 1 |
---|
Venetoclax PK Popluation | 2.19 | 3.80 |
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Prednisone Plasma PK: AUC
AUC was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Intervention | hr*mcg/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 2, Day 1 |
---|
Venetoclax PK Popluation | 195 | 184 |
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Vincristine PK: Cmax
Cmax was determined using the post-dose Vincristine plasma concentrations. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Intervention | mcg/mL (Mean) |
---|
Venetoclax PK Popluation | 54.0 |
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Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)
Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts. (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
Intervention | Hour (Mean) |
---|
Venetoclax + R-CHOP 100 mg | 4.0 |
Venetoclax 200 mg + R-CHOP | 4.59 |
Venetoclax 400 mg + R-CHOP | 6.50 |
Venetoclax 600 mg + R-CHOP | 5.52 |
Venetoclax 800mg + R-CHOP | 5.53 |
Venetoclax 200mg + G-CHOP | 5.72 |
Venetoclax 400mg + G-CHOP | 6.56 |
Venetoclax 600mg + G-CHOP | 5.30 |
Venetoclax + G-CHOP 800 mg | 5.79 |
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Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval
Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts. (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
Intervention | mcg/mL (Mean) |
---|
Venetoclax + R-CHOP 100 mg | 0.0714 |
Venetoclax 200 mg + R-CHOP | 0.522 |
Venetoclax 400 mg + R-CHOP | 0.253 |
Venetoclax 600 mg + R-CHOP | 0.387 |
Venetoclax 800mg + R-CHOP | 0.640 |
Venetoclax 200mg + G-CHOP | 0.134 |
Venetoclax 400mg + G-CHOP | 0.395 |
Venetoclax 600mg + G-CHOP | 0.612 |
Venetoclax + G-CHOP 800 mg | 0.628 |
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Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)
"Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.~Data are reported as micrograms per milliliter" (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
Intervention | Ug/ML (Mean) |
---|
Venetoclax + R-CHOP 100 mg | .09 |
Venetoclax 200 mg + R-CHOP | .58 |
Venetoclax 400 mg + R-CHOP | .92 |
Venetoclax 600 mg + R-CHOP | .85 |
Venetoclax 800mg + R-CHOP | 1.15 |
Venetoclax 200mg + G-CHOP | .52 |
Venetoclax 400mg + G-CHOP | 1.26 |
Venetoclax 600mg + G-CHOP | 1.00 |
Venetoclax + G-CHOP 800 mg | 1.54 |
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Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)
"AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.~Data are reported as hour*micrograms per milliliter (hr*mcg/mL)" (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)
Intervention | hr*mcg/mL (Mean) |
---|
Venetoclax 800mg + R-CHOP | .66 |
Venetoclax 200 mg + R-CHOP | 2.51 |
Venetoclax 400 mg + R-CHOP | 3.87 |
Venetoclax 600 mg + R-CHOP | 3.70 |
Venetoclax + R-CHOP 800 mg | 4.51 |
Venetoclax 200mg + G-CHOP | 2.55 |
Venetoclax 400mg + G-CHOP | 4.33 |
Venetoclax 600mg + G-CHOP | 5.13 |
Venetoclax + G-CHOP 800mg | 6.20 |
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Safety: Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT02055820)
Timeframe: Baseline up to approximately 36 months
Intervention | Percentage of Participants (Number) |
---|
Venetoclax 200 mg + R-CHOP | 100.00 |
Venetoclax 400 mg + R-CHOP | 100.00 |
Venetoclax 600 mg + R-CHOP | 100.00 |
Venetoclax 800mg + R-CHOP | 100.00 |
Venetoclax + R-CHOP 800 mg Phase II | 99.0 |
Venetoclax 200mg + G-CHOP | 100.00 |
Venetoclax 400mg + G-CHOP | 100.00 |
Venetoclax 600mg + G-CHOP | 100.00 |
Venetoclax 800 mg + G-CHOP A | 100.00 |
Venetoclax 800 mg + G-CHOP B | 100.00 |
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Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)
DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade >/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs. (NCT02055820)
Timeframe: Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)
Intervention | Participants (Number) |
---|
Venetoclax 200 mg + R-CHOP | 1 |
Venetoclax 400 mg + R-CHOP | 0 |
Venetoclax 600 mg + R-CHOP | 1 |
Venetoclax 800mg + R-CHOP | 0 |
Venetoclax 200mg + G-CHOP | 2 |
Venetoclax 400mg + G-CHOP | 1 |
Venetoclax 600mg + G-CHOP | 1 |
Venetoclax 800 mg + G-CHOP A | 0 |
Venetoclax 800 mg + G-CHOP B | 0 |
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Rituximab PK: Cmin Within the Dosing Interval
Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2. (NCT02055820)
Timeframe: Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)
Intervention | mcg/mL (Mean) |
---|
Venetoclax 800 mg | 26.1 |
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Rituximab PK: Cmax
Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Intervention | mcg/mL (Mean) |
---|
Venetoclax 800 mg | 173 |
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Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)
CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake = mediastinum; 3) uptake < mediastinum but = liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy (NCT02055820)
Timeframe: Baseline up to end of treatment (up to approximately 6 months)
Intervention | Percentage of participants (Number) |
---|
Venetoclax + R-CHOP 800 mg Phase II | 68.2 |
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Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC
"Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.~CR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~PR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR" (NCT02055820)
Timeframe: Baseline to end of treatment (up to approximately 6 months)
Intervention | Percentage of Participants (Number) |
---|
Venetoclax + R-CHOP 800 mg Phase II | 81.5 |
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Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC
CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake = mediastinum; 3) uptake < mediastinum but = liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. (NCT02055820)
Timeframe: Baseline up to end of treatment (up to approximately 6 months)
Intervention | Percentage of participants (Number) |
---|
Venetoclax + R-CHOP 800 mg Phase II | 66.7 |
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Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification
CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to = 1.5 cm in longest transverse diameter of a lesion (LDi), no extra-lymphatic sites of disease, absence of non-measured lesions, organ enlargement must have regressed to normal, no new lesions, and if the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. (NCT02055820)
Timeframe: Baseline up to end of treatment (approx. 6 months)
Intervention | Percentage of Participants (Number) |
---|
Venetoclax + R-CHOP 800 mg Phase II | 37.4 |
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Percentage of Participants Who Are Alive and Without Disease Progression at Month 12
Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: >/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions. (NCT02055820)
Timeframe: Month 12
Intervention | Percentage of Participants (Number) |
---|
Venetoclax 200 mg + R-CHOP | 85.71 |
Venetoclax 400 mg + R-CHOP | 100.00 |
Venetoclax 600 mg + R-CHOP | 87.50 |
Venetoclax 800mg + R-CHOP | 66.67 |
Venetoclax + R-CHOP 800 mg Phase II | 88.99 |
Venetoclax 200mg + G-CHOP | 100.00 |
Venetoclax 400mg + G-CHOP | 75.00 |
Venetoclax 600mg + G-CHOP | 100.00 |
Venetoclax 800 mg + G-CHOP A | 100.00 |
Venetoclax 800 mg + G-CHOP B | 100.00 |
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Obinutuzumab PK: Cmax
Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Intervention | mcg/mL (Mean) |
---|
Venetoclax 800 mg | 326 |
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Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary
"Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness.~Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure." (NCT02072200)
Timeframe: Baseline and 12 weeks
Intervention | minutes (Mean) |
---|
Modified Release Prednisone | -16.76 |
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Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale
The VAS is a 100 mm line ranging from 0 mm (no pain) on the left end and 100 mm (worst pain) on the right end. Subjects marked on the line to indicate their pain severity. The distance in mm was measured from the left end to the subject's marking. (NCT02072200)
Timeframe: Baseline and 12 weeks
Intervention | mm (Mean) |
---|
Modified Release Prednisone | -25.70 |
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Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12
Change in KHAQ score from baseline to Week 12 post-treatment: KHAQ is composed of 8 functional disability indices. The scale for each index is from 0 (without any difficulty) to 3 (unable to do). Scores for each disability index were summed to obtain the total score for each subject, ranging between 0 to 24, with higher scores reflecting higher functional disability. The scores were then averaged across all subjects. (NCT02072200)
Timeframe: 12 weeks
Intervention | scores on a scale (Mean) |
---|
Modified Release Prednisone | -4.76 |
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Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment
[Not specified] (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
Intervention | ng/dL (Mean) |
---|
| ALP (Baseline) | ALP (EOT) | PSA (Baseline) | PSA (EOT) |
---|
Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 261 | 110 | 87 | 137 |
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Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported.
All adverse events relevant to advanced mCRPC subjects as well as adverse events of interest for both Abiraterone Acetate plus Prednisone and Radium Ra 223 dichloride will be reported. (NCT02097303)
Timeframe: Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.
Intervention | Adverse Events (Number) |
---|
| Overall Adverse Events | Grade I or II Adverse Events | Treatment Related Adverse Events |
---|
Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 186 | 179 | 70 |
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Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment
[Not Specified] (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
Intervention | Lesions (Mean) |
---|
| Baseline | EOT |
---|
Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 11.6 | 5.6 |
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Overall Response Rate
Determination of measurable disease progression or response was based on modified RECIST criteria. Reported is the number of participants with either a partial or complete response, and who had radiological extraskeletal progression. (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
Intervention | Participants (Count of Participants) |
---|
| Partial or complete response | Progression |
---|
Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 4 | 8 |
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Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment)
"Improvement in Bone Pain was assessed using the Bone Pain Inventory (BPI)~Pain Severity: Pain severity is the composite of scores of worst pain, least pain, average pain, and pain now. CMI criteria: Decrease >30% at two consecutive visits in Pain Severity Score in 24 hours without an increase in analgesic use.~Pain interference: Pain interference is the composite scores on general activity, mood, walking ability, normal work, relationships with others, sleep and enjoyment of life. CMI criteria: Decrease by 1.25 points or more compared with baseline at two consecutive visits.~Transient Pain Flare: Based on the work of Atkinson et al, a transient pain flare was assessed by pain at its worst in 24 hours. CMI criteria: > 2 points on the BPI-SF Worst Pain scale and subsequent reduction after initiation of Ra-223 and during the first 3 cycles." (NCT02097303)
Timeframe: Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.
Intervention | Participants (Count of Participants) |
---|
| Pain Severity | Pain Interference | Transient Pain Flare |
---|
Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 18 | 12 | 2 |
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Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria
"Following Quality of Life questionnaires were given at each visit:~FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the PCS (Range 1-156, higher scores better).~The FACT-General (FACT-G) is a 28 item QOL measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), Emotional (0-24) Well-being, and Satisfaction with Treatment was not assessed for this study (The total range was between 1-108, higher scores better)~FACT-TOI is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better)~PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better)." (NCT02097303)
Timeframe: Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.
Intervention | Participants (Count of Participants) |
---|
| FACT-P Total Scale | FACT-G Total Scale | Treatment Outcome Index (FACT-TOI) | Prostate Cancer Subscale (PCS) | Physical Well-being | Functional Well-being | Emotional Well-being | Social Well-being |
---|
Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 20 | 18 | 18 | 25 | 19 | 17 | 18 | 15 |
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Bone Imaging Response (Number of Participants With Progression and Stable Disease)
Bone imaging response was assessed at baseline and at EOT visit. Progression was defined as two or more additional lesions in comparison to the baseline. (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
Intervention | Participants (Count of Participants) |
---|
| Stable Disease | Progression |
---|
Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 29 | 2 |
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Time to Discontinuation of Steroid Therapy
Time in days to discontinuation of steroid therapy. (NCT02133924)
Timeframe: up to 365 days
Intervention | days (Median) |
---|
Participants With High Risk Acute Graft-Versus-Host Disease | 108 |
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Number of Participants With Non-Relapse Mortality (NRM)
Number of participants with Non-Relapse Mortality (NRM) at 6 months and 1 year (NCT02133924)
Timeframe: 6 months and 1 year
Intervention | Participants (Count of Participants) |
---|
| 6 months | 1 year |
---|
Participants With High Risk Acute Graft-Versus-Host Disease | 25 | 28 |
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Number of Participants Who Received Additional GVHD Therapies
Number of participants who received additional GVHD therapies (defined as the initiation of a new acute GVHD therapy, regardless of duration) (NCT02133924)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Participants With High Risk Acute Graft-Versus-Host Disease | 33 |
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Number of Participants With Complete Response (CR)
The primary endpoint for this clinical study is the proportion of complete response, CR (that is, the percent of patients with skin, liver, and GI GVHD - all stage 0) at day 28 of study treatment. Stage 0 = no rash, total bilirubin <2 mg/dl, diarrhea <500 ml/d (NCT02133924)
Timeframe: Day 28
Intervention | Participants (Count of Participants) |
---|
Participants With High Risk Acute Graft-Versus-Host Disease | 34 |
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Number of Participants With Overall Response Rate (CR + PR)
Overall response rate (CR + PR) at day 28. Partial Response (PR) is defined as improvement in one or more organs involved with GVHD symptoms without progression in others. For a response to be scored as PR on day 28, the patient must be in PR on day 28 and have had no intervening non-study therapy for acute GVHD. (NCT02133924)
Timeframe: Day 28
Intervention | Participants (Count of Participants) |
---|
Participants With High Risk Acute Graft-Versus-Host Disease | 45 |
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Number of Participants With Overall Survival (OS)
Number of participants with overall survival at 1 year (NCT02133924)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Participants With High Risk Acute Graft-Versus-Host Disease | 37 |
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Number of Participants With SR GVHD
Number of participants with steroid-refractory (SR) GVHD to express cumulative incidence of treatment-refractory GVHD (defined as absence of CR or PR on day 28 of treatment or who receive additional immunosuppression prior to day 28) (NCT02133924)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Participants With High Risk Acute Graft-Versus-Host Disease | 30 |
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Number of Serious Infections
Number of serious infections (defined as score 3 by the Blood and Marrow Transplant Clinical Trials Network) (NCT02133924)
Timeframe: 6 months
Intervention | events (Number) |
---|
Participants With High Risk Acute Graft-Versus-Host Disease | 52 |
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Absolute Calculated Glomerular Filtration Rate (cGFR): Mean
Absolute (mean and median) cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula (NCT02137239)
Timeframe: Up 24 Months post-transplant
Intervention | mL/min/1.73 m^2 (Mean) |
---|
| At 3 Months | At 6 Months | At 12 Months | At 24 Months |
---|
Treatment A | 69.2 | 66.0 | 66.2 | 71.8 |
,Treatment B | 62.2 | 63.9 | 62.0 | 68.7 |
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Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).
Time to Clinically suspected biopsy proven acute rejection (NCT02137239)
Timeframe: Up to 24 Months
Intervention | Months (Mean) |
---|
Treatment A | NA |
Treatment B | NA |
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Treatment Differences in Therapeutic Modalities
Treatment Received for Biopsy Proven Acute Rejection (Banff Grade IA or Higher), or Humoral (Antibody Mediated) Rejection Treatment regimen: Categorical analysis of CSBPAR episodes by treatment received. (NCT02137239)
Timeframe: at 6, 12 and 24 Months
Intervention | Percentage of participants with CSBPARs (Number) |
---|
| Corticosteroids (6 months) | Lymphocyte depleting agent (6 months) | Plasmapheresis (6 months) | IVIG (6 months) | Rituximab (6 months) | Corticosteroids (12 months) | Lymphocyte depleting agent (12 months) | Plasmapheresis (12 months) | IVIG (12 months) | Rituximab (12 months) | Corticosteroids (24 months) | Lymphocyte depleting agent (24 months) | Plasmapheresis (24 months) | IVIG (24 months) | Rituximab (24 months) |
---|
Treatment A | 7.7 | 0 | 0 | 0 | 0 | 15.4 | 3.8 | 0 | 0 | 0 | 19.2 | 3.8 | 0 | 0 | 0 |
,Treatment B | 9.4 | 6.3 | 0 | 3.1 | 0 | 12.5 | 6.3 | 0 | 3.1 | 0 | 12.5 | 6.3 | 0 | 3.1 | 0 |
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Number of Participants Who Experience Graft Loss Post Transplant
Number of all participants who experience graft loss at 6, 12 and 24 months post transplant (NCT02137239)
Timeframe: At 6, 12 and 24 months
Intervention | Participants (Count of Participants) |
---|
| At 6 Months | At 12 Months | At 24 Months |
---|
Treatment A | 1 | 1 | 1 |
,Treatment B | 1 | 1 | 1 |
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Percentage of Participants With Serious Adverse Events (SAEs)
Percentage of participants with SAEs up to 24 months post-transplant (NCT02137239)
Timeframe: Up to 24 months Post-Transplant
Intervention | Percentage of participants with SAEs (Number) |
---|
Treatment A | 52.0 |
Treatment B | 60.6 |
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Number of Participants Who Survive With a Functioning Graft
Number of all participants who survive with a functioning graft at 6, 12 and 24 months post transplant (NCT02137239)
Timeframe: At 6, 12 and 24 months
Intervention | Participants (Count of Participants) |
---|
| At 6 Months | At 12 Months | At 24 Months |
---|
Treatment A | 25 | 25 | 25 |
,Treatment B | 31 | 31 | 31 |
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Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
"Treatment differences in the severity grades to treat all episodes of CSBPAR at 6, 12, and 24 months post-transplant.~Type 1A - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/Tubular cross section or group of 10 Tubular cell). Type 1B - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/Tubular cross section or group of 10 Tubular cell).Type 2A - Cases with mild to moderate intimal arteritis.Type 2B - Cases with severe intimal arteritis comprising >25% of the luminal area. Type 3 - Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (v3 with accompanying lymphocytic inflammation)" (NCT02137239)
Timeframe: At 6, 12 and 24 Months
Intervention | Percentage of Participants (Number) |
---|
| 6 Months: Mild Acute (1A) | 6 Months: Mild Acute (1B) | 6 Months: Moderate Acute (2A) | 6 Months: Moderate Acute (2B) | 6 Months: Severe Acute | 12 Months: Mild Acute (1A) | 12 Months: Mild Acute (1B) | 12 Months: Moderate Acute (2A) | 12 Months: Moderate Acute (2B) | 12 Months: Severe Acute | 24 Months: Mild Acute (1A) | 24 Months: Mild Acute (1B) | 24 Months: Moderate Acute (2A) | 24 Months: Moderate Acute (2B) | 24 Months: Severe Acute |
---|
Treatment A | 3.8 | 0 | 7.7 | 0 | 0 | 7.7 | 0 | 7.7 | 0 | 0 | 11.5 | 0 | 7.7 | 0 | 0 |
,Treatment B | 0 | 3.1 | 6.3 | 0 | 0 | 3.1 | 3.1 | 6.3 | 0 | 0 | 3.1 | 3.1 | 6.3 | 0 | 0 |
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Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
Characterization of any de novo DSA detected by IgM and IgG subclasses, and by the presence or absence of complement fixing properties. (NCT02137239)
Timeframe: Up to 24 Months
Intervention | Percentage (Number) |
---|
| Baseline Class 1 DSA | Baseline Class 2 DSA | Baseline Both Class 1 and 2 DSA | De Novo 12 Month Class 1 DSA | De Novo 12 Month Class 2 DSA | De Novo 12 Month Both Class 1 and 2 DSA | De Novo 24 Month Class 1 DSA | De Novo 24 Month Class 2 DSA | De Novo 24 Month Both Class 1 and 2 DSA |
---|
Treatment A | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Treatment B | 0 | 0 | 0 | 0 | 0 | 0 | 3.45 | 0 | 0 |
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Absolute Values of Blood Pressure: Mean
Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; (NCT02137239)
Timeframe: Up to 24 Months
Intervention | mmHg (Mean) |
---|
| Diastolic Month 3 | Systolic Month 3 | Diastolic Month 6 | Systolic Month 6 | Diastolic Month 12 | Systolic Month 12 | Diastolic Month 24 | Systolic Month 24 |
---|
Treatment A | 78.7 | 134.2 | 77.4 | 128.1 | 78.7 | 131.0 | 78.1 | 130.9 |
,Treatment B | 77.7 | 131.0 | 79.4 | 133.0 | 80.1 | 131.0 | 78.5 | 131.7 |
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Absolute Values of Fasting Lipid Values: Mean
"Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following:~Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)" (NCT02137239)
Timeframe: Up to 24 Months
Intervention | mg/dL (Mean) |
---|
| TC Month 3 | TC Month 6 | TC Month 12 | TC Month 24 | HDL Month 3 | HDL Month 6 | HDL Month 12 | HDL Month 24 | LDL Month 3 | LDL Month 6 | LDL Month 12 | LDL Month 24 | TG Month 3 | TG Month 6 | TG Month 12 | TG Month 24 |
---|
Treatment A | 181.2 | 197.7 | 189.0 | 193.2 | 50.6 | 46.4 | 49.4 | 50.1 | 96.9 | 115.2 | 107.5 | 97.9 | 171.6 | 180.0 | 162.4 | 263.4 |
,Treatment B | 174.4 | 175 | 169.9 | 168.2 | 50.4 | 53.9 | 49.6 | 51.3 | 96.5 | 93.7 | 88.0 | 91.5 | 137.8 | 138.3 | 161.3 | 145.0 |
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Mean and Mean Change From Baseline in Blood Glucose
Mean fasting blood glucose levels, and mean changes from baseline values at Months 6, 12 and 24 months post- transplant (NCT02137239)
Timeframe: Up to 24 months
Intervention | mg/dL (Mean) |
---|
| Mean Value at 6 months | Change from baseline at 6 months | Mean Value at 12 months | Change from baseline at 12 months | Mean Value at 24 months | Change from baseline at 24 months |
---|
Treatment A | 107.2 | 4.9 | 101.1 | -1.3 | 127.5 | 22.3 |
,Treatment B | 107.2 | 4.8 | 127.5 | 20.6 | 111.8 | 15.0 |
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Mean and Mean Change From Baseline in Whole Blood HbA1c
Mean whole blood HbA1C concentrations, and mean changes from baseline values at Months 6, 12 and 24 months post-transplant. (NCT02137239)
Timeframe: Up to 24 months
Intervention | mg/dL (Mean) |
---|
| Mean Value at 6 months | Change from baseline at 6 months | Mean Value at 12 months | Change from baseline at 12 months | Mean Value at 24 months | Change from baseline at 24 months |
---|
Treatment A | 6.11 | 0.34 | 6.18 | 0.47 | 6.24 | 0.66 |
,Treatment B | 6.13 | 0.48 | 6.21 | 0.32 | 6.29 | 0.41 |
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Mean Change From Month 3 in cGFR
The mean change from Month 3 cGFR at 3, 6, 12 and 24 months post-transplant (NCT02137239)
Timeframe: Up 24 Months post-transplant
Intervention | mL/min/1.73 m^2 (Mean) |
---|
| At 3 Months | At 6 Months | At 12 Months | At 24 Months |
---|
Treatment A | 0 | -3.2 | -3.1 | 3.1 |
,Treatment B | 0 | 2.8 | 1.4 | 6.3 |
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Mean Changes From Baseline Values for Blood Pressure
Mean changes from baseline values for SBP and DBP at 6, 12 and 24 months post-transplant (NCT02137239)
Timeframe: Up to 24 Months
Intervention | mmHg (Mean) |
---|
| Diastolic Month 6 | Systolic Month 6 | Diastolic Month 12 | Systolic Month 12 | Diastolic Month 24 | Systolic Month 24 |
---|
Treatment A | 1.0 | -4.0 | 2.3 | -1.1 | 0.9 | -2.3 |
,Treatment B | 4.8 | -0.7 | 5.4 | -3.2 | 2.1 | -4.2 |
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Mean Changes From Baseline Values of Lipid Values
"Mean changes from baseline values in the following:~Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)" (NCT02137239)
Timeframe: at months 12 and 24
Intervention | mg/dL (Mean) |
---|
| TC Month 12 | TC Month 24 | HDL Month 12 | HDL Month 24 | LDL Month 12 | LDL Month 24 | TG Month 12 | TG Month 24 |
---|
Treatment A | 25.7 | 26.6 | 5.4 | 6.2 | 25.7 | 17.4 | 3.3 | 106.8 |
,Treatment B | -2.8 | 10.0 | 1.9 | 4.8 | 10.8 | 15.7 | -86.1 | -13.6 |
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Percentage of Participants With Adverse Events (AEs)
Percentage of participants with AEs up to 24 months post-transplant (NCT02137239)
Timeframe: Up to 24 months Post-Transplant
Intervention | Percentage of participants with AEs (Number) |
---|
Treatment A | 100.0 |
Treatment B | 97.0 |
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Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months
Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months (NCT02137239)
Timeframe: 6 Months
Intervention | Percentage of participants (Number) |
---|
Treatment A | 7.7 |
Treatment B | 9.4 |
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Number of Participants Deaths Post Transplant
Number of participant deaths at 6, 12 and 24 months post transplant (NCT02137239)
Timeframe: up to 24 months
Intervention | Participants (Count of Participants) |
---|
| At 6 Months | At 12 Months | At 24 Months |
---|
Treatment A | 0 | 0 | 0 |
,Treatment B | 0 | 0 | 0 |
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Time to Event: Graft Loss and Death
The Number of days to participant Graft Loss and death for any reason (NCT02137239)
Timeframe: Up to 728 Days
Intervention | Days (Number) |
---|
| Graft Loss |
---|
Treatment A | 107 |
,Treatment B | 2 |
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Urine Protein Creatinine Ratio (UPr/Cr)
Urine protein to creatinine ratio (UPr/Cr) at 3, 6, 12 and 24 months post-transplant. (NCT02137239)
Timeframe: Up 24 Months post-transplant
Intervention | mg Protein/mg Creatinine (Mean) |
---|
| At 3 Months | At 6 Months | At 12 Months | At 24 Months |
---|
Treatment A | 0.3146 | 0.3896 | 0.2835 | 0.3940 |
,Treatment B | 0.1412 | 0.1461 | 0.1849 | 0.1685 |
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Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
Percentage of participants with, and titers of pre-existing (pre-transplant) DSA on Day 1 (pre-transplant, pre-dose), and at Months 12 and 24 posttransplant (NCT02137239)
Timeframe: Up to 24 Months
Intervention | Percentage of Participants (Number) |
---|
| Baseline Class 1 DSA | Baseline Class 2 DSA | Baseline Both Class 1 and 2 DSA | 12 Month Class 1 DSA | 12 Month Class 2 DSA | 12 Month Both Class 1 and 2 DSA | 24 Month Class 1 DSA | 24 Month Class 2 DSA | 24 Month Both Class 1 and 2 DSA |
---|
Treatment A | 10 | 0 | 0 | 8.00 | 0 | 0 | 8.00 | 0 | 0 |
,Treatment B | 0 | 0 | 0 | 0 | 3.03 | 0 | 3.03 | 3.03 | 0 |
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Percentage of Participants With Events of Special Interest (ESIs)
"Percentage of participants which have one of the following events of special interest:~Serious Infections Post-Transplant Lymphoproliferative Disorder (PTLD) Progressive multifocal leukoencephalopathy (PML) Malignancies (Other than PTLD) including non-melanoma skin carcinomas (Malignancies) Tuberculosis Infections Central Nervous System (CNS) Infections Viral Infections Infusion Related reactions within 24 hours since belatacept infusion" (NCT02137239)
Timeframe: Up to 24 Months
Intervention | Percentage of participants with ESIs (Number) |
---|
| Serious Infections | PTLD | PML | Malignancies | TB | CNS Infections | Viral Infections | Infusion Related Reactions |
---|
Treatment A | 16 | 4.0 | 0 | 4.0 | 0 | 0 | 0 | 1 |
,Treatment B | 15.2 | 3.0 | 0 | 3.0 | 0 | 0 | 0 | 0 |
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Percentage of Participants With New Onset Diabetes After Transplant
Percentage of participants with New Onset Diabetes After Transplantation (NODAT) at 6, 12, and 24 months post-transplant. (NCT02137239)
Timeframe: up to 24 months
Intervention | Percentage of participants (Number) |
---|
| Up to 6 Months | Up to 12 Months | Up to 24 Months |
---|
Treatment A | 11.5 | 11.5 | 15.4 |
,Treatment B | 6.3 | 6.3 | 12.5 |
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Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Percentage of participants with laboratory tests with marked laboratory abnormalities (NCT02137239)
Timeframe: At 24 Months
Intervention | Percentage of participants (Number) |
---|
| Hemoglobin (Low) | Leukocytes (low) | Lymphocyte (Absolute) (low) | Neutrophils (Absolute) (low) | Aspartate Aminotransferase (High) | Creatinine (High) | Inorganic Phosphorus (low) | Potassium (high) | Sodium (low) | Albumin (low) | Glucose (high) | Triglycerides (high) | Uric Acid (high) |
---|
Treatment A | 12.0 | 0 | 84.0 | 0 | 4.0 | 16.0 | 24.0 | 4.0 | 4.0 | 0 | 8.0 | 12.0 | 8.0 |
,Treatment B | 6.1 | 3.0 | 69.7 | 3.0 | 0 | 3.0 | 12.1 | 0 | 0 | 3.0 | 12.1 | 0 | 0 |
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Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months
"Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6, 12 and 24 Months~Change in the incidence of CSBPAR at 6, 12 and 24 months post transplant, in the belatacept + EVL(Treatment A) as compared to TAC + MMF (Treatment B)." (NCT02137239)
Timeframe: Up to 24 Months
Intervention | Percentage of CSBPAR (Number) |
---|
| CSBPAR at 6 Months | CSBPAR at 12 months | CSBPAR at 24 Months |
---|
Treatment A | 7.7 | 11.5 | 15.4 |
,Treatment B | 9.4 | 12.5 | 12.5 |
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Disease-free Survival (Cohort II)
An estimate of disease free survival in Ph-positive ALL and Ph-like DSMKF ALL (Cohort II). Disease free survival is measured by the number of years between the date the patient first achieves complete remission (CR) or complete remission with incomplete platelet recovery (CRi) until relapse from CR/CRi or death from any cause. CR is defined as having <5% marrow aspirate blasts, ANC >1,000/mcL, platelets > 100,000/mcL, no blasts in peripheral blood, and C1 extramedullary disease status. CRi is the same as CR but platelet count may be <= 100,000/mcL and/or ANC <=1,000/mcL. (NCT02143414)
Timeframe: Duration of treatment and follow up until death or date of primary analysis (about 7.5 years)
Intervention | years (Median) |
---|
Cohort II (Ph+/Ph-like) | 5.3 |
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Overall Survival Rate (Cohort I)
To evaluate the 3-year overall survival rate in elderly participants with newly diagnosed Ph-negative ALL treated with blinatumomab followed by POMP maintenance. Overall (NCT02143414)
Timeframe: From the day of registration on study until death from any cause, assessed at 3 years
Intervention | percentage of participants (Number) |
---|
Cohort I (Ph-) | 34 |
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Complete Response Rate (Cohort I)
Complete response rate is measured by the number of participants achieving complete remission (CR) or complete remission with incomplete platelet recovery (CRi) rate. CR is defined as having <5% marrow aspirate blasts, ANC >1,000/mcL, platelets > 100,000/mcL, no blasts in peripheral blood, and C1 extramedullary disease status. CRi is the same as CR but platelet count may be <= 100,000/mcL and/or ANC <=1,000/mcL. (NCT02143414)
Timeframe: Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration)
Intervention | Participants (Count of Participants) |
---|
| CR or CRi | No CR or CRi |
---|
Cohort I (Ph-) | 19 | 10 |
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Incidence of Dose-limiting Toxicity (Cohort II)
Defined as any grade 4 or higher treatment-related, non-hematologic toxicity in the first cycle of post-remission therapy (blinatumomab/dasatinib) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only participants with Ph-positive ALL or Ph-like DSMKF ALL were evaluated. (NCT02143414)
Timeframe: Up to day 42 of post-remission therapy
Intervention | Participants (Count of Participants) |
---|
Cohort II (Ph+/Ph-like) | 0 |
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Minimal Residual Disease Negativity
To estimate in each cohort the rate of minimal residual disease (MRD) negativity. (NCT02143414)
Timeframe: Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration)
Intervention | Participants (Count of Participants) |
---|
| MRD- | MRD+ |
---|
Cohort I (Ph-) | 12 | 1 |
,Cohort II (Ph+/Ph-like) | 7 | 9 |
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B-cell Kinetics (B-cell Depletion and Recovery)
B-cell kinetics were demonstrated by median values of B-cell counts (Lower limit of quantification was 20 cells/uL). (NCT02162771)
Timeframe: Cycles 1 to 8 during the Core Study Period
Intervention | cells/uL (Median) |
---|
| Core Cycle 1 (Predose) | Core Cycle 1 (1 hour after the end of infusion) | Core Cycle 2 (Predose) | Core Cycle 3 (Predose) | Core Cycle 4 (Predose) | Core Cycle 5 (Predose) | Core Cycle 6 (Predose) | Core Cycle 7 (Predose) | Core Cycle 8 (Predose) |
---|
CT-P10 | 92.5 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 |
,Rituxan | 62.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 |
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Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria
"ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review.~Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: >=50% decrease in SPD of target lesions and no evidence of disease progression." (NCT02162771)
Timeframe: During the Core Study Period (up to 8 cycles; Week 24)
Intervention | Participants (Count of Participants) |
---|
CT-P10 | 64 |
Rituxan | 63 |
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Maximum Serum Concentration at Steady State (Cmax,ss)
"Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals.~PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained." (NCT02162771)
Timeframe: Core Cycle 4 (Week 12)
Intervention | ug/mL (Geometric Mean) |
---|
CT-P10 | 256.19 |
Rituxan | 254.49 |
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Area Under the Serum Concentration-time Curve at Steady State (AUCtau)
"AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state.~PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained." (NCT02162771)
Timeframe: Core Cycle 4 (Week 12)
Intervention | h*ug/mL (Geometric Mean) |
---|
CT-P10 | 41002.43 |
Rituxan | 40099.08 |
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Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma. (NCT02166463)
Timeframe: Up to 48 months after the last enrollment
Intervention | percentage of participants (Number) |
---|
Arm I (ABVE-PC) | 82.5 |
ARM II (Bv-AVEPC) | 92.1 |
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Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons. (NCT02166463)
Timeframe: After 42 days of chemotherapy
Intervention | Percentage of patients (Number) |
---|
Arm I (ABVE-PC) | 80.7 |
ARM II (Bv-AVEPC) | 81.2 |
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Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
"The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The Modified Balis scale of Pediatric Neuropathy allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score >/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05." (NCT02166463)
Timeframe: From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.
Intervention | Percentage of patients (Number) |
---|
Arm I (ABVE-PC) | 5.5 |
ARM II (Bv-AVEPC) | 6.7 |
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Vasculitis Damage Index (VDI)
The Vasculitis Damage Index (VDI) is a single-page catalog of damage items separated into 11 groupings of items by organ system. There are a total of 60 items. Each item is recorded if it occurred since the onset of vasculitis, has been present for at least 3 months, or occurred at least 3 months ago. Each item of damage is scored as present (1) or absent (0), yielding a maximum score of 60. (NCT02169219)
Timeframe: 24 months
Intervention | units on a scale (Mean) |
---|
| Baseline VDI score | 24 month VDI score |
---|
Glucocorticoids and Rituximab | 0 | 0.5 |
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Sustained Complete Remission
Number of patients entering sustained remission defined as BVAS/WG = 0, prednisone dose = 0 and no disease flares during the study period. (NCT02169219)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Glucocorticoids and Rituximab | 14 |
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Severe Flares
Number of severe flares defined as flare with BVAS/WG > 3 or experiencing one of the major BVAS/WG items (NCT02169219)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Glucocorticoids and Rituximab | 5 |
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Partial Remission
Number of patients entering partial remission, defined as no new disease manifestations, no worsening of existing disease and BVAS/WG < 3. (NCT02169219)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) |
---|
Glucocorticoids and Rituximab | 20 |
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Limited Flares
Number of limited flares defined as a new occurrence or worsening of one or more minor BVAS/WG items and a total BVAS/WG ≤ 3 (NCT02169219)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Glucocorticoids and Rituximab | 2 |
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Early Treatment Failures
Number of early treatment failures defined as patients who have new or worsening disease manifestations assessed at 4 weeks after study entry (NCT02169219)
Timeframe: 4 weeks
Intervention | Participants (Count of Participants) |
---|
Glucocorticoids and Rituximab | 0 |
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Disease Response
Number of patients achieving disease response defined as, no new disease manifestations; no worsening of existing disease; stable or improved BVAS/WG score at 4 weeks. (NCT02169219)
Timeframe: 4 weeks
Intervention | Participants (Count of Participants) |
---|
Rituximab and Glucocorticoids | 20 |
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Complete Remission
We examined whether an 8-week glucocorticoid course in combination with rituximab (RTX) would induce disease remission in patients with AAV. The primary outcome was disease remission off steroids at 6 months. (NCT02169219)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Glucocorticoids and Rituximab | 14 |
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Percent of Participants With Grade 3 or Higher Wound Complication(s) Adverse Event(s)
"The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009):~Grade 3 wound complications are defined as Hernia without evidence of strangulation; fascial disruption/dehiscence; primary wound closure or revision by operative intervention indicated~Grade 4 complications are defined as Hernia with evidence of strangulation; major reconstruction flap, grafting, resection, or amputation indicated" (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation
Intervention | Percent of Participants (Number) |
---|
Cohort 1 | 0 |
Cohort 2 | 0 |
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Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection
"Biopsy-proven acute rejection graded as Mild, Moderate or Severe, per 1997 Banff classification. Chronic Rejection graded using Banff 2000 classification.~References: 1.) Banff Schema for Grading Liver Allograft Rejection: An International Consensus Document developed by an international panel of experts in liver transplantation pathology, hepatology, and surgery (Hepatology 1997; 25(3): 658-663). 2.) Update of the International Banff Schema for Liver Allograft Rejection: Working Recommendations for the Histopathologic Staging and Reporting of Chronic Rejection (Hepatology 2000; 31(3): 792-799)." (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation
Intervention | Percent of Participants (Number) |
---|
| Mild Acute Rejection | Moderate Acute Rejection | Severe Acute Rejection | Chronic Rejection |
---|
Cohort 1 | 0 | 0 | 0 | 0 |
,Cohort 2 | 11.1 | 0 | 0 | 0 |
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Percent of Participants With Grade 2 or Higher Hematologic Adverse Events (AEs) of Anemia, Neutropenia, and/or Thrombocytopenia
"The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009):~Grade 1 = mild AE~Grade 2 = moderate AE~Grade 3 = severe and undesirable AE~Grade 4 = life-threatening or disabling AE~Grade 5 = death" (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation
Intervention | Percent of Participants (Number) |
---|
| Anemia | Neutropenia | Thrombocytopenia |
---|
Cohort 1 | 66.7 | 16.7 | 16.7 |
,Cohort 2 | 22.2 | 0 | 0 |
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Percent of Participants With Adverse Events (AEs) Attributable to the Donor Alloantigen Reactive Tregs (darTregs) Infusion
"AEs classified by the site investigator/clinician as possibly or definitely related to the study treatment, the Donor Alloantigen Reactive Tregs (darTregs) infusion. These AEs include:~infusion reaction~Grade 3 or higher cytokine release syndrome (Reference: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009) grading criteria~malignant cellular transformation." (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation
Intervention | Percent of Participants (Number) |
---|
Cohort 2 | 0 |
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Percent of Participants With Grade 3 or Higher Infectious Adverse Event(s)
"The severity of infectious adverse events (AEs) was classified into grades as follows:~Grade 1 = asymptomatic; clinical or diagnostic observation only; intervention with oral antibiotic, antifungal, or antiviral agent only; no invasive intervention required~Grade 2 = symptomatic; intervention with intravenous antibiotic, antifungal, or antiviral agent; invasive intervention may be required~Grade 3 = any infection associated with hemodynamic compromise requiring pressors; any infection necessitating intensive care unit level of care; any infection necessitating operative intervention; any infection involving the central nervous system; any infection with a positive fungal blood culture; any proven or probable aspergillus infection; any tissue invasive fungal infection; any pneumocystis jiroveci infection~Grade 4 = life-threatening infection~Grade 5 = death resulting from infection" (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation
Intervention | Percent of Participants (Number) |
---|
Cohort 1 | 0 |
Cohort 2 | 11.1 |
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Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score
"The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from 1-not at all to 4-very much to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement." (NCT02195479)
Timeframe: Baseline, Months 3, 6, 9, 12 and 18
Intervention | Units on a scale (Least Squares Mean) |
---|
| Month 3 | Month 6 | Month 9 | Month 12 | Month 18 |
---|
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 8.8 | 10.6 | 11.1 | 12.6 | 11.4 |
,Velcade, Melphalan and Prednisone (VMP) | 9.4 | 10.5 | 11.9 | 11 | 12.7 |
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Time to Response
Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. (NCT02195479)
Timeframe: From randomization to first documented PR or better (up to 2.4 years)
Intervention | Months (Median) |
---|
Velcade, Melphalan and Prednisone (VMP) | 0.82 |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 0.79 |
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Time to Next Treatment (TNT)
Time to next treatment is defined as the time from randomization to the start of the next-line treatment. (NCT02195479)
Timeframe: Approximately up to 2.4 years
Intervention | Months (Median) |
---|
Velcade, Melphalan and Prednisone (VMP) | NA |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | NA |
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Time to Disease Progression (TTP)
TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 milligram per deciliter [mg/dL]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % >=10%); Bone marrow PC %: absolute % >10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. (NCT02195479)
Timeframe: From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)
Intervention | Months (Median) |
---|
Velcade, Melphalan and Prednisone (VMP) | 19.35 |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | NA |
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Progression Free Survival on Next Line of Therapy (PFS2)
Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment. (NCT02195479)
Timeframe: From randomization to either disease progression or death whichever occurs first (up to 2.4 years)
Intervention | Months (Median) |
---|
Velcade, Melphalan and Prednisone (VMP) | NA |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | NA |
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Progression Free Survival (PFS)
PFS- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase>10 mg/dL); Only participants without measurable serum and urine M-protein levels,without measurable disease by FLC levels,bone marrow Plasma cells (PC) %(absolute % >=10%);Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. (NCT02195479)
Timeframe: From randomization to either disease progression or death whichever occurs first (up to 2.4 years)
Intervention | Months (Median) |
---|
Velcade, Melphalan and Prednisone (VMP) | 18.14 |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | NA |
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Percentage of Participants With Very Good Partial Response (VGPR) or Better
VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response[sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and < 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry. (NCT02195479)
Timeframe: From randomization to disease progression (up to 2.4 years)
Intervention | Percentage of participants (Number) |
---|
Velcade, Melphalan and Prednisone (VMP) | 49.7 |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 71.1 |
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Percentage of Participants With Stringent Complete Response (sCR)
sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; <5% plasma cells (PCs) in bone marrow. (NCT02195479)
Timeframe: From randomization to disease progression (up to 2.4 years)
Intervention | Percentage of participants (Number) |
---|
Velcade, Melphalan and Prednisone (VMP) | 9.3 |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 20.3 |
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Percentage of Participants With Negative Minimal Residual Disease (MRD)
The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). (NCT02195479)
Timeframe: From randomization to disease progression (up to 2.4 years)
Intervention | Percentage of participants (Number) |
---|
Velcade, Melphalan and Prednisone (VMP) | 6.2 |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 22.3 |
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Percentage of Participants With Complete Response (CR) or Better
CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. (NCT02195479)
Timeframe: From randomization to disease progression (up to 2.4 years)
Intervention | Percentage of participants (Number) |
---|
Velcade, Melphalan and Prednisone (VMP) | 24.4 |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 42.6 |
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Overall Response Rate (ORR)
The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (>=) 50 percentage(%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required. (NCT02195479)
Timeframe: From randomization to disease progression (up to 2.4 years)
Intervention | Percentage of participants (Number) |
---|
Velcade, Melphalan and Prednisone (VMP) | 73.9 |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 90.9 |
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Duration of Response (DOR)
DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase>=0.5 g/dL); Urine M-component (absolute increase>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%>=10%); Bone marrow PC's %: absolute%>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. (NCT02195479)
Timeframe: Up to 2.4 years
Intervention | Months (Median) |
---|
Velcade, Melphalan and Prednisone (VMP) | 21.3 |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | NA |
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Overall Survival (OS)
Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. (NCT02195479)
Timeframe: From randomization to death (up to approximately 2.4 years)
Intervention | Months (Median) |
---|
Velcade, Melphalan and Prednisone (VMP) | NA |
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | NA |
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Percentage of Participants With Best M-protein Response
Percentage of participants with Best M- protein response of 100% reduction and >=90% to < 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC). (NCT02195479)
Timeframe: Approximately up to 2.4 years
Intervention | Percentage of participants (Number) |
---|
| Best M-protein response in serum: 100% reduction | Best M-protein response in serum:>= 90 to < 100% | Best M-protein response in urine:100% reduction | Best M-protein response in urine:>=90 to < 100% | Best response in dFLC:100% reduction | Best response in dFLC: >=90% to < 100% reduction |
---|
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 58.5 | 15.2 | 90.5 | 7.1 | 0 | 100.0 |
,Velcade, Melphalan and Prednisone (VMP) | 38.7 | 14.6 | 69.4 | 13.9 | 0 | 77.8 |
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Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)
EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. (NCT02195479)
Timeframe: Baseline, Months 3, 6, 9, 12 and 18
Intervention | Units on a scale (Mean) |
---|
| Baseline | Month 3 | Month 6 | Month 9 | Month 12 | Month 18 |
---|
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 57.90 | 9.28 | 10.83 | 12.50 | 10.79 | 12.04 |
,Velcade, Melphalan and Prednisone (VMP) | 60.33 | 4.20 | 7.40 | 9.89 | 10.80 | 7.65 |
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Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score
EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm. (NCT02195479)
Timeframe: Baseline, Months 3, 6, 9, 12 and 18
Intervention | Units on a scale (Mean) |
---|
| Baseline | Month 3 | Month 6 | Month 9 | Month 12 | Month 18 |
---|
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 0.57 | 0.12 | 0.13 | 0.16 | 0.17 | 0.13 |
,Velcade, Melphalan and Prednisone (VMP) | 0.59 | 0.09 | 0.12 | 0.16 | 0.15 | 0.13 |
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Overall Survival
Overall survival was defined as the time from date of the first dose of abiraterone acetate to the date of death due to any cause. For participants who did not die until the time of analysis, survival time was censored at the time of last contact alive. (NCT02217566)
Timeframe: Up to 4 years
Intervention | Months (Median) |
---|
Abiraterone Acetate | 29.6 |
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Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response
The PSA response according to Prostate Specific Antigen Working Group 3 criteria was defined as at least 50% decrease in PSA level from Baseline. (NCT02217566)
Timeframe: Week 12 to any time up to 2 years
Intervention | Percentage of participants (Number) |
---|
Abiraterone Acetate | 57.50 |
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Time to Prostate-specific Antigen (PSA) Progression
Time to PSA progression was calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression was defined as greater than or equal to (>=) 25 percent (%) and >=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is >=25% and >=2 ng/mL above the nadir, and which was confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline). (NCT02217566)
Timeframe: Up to 2 years
Intervention | Months (Median) |
---|
Abiraterone Acetate | 7.3 |
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly. (NCT02217566)
Timeframe: Up to 4 years
Intervention | Participants (Count of Participants) |
---|
| Participants with AEs | Participants with SAEs |
---|
Abiraterone Acetate | 45 | 11 |
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Radiographic Progression-free Survival (rPFS)
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. (NCT02257736)
Timeframe: Up to 3 years and 4 months
Intervention | months (Median) |
---|
Placebo+ Abiraterone Acetate - Prednisolone | 16.59 |
Apalutamide + Abiraterone Acetate - Prednisolone | 23.98 |
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Overall Survival (OS)
The OS was defined as the time from randomization to date of death from any cause. (NCT02257736)
Timeframe: Up to 5 years and 10 months
Intervention | months (Median) |
---|
Placebo+ Abiraterone Acetate - Prednisolone | 33.71 |
Apalutamide + Abiraterone Acetate - Prednisolone | 36.17 |
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Time to Chronic Opioid Use
Time to chronic opioid use was defined as the time from date of randomization to the first date of opioid use. (NCT02257736)
Timeframe: Up to 5 years and 10 months
Intervention | months (Median) |
---|
Placebo+ Abiraterone Acetate - Prednisolone | 53.26 |
Apalutamide + Abiraterone Acetate - Prednisolone | 46.98 |
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Time to Initiation of Cytotoxic Chemotherapy
Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy. (NCT02257736)
Timeframe: Up to 5 years and 10 months
Intervention | months (Median) |
---|
Placebo+ Abiraterone Acetate - Prednisolone | 34.23 |
Apalutamide + Abiraterone Acetate - Prednisolone | 36.11 |
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Time to Pain Progression
"Time to pain progression: time from randomization to first date that participant either experienced an increase by 2 points from baseline in Brief Pain Inventory Short Form (BPI-SF) worst pain intensity item (item 3) or Case Report Form (CRF) pain, observed at 2 consecutive evaluations >=4 wks apart, or initiation of chronic opioids as defined in time to chronic opioid use, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3(worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where 0 indicates No pain and 10 indicates Pain as bad as you can imagine. A lower score is better.CRF pain refers to participant's response to global pain assessment How would you rate your pain over the past 7 days?with a scale of 0(No pain) to 10(Pain as bad as you can imagine),that is systematically reported and recorded on the eCRF." (NCT02257736)
Timeframe: Up to 5 years and 10 months
Intervention | months (Median) |
---|
Placebo+ Abiraterone Acetate - Prednisolone | 26.51 |
Apalutamide + Abiraterone Acetate - Prednisolone | 21.82 |
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Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96
"The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels <30 IU/mL.~Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
Intervention | percentage of participants (Number) |
---|
| Week 24 | Week 48 | Week 96 |
---|
Rituximab/Cyclophosphamide (RC) | 14.3 | 20.0 | 0.0 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 15.8 | 30.0 | 27.8 |
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Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96
"The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs." (NCT02260934)
Timeframe: Week 0 to Week 96
Intervention | percentage of participants (Number) |
---|
| Week 0 to Week 24 | Week 0 to Week 48 | Week 0 to Week 96 |
---|
Rituximab/Cyclophosphamide (RC) | 9.1 | 22.7 | 27.3 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 4.8 | 9.5 | 9.5 |
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Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96
"The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.~Normal peripheral blood B Cell count: 107 to 698 cells/µL." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
Intervention | Percentage of Participants (Number) |
---|
| Week 24 | Week 48 | Week 96 |
---|
Rituximab/Cyclophosphamide (RC) | 31.3 | 35.7 | 40.0 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 6.3 | 11.8 | 30.8 |
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Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96
The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level < 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
Intervention | percentage of participants (Number) |
---|
| Week 0 to Week 24 | Week 0 to Week 48 | Week 0 to Week 96 |
---|
Rituximab/Cyclophosphamide (RC) | 0 | 0 | 0 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 0 | 0 | 0 |
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Frequency of Specific Adverse Events of Interest By Event by Week 96
"Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96
Intervention | Events (Number) |
---|
| Any event leading to death | ≥Grade 2 leukopenia or thrombocytopenia | Premature ovarian failure | Malignancy | Venous thromboembolic event |
---|
Rituximab/Cyclophosphamide (RC) | 0 | 13 | 0 | 0 | 3 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 0 | 16 | 0 | 0 | 0 |
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Frequency of Specific Adverse Events of Interest By Participant, By Week 96
"Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96
Intervention | Participants (Count of Participants) |
---|
| Any event leading to death | ≥Grade 2 leukopenia or thrombocytopenia | Premature ovarian failure | Malignancy | Venous thromboembolic event |
---|
Rituximab/Cyclophosphamide (RC) | 0 | 6 | 0 | 0 | 2 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 0 | 6 | 0 | 0 | 0 |
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Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96
"The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:~>50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
Intervention | percentage of participants (Number) |
---|
| Week 24 | Week 48 | Week 96 |
---|
Rituximab/Cyclophosphamide (RC) | 46.7 | 60.0 | 53.3 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 55.0 | 73.7 | 71.4 |
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Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96
The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity. (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
Intervention | percentage of participants (Number) |
---|
| Week 0 to Week 24 | Week 0 to Week 48 | Week 0 to Week 96 |
---|
Rituximab/Cyclophosphamide (RC) | 18.2 | 45.5 | 63.6 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 14.3 | 28.6 | 47.6 |
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Count of Participants: Frequency of Non-renal Flares by Week 96
"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 96
Intervention | Participants (Count of Participants) |
---|
| 0 Non-renal flares | 1 Non-renal flare | 2 Non-renal flares |
---|
Rituximab/Cyclophosphamide (RC) | 18 | 4 | 0 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 19 | 1 | 1 |
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Count of Participants: Frequency of Non-renal Flares by Week 48
"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
| 0 Non-renal flares | 1 Non-renal flares | 2 Non-renal flare |
---|
Rituximab/Cyclophosphamide (RC) | 20 | 2 | 0 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 20 | 0 | 1 |
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Count of Participants: Frequency of Non-renal Flares by Week 24
"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
| 0 Non-renal flares | 1 Non-renal flare | 2 Non-renal flares |
---|
Rituximab/Cyclophosphamide (RC) | 21 | 1 | 0 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 20 | 0 | 1 |
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Percentage of Participants With a Sustained Complete Response
"The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.~Complete response was defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 48, Week 96
Intervention | percentage of participants (Number) |
---|
Rituximab/Cyclophosphamide (RC) | 26.7 |
Rituximab/Cyclophosphamide/Belimumab (RCB) | 28.6 |
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Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96
"The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
Intervention | percentage of participants (Number) |
---|
| Week 24 | Week 48 | Week 96 |
---|
Rituximab/Cyclophosphamide (RC) | 23.8 | 35.0 | 33.3 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 30.0 | 42.1 | 42.9 |
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Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96
"The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level <10 mg/dL.~Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
Intervention | percentage of participants (Number) |
---|
| Week 24 | Week 48 | Week 96 |
---|
Rituximab/Cyclophosphamide (RC) | 19.0 | 15.0 | 16.7 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 5.0 | 15.0 | 11.1 |
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Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96
"The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level <90 mg/dL.~Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
Intervention | percentage of participants (Number) |
---|
| Week 24 | Week 48 | Week 96 |
---|
Rituximab/Cyclophosphamide (RC) | 57.1 | 55.0 | 61.1 |
,Rituximab/Cyclophosphamide/Belimumab (RCB) | 30.0 | 30.0 | 27.8 |
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Post Bronchodilator FEV1
The change in post bronchodilator FEV1 from baseline to 48 weeks (NCT02261727)
Timeframe: Change at 48 weeks
Intervention | L/sec (Mean) |
---|
Placebo | -0.02 |
Low-dose Theophylline Arm | -0.01 |
Theophylline and Prednisone Arm | -0.02 |
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Change in COPD Assessment Test (CAT) Score
The COPD Assessment Test (CAT) is a patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. The range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The outcome measure is assessing the change in score from baseline to 48 weeks. A negative change denotes an improvement in health status. (NCT02261727)
Timeframe: 48 weeks
Intervention | Score on a scale (Mean) |
---|
Placebo | -2.29 |
Low-dose Theophylline Arm | -2.77 |
Theophylline and Prednisone Arm | -2.57 |
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Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)
THe St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations. (NCT02261727)
Timeframe: Change over 48 week study duration
Intervention | Scores on a scale (Mean) |
---|
Placebo | -4.95 |
Low-dose Theophylline Arm | -6.85 |
Theophylline and Prednisone Arm | -6.48 |
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Total COPD Exacerbation Rate
The total number of COPD exacerbations reported within 48 weeks (NCT02261727)
Timeframe: 48 weeks observation; rate annualised
Intervention | Exacerbations per participant year (Number) |
---|
Placebo | 1.00 |
Low-dose Theophylline Arm | 0.86 |
Theophylline and Prednisone Arm | 0.89 |
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Time to First COPD Exacerbation
The median time (days) from randomisation to first exacerbation per participant (NCT02261727)
Timeframe: Median time (days) from randomisation to first exacerbation over a 48 week period per participant
Intervention | Days (Median) |
---|
Placebo | 137 |
Low-dose Theophylline Arm | 150 |
Theophylline and Prednisone Arm | 151 |
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Hospitalisations
The total number of hospitalisation events within 48 weeks (NCT02261727)
Timeframe: 48 weeks
Intervention | Number of hospitalisation events (Number) |
---|
Placebo | 120 |
Low-dose Theophylline Arm | 101 |
Theophylline and Prednisone Arm | 122 |
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Participants With Pathologic Complete Response (pCR)
pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen. (NCT02268175)
Timeframe: after RP approximately 24 weeks from study entry
Intervention | Participants (Count of Participants) |
---|
ARM 1 | 5 |
ARM 2 | 2 |
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Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD)
pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen. MRD is defined as the largest cross-sectional dimension of residual tumor measuring = 0.5 cm. If the tumor is multifocal, the size of the largest focus will be used to determine the size of the residual tumor. (NCT02268175)
Timeframe: after RP approximately 24 weeks from study entry
Intervention | percentage of participants (Number) |
---|
ARM 1 | 30 |
ARM 2 | 16 |
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Residual Cancer Burden (RCB)
RCB was analyzed using radical prostatectomy (RP) tissue. The largest area of tumor was measured by ruler and the longest tumor dimension in this area was used as the dimension for calculation. (NCT02268175)
Timeframe: after RP approximately 24 weeks from study entry
Intervention | cm (Median) |
---|
ARM 1 | 0.03 |
ARM 2 | 0.05 |
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Renal Function
Renal function after kidney transplant in both groups at 24 months measured according to the proteinuria (mg/24 h) concentrations (NCT02284464)
Timeframe: 24 months
Intervention | mg/24h (Mean) |
---|
Steroids, Tacrolimus and Mycophenolate | 209 |
Tacrolimus and Mycophenolate | 148 |
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Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups
The Basle scale was used to assess adherence (BAASIS questionnaire) to immunosuppressive therapy. (NCT02284464)
Timeframe: At 24 months
Intervention | Participants (Count of Participants) |
---|
| Forgot at least one dose during last 4 weeks | Dose taken 2 hours or more before or after time |
---|
Steroids, Tacrolimus and Mycophenolate | 0 | 3 |
,Tacrolimus and Mycophenolate | 1 | 11 |
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Number of Participants With Acute Rejection Lesions
Patients with acute rejection lesions (including subclinical rejection) at 24 months according to Banff classification (NCT02284464)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Steroids, Tacrolimus and Mycophenolate | 2 |
Tacrolimus and Mycophenolate | 3 |
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Mean Score on the Protocol Biopsies in the Two Treatment Groups
Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant. The scale ranges from 0 to 3, 3 being the worst. (NCT02284464)
Timeframe: 24 months
Intervention | score on a scale (Mean) |
---|
| Interstitial fibrosis and tubular atrophy | Chronic graft lesion | Glomerulitis | Peritubular capillaritis | Tubulitis | Interstitial inflammation | Arteritis | Interstitial fibrosis | Tubular atrophy | Graft glomerulopathy | Chronic vascular lesions | Arteriolar hyalinosis |
---|
Steroids, Tacrolimus and Mycophenolate | 1.18 | 1.96 | 0.17 | 0.24 | 0.5 | 0.82 | 0 | 0.6 | 0.6 | 0.14 | 0.58 | 0.53 |
,Tacrolimus and Mycophenolate | 1.83 | 2.6 | 0.08 | 0.20 | 0.56 | 0.68 | 0 | 0.88 | 0.88 | 0 | 0.64 | 0.69 |
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Patient Survival
Patient survival after kidney transplant in both groups (NCT02284464)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Steroids, Tacrolimus and Mycophenolate | 39 |
Tacrolimus and Mycophenolate | 36 |
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Graft Survival
Graft survival after kidney transplant in both groups (NCT02284464)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Steroids, Tacrolimus and Mycophenolate | 39 |
Tacrolimus and Mycophenolate | 36 |
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Cases of Kidney Transplant Patients With DSA
Measurements of DSA at baseline, and at 3, 6, 12, 18 and 24 months (NCT02284464)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Steroids, Tacrolimus and Mycophenolate | 0 |
Tacrolimus and Mycophenolate | 0 |
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Lipid Profile
Lipid profile after kidney transplant in both groups at 24 months (NCT02284464)
Timeframe: 24 months
Intervention | mg/dl (Mean) |
---|
| Cholesterol | HDL | LDL | Triglycerides |
---|
Steroids, Tacrolimus and Mycophenolate | 164 | 51 | 86 | 140 |
,Tacrolimus and Mycophenolate | 161 | 44.7 | 92 | 127 |
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Blood Pressure
Blood pressure after kidney transplant in both groups at 24 months (NCT02284464)
Timeframe: 24 months
Intervention | mmHg (Mean) |
---|
| Systolic BP | Diastolic BP |
---|
Steroids, Tacrolimus and Mycophenolate | 133 | 74.9 |
,Tacrolimus and Mycophenolate | 125 | 76 |
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Renal Function
Renal function after kidney transplant in both groups at 24 months measured according to the creatinine (mg/dL) concentrations (NCT02284464)
Timeframe: 24 months
Intervention | mg/dl (Mean) |
---|
Steroids, Tacrolimus and Mycophenolate | 1.34 |
Tacrolimus and Mycophenolate | 1.4 |
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Incidence of Diabetes Mellitus
Incidence of diabetes mellitus after kidney transplant in both groups at 1, 2, 3, 4, 6, 9, 12, 18 and 24 months (NCT02284464)
Timeframe: 24 months
Intervention | Participants (Count of Participants) |
---|
Steroids, Tacrolimus and Mycophenolate | 10 |
Tacrolimus and Mycophenolate | 6 |
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Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS)
EFS was defined as the time (months) from randomization until occurrence of one of the following events, whichever occurred first: • Disease progression • Initiation of subsequent systemic anti-lymphoma therapy • Death due to any cause The assessment of EFS was conducted by the IRAC using the International Working Group (IWG) criteria for NHL. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as an EFS event (initiation of subsequent systemic anti-lymphoma therapy) if the decision to treat and the location to be treated was determined prior to randomization. Participants who did not experience any of the events defined in the categories above before the clinical data cutoff date were censored at date last known alive. (NCT02285062)
Timeframe: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months
Intervention | Months (Median) |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | NA |
Placebo Plus R-CHOP | NA |
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Kaplan-Meier Estimate of Progression Free Survival (PFS)
Progression free survival was defined as the time (months) from the date of randomization to the date of disease progression or death (any cause), whichever occurred earlier and was assessed by the Independent Response Adjudication Committee (IRAC). Relapse from complete response (CR) was considered as disease progression throughout the study. Disease progression was determined based on the Revised Response Criteria for Malignant Lymphoma. The PFS analysis was based on the censoring rules using the Food and Drug Administration (FDA) Guidance. Participants who did not experience disease progression and who did not die before the clinical data cutoff date were censored at the date of last adequate response assessment. (NCT02285062)
Timeframe: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months
Intervention | months (Median) |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | NA |
Placebo Plus R-CHOP | NA |
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Percentage of Participants Who Achieved a Complete Response (CR)
The percentage of participants who achieved a CR after initiation of the study treatment and prior to initiation of subsequent systemic antilymphoma therapy as assessed by the IRAC. A CR = complete metabolic response; target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow per International Working Group (IWG) 2014 for Non-Hodgkin's Lymphoma (NHL). Participants who did not have any adequate response assessments during this period were not considered as responders. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months
Intervention | Percentage of Participants (Number) |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | 69.1 |
Placebo Plus R-CHOP | 64.9 |
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Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS)
"The EQ-5D-3L questionnaire includes a visual analogue scale which records the respondent's self-rated health on a vertical, 0-100 scale where 100 = Best imaginable health state and 0 = Worst imaginable health state. Higher scores again indicate better HRQoL and positive change scores indicate that post screening values were higher than those observed at screening. The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to no problems, some problems and extreme problems." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
Intervention | Units on a Scale (Mean) |
---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | 4.0 | 6.0 | 8.0 | 12.0 |
,Placebo Plus R-CHOP | 3.0 | 9.0 | 6.0 | 9 |
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Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score
"The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to no problems, some problems and extreme problems. The instrument is scored as a single summary index using one of the available EQ-5D-3L value sets; in this study the UK scoring weights 9 were used. The UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health (-0.594 is considered 'worse than death')." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
Intervention | Units on a Scale (Mean) |
---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | 0.08 | 0.10 | 0.10 | 0.15 |
,Placebo Plus R-CHOP | 0.08 | 0.14 | 0.06 | 0.09 |
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Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale
"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms such as pain, itching, night sweats,trouble sleeping, fatigue and trouble concentrating and concerns regarding lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The Additional Concerns subscale ranges from 0 to 60, where higher scores reflect better HRQoL." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
Intervention | Units on a Scale (Mean) |
---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | 3.8 | 5.8 | 6.6 | 8.3 |
,Placebo Plus R-CHOP | 4.1 | 5.2 | 4.5 | 6.5 |
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Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale
"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The functional well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
Intervention | Units on a Scale (Mean) |
---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | -0.5 | 0.0 | 1.0 | 2.3 |
,Placebo Plus R-CHOP | 0.5 | 1.4 | 0.7 | 3.1 |
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Percentage of Participants Who Achieved an Objective Response
An objective response = percentage of participants who achieved a complete response or partial response after initiation of the treatment and prior to initiation of subsequent systemic anti-lymphoma therapy. A CR = complete metabolic response; Target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic nodules regressed by ≥ 50% in their SPD or for single nodules, in the greatest transverse diameter; no new lesions. Participants who did not have any adequate response assessments during this period were not considered as responders. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median total treatment duration was 18.10 weeks for both treatment arms; range = 1.6 to 29.0 weeks for R2-CHOP arm and 0.3 to 22.9 weeks for placebo-R-CHOP arm
Intervention | Percentage of Participants (Number) |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | 90.9 |
Placebo Plus R-CHOP | 90.9 |
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K-M Estimate of Overall Survival (OS)
Overall survival was assessed by the Independent Response Adjudication Committee (IRAC) and defined as time from randomization until death due to any cause. Participants who withdrew consent were censored at the time of withdrawal. Participants who were still alive before the clinical data cutoff date and participants who were lost to follow-up were censored at date last known alive. (NCT02285062)
Timeframe: From randomization until death due to any cause (up to approximately 86 months)
Intervention | Months (Median) |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | NA |
Placebo Plus R-CHOP | NA |
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Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI)
"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The FACT-Lym TOI is calculated by summing the Physical Well-being, Functional Well-being and Additional Concerns scores and has a range of 0 to 116. Higher scores reflect better HRQoL or fewer symptoms." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
Intervention | Units on a Scale (Mean) |
---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | 2.6 | 5.9 | 9.1 | 13.5 |
,Placebo Plus R-CHOP | 4.6 | 7.5 | 5.8 | 12.2 |
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Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire
The completion rate for FACT-Lym assessments was judged by looking at the number of completed FACT-Lym assessments at each time point. The FACT-Lym was considered completed if at least 1 calculable score was present. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The FACT-Lym is a health related quality of life (HRQoL) questionnaire targeted to the management of chronic illness, predominantly within oncology and is considered an extension of the FACT-General questionnaire. (NCT02285062)
Timeframe: Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
Intervention | Percentage of Participants (Number) |
---|
| Screening | Midcycle = After Cycle 3, but before Cycle 4 | End of Treatment (EoT) = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | 98.6 | 87.0 | 76.1 | 67.7 |
,Placebo Plus R-CHOP | 98.2 | 86.3 | 79.6 | 69.5 |
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Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale
"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The physical well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
Intervention | Units on a Scale (Mean) |
---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | -0.7 | -0.0 | 1.5 | 2.8 |
,Placebo Plus R-CHOP | 0.2 | 0.9 | 0.7 | 2.6 |
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K-M Estimate of Duration of Complete Response
Duration of complete response was calculated for complete responders only and was defined as the time from documented initial complete response prior to initiation of subsequent systemic antilymphoma therapy until documented disease progression or death, whichever occurred earlier. Participants who had not progressed or died at the time of the analysis were censored at the date of last response assessment demonstrating no disease progression. Participants who changed treatment without evidence of disease progression were censored at the last assessment showing no progression prior to treatment change. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months.
Intervention | Months (Median) |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | NA |
Placebo Plus R-CHOP | NA |
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K-M Estimate of Time to Next Lymphoma Therapy (TTNLT)
Time to next lymphoma therapy was defined as the time from randomization to the time of treatment change for the next lymphoma treatment. Participants without treatment change were censored at date last known alive. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as treatment change for the next lymphoma therapy if the decision to treat and the location to be treated were determined prior to randomization. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months
Intervention | Months (Median) |
---|
Lenalidomide Plus R-CHOP (R2-CHOP) | NA |
Placebo Plus R-CHOP | NA |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) the Rheumatoid Arthritis Disease Activity Index (RADAI) Patient Self-report Joint Count (PTJT) Component From Baseline to Final Visit (Final Follow-up Visit)
"For the Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - the Rheumatoid Arthritis disease Activity Index (RADAI) patient self-report joint count (PTJT), participants were asked to score the amount of pain they were experiencing in each of 16 joints (left joint, left wrist, right shoulder etc.) as None (score of 0), Mild (score of 1), Moderate (score of 2) or Severe (score of 3). The raw 0-48 score is adjusted to 0-10 using a scoring template. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTJT was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.29 |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit)
Multidimensional Health Assessment Questionnaire (MDHAQ) - review of symptoms (ROS) was gathered using a symptom checklist and was calculated by summing the total number of items checked (0 to 60 symptoms could be checked). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ ROS was only calculated for participants that had measurements at both baseline and final follow-up. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | number of symptoms (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.3 |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit)
"Multidimensional Health Assessment Questionnaire (MDHAQ) - recent medical history was gathered using a medical history checklist and was calculated by summing the total number of items checked Yes (0 to 12 items could be checked). A negative change from baseline indicates fewer items were checked at the follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ recent medical history was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | number of items checked (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.2 |
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Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit
"Mean change in severity of morning stiffness was assessed using a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to Not Severe at All and 100 to Extremely Severe. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the mean change was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -5.2 |
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Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit)
American College of Rheumatology (ACR) 20, a patient must demonstrate a >= 20% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 20% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | percentage of participants (Number) |
---|
Delayed-release Prednisone (RAYOS) | 5.4 |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit)
"The change in Multidimensional Health Assessment Questionnaire (MDHAQ) - Psychological status (PS) was assessed by asking participants to score how they were sleeping, dealing with anxiety/nervousness, and dealing with depression as without any difficulty (score of 0), with some difficulty (score of 1.1), with much difficulty (score of 2.2) or unable to do (score of 3.3). The results were summed to give a score ranging from 0 to 9.9. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in psychological status was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | 0.17 |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit)
Multidimensional Health Assessment Questionnaire (MDHAQ) - patient global assessment (PTGL) was measured by asking the participant to rate on a 0 to 10 scale how they were doing considering all of the ways in which their illness and health conditions affected them: 0 - Very Well, 10 - Very Poor. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTGL was only calculated for participants that had measurements at both baseline and final follow-up. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.53 |
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Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit)
"European League Against Rheumatism (EULAR) response is based on change (improvement) in Disease Activity Score in 28 Joints score from baseline to last follow-up visit. DAS28 scores were broken into 3 categories: ≤3.2 at last follow-up (low disease activity), >3.2 and ≤ 5.1 at last follow-up (moderate or high disease activity), and DAS28 >5.1 at last follow-up (high disease activity). Then based on the category and magnitude of the change in DAS28 from baseline, the EULAR response of Good, Moderate or No Response was determined.~DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined as erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity)." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | percentage of participants (Number) |
---|
| Good response | Moderate response | No response | Missing | No follow-up visit/unable to calculate |
---|
Delayed-release Prednisone (RAYOS) | 3.6 | 14.3 | 28.6 | 44.6 | 8.9 |
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Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit)
American College of Rheumatology (ACR) 50, a patient must demonstrate a >= 50% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 50% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | percentage of participants (Number) |
---|
Delayed-release Prednisone (RAYOS) | 1.8 |
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Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit)
American College of Rheumatology (ACR) 70 a patient must demonstrate a >= 70% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 70% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | percentage of particpants (Number) |
---|
Delayed-release Prednisone (RAYOS) | 1.8 |
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ACR-N From Baseline to Final Visit (Final Follow-up Visit)
ACR-N is the index of improvement in rheumatoid arthritis, and is defined as the lowest of 3 values: percent change in the number of swollen joints (scored 0-28 with higher scores indicating higher disease activity), percent change in the number of tender joints (scored 0-28 with higher scores indicating higher disease activity), and the median of the other 5 measures in the American College of Rheumatology core data set-Patient's global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician's global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). Positive percent change indicates improvement. Negative percent change indicates worsening. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | percent change (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -15.4 |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit)
"Multidimensional Health Assessment Questionnaire (MDHAQ) - pain (PN) scoring was gathered using a 0-10 scale where 0 corresponded to No Pain and 10 to Pain as bad as it could be because of the condition (over the past week). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in pain was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.62 |
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Change in Physician's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)
"Physician's Overall Assessment in Disease Activity was measured with a 10-cm visual analogue scale (VAS) where 0 corresponded to Very Well' and 10 to Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Physician's Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow-up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.86 |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit)
"For the Multidimensional Health Assessment Questionnaire (MDHAQ) - neck and back (NB), participants were asked to score the amount of pain they were experiencing in their neck and back as None (score of 0), Mild (score of 1), Moderate (score of 2) or Severe (score of 3). The raw 0-6 score was adjusted to 0-10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in NB measure was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.35 |
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Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit)
"Routine Assessment of Patient Index Data (RAPID3) was calculated by summing three measures: physical function (0 to 10 with higher scores indicating less function), pain (0 to 10 with higher scores indicating higher pain), and patient global assessment (0 to 10 with higher scores indicating the participant was doing very poorly considering the ways in which the illness was affecting them). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in RAPID3 was only calculated for participants that had measurements at both baseline and final follow-up.~RAPID3 scores range from 0 to 30 with higher scores meaning worse condition. A negative change from baseline indicates improvement in condition." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -2.06 |
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"Change in Multidimensional Health Assessment Questionnaire (MDHAQ) How do You Feel Today (Compared to One Week Ago) Component From Baseline to Final Visit (Final Follow-up Visit)"
"The Multidimensional Health Assessment Questionnaire (MDHAQ) - how do you feel today compared to one week ago question was scored as follows: 1: Much Better, 2: Better, 3: The Same, 4: Worse, 5: Much Worse. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in How do you feel measure was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.2 |
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Change in Patient's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)
Patient's Overall Assessment in Disease Activity was measured by asking the participant to rate on a 10-cm visual analogue scale (VAS) how well they were doing considering all of the ways their arthritis affected them: 0 - Very Well, 10 - Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Patient's Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.47 |
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Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit)
The change in total daily prednisone from baseline to follow-up (whether the patient was taking RAYOS or returned to conventional prednisone) was calculated for all participants. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | milligrams (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.96 |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit)
The duration of morning stiffness was the amount of time participants experienced stiffness after waking up in the morning (over the last week). This measure was collected at baseline and at the last follow-up visit. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | minutes (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -2.5 |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit)
"The change in Multidimensional Health Assessment Questionnaire (MDHAQ) - function (FN) was assessed by asking participants to score the performance of multiple activities as without any difficulty (score of 0), with some difficulty (score of 1), with much difficulty (score of 2) or unable to do (score of 3). The results were summed and divided by 3 to give a score from 0 to10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in function was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.05 |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit)
"Multidimensional Health Assessment Questionnaire (MDHAQ) - fatigue (FAT) scoring was gathered using a 0-10 scale where 0 corresponded to Fatigue is no problem and 10 to Fatigue is a major problem over the past week. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in fatigue was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.12 |
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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit)
"The exercise aerobically for at least one-half hour (30 minutes) measure of the multidimensional health assessment questionnaire (MDHAQ) was scored as follows: 3 or more times a week (3), 1-2 times per week (2), 1-2 times per month (1), Do not exercise regularly (0), Cannot exercise due to disability/handicap (-1). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ exercise measure was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.1 |
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Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)
The duration of morning stiffness was the amount of time participants experienced stiffness after getting up in the morning. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | minutes (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -18.9 |
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Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit)
Simple Disease Activity Index (SDAI) is the sum of the following 5 components to assess rheumatoid arthritis severity: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + C-reactive Protein (CRP). SDAI scores indicate whether a participant is in remission or low, moderate or high activity. A negative change in SDAI indicates improvement. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -6.28 |
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Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit)
"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).~DAS28-ESR was calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * PGA in mm]. A negative change from baseline indicates improvement.~As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-ESR was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.39 |
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Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit)
"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).~DAS28-CRP was calculated according to the following formula: DAS28-CRP equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.36 * the natural logarithm (ln) of (CRP + 1)] + [0.014 * PGA in mm] + 0.96. A negative change from baseline indicated improvement.~As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-CRP was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -0.62 |
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Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit)
"Clinical Disease Activity Index (CDAI) is the sum of 4 parameters: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity). CDAI scores range from 0 to 76 and indicate whether a participant is in remission or low, moderate or high activity; higher scores indicate higher disease activity. A negative change from baseline indicates improvement in condition.~As this study was a non-interventional research initiative and no assessments/visits were mandated, the change in CDAI was only calculated for participants that had both baseline and final follow-up measurements." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | units on a scale (Mean) |
---|
Delayed-release Prednisone (RAYOS) | -5.59 |
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Assessment of Unsolicited Serious Adverse Events
Please refer to the safety section for further details. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | Participants (Count of Participants) |
---|
Delayed-release Prednisone (RAYOS) | 1 |
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Assessment of Unsolicited Adverse Events
Please refer to the safety section for further details. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)
Intervention | Participants (Count of Participants) |
---|
Delayed-release Prednisone (RAYOS) | 11 |
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Crohn's Disease Activity Index (CDAI)
Clinical remission, defined as CDAI < 150, in group with steroid co-induction vs. placebo co-induction. The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. CDAI scores below 150 indicate a better prognosis than higher scores (NCT02324699)
Timeframe: baseline, week 6, week 10
Intervention | score on a scale (Number) |
---|
| Baseline | Week 6 | Week 10 |
---|
Prednisone Co-inductive Therapy | 263 | 112.6 | 137.5 |
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Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)
The SES-CD tool is used to quantify and compare inflammatory load. The Simple Endoscopic Score for Crohn Disease (SES-CD) assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. (NCT02324699)
Timeframe: baseline and week 10
Intervention | score on a scale (Number) |
---|
| Baseline | Week 10 |
---|
Prednisone Co-inductive Therapy | 24 | 18 |
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Change in C-Reactive Protein (CRP)
Comparison of absolute change in CRP from baseline to week 10. C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. (NCT02324699)
Timeframe: baseline and week 10
Intervention | mg/L (Number) |
---|
| baseline | week 10 |
---|
Prednisone Co-inductive Therapy | 11.0 | 43.0 |
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Remission Duration
Percentage of patients in ongoing remission at 6 months (NCT02334813)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Arm A: Daily Prednisone | 3 |
Arm B: Pulsed Dexamethasone | 11 |
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Number of Participants With Response or Remission at End of 4 Weeks
Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 4 weeks (NCT02392286)
Timeframe: 4 weeks
Intervention | Participants (Count of Participants) |
---|
Weight-based | 5 |
Fixed Dose | 5 |
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Number of Participants With Response at End of 2 Weeks
Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks (NCT02392286)
Timeframe: 2 weeks
Intervention | Participants (Count of Participants) |
---|
Weight-based | 4 |
Fixed Dose | 6 |
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Number of Participants With Response or Remission at End of 1 Week
Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 1 week (NCT02392286)
Timeframe: 1 week
Intervention | Participants (Count of Participants) |
---|
Weight-based | 5 |
Fixed Dose | 5 |
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Number of Participants in Remission at End of 2 Weeks
Number of participants with Harvey Bradshaw Index < 5 at end of 2 weeks. The minimum score obtainable is 0, suggesting absence of disease or remission, while the maximum score obtainable goes beyond 18 points, depending on the number of stools the patient identifies per day (because 1 point is given for each stool in a day, there is no specific maximum score. A higher score represents more severe disease. <5 is determined to be remission. (NCT02392286)
Timeframe: 2 weeks
Intervention | Participants (Count of Participants) |
---|
Weight-based | 2 |
Fixed Dose | 3 |
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Number of Participants With Corticosteroid-associated Side Effects
Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias. (NCT02392286)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
Weight-based | 5 |
Fixed Dose | 7 |
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Number of Participants With Response or Remission at End of 12 Weeks
Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 12 weeks (NCT02392286)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
Weight-based | 5 |
Fixed Dose | 7 |
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Event Free Survival (EFS)
Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%. (NCT02419469)
Timeframe: 3 years
Intervention | Participants (Count of Participants) |
---|
Ofatumumab Plus Chemotherapy | NA |
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Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I)
The method of Thall, Simon and Estey will be used for toxicity monitoring for this study. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 whenever possible. Safety data will be summarized by category, severity and frequency. (NCT02420717)
Timeframe: 42 days
Intervention | Milligrams (mg) (Number) |
---|
Phase I Ruxolitinib 15mg | 25 |
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Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT02420717)
Timeframe: Up to 4 years 7 months
Intervention | Months (Median) |
---|
Phase I Ruxolitinib 15mg | 4.8 |
Phase I Ruxolitinib 20mg | 5.4 |
Phase I Ruxolitinib 25mg | 38.5 |
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Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II)
Complete Response (CR) is disappearance of all clinical and/or radiologic evidence of disease, Neutrophil count ≥ 1.0 x 10^9/L, Platelet count ≥ 100 x 10^9/L, Normal bone marrow differential (≤ 5% blasts), No extra-medullary leukemia. Complete Remission with Incomplete Blood Count Recovery (CRi) is CR except for ANC < 1.0 x 10^9/L and/or platelets < 100 x 10^9/L. (NCT02420717)
Timeframe: 42 days
Intervention | Participants (Count of Participants) |
---|
Phase I Ruxolitinib 15mg | 0 |
Phase I Ruxolitinib 20mg | 1 |
Phase I Ruxolitinib 25mg | 0 |
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Progression-free Survival
Time from date of treatment start until the date of first objective documentation of disease-relapse. (NCT02420717)
Timeframe: Up to 4 years 7 months
Intervention | Months (Median) |
---|
Phase I Ruxolitinib 15mg | 2.3 |
Phase I Ruxolitinib 20mg | 1.8 |
Phase I Ruxolitinib 25mg | 1.9 |
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Histopathological Response to Therapy
Histopathological response is achieved when there is minimal or no inflammation in hepatic tissue, as assessed by liver biopsy. (NCT02463331)
Timeframe: liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response
Intervention | Participants (Count of Participants) |
---|
Chloroquine Plus Prednisone | 4 |
Azathioprine Plus Prednisone | 10 |
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Biochemical Response to Therapy
The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT. (NCT02463331)
Timeframe: six months
Intervention | Participants (Count of Participants) |
---|
Chloroquine Plus Prednisone | 14 |
Azathioprine Plus Prednisone | 21 |
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12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II)
12-month PFS will be defined as the percentage of patients alive and progression free 12 months from start of therapy. Patients lost to follow up will be censored from last point of contact. PFS was calculated using a Kplan-meier estimation with the probability of patients being progression free at 12 months, presented as the percentage based on this probability. (NCT02481310)
Timeframe: Up to 12 months from initiation of treatment
Intervention | probability (%) of patients alive (Number) |
---|
Treatment (Combination Chemotherapy, Rituximab, Ixazomib) | 75.84 |
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To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R.
"The RP2D will be determined by the evaluation of dose-limiting toxicities (DLT) to find the Maximum Tolerated Dose (MTD) which will constitute the RP2D. DLTs will be defined as the occurrence of ≥ Grade 3 toxicity experienced during the first cycle (3 weeks or 21 days) of study treatment, will be determined, except for cytopenias.~The dose of ixazomib will start at 2.3 mg weekly (for phase I patients) when given concurrently with DA-EPOCH-R. Single-subject cohorts (escalating in ixazomib dose) will be enrolled until the MTD is encountered, after which expansion to 3-subject cohorts will be undertaken. The MTD from phase I will equate the RP2D for ixazomib given in conjunction with DA-EPOCH-R." (NCT02481310)
Timeframe: The first 21 days of treatment
Intervention | mg (Number) |
---|
Treatment (Combination Chemotherapy, Rituximab, Ixazomib) | 3 |
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Radiographic Progression-Free Survival (rPFS)
Radiographic progression-free survival: time (in months) from randomization to occurrence of any one of following: radiological tumor progressions using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 2 (PCWG2) criteria or occurrence of death due to any cause. Progression as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with >= 2 new lesions compared to Baseline observed less than (<) 12 weeks from randomization and confirmed by a second bone scan performed >=6 weeks; first bone scan with >=2 new lesions compared to Baseline observed >=12 weeks from randomization. In accordance with protocol, data cut-off date for final analysis of this endpoint was the date when 196 rPFS events had occurred. Analysis done by Kaplan-Meier method. (NCT02485691)
Timeframe: From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
Intervention | months (Median) |
---|
Cabazitaxel | 8.0 |
Abiraterone Acetate or Enzalutamide | 3.7 |
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Time to Pain Progression
Time to pain progression was defined as the time duration (in months) between the date of randomization and the date of first documented pain progression. Pain progression, in participants with no pain or stable pain at Baseline was defined as increase of >=30% from baseline in the BPI-SF pain intensity score observed at 2 consecutive evaluations >=3 weeks apart without decrease in analgesic usage score or increase in analgesic usage score (calculated from analgesic use data, with non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points) >=30%. The BPI-SF is a self-administered questionnaire developed to assess the severity of pain on a 0-10 categorical scale where 0=no pain, 10=pain as bad as you can imagine. Higher scores indicated worst outcomes. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: Baseline until pain progression or data cut-off whichever comes first (maximum duration: up to 141 weeks)
Intervention | months (Median) |
---|
Cabazitaxel | NA |
Abiraterone Acetate or Enzalutamide | 8.5 |
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Time to PSA Progression (TTPP)
TTPP was defined as the time duration (in months) between the date of randomization and the date of first documented PSA progression. PSA progression (as per PCWG 2) was defined as: 1) If decline from Baseline value: an increase of >=25% (at least 2 ng/mL) over the nadir value, confirmed by a second PSA value at least 3 weeks apart; 2) If no decline from Baseline value: an increase of >=25% (at least 2 ng/mL) over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart. Analysis performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From time from randomization until PSA progression, death due to any cause or data cut-off whichever comes first (maximum duration: up to 141 weeks)
Intervention | months (Median) |
---|
Cabazitaxel | 6.3 |
Abiraterone Acetate or Enzalutamide | 2.1 |
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Time to Symptomatic Skeletal Event
Time to SSE was defined as the time duration (in months) between the date of randomization and the date of occurrence of the first SSE. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From date of randomization until first SSE, or data cut-off whichever comes first (maximum duration: up to 141 weeks)
Intervention | months (Median) |
---|
Cabazitaxel | NA |
Abiraterone Acetate or Enzalutamide | 16.7 |
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Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Utility Single Index and Visual Analogue Scale (VAS) Scores at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment
EQ-5D was a standardized HRQOL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS scale ranging from 0-100, where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. Baseline corresponded to last evaluable assessment before treatment administration. (NCT02485691)
Timeframe: Baseline, Day 1 of each Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8 and at End of Treatment (any time up to: 141 weeks)
Intervention | score on a scale (Mean) |
---|
| Cycle 2: VAS | Cycle 3: VAS | Cycle 4: VAS | Cycle 5: VAS | Cycle 6: VAS | Cycle 7: VAS | Cycle 8: VAS | End of treatment: VAS | Cycle 2: Utility Index Score | Cycle 3: Utility Index Score | Cycle 4: Utility Index Score | Cycle 5: Utility Index Score | Cycle 6: Utility Index Score | Cycle 7: Utility Index Score | Cycle 8: Utility Index Score | End of treatment: Utility Index Score |
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Abiraterone Acetate or Enzalutamide | 0.9 | 1.5 | -1.1 | 3.2 | -1.5 | -0.2 | 1.2 | -5.9 | -0.010 | -0.011 | -0.002 | -0.035 | -0.000 | 0.024 | -0.014 | -0.079 |
,Cabazitaxel | 3.6 | 4.5 | 4.6 | 0.6 | -1.3 | 2.9 | 2.8 | -3.3 | 0.026 | 0.041 | 0.051 | 0.027 | 0.015 | 0.029 | 0.008 | -0.048 |
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Radiographic Progression-Free Survival (rPFS) in Participants With Presence and Absence of Biomarker
Circulating tumor cell (CTC) counts were considered as biomarker in a liquid biopsy. rPFS in participants with presence and absence of subtypes of CTC biomarker i.e. chromosomal instability (CIN) and neuroendocrine (NE) was reported in this outcome measure. rPFS was defined as: time (in months) from randomization to the first occurrence of any one of following: radiological tumor progressions (RECIST1.1), progression of bone lesions (PCWG2 criteria) or death due to any cause. Progression (RECIST1.1): at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with >= 2 new lesions compared to Baseline observed <12 weeks from randomization and confirmed by a second bone scan performed >=6 weeks later; first bone scan with >=2 new lesions compared to Baseline observed >=12 weeks from randomization and new lesions were verified on next bone scan >= 6 weeks later. (NCT02485691)
Timeframe: From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
Intervention | months (Median) |
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| Presence of CIN | Absence of CIN | Presence of NE | Absence of NE |
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Abiraterone Acetate or Enzalutamide | 4.2 | 3.4 | 3.9 | 3.5 |
,Cabazitaxel | 4.2 | 8.5 | 3.0 | 8.2 |
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Percentage of Participants With Prostate Specific Antigen (PSA) Response
PSA response was defined as >= 50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later. (NCT02485691)
Timeframe: Baseline up to PSA response, death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
Intervention | percentage of participants (Number) |
---|
Cabazitaxel | 36.3 |
Abiraterone Acetate or Enzalutamide | 14.3 |
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Progression Free Survival (PFS)
PFS:time duration (in months) from date of randomization to date of first occurrence of any of following events: radiological tumor progression (RECIST 1.1); progression of bone lesions (PCWG2); symptomatic progression (developing urinary or bowel symptoms; need to change anti-cancer therapy), pain progression or death due to any cause. Tumor Progression(RECIST 1.1): at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesion (PCWG2 criteria): first bone scan with >=2 new lesions compared to Baseline and confirmed by second bone scan performed >=6 weeks later; pain progression: increase by >=30% from Baseline in pain intensity score (calculated using scale ranged from 0=no pain to 5=extreme pain) or increase in analgesic usage score >=30% (calculated from analgesic use data, non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). Analyzed by Kaplan-Meier method. (NCT02485691)
Timeframe: From randomization until tumor progression or bone lesion progression, pain progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
Intervention | months (Median) |
---|
Cabazitaxel | 4.4 |
Abiraterone Acetate or Enzalutamide | 2.7 |
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Percentage of Participants With Overall Objective Tumor Response
Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT02485691)
Timeframe: From randomization until disease progression, death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
Intervention | percentage of participants (Number) |
---|
Cabazitaxel | 36.5 |
Abiraterone Acetate or Enzalutamide | 11.5 |
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Duration of Tumor Response
Duration of tumor response was defined as the time (in months) from date of first response (CR or PR) until date of first documentation of tumor progression or death, whichever occurs first. As per RECIST 1.1 CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progression was defined as at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From the date of the first response to the date of first documented tumor progression, or death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
Intervention | months (Median) |
---|
Cabazitaxel | 6.5 |
Abiraterone Acetate or Enzalutamide | 8.0 |
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Number of Symptomatic Skeletal Events (SSE)
SSE was defined as occurrence of a new symptomatic pathological fracture, use of external beam radiation to relieve bone pain, occurrence of spinal cord compression or tumor- related orthopedic surgical intervention. (NCT02485691)
Timeframe: Baseline until occurrence of first SSE or data cut-off, whichever comes first (maximum duration: up to 141 weeks)
Intervention | events (Number) |
---|
Cabazitaxel | 24 |
Abiraterone Acetate or Enzalutamide | 35 |
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Overall Survival (OS)
Overall survival was defined as the time interval (in months) from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date whichever comes first. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From randomization to death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
Intervention | months (Median) |
---|
Cabazitaxel | 13.6 |
Abiraterone Acetate or Enzalutamide | 11.0 |
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Probability of Event Free Survival (EFS)
EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression. (NCT02486952)
Timeframe: Up to 41 months
Intervention | probability of EFS (Number) |
---|
Diffuse Large B-Cell Lymphoma | 0.695 |
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Percentage of Participants Who Were Alive
Percentage of participants with survival was calculated 41 months after the first dose of study treatment. (NCT02486952)
Timeframe: Up to 41 months
Intervention | percentage of participants (Number) |
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Diffuse Large B-Cell Lymphoma | 74.4 |
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Objective Response Rate (ORR) (Phase1b/2 RP2D)
ORR will be assessed using RECIST version 1.1 criteria, and defined as participants who were determined to have demonstrated a complete response (CR) and/or partial response (PR). Participants must have measurable disease at baseline with at least one restaging scan on treatment to be included in the analysis. (NCT02494921)
Timeframe: Up to 2 years
Intervention | percentage of participants (Number) |
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Treatment (Phase 1b/2 RP2D) | 23.1 |
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RP2D of Docetaxel (Phase 1b)
The RP2D of docetaxel will be reported when used in combination with ribociclib and prednisone based upon evaluation of dose-limiting toxicities (DLTs) and adverse events for all participants in the Phase Ib group. Per Investigator discretion, the RP2D schedule of docetaxel and ribociclib may be established in the absence of reaching MTD, based on the cumulative safety data of the treatment regimen. (NCT02494921)
Timeframe: Up to 2 years
Intervention | mg/m^2 (Number) |
---|
Treatment (Phase 1b) | 60 |
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Prostate-Specific Antigen (PSA) Response Rate (Phase 1b/2 RP2D)
PSA progression occurs when the PSA value has increased 25% or greater above nadir and an absolute increase of 2 ng/mL or more from the nadir is documented. Where no decline is observed, PSA progression similarly occurs when a 25% increase from baseline value along with an increase in absolute value of 2 ng/mL or more per the Prostate Cancer Working Group 2 (PCWG2) Criteria. (NCT02494921)
Timeframe: Up to 2 years
Intervention | percentage of participants (Number) |
---|
Treatment (Phase 1b/2 RP2D) | 32 |
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Percentage of Participants With Radiographic Progression-free Survival at 6 Months (Phase 1b/2 RP2D)
Radiographic progression-free survival will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percent of participants has been estimated using the Kaplan-Meier product limit method. Duration will be measured from day 1 of study treatment to first date of radiographic progression or death, whichever occurs first, for all Phase 1b or Phase 2 participants receiving the RP2D. Participants who discontinue study therapy for toxicity, withdrawal from study, or prostate-specific antigen (PSA)-only progression, will be censored at the date of last radiographic tumor assessment for this analysis. Patients who discontinue therapy for evidence of clinical progression/clinical deterioration will be included in this analysis. (NCT02494921)
Timeframe: Up to 6 months
Intervention | percentage of participants (Number) |
---|
Treatment (Phase 1b/2 RP2D) | 65.8 |
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Maximally Tolerated Dose (MTD) (Phase 1b)
Maximally tolerated dose (MTD) of ribociclib in combination with docetaxel and prednisone is based upon evaluation of dose-limiting toxicities (DLTs) and adverse events for all participants who received treatment in Phase Ib. If 1 of 3 participants in a cohort experiences a DLT, then the cohort will be expanded to treat an additional 3 participants. If only 1 of 6 participants experiences a DLT, the next cohort of participants will be treated at the next higher dose level. If 2 or more participants in a cohort experience a DLT, then MTD has been exceeded and the previous dose level will be considered the MTD. If more than 1 of 6 patients experience a DLT at dose level IA then the study will be terminated, as the MTD cannot be determined and de-escalation from dose level IA is not planned. Per Investigator discretion the Recommended Phase 2 Dose (RP2D) schedule of ribociclib and docetaxel may be established in the absence of reaching MTD. (NCT02494921)
Timeframe: Up to 2 years
Intervention | mg/m^2 (Number) |
---|
Treatment (Phase 1b) | NA |
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Mean Maximum Serum Concentration of Ribociclib (Cmax) (Phase 1b)
The maximum concentration (Cmax) is shown to reflect not only the rate but also the extent of absorption. The mean Cmax for serum concentration of ribociclib will be reported using descriptive statistics for all participants in Phase 1b who received at least one dose of study treatment and completed a serum blood draw. (NCT02494921)
Timeframe: Pre-dose on day 1, and 1, 2, 4, and 24 hours post-dose
Intervention | ng/mL (Mean) |
---|
| 200 mg Ribociclib | 300 mg Ribociclib |
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Treatment (Phase 1b, Non-RP2D) | 207.5 | 289.8 |
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Mean Maximum Serum Concentration of Ribociclib (Cmax) (Phase 1b)
The maximum concentration (Cmax) is shown to reflect not only the rate but also the extent of absorption. The mean Cmax for serum concentration of ribociclib will be reported using descriptive statistics for all participants in Phase 1b who received at least one dose of study treatment and completed a serum blood draw. (NCT02494921)
Timeframe: Pre-dose on day 1, and 1, 2, 4, and 24 hours post-dose
Intervention | ng/mL (Mean) |
---|
| 400 mg Ribociclib |
---|
Treatment (Phase 1b, RP2D) | 393.6 |
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Mean Area Under Curve (AUC) 0-24 Hour (Phase 1b)
The estimated AUC for serum concentration of ribociclib for a 24 hour interval after dose will be reported using descriptive statistics for all participants in Phase 1b who received at least one dose of study treatment and completed a serum blood draw. (NCT02494921)
Timeframe: Pre-dose on day 1, and 1, 2, 4, and 24 hours post-dose
Intervention | ng*hrs/mL (Mean) |
---|
| 200 mg ribociclib | 300 mg ribociclib |
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Treatment (Phase 1b, Non-RP2D) | 2909 | 3340.3 |
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Mean Area Under Curve (AUC) 0-24 Hour (Phase 1b)
The estimated AUC for serum concentration of ribociclib for a 24 hour interval after dose will be reported using descriptive statistics for all participants in Phase 1b who received at least one dose of study treatment and completed a serum blood draw. (NCT02494921)
Timeframe: Pre-dose on day 1, and 1, 2, 4, and 24 hours post-dose
Intervention | ng*hrs/mL (Mean) |
---|
| 400 mg ribociclib |
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Treatment (Phase 1b, RP2D) | 6531.6 |
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Percent of Participants With Death or Graft Failure.
Participants who died or experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
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Experimental | 5.3 |
Control | 7.1 |
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Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision
Participants were considered to have met this endpoint if they had a reported case of impaired wound healing at the site of the transplant incision manifested by one wound dehiscence, wound infection, or hernia. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | Percent of participants (Number) |
---|
Experimental | 7.9 |
Control | 11.6 |
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Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.
Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the 24 month post-transplant follow-up. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 16.2 |
Control | 27 |
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Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.
Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the first 6 months post-transplant. (NCT02495077)
Timeframe: 6 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 12.6 |
Control | 20.5 |
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Percent of Participants With Malignancy.
Participants were considered to have met this endpoint if they had a reported case of malignancy. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | Percent of Participants (Number) |
---|
Experimental | 1.8 |
Control | 0.9 |
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Percent of Participants With Mycobacterial or Fungal Infections
Participants were considered to have met this endpoint if they had at least one mycobacterial of fungal infection. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 6.1 |
Control | 6.3 |
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Percent of Participants With Only Graft Failure.
Participants who experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 2.7 |
Control | 2.7 |
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Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months.
Post-transplant dialysis is sometimes required in the setting of kidney transplant. If such dialysis continues for more than 3 months, the participant is considered to have PNF and, as such, meets this endpoint definition. (NCT02495077)
Timeframe: Transplantation through at least month 3 up to month 24
Intervention | Percent of Participants (Number) |
---|
Experimental | 2.8 |
Control | 0.9 |
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The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups.
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the month 24 eGFR for each treatment group. (NCT02495077)
Timeframe: 24-Month post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
---|
Experimental | 52.45 |
Control | 57.35 |
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The Percent of Participants Who Need Dialysis After Week 1.
Participants who needed dialysis after the first week post-transplant were considered to have met this endpoint. (NCT02495077)
Timeframe: 1 week to 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 9.0 |
Control | 2.8 |
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The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%.
Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 2 serum CRR was less than 30%. (NCT02495077)
Timeframe: Day 2 post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 57.1 |
Control | 68.6 |
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The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%.
Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 5 serum CRR was less than 70%. (NCT02495077)
Timeframe: Day 5 post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 74.4 |
Control | 88.4 |
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The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL.
Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. This endpoint is ascertaining slow graft function in the immediate days post-transplant. A participant was considered to have met this endpoint if their day 5 serum creatinine was greater than 3 mg/dL. (NCT02495077)
Timeframe: Day 5 post-transplantation
Intervention | percentage of participants (Number) |
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Experimental | 47.4 |
Control | 42.9 |
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eGFR Values as Measured by CKD-EPI
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Days 30, 90, and 180 post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
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| Day 30 | Day 90 | Day 180 |
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Control | 50.63 | 51.44 | 52.65 |
,Experimental | 49.29 | 49.80 | 50.56 |
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eGFR Values as Measured by MDRD
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Days 30, 60, and 180 post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
---|
| Day 30 | Day 90 | Day 180 |
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Control | 48.20 | 48.99 | 50.16 |
,Experimental | 46.64 | 47.14 | 47.89 |
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BANFF Grades of First AMR.
Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 6 months post-transplantation
Intervention | Participants (Count of Participants) |
---|
Experimental | 0 |
Control | 0 |
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Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 3 months and 24 months post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
---|
Experimental | 2.7 |
Control | 4.4 |
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Change in eGFR Between 3 Months and 24 Months as Measured by MDRD
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 3 months and 24 months post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
---|
Experimental | 2.8 |
Control | 4.8 |
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Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
---|
Experimental | 0.8 |
Control | 4.8 |
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Change in eGFR Between 6 Months and 24 Months as Measured by MDRD
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
---|
Experimental | 1.0 |
Control | 5.2 |
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Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
---|
Experimental | 8.5 |
Control | 12.0 |
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Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
---|
Experimental | 8.1 |
Control | 11.6 |
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Percent of Participants That Required at Least One Dialysis Treatment.
Dialysis within the first week post-transplant is used in the setting of delayed graft function (DGF). Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. (NCT02495077)
Timeframe: 1 week post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 31.0 |
Control | 35.7 |
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Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery
Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. (NCT02495077)
Timeframe: Day 2 post-transplantation
Intervention | Percentage (Mean) |
---|
Experimental | 24.28 |
Control | 20.97 |
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Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery.
Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. (NCT02495077)
Timeframe: Day 5 post-transplantation
Intervention | Percentage (Mean) |
---|
Experimental | 47.06 |
Control | 43.37 |
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Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy)
Participants are considered to have met this endpoint if they experienced biopsy-proven T-cell mediated rejection (ACR) or antibody mediated rejection (AMR) based on central pathology reading or were hospitalized for infection and/or malignancy. For participants who met one or more of these three components, the earliest event date of the three components was used as the time of meeting the endpoint. Participants who did not meet any of the three components were censored at their last date of follow-up. Event (or censor) day was calculated as event (or censor) date minus transplant date. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | Days to event (Median) |
---|
Experimental | 642 |
Control | 613 |
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Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment.
Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. For this endpoint, duration was calculated as the date of last post-transplant dialysis treatment minus the date of the first post-transplant dialysis treatment. (NCT02495077)
Timeframe: First post-transplant dialysis treatment to last post-transplant dialysis treatment
Intervention | Days (Mean) |
---|
Experimental | 13.27 |
Control | 15.74 |
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eGFR Values as Measured by CKD-EPI
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Day 7 post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
---|
Experimental | 41.01 |
Control | 41.85 |
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eGFR Values as Measured by MDRD
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Day 7 post-transplantation
Intervention | mL/min/1.73m2 (Mean) |
---|
Experimental | 38.93 |
Control | 39.96 |
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Number of Dialysis Sessions.
The number of dialysis sessions a person had during their first 8 weeks post-transplant was used for this endpoint. (NCT02495077)
Timeframe: 8 weeks post-transplantation
Intervention | Dialysis sessions (Mean) |
---|
Experimental | 0.14 |
Control | 0.26 |
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Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death.
Participants were considered to have met this endpoint if they had an infection that required hospitalization or resulted in death. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 43.0 |
Control | 39.3 |
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Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy.
The Banff 2013 classification involves scoring numerous characteristics of renal biopsy specimens. The ci (interstitial fibrosis) and ct (tubular atrophy) scores are two such characteristics. The scores can take values of 0, 1, 2, or 3 for each characteristic (ci and ct), indicating increasing severity of disease as the scores increase. Participants are considered to have met this endpoint if their ci + ct score on the 24 month biopsy summed to be > or equal to 2. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 73.1 |
Control | 36.4 |
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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR)
Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive.Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 6 months post-transplantation
Intervention | Participants (Count of Participants) |
---|
Experimental | 0.0 |
Control | 0.0 |
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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR).
Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participant (Number) |
---|
Experimental | 1.3 |
Control | 0.0 |
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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR
Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present. (NCT02495077)
Timeframe: 6 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 2.8 |
Control | 0.0 |
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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR.
Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 3.8 |
Control | 1.4 |
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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR)
Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection.Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 6 month post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 4.2 |
Control | 3.0 |
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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection
Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection. Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 12.8 |
Control | 7 |
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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection.
Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection.Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 6 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 8.5 |
Control | 6.1 |
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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR).
Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 5.1 |
Control | 4.2 |
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Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site.
Participants were considered to have met this endpoint if they had a reported case of BK viremia that required a change in their existing immunosuppression or the use of anti-viral therapy. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | Percent of participants (Number) |
---|
Experimental | 28.9 |
Control | 13.4 |
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Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site
Participants were considered to have met this endpoint if they had a reported case of CMV viremia that required a change in their existing immunosuppression or the use of anti-viral therapy. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 18.4 |
Control | 11.6 |
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Percent of Participants With de Novo DSA.
Donor specific antibody (DSA) can be formed post-transplant as part of the recipient's alloimmune response to the transplanted organ. DSA was determined by a central laboratory. Participants with newly developed DSA (i.e., de novo) following transplant were considered to have met this endpoint. (NCT02495077)
Timeframe: 24 months post-transplantation
Intervention | percentage of participants (Number) |
---|
Experimental | 8.0 |
Control | 3.6 |
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Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks
"SF-36V MCS is a measure of HRQOL with respect to mental functioning. The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS).~To calculate MCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V MCS is a measure of HRQOL with respect to mental functioning and symptoms. Higher scores indicate better health status," (NCT02506192)
Timeframe: 0, 8, and 16 weeks
Intervention | units on a scale (Mean) |
---|
| baseline | 8 weeks | 16 weeks |
---|
Modified-Release Prednisone | 40.8 | 42.4 | 40.1 |
,Placebo | 40.4 | 43.1 | 42.7 |
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Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks
"The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS).~To calculate PCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V PCS is a measure of HRQOL with respect to physical functioning and symptoms. Higher scores indicate better health status," (NCT02506192)
Timeframe: 0, 8, and 16 weeks
Intervention | units on a scale (Mean) |
---|
| baseline | 8 weeks | 16 weeks |
---|
Modified-Release Prednisone | 40.8 | 43.5 | 40.8 |
,Placebo | 41.5 | 43.4 | 41.4 |
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Percentage of Participants With Dose Limiting ToxicitiesGgraded by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (Phase I)
The percentage of participants will be reported with 95% confidence interval using exact method. (NCT02522715)
Timeframe: Up to 42 days
Intervention | percentage of participants (Number) |
---|
Phase I - Treatment (Cabazitaxel, Enzalutamide) | 0.0 |
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PSA Response 1, Defined as >= 90% PSA Decline From Baseline
The percentage of participants with a >= 90% PSA decline from baseline will be reported with 95% confidence interval using exact method. 'PSA response' is based on Prostate Cancer Working Group 2's (PCWG2) recommendations, which do not offer a specific definition as no single degree of decline has been established. (NCT02522715)
Timeframe: Baseline to time of >= 90% PSA decline, assessed up to 68 weeks
Intervention | percentage of subjects (Number) |
---|
Phase I and Phase II - Treatment (Cabazitaxel, Enzalutamide) | 55.6 |
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PSA Response 2, Defined as >= 50% PSA Decline From Baseline
The percentage of participants with a >= 50% PSA decline from baseline will be reported with 95% confidence interval using exact method. 'PSA response' is based on Prostate Cancer Working Group 2's (PCWG2) recommendations, which do not offer a specific definition as no single degree of decline has been established. (NCT02522715)
Timeframe: Baseline to time of >= 50% PSA decline, assessed up to 68 weeks
Intervention | percentage of subjects (Number) |
---|
Phase I and Phase II - Treatment (Cabazitaxel, Enzalutamide) | 77.8 |
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PSA Response 3, Defined as >= 30% PSA Decline From Baseline
The percentage of participants with a >= 30% PSA decline from baseline will be reported with 95% confidence interval using exact method. 'PSA response' is based on Prostate Cancer Working Group 2's (PCWG2) recommendations, which do not offer a specific definition as no single degree of decline has been established. (NCT02522715)
Timeframe: Baseline to time of >= 30% PSA decline, assessed up to 68 weeks
Intervention | percentage of subjects (Number) |
---|
Phase I and Phase II - Treatment (Cabazitaxel, Enzalutamide) | 80.6 |
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Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 12 and Week 24
The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. And, the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains. (NCT02528214)
Timeframe: Baseline, Week 12 and Week 24
Intervention | score on a scale (Mean) |
---|
| Change at Week 12 | Change at Week 24 |
---|
Dupilumab 300 mg q2w | -2.13 | -2.53 |
,Placebo q2w | -0.75 | -0.99 |
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Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. (NCT02528214)
Timeframe: Baseline, Week 12 and Week 24
Intervention | liter (Mean) |
---|
| Baseline | Week 12 | Change at Week 12 | Week 24 | Change at Week 24 |
---|
Dupilumab 300 mg q2w | 1.53 | 1.82 | 0.29 | 1.84 | 0.29 |
,Placebo q2w | 1.63 | 1.68 | 0.06 | 1.63 | 0.00 |
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Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12 and Week 24
AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that were most important to participants with asthma. AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life. (NCT02528214)
Timeframe: Baseline, Week 12 and Week 24
Intervention | score on a scale (Mean) |
---|
| Change at Week 12 | Change at Week 24 |
---|
Dupilumab 300 mg q2w | 0.78 | 0.94 |
,Placebo q2w | 0.56 | 0.56 |
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Change From Baseline in Sino Nasal Outcome Test-22 (SNOT-22) Global Score at Week 12 and Week 24
The SNOT-22 is a validated measure of health related quality of life in sino nasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life. (NCT02528214)
Timeframe: Baseline, Week 12 and Week 24
Intervention | score on a scale (Mean) |
---|
| Change at Week 12 | Change at Week 24 |
---|
Dupilumab 300 mg q2w | -12.45 | -14.56 |
,Placebo q2w | -3.79 | -2.46 |
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Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Week 12 and Week 24
EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). (NCT02528214)
Timeframe: Baseline, Week 12 and Week 24
Intervention | score on a scale (Median) |
---|
| Single Index: Change at Week 12 | Single Index: Change at Week 24 | VAS Score: Change at Week 12 | VAS Score: Change at Week 24 |
---|
Dupilumab 300 mg q2w | 0.03 | 0.05 | 9.34 | 11.06 |
,Placebo q2w | 0.04 | 0.05 | 5.99 | 4.16 |
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Annualized Rate of Severe Exacerbation Events During The 24-Week Treatment Period
A severe asthma exacerbation event was defined as a deterioration of asthma during the 24-week treatment period requiring: use of systemic corticosteroids for >=3 days (at least double the dose currently used); and/or hospitalization related to asthma symptoms or emergency room visit because of asthma requiring intervention with a systemic corticosteroid treatment. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. (NCT02528214)
Timeframe: Baseline to Week 24
Intervention | Exacerbation per participant-year (Number) |
---|
Placebo q2w | 1.597 |
Dupilumab 300 mg q2w | 0.649 |
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Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
Participants were classified according to the binary status of whether or not the 50% OCS dose reduction criterion was achieved at week 24. (NCT02528214)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
Placebo q2w | 53.3 |
Dupilumab 300 mg q2w | 79.6 |
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Percentage of Participants Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control
Participants were classified according to the binary status of whether or not the reduction of OCS dose to <5 mg/day was achieved at Week 24. (NCT02528214)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
Placebo q2w | 37.4 |
Dupilumab 300 mg q2w | 71.8 |
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Percentage of Participants Achieving Maximum Possible Reduction in Oral Corticosteroids Dose Per Protocol at Week 24 While Maintaining Asthma Control
For all participants except those with baseline OCS dose at 35 mg/day, the maximum possible reduction corresponds to reduction to 0 mg/day (no longer requiring OCS). For participants starting with 35 mg/day at baseline, the maximum possible reduction is 32.5 mg/day (i.e. minimum dose per protocol is 2.5 mg). (NCT02528214)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
Placebo q2w | 29.9 |
Dupilumab 300 mg q2w | 52.4 |
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Percentage of Participants Who No Longer Required Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
Participants were classified according to the binary status of whether or not the participant still required OCS at Week 24 while maintaining asthma control. (NCT02528214)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
Placebo q2w | 29.2 |
Dupilumab 300 mg q2w | 52.4 |
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Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control
Percentage reduction of OCS dose was calculated as (optimized OCS dose [mg/day] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. Result is presented as Least Squares Mean (Standard Error) percentage reduction from baseline derived from ANCOVA model with missing data multiply imputed. (NCT02528214)
Timeframe: Baseline, Week 24
Intervention | Percentage reduction from baseline (Least Squares Mean) |
---|
Placebo q2w | 41.85 |
Dupilumab 300 mg q2w | 70.09 |
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Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
The Primary Outcome Measure (Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control) is summarized above, as LS Mean (SE). Table below provides a supplementary presentation of the Primary Outcome Measure data; result is presented as median (inter-quartile range). Percentage reduction of OCS dose was calculated as (optimized OCS dose [mg/day] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. (NCT02528214)
Timeframe: Baseline, Week 24
Intervention | percentage reduction from baseline (Median) |
---|
Placebo q2w | 50.0 |
Dupilumab 300 mg q2w | 100.0 |
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Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
Absolute reduction was calculated by subtracting Week 24 value from baseline value. (NCT02528214)
Timeframe: Baseline and Week 24
Intervention | mg/day (Mean) |
---|
| Baseline | Week 24 | Absolute reduction at Week 24 |
---|
Dupilumab 300 mg q2w | 10.75 | 3.13 | 7.66 |
,Placebo q2w | 11.75 | 6.32 | 5.45 |
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Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24
The ACQ-5 has 5 questions, reflecting top-scoring 5 asthma symptoms: woken at night by symptoms, wake in mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during previous week and to respond to each of 5 symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. (NCT02528214)
Timeframe: Baseline and at Weeks 2, 4, 8, 12, 16, 20, and 24
Intervention | score on a scale (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 16 | Change at Week 20 | Change at Week 24 |
---|
Dupilumab 300 mg q2w | -0.49 | -0.61 | -0.68 | -0.92 | -0.87 | -0.83 | -0.94 |
,Placebo q2w | -0.18 | -0.36 | -0.39 | -0.54 | -0.57 | -0.53 | -0.57 |
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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Giga cells per liter (Mean) |
---|
| Eosinophils,Week 2,n=1,1,0,1,2 | Eosinophils,Week 4,n=2,1,1,2,2 | Eosinophils,Week 8,n=2,1,1,2,1 | Eosinophils,Week 12,n=2,0,1,1,0 | Eosinophils,Week 16,n=2,0,0,1,0 | Eosinophils,Week 24,n=2,0,0,0,0 | Eosinophils,Week 36,n=2,0,0,0,0 | Eosinophils,Week 38,n=1,0,0,0,0 | Eosinophils,Week 40,n=1,0,0,0,0 | Leukocytes,Week 2,n=1,1,0,1,2 | Leukocytes,Week 4,n=2,1,1,2,2 | Leukocytes,Week 8,n=2,1,1,2,1 | Leukocytes,Week 12,n=2,0,1,1,0 | Leukocytes,Week 16,n=2,0,0,1,0 | Leukocytes,Week 24,n=2,0,0,0,0 | Leukocytes,Week 36,n=2,0,0,0,0 | Leukocytes,Week 38,n=1,0,0,0,0 | Leukocytes,Week 40,n=1,0,0,0,0 | Lymphocytes,Week 2,n=1,1,0,1,2 | Lymphocytes,Week 4,n=2,1,1,2,2 | Lymphocytes,Week 8,n=2,1,1,2,1 | Lymphocytes,Week 12,n=2,0,1,1,0 | Lymphocytes,Week 16,n=2,0,0,1,0 | Lymphocytes,Week 24,n=2,0,0,0,0 | Lymphocytes,Week 36,n=2,0,0,0,0 | LymphocytesWeek 38,n=1,0,0,0,0 | Lymphocytes,Week 40,n=1,0,0,0,0 | Neutrophils ,Week 2,n=1,1,0,1,2 | Neutrophils ,Week 4,n=2,1,1,2,2 | Neutrophils ,Week 8,n=2,1,1,2,2 | Neutrophils ,Week 12,n=2,0,1,1,0 | Neutrophils ,Week 16,n=2,0,0,1,0 | Neutrophils ,Week 24,n=2,0,0,0,0 | Neutrophils ,Week 36,n=2,0,0,0,0 | Neutrophils ,Week 38,n=1,0,0,0,0 | Neutrophils,Week 40,n=1,0,0,0,0 | Platelets ,Week 2,n=1,1,0,1,2 | Platelets,Week 4,n=2,1,1,2,2 | Platelets,Week 8,n=2,1,1,2,1 | Platelets,Week 12,n=2,0,1,1,0 | Platelets,Week 16,n=2,0,0,1,0 | Platelets,Week 24,n=2,0,0,0,0 | Platelets,Week 36,n=2,0,0,0,0 | Platelets,Week 38,n=1,0,0,0,0 | Platelets,Week 40,n=1,0,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | -0.010 | -0.015 | -0.010 | -0.030 | 0.030 | -0.015 | -0.010 | 0.020 | -0.030 | -0.20 | 0.25 | -0.25 | -0.10 | -0.45 | -0.20 | 0.65 | -0.50 | -1.30 | -0.170 | 0.110 | -0.120 | -0.030 | -0.230 | -0.320 | 0.195 | 0.010 | -0.160 | -0.040 | 0.205 | -0.265 | 0.020 | -0.235 | 0.085 | 0.540 | -0.460 | -0.770 | 5.0 | -1.0 | 7.0 | 7.0 | 2.0 | -18.5 | 10.0 | -15.0 | -6.0 |
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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Grams per liter (Mean) |
---|
| MCHC,Week 4,n=3,3,2,1,2 | MCHC,Week 8,n=0,1,2,0,2 | MCHC,Week 12,n=0,1,1,1,1 | MCHC,Week 16,n=0,1,1,1,0 | MCHC,Week 24,n=0,1,0,0,0 | MCHC,Week 36,n=0,1,0,0,0 | Hemoglobin,Week 4,n=3,3,2,1,2 | Hemoglobin,Week 8,n=2,1,2,0,2 | Hemoglobin,Week 12,n=1,1,1,1,1 | Hemoglobin,Week 16,n=0,1,1,1,0 | Hemoglobin,Week 24,n=0,1,0,0,0 | Hemoglobin,Week 36,n=0,1,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | -14.0 | -8.0 | -10.0 | -9.0 | -17.0 | -15.0 | -6.3 | -4.0 | -1.0 | -2.0 | -4.0 | 2.0 |
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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Grams per liter (Mean) |
---|
| MCHC,Week 4,n=3,3,2,1,2 | Hemoglobin,Week 4,n=3,3,2,1,2 | Hemoglobin,Week 8,n=2,1,2,0,2 | Hemoglobin,Week 12,n=1,1,1,1,1 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | -18.0 | -4.0 | -6.0 | -5.0 |
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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Grams per liter (Mean) |
---|
| MCHC,Week 4,n=3,3,2,1,2 | MCHC,Week 12,n=0,1,1,1,1 | MCHC,Week 16,n=0,1,1,1,0 | Hemoglobin,Week 4,n=3,3,2,1,2 | Hemoglobin,Week 12,n=1,1,1,1,1 | Hemoglobin,Week 16,n=0,1,1,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | 0.0 | 21.0 | 8.0 | -2.0 | 8.0 | 2.0 |
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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Grams per liter (Mean) |
---|
| MCHC,Week 4,n=3,3,2,1,2 | MCHC,Week 8,n=0,1,2,0,2 | MCHC,Week 12,n=0,1,1,1,1 | Hemoglobin,Week 4,n=3,3,2,1,2 | Hemoglobin,Week 8,n=2,1,2,0,2 | Hemoglobin,Week 12,n=1,1,1,1,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | -7.0 | 8.0 | 11.0 | -5.5 | -1.5 | 5.0 |
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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Grams per liter (Mean) |
---|
| MCHC,Week 4,n=3,3,2,1,2 | MCHC,Week 8,n=0,1,2,0,2 | MCHC,Week 12,n=0,1,1,1,1 | MCHC,Week 16,n=0,1,1,1,0 | Hemoglobin,Week 4,n=3,3,2,1,2 | Hemoglobin,Week 8,n=2,1,2,0,2 | Hemoglobin,Week 12,n=1,1,1,1,1 | Hemoglobin,Week 16,n=0,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | -3.0 | -0.5 | 11.0 | -1.0 | 2.0 | 4.0 | 20.0 | 19.0 |
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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Grams per liter (Mean) |
---|
| MCHC,Week 2,n=1,1,0,1,1 | MCHC,Week 4,n=2,1,0,2,1 | MCHC,Week 8,n=2,1,0,2,1 | MCHC,Week 12,n=2,0,0,1,0 | MCHC,Week 14,n=0,0,0,1,0 | MCHC,Week 16,n=2,0,0,1,0 | Hemoglobin,Week 2,n=1,1,0,1,2 | Hemoglobin,Week 4,n=2,1,1,2,2 | Hemoglobin,Week 8,n=2,1,1,2,1 | Hemoglobin,Week 12,n=2,0,1,1,0 | Hemoglobin,Week 14,n=0,0,0,1,0 | Hemoglobin,Week 16,n=2,0,0,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | -3.0 | 3.5 | 3.5 | 19.0 | 5.0 | 11.0 | 7.0 | -0.5 | -0.5 | -6.0 | 0.0 | 8.0 |
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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Grams per liter (Mean) |
---|
| MCHC,Week 2,n=1,1,0,1,1 | MCHC,Week 4,n=2,1,0,2,1 | MCHC,Week 8,n=2,1,0,2,1 | MCHC,Week 12,n=2,0,0,1,0 | MCHC,Week 16,n=2,0,0,1,0 | MCHC,Week 24,n=2,0,0,0,0 | MCHC,Week 36,n=2,0,0,0,0 | MCHC,Week 38,n=1,0,0,0,0 | MCHC,Week 40,n=1,0,0,0,0 | Hemoglobin,Week 2,n=1,1,0,1,2 | Hemoglobin,Week 4,n=2,1,1,2,2 | Hemoglobin,Week 8,n=2,1,1,2,1 | Hemoglobin,Week 12,n=2,0,1,1,0 | Hemoglobin,Week 16,n=2,0,0,1,0 | Hemoglobin,Week 24,n=2,0,0,0,0 | Hemoglobin,Week 36,n=2,0,0,0,0 | Hemoglobin,Week 38,n=1,0,0,0,0 | Hemoglobin,Week 40,n=1,0,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | -3.0 | -1.5 | 0.0 | -5.5 | 0.0 | -3.0 | -4.0 | -3.0 | 4.0 | -4.0 | 0.5 | 4.0 | 1.5 | 0.0 | -0.5 | -1.5 | -3.0 | -3.0 |
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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Grams per liter (Mean) |
---|
| Hemoglobin,Week 4,n=2,1,1,2,2 | Hemoglobin,Week 8,n=2,1,1,2,1 | Hemoglobin,Week 12,n=2,0,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | -9.0 | 0.0 | 0.0 |
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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Grams per liter (Mean) |
---|
| MCHC,Week 2,n=1,1,0,1,1 | MCHC,Week 4,n=2,1,0,2,1 | MCHC,Week 8,n=2,1,0,2,1 | Hemoglobin,Week 2,n=1,1,0,1,2 | Hemoglobin,Week 4,n=2,1,1,2,2 | Hemoglobin,Week 8,n=2,1,1,2,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | 20.0 | 23.0 | 9.0 | 10.0 | 8.0 | 9.0 |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | -1.0 | 1.0 | 16.0 | -2.0 | -2.0 | 3.0 |
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Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
"The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported." (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
Intervention | Scores on scale (Number) |
---|
| Par 1, Day 30 | Par 2, Day 29 | Par 3, Day 23 | Par 4, Week 4 | Par 4, Week 8 | Par 4, Week 12 | Par 4, Day 113 | Par 5, Week 4 | Par 5, Week 8 | Par 5, Day 85 | Par 6, Week 4 | Par 6, Day 65 | Par 7, Week 4 | Par 7, Week 8 | Par 7, Week 12 | Par 7, Day 373 | Par 8, Week 4 | Par 8, Day 64 | Par 9, Day 29 | Par 10, Week 4 | Par 10, Day 57 | Par 11, Week 4 | Par 11, Week 8 | Par 11, Week 12 | Par 11, Day 163 | Par 12, Week 4 | Par 12, Week 8 | Par 12, Day 85 | Par 13, Week 4 | Par 13, Day 59 | Par 14, Week 4 | Par 14, Day 57 | Par 16, Day 169 | Par 17, Week 4 | Par 17, Week 12 | Par 17, Day 112 | Par 18, Week 8 | Par 18, Day 85 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -2 | -2 | -2 | 1 | 0 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0 | -1 | -3 | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 1 | 0 | 0 | 0 | 0 | -1 | 0 | 0 | -1 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0 | 0 | -1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0 | 0 | 1 | 1 | 0 | -1 | 0 | 0 | 0 | NA | NA | NA | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
"The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value." (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
Intervention | Scores on scale (Number) |
---|
| Par 1, Week 2 | Par 1, Week 4 | Par 1, Week 8 | Par 1, Week 12 | Par 1, Week 24 | Par 1, Day 339 | Par 2, Week 4 | Par 2, Week 8 | Par 2, Week 12 | Par 2, Week 24 | Par 2, Week 38 | Par 2, Week 40 | Par 2, Day 344 | Par 3, Day 113 | Par 4, Week 4 | Par 4, Week 8 | Par 4, Week 12 | Par 5, Week 4 | Par 5, Week 8 | Par 5, Week 12 | Par 5, Week 14 | Par 5, Week 16 | Par 5, Day 162 | Par 6, Week 2 | Par 6, Week 4 | Par 6, Week 8 | Par 6, Day 91 | Par 7, Week 2 | Par 7, Week 4 | Par 7, Week 8 | Par 7, Day 85 | Par 8, Week 2 | Par 8, Week 4 | Par 8, Day 87 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -1 | 0 | 1 | 0 | 2 | 0 | 0 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0 | 1 | 0 | 1 | 0 | 1 | 2 | -2 | -2 | -1 | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | 0 | NA | NA | NA | NA | -2 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 4 | -1 | -1 | 4 | 0 | -2 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -2 | 0 | -3 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
"In PhGA was based on What is physician's assessment of the participant's current disease activity. PhGA used a 10 cm VAS ranging from 0 (none) to 10 (extremely active). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported." (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373
Intervention | Scores on scale (Number) |
---|
| Par 1, Day 30 | Par 2, Day 29 | Par 3, Day 23 | Par 3, Week 12 | Par 4, Day 113 | Par 5, Week 4 | Par 5, Day 85 | Par 6, Week 4 | Par 6, Day 65 | Par 7, Week 4 | Par 7, Week 8 | Par 7, Week 12 | Par 7, Week 16 | Par 7, Week 36 | Par 7, Day 373 | Par 8, Week 4 | Par 8, Day 64 | Par 9, Day 29 | Par 10, Week 4 | Par 10, Day 57 | Par 11, Week 12 | Par 11, Week 16 | Par 11, Day 163 | Par 12, Week 4 | Par 12, Week 8 | Par 12, Day 85 | Par 13, Week 4 | Par 13, Day 59 | Par 14, Week 4 | Par 14, Day 57 | Par 15, Day 169 | Par 16, Week 4 | Par 16, Week 12 | Par 16, Day 112 | Par 17, Week 8 | Par 17, Day 85 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -0.1 | 0.0 | 0.4 | 0.1 | 0.2 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -0.3 | 0.3 | -0.5 | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0.2 | 0.0 | 0.2 | 0.4 | 0.2 | 0.0 | 0.4 | 0.1 | 0.2 | 0.0 | 0.1 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.0 | 0.1 | 0.0 | 0.7 | 0.0 | -0.3 | 0.3 | -0.2 | -0.3 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0.9 | 0.9 | 0.4 | -0.1 | 0.1 | -0.1 | -0.6 | -0.3 | NA | NA | NA | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
"In PhGA was based on What is physician's assessment of the participant's current disease activity. PhGA used a 10 cm VAS ranging from 0 (none) to 10 (extremely active). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value." (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40
Intervention | Scores on scale (Number) |
---|
| Par 1, Week 2 | Par 1, Week 4 | Par 1, Week 8 | Par 1, Week 12 | Par 1, Week 16 | Par 1, Week 24 | Par 1, Week 36 | Par 1, Day 339 | Par 2, Week 4 | Par 2, Week 8 | Par 2, Week 12 | Par 2, Week 16 | Par 2, Week 24 | Par 2, Week 36 | Par 2, Week 38 | Par 2, Week 40 | Par 2, Day 344 | Par 3, Day 113 | Par 4, Week 4 | Par 4, Week 12 | Par 5, Week 4 | Par 5, Week 8 | Par 5, Week 12 | Par 5, Week 14 | Par 5, Week 16 | Par 5, Day 162 | Par 6, Day 203 | Par 7, Week 2 | Par 7, Week 4 | Par 7, Week 8 | Par 7, Day 85 | Par 8, Week 2 | Par 8, Week 4 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0.0 | 0.1 | 0.0 | 0.0 | -6.0 | -6.3 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 1.8 | -1.1 | -0.7 | 1.5 | -1.1 | -0.4 | 7.6 | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -0.2 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.0 | -0.5 | -1.2 | -0.6 | -0.9 | -0.6 | -1.1 | -1.2 | 0.0 | 0.1 | 0.4 | 0.1 | 0.0 | 0.1 | 0.7 | 0.4 | 0.2 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -0.2 | 0.1 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
"The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported." (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373
Intervention | Scores on scale (Number) |
---|
| Par 1, Day 30 | Par 2, Day 29 | Par 3, Day 23 | Par 4, Week 4 | Par 4, Week 8 | Par 4, Week 12 | Par 4, Day 113 | Par 5, Week 4 | Par 5, Week 8 | Par 5, Day 85 | Par 6, Week 4 | Par 6, Day 65 | Par 7, Week 4 | Par 7, Week 8 | Par 7, Week 12 | Par 7, Week 16 | Par 7, Week 36 | Par 7, Day 373 | Par 8, Week 4 | Par 8, Day 64 | Par 9, Day 29 | Par 10, Week 4 | Par 10, Day 57 | Par 11, Week 4 | Par 11, Week 8 | Par 11, Week 12 | Par 11, Week 16 | Par 11, Day 163 | Par 12, Week 4 | Par 12, Week 8 | Par 12, Day 85 | Par 13, Week 4 | Par 13, Day 59 | Par 14, Week 4 | Par 14, Day 57 | Par 15, Day 169 | Par 16, Week 4 | Par 16, Week 12 | Par 16, Day 112 | Par 17, Week 8 | Par 17, Day 85 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -0.3 | -0.3 | -0.1 | 0.2 | -0.1 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -0.4 | -0.9 | -1.1 | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 1.0 | 0.0 | 0.0 | 0.2 | 0.2 | 0.9 | -0.2 | -0.4 | 0.1 | 0.0 | -0.3 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.2 | -0.1 | 0.0 | -0.2 | 0.1 | 0.0 | 0.0 | 0.1 | 0.4 | 2.3 | -1.0 | 0.5 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -0.1 | 0.2 | 0.2 | 1.2 | 0.3 | -0.8 | -0.7 | 0.9 | -0.7 | 1.0 | NA | NA | NA | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
"The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value." (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344
Intervention | Scores on scale (Number) |
---|
| Par 1, Week 2 | Par 1, Week 4 | Par 1, Week 8 | Par 1, Week 12 | Par 1, Week 16 | Par 1, Week 24 | Par 1, Week 36 | Par 1, Day 339 | Par 2, Week 4 | Par 2, Week 8 | Par 2, Week 12 | Par 2, Week 16 | Par 2, Week 24 | Par 2, Week 36 | Par 2, Week 38 | Par 2, Week 40 | Par 2, Day 344 | Par 3,Par 3,, Day 113 | Par 4, Week 4 | Par 4, Week 8 | Par 4, Week 12 | Par 5, Week 4 | Par 5, Week 8 | Par 5, Week 12 | Par 5, Week 14 | Par 5, Week 16 | Par 5, Day 162 | Par 6, Week 4 | Par 6, Week 8 | Par 6, Day 91 | Par 7, Week 2 | Par 7, Week 4 | Par 7, Week 8 | Par 7, Day 85 | Par 8, Week 2 | Par 8, Week 4 | Par 8, Day 87 | Par 6, Week 2 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0.4 | NA | NA | NA | NA | NA | NA | NA | -0.7 | 0.7 | 0.8 | -0.4 | -0.1 | -3.7 | -3.1 | NA |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 2.0 | NA | 0.2 | 1.0 | 1.0 | 0.8 | -3.1 | -3.2 | -3.5 | NA | NA | NA | NA | NA | NA | NA | -0.1 |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 2.1 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 4.3 | 2.3 | -0.2 | 4.0 | 4.7 | 2.2 | 0.4 | -0.7 | -1.0 | -0.3 | -0.6 | -0.7 | 0.5 | -0.6 | 0.9 | -0.3 | -0.7 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -1.0 | 4.9 | 0.4 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | beats per minute (Mean) |
---|
| Week 4,n=3,3,3,1,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 | Week follow up,n=5,4,2,3,2 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | -29.0 | 6.0 | 6.0 | -7.7 |
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Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | beats per minute (Mean) |
---|
| Week 4,n=3,3,3,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week follow up,n=5,4,2,3,2 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | -1.5 | -0.5 | 6.0 | 7.5 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 3.7 | 8.0 | 11.0 | 1.4 |
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Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | beats per minute (Mean) |
---|
| Week 4,n=3,3,3,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 | Week follow up,n=5,4,2,3,2 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | -14.7 | -5.5 | 4.0 | -4.0 | -1.5 |
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Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | beats per minute (Mean) |
---|
| Week 4,n=3,3,3,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 | Week 24,n=0,1,0,0,0 | Week 36,n=0,1,0,0,0 | Week follow up,n=5,4,2,3,2 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | 0.3 | 4.0 | -4.0 | -4.0 | 0.0 | 0.0 | 4.0 |
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Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | beats per minute (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,1,1,1,0 | Week 16,n=2,0,0,1,0 | Week 24,n=2,0,0,0,0 | Week 36,n=2,0,0,0,0 | Week 38,n=1,0,0,0,0 | Week 40,n=1,0,0,0,0 | Week follow up,n=2,1,0,1,1 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | 4.0 | -2.0 | 0.0 | -2.0 | 2.0 | 5.0 | -2.0 | 0.0 | 0.0 | 5.0 |
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Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | beats per minute (Mean) |
---|
| Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | -10.0 | 4.0 | 4.0 |
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Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | beats per minute (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week follow up,n=2,1,0,1,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | 4.0 | -5.5 | -4.0 | 6.0 |
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Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | beats per minute (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,1,1,1,0 | Week follow up,n=2,1,0,1,1 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | 7.0 | 6.0 | 3.0 | 2.0 | -3.0 |
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Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | beats per minute (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,1,1,1,0 | Week 14,n=0,0,0,1,0 | Week 16,n=2,0,0,1,0 | Week follow up,n=2,1,0,1,1 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | 0.0 | -17.0 | -12.5 | -12.0 | -24.0 | -14.0 | -22.0 |
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Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | Millimeters of mercury (Mean) |
---|
| SBP,Week 4,n=3,3,3,1,2 | SBP,Week 8,n=2,1,2,0,2 | SBP,Week 12,n=1,1,1,1,1 | SBP,Week 16,n=0,1,1,1,0 | SBP,Week follow up,n=5,4,2,3,2 | DBP,Week 4,n=3,3,3,1,2 | DBP,Week 8,n=2,1,2,0,2 | DBP,Week 12,n=1,1,1,1,1 | DBP,Week 16,n=0,1,1,1,0 | DBP,Week follow up,n=5,4,2,3,2 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | 7.0 | -7.5 | 15.0 | 25.0 | -17.5 | 7.7 | 16.5 | 15.0 | 15.0 | 12.5 |
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Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | Millimeters of mercury (Mean) |
---|
| SBP,Week 4,n=3,3,3,1,2 | SBP,Week 8,n=2,1,2,0,2 | SBP,Week 12,n=1,1,1,1,1 | SBP,Week 16,n=0,1,1,1,0 | SBP,Week 24,n=0,1,0,0,0 | SBP,Week 36,n=0,1,0,0,0 | SBP,Week follow up,n=5,4,2,3,2 | DBP,Week 4,n=3,3,3,1,2 | DBP,Week 8,n=2,1,2,0,2 | DBP,Week 12,n=1,1,1,1,1 | DBP,Week 16,n=0,1,1,1,0 | DBP,Week 24,n=0,1,0,0,0 | DBP,Week 36,n=0,1,0,0,0 | DBP,Week follow up,n=5,4,2,3,2 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | -6.3 | -6.0 | -4.0 | -8.0 | 4.0 | -26.0 | -3.3 | 0.3 | -10.0 | -6.0 | 0.0 | -10.0 | -10.0 | -2.8 |
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Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | Millimeters of mercury (Mean) |
---|
| SBP,Week 4,n=3,3,3,1,2 | SBP,Week 12,n=1,1,1,1,1 | SBP,Week 16,n=0,1,1,1,0 | SBP,Week follow up,n=5,4,2,3,2 | DBP,Week 4,n=3,3,3,1,2 | DBP,Week 12,n=1,1,1,1,1 | DBP,Week 16,n=0,1,1,1,0 | DBP,Week follow up,n=5,4,2,3,2 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | 10.0 | 13.0 | -8.0 | 10.7 | -4.0 | 8.0 | -17.0 | 6.0 |
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Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | Millimeters of mercury (Mean) |
---|
| SBP,Week 4,n=3,3,3,1,2 | SBP,Week 8,n=2,1,2,0,2 | SBP,Week 12,n=1,1,1,1,1 | SBP,Week follow up,n=5,4,2,3,2 | DBP,Week 4,n=3,3,3,1,2 | DBP,Week 8,n=2,1,2,0,2 | DBP,Week 12,n=1,1,1,1,1 | DBP,Week follow up,n=5,4,2,3,2 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | -23.7 | -32.5 | -59.0 | -7.4 | -8.3 | -9.0 | -22.0 | 3.4 |
,PartB:Placebo SC q2w + 12 Month Prednisone | -2.0 | -1.5 | -2.0 | 5.0 | -11.0 | -6.0 | -9.0 | -2.0 |
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Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | Millimeters of mercury (Mean) |
---|
| SBP,Week 2,n=1,1,0,1,2 | SBP,Week 4,n=2,1,1,2,2 | SBP,Week 8,n=2,1,1,2,1 | SBP,Week 12,n=2,1,1,1,0 | SBP,Week follow up,n=2,1,0,1,1 | DBP,Week 2,n=1,1,0,1,2 | DBP,Week 4,n=2,1,1,2,2 | DBP,Week 8,n=2,1,1,2,1 | DBP,Week 12,n=2,1,1,1,0 | DBP,Week follow up,n=2,1,0,1,1 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | 15.0 | 0.0 | 18.0 | 14.0 | -1.0 | -8.0 | -15.0 | -5.0 | -5.0 | -7.0 |
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Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | Millimeters of mercury (Mean) |
---|
| SBP,Week 2,n=1,1,0,1,2 | SBP,Week 4,n=2,1,1,2,2 | SBP,Week 8,n=2,1,1,2,1 | SBP,Week 12,n=2,1,1,1,0 | SBP,Week 14,n=0,0,0,1,0 | SBP,Week 16,n=2,0,0,1,0 | SBP,Week follow up,n=2,1,0,1,1 | DBP,Week 2,n=1,1,0,1,2 | DBP,Week 4,n=2,1,1,2,2 | DBP,Week 8,n=2,1,1,2,1 | DBP,Week 12,n=2,1,1,1,0 | DBP,Week 14,n=0,0,0,1,0 | DBP,Week 16,n=2,0,0,1,0 | DBP,Week follow up,n=2,1,0,1,1 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | 0.0 | -1.5 | -11.5 | 2.0 | 9.0 | 11.0 | 22.0 | 0.0 | 2.0 | 4.0 | 4.0 | 7.0 | 15.0 | 21.0 |
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Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | Millimeters of mercury (Mean) |
---|
| SBP,Week 2,n=1,1,0,1,2 | SBP,Week 4,n=2,1,1,2,2 | SBP,Week 8,n=2,1,1,2,1 | SBP,Week 12,n=2,1,1,1,0 | SBP,Week 16,n=2,0,0,1,0 | SBP,Week 24,n=2,0,0,0,0 | SBP,Week 36,n=2,0,0,0,0 | SBP,Week 38,n=1,0,0,0,0 | SBP,Week 40,n=1,0,0,0,0 | SBP,Week follow up,n=2,1,0,1,1 | DBP,Week 2,n=1,1,0,1,2 | DBP,Week 4,n=2,1,1,2,2 | DBP,Week 8,n=2,1,1,2,1 | DBP,Week 12,n=2,1,1,1,0 | DBP,Week 16,n=2,0,0,1,0 | DBP,Week 24,n=2,0,0,0,0 | DBP,Week 36,n=2,0,0,0,0 | DBP,Week 38,n=1,0,0,0,0 | DBP,Week 40,n=1,0,0,0,0 | DBP,Week follow up,n=2,1,0,1,1 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | 2.0 | 5.0 | 14.0 | 7.0 | 0.0 | 8.0 | 11.0 | -6.0 | -10.0 | 3.0 | -10.0 | -3.0 | 3.0 | -5.0 | -5.0 | 1.0 | -2.0 | -8.0 | -10.0 | -2.0 |
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Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | Millimeters of mercury (Mean) |
---|
| SBP,Week 4,n=2,1,1,2,2 | SBP,Week 8,n=2,1,1,2,1 | SBP,Week 12,n=2,1,1,1,0 | DBP,Week 4,n=2,1,1,2,2 | DBP,Week 8,n=2,1,1,2,1 | DBP,Week 12,n=2,1,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | 6.0 | -12.0 | 8.0 | 6.0 | -4.0 | 1.0 |
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Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | Millimeters of mercury (Mean) |
---|
| SBP,Week 2,n=1,1,0,1,2 | SBP,Week 4,n=2,1,1,2,2 | SBP,Week 8,n=2,1,1,2,1 | SBP,Week follow up,n=2,1,0,1,1 | DBP,Week 2,n=1,1,0,1,2 | DBP,Week 4,n=2,1,1,2,2 | DBP,Week 8,n=2,1,1,2,1 | DBP,Week follow up,n=2,1,0,1,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | 6.5 | 1.5 | 5.0 | 12.0 | 7.0 | 4.5 | -1.0 | 3.0 |
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Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | Celsius (Mean) |
---|
| Week 4,n=3,3,3,1,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 | Week follow up,n=5,4,2,3,2 |
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PartB:Placebo SC q2w + 6 Month Prednisone | -0.20 | 0.00 | -0.10 | -0.13 |
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Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | Celsius (Mean) |
---|
| Week 4,n=3,3,3,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week follow up,n=5,4,2,3,2 |
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PartB:Placebo SC q2w + 12 Month Prednisone | 0.10 | 0.05 | -0.50 | 0.20 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.10 | -0.10 | -0.30 | 0.06 |
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Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | Celsius (Mean) |
---|
| Week 4,n=3,3,3,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 | Week follow up,n=5,4,2,3,2 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0.00 | -0.10 | 0.00 | 0.00 | 0.00 |
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Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Intervention | Celsius (Mean) |
---|
| Week 4,n=3,3,3,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 | Week 24,n=0,1,0,0,0 | Week 36,n=0,1,0,0,0 | Week follow up,n=5,4,2,3,2 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | 0.07 | 0.00 | 0.40 | 0.20 | 0.00 | 0.00 | 0.15 |
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Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | Celsius (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,1,1,1,0 | Week 16,n=2,0,0,1,0 | Week 24,n=2,0,0,0,0 | Week 36,n=2,0,0,0,0 | Week 38,n=1,0,0,0,0 | Week 40,n=1,0,0,0,0 | Week follow up,n=2,1,0,1,1 |
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PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.20 | 0.15 | -0.15 | -0.25 | -0.05 | -0.42 | -0.25 | 0.00 | 0.00 | 0.15 |
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Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | Celsius (Mean) |
---|
| Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | -0.30 | 0.10 | 0.50 |
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Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | Celsius (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week follow up,n=2,1,0,1,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | -0.65 | 0.30 | -0.50 | -0.60 |
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Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | Celsius (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,1,1,1,0 | Week follow up,n=2,1,0,1,1 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | 0.50 | -0.50 | 0.00 | 0.90 | 0.00 |
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Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Intervention | Celsius (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,1,1,1,0 | Week 14,n=0,0,0,1,0 | Week 16,n=2,0,0,1,0 | Week follow up,n=2,1,0,1,1 |
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PartB:Placebo SC q2w + 6 Month Prednisone | -0.40 | -0.10 | -0.20 | 0.00 | -0.20 | -0.10 | 0.50 |
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Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
Intervention | Milligrams (Mean) |
---|
| Week 4,n=0,0,0,1,1 | Week 8,n=0,0,0,1,1 | Week 24,n=0,0,0,1,0 |
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PartBPlacebo SC q2w + 6 Month Prednisone | 203.750 | 357.500 | 397.500 |
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Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
Intervention | Milligrams (Mean) |
---|
| Week 4,n=0,0,0,1,1 | Week 8,n=0,0,0,1,1 | Week 12,n=0,0,0,0,1 | Week 16,n=0,0,0,0,1 | Week 32,n=0,0,0,0,1 |
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PartBPlacebo SC q2w + 12 Month Prednisone | 325.000 | 596.250 | 830.000 | 1020.000 | 1211.250 |
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Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
Intervention | Milligrams (Mean) |
---|
| Week 2, n=0,0,0,1,1 | Week 4,n=0,0,0,2,1 | Week 12,n=0,0,0,2,1 | Week 32,n=0,0,0,0,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | 550.000 | 775.000 | 1600.000 | 1600.000 |
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Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
Intervention | Milligrams (Mean) |
---|
| Week 2, n=0,0,0,1,1 | Week 4,n=0,0,0,2,1 | Week 8,n=0,0,0,2,0 | Week 12,n=0,0,0,2,1 | Week 14,n=0,0,0,1,0 | Week 16,n=0,0,0,1,0 | Week 24,n=0,0,0,1,0 | Week 28,n=0,0,0,1,0 | Week 38,n=0,0,0,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | 561.000 | 596.125 | 956.125 | 1201.125 | 843.750 | 1233.750 | 1853.750 | 1908.500 | 2153.750 |
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Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
"Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability" (NCT02531633)
Timeframe: Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12
Intervention | Scores on scale (Number) |
---|
| Par 1, Day 29, Able to Do Chores | Par 1, Day 29, Get In and Out of a car | Par 1, Day 29, Run Errands and Shop | Par 1, Day 29, Get In and Out of Bed | Par 1, Day 29, Stand Up From a Straight Chair | Par 1, Day 29, Dress yourself | Par 1, Day 29, Shampoo your hair | Par 1, Day 29, Cut your meat | Par 1, Day 29, Lift a Full Cup or Glass to Mouth | Par 1, Day 29, Open a New Milk Carton | Par 1, Day 29, Open car doors | Par 1, Day 29, Open Jars Previously Opened | Par 1, Day 29, Turn Faucets On And Off | Par 1, Day 29, Get On and Off The Toilet | Par 1, Day 29, Take a Tub Bath | Par 1, Day 29, Wash and Dry Your Body | Par 1, Day 29, Bend Down Pick Up Clothing- Floor | Par 1, Day 29, Reach-Get Down 5 Lb Obj Above Head | Par 1, Day 29, Climb Up Five Steps | Par 1, Day 29, Walk Outdoors on Flat Ground | Par 2, Week 12, Able to Do Chores | Par 2, Week 12, Get In and Out of a car | Par 2, Week 12, Run Errands and Shop | Par 2, Week 12, Get In and Out of Bed | Par 2, Week 12, Stand Up From a Straight Chair | Par 2, Week 12, Dress yourself | Par 2, Week 12, Shampoo your hair | Par 2, Week 12, Cut your meat | Par 2, Week 12, Lift a Full Cup or Glass to Mouth | Par 2, Week 12, Open a New Milk Carton | Par 2, Week 12, Open r car doors | Par 2, Week 12, Open Jars Previously Opened | Par 2, Week 12, Turn Faucets On And Off | Par 2, Week 12, Get On and Off The Toilet | Par 2, Week 12, Take a Tub Bath | Par 2, Week 12, Wash and Dry Your Body | Par 2, Week 12, Bend Down Pick Up Clothing- Floor | Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head | Par 2, Week 12, Climb Up Five Steps | Par 2, Week 12, Walk Outdoors on Flat Ground | Par 2, Day 113, Able to Do Chores | Par 2, Day 113, Get In and Out of a car | Par 2, Day 113, Run Errands and Shop | Par 2, Day 113, Get In and Out of Bed | Par 2, Day 113, Stand Up From a Straight Chair | Par 2, Day 113, Dress yourself | Par 2, Day 113, Shampoo your hair | Par 2, Day 113, Cut your meat | Par 2, Day 113, Lift a Full Cup or Glass to Mouth | Par 2, Day 113, Open a New Milk Carton | Par 2, Day 113, Open car doors | Par 2, Day 113, Open Jars Previously Opened | Par 2, Day 113, Turn Faucets On And Off | Par 2, Day 113, Get On and Off The Toilet | Par 2, Day 113, Take a Tub Bath | Par 2, Day 113, Wash and Dry Your Body | Par 2, Day 113, Bend Down Pick Up Clothing- Floor | Par 2, Day 113, Reach-Get Down 5 Lb Obj Above Head | Par 2, Day 113, Climb Up Five Steps | Par 2, Day 113, Walk Outdoors on Flat Ground | Par 3, Day 65, Able to Do Chores | Par 3, Day 65, Get In and Out of a car | Par 3, Day 65, Run Errands and Shop | Par 3, Day 65, Get In and Out of Bed | Par 3, Day 65, Stand Up From a Straight Chair | Par 3, Day 65, Dress yourself | Par 3, Day 65, Shampoo your hair | Par 3, Day 65, Cut your meat | Par 3, Day 65, Lift a Full Cup or Glass to Mouth | Par 3, Day 65, Open a New Milk Carton | Par 3, Day 65, Open car doors | Par 3, Day 65, Open Jars Previously Opened | Par 3, Day 65, Turn Faucets On And Off | Par 3, Day 65, Get On and Off The Toilet | Par 3, Day 65, Take a Tub Bath | Par 3, Day 65, Wash and Dry Your Body | Par 3, Day 65, Bend Down Pick Up Clothing- Floor | Par 3, Day 65, Reach-Get Down 5 Lb Obj Above Head | Par 3, Day 65, Climb Up Five Steps | Par 3, Day 65, Walk Outdoors on Flat Ground | Par 4, Week 12, Able to Do Chores | Par 4, Week 12, Get In and Out of a car | Par 4, Week 12, Run Errands and Shop | Par 4, Week 12, Get In and Out of Bed | Par 4, Week 12, Stand Up From a Straight Chair | Par 4, Week 12, Dress yourself | Par 4, Week 12, Shampoo your hair | Par 4, Week 12, Cut your meat | Par 4, Week 12, Lift a Full Cup or Glass to Mouth | Par 4, Week 12, Open a New Milk Carton | Par 4, Week 12, Open car doors | Par 4, Week 12, Open Jars Previously Opened | Par 4, Week 12, Turn Faucets On And Off | Par 4, Week 12, Get On and Off The Toilet | Par 4, Week 12,Take a Tub Bath | Par 4, Week 12, Wash and Dry Your Body | Par 4, Week 12, Bend Down Pick Up Clothing- Floor | Par 4, Week 12, Reach-Get Down 5 Lb Obj Above Head | Par 4, Week 12, Climb Up Five Steps | Par 4, Week 12, Walk Outdoors on Flat Ground | Par 4, Day 373, Able to Do Chores | Par 4, Day 373, Get In and Out of a car | Par 4, Day 373, Run Errands and Shop | Par 4, Day 373, Get In and Out of Bed | Par 4, Day 373, Stand Up From a Straight Chair | Par 4, Day 373, Dress yourself | Par 4, Day 373, Shampoo your hair | Par 4, Day 373, Cut your meat | Par 4, Day 373, Lift a Full Cup or Glass to Mouth | Par 4, Day 373, Open a New Milk Carton | Par 4, Day 373, Open car doors | Par 4, Day 373, Open Jars Previously Opened | Par 4, Day 373, Turn Faucets On And Off | Par 4, Day 373, Get On and Off The Toilet | Par 4, Day 373,Take a Tub Bath | Par 4, Day 373, Wash and Dry Your Body | Par 4, Day 373, Bend Down Pick Up Clothing- Floor | Par 4, Day 373, Reach-Get Down 5 Lb Obj Above Head | Par 4, Day 373, Climb Up Five Steps | Par 4, Day 373, Walk Outdoors on Flat Ground | Par 5, Day 64, Able to Do Chores | Par 5, Day 64, Get In and Out of a car | Par 5, Day 64, Run Errands and Shop | Par 5, Day 64, Get In and Out of Bed | Par 5, Day 64, Stand Up From a Straight Chair | Par 5, Day 64, Dress yourself | Par 5, Day 64, Shampoo your hair | Par 5, Day 64, Cut your meat | Par 5, Day 64, Lift a Full Cup or Glass to Mouth | Par 5, Day 64, Open a New Milk Carton | Par 5, Day 64, Open car doors | Par 5, Day 64, Open Jars Previously Opened | Par 5, Day 64, Turn Faucets On And Off | Par 5, Day 64, Get On and Off The Toilet | Par 5, Day 64,Take a Tub Bath | Par 5, Day 64, Wash and Dry Your Body | Par 5, Day 64, Bend Down Pick Up Clothing- Floor | Par 5, Day 64, Reach-Get Down 5 Lb Obj Above Head | Par 5, Day 64, Climb Up Five Steps | Par 5, Day 64, Walk Outdoors on Flat Ground | Par 6, Day 85 Able to Do Chores | Par 6, Day 85, Get In and Out of a car | Par 6, Day 85, Run Errands and Shop | Par 6, Day 85, Get In and Out of Bed | Par 6, Day 85, Stand Up From a Straight Chair | Par 6, Day 85, Dress yourself | Par 6, Day 85,Shampoo your hair | Par 6, Day 85, Cut your meat | Par 6, Day 85, Lift a Full Cup or Glass to Mouth | Par 6, Day 85, Open a New Milk Carton | Par 6, Day 85, Open car doors | Par 6, Day 85, Open Jars Previously Opened | Par 6, Day 85, Turn Faucets On And Off | Par 6, Day 85, Get On and Off The Toilet | Par 6, Day 85,Take a Tub Bath | Par 6, Day 85, Wash and Dry Your Body | Par 6, Day 85, Bend Down Pick Up Clothing- Floor | Par 6, Day 85, Reach-Get Down 5 Lb Obj Above Head | Par 6, Day 85, Climb Up Five Steps | Par 6, Day 85, Walk Outdoors on Flat Ground | Par 7, Day 169, Able to Do Chores | Par 7, Day 169, Get In and Out of a car | Par 7, Day 169, Run Errands and Shop | Par 7, Day 169, Get In and Out of Bed | Par 7, Day 169, Stand Up From a Straight Chair | Par 7, Day 169, Dress yourself | Par 7, Day 169,Shampoo your hair | Par 7, Day 169, Cut your meat | Par 7, Day 169, Lift a Full Cup or Glass to Mouth | Par 7, Day 169, Open a New Milk Carton | Par 7, Day 169, Open car doors | Par 7, Day 169, Open Jars Previously Opened | Par 7, Day 169, Turn Faucets On And Off | Par 7, Day 169, Get On and Off The Toilet | Par 7, Day 169,Take a Tub Bath | Par 7, Day 169, Wash and Dry Your Body | Par 7, Day 169, Bend Down Pick Up Clothing- Floor | Par 7, Day 169, Reach-Get Down 5 Lb Obj Above Head | Par 7, Day 169, Climb Up Five Steps | Par 7, Day 169, Walk Outdoors on Flat Ground | Par 8, Week 12, Able to Do Chores | Par 8, Week 12, Get In and Out of a car | Par 8, Week 12, Run Errands and Shop | Par 8, Week 12, Get In and Out of Bed | Par 8, Week 12, Stand Up From a Straight Chair | Par 8, Week 12, Dress yourself | Par 8, Week 12,Shampoo your hair | Par 8, Week 12, Cut your meat | Par 8, Week 12, Lift a Full Cup or Glass to Mouth | Par 8, Week 12, Open a New Milk Carton | Par 8, Week 12, Open car doors | Par 8, Week 12, Open Jars Previously Opened | Par 8, Week 12, Turn Faucets On And Off | Par 8, Week 12, Get On and Off The Toilet | Par 8, Week 12,Take a Tub Bath | Par 8, Week 12, Wash and Dry Your Body | Par 8, Week 12, Bend Down Pick Up Clothing- Floor | Par 8, Week 12 Reach-Get Down 5 Lb Obj Above Head | Par 8, Week 12, Climb Up Five Steps | Par 8, Week 12, Walk Outdoors on Flat Ground | Par 8, Day 112, Able to Do Chores | Par 8, Day 112, Get In and Out of a car | Par 8, Day 112, Run Errands and Shop | Par 8, Day 112, Get In and Out of Bed | Par 8, Day 112, Stand Up From a Straight Chair | Par 8, Day 112, Dress yourself | Par 8, Day 112, Shampoo your hair | Par 8, Day 112, Cut your meat | Par 8, Day 112, Lift a Full Cup or Glass to Mout | Par 8, Day 112, Open a New Milk Carton | Par 8, Day 112, Open car doors | Par 8, Day 112, Open Jars Previously Opened | Par 8, Day 112, Turn Faucets On And Off | Par 8, Day 112, Get On and Off The Toilet | Par 8, Day 112, Take a Tub Bath | Par 8, Day 112, Wash and Dry Your Body | Par 8, Day 112, Bend Down Pick Up Clothing- Floor | Par 8, Day 112, Reach-Get Down 5 Lb Obj Above Head | Par 8, Day 112, Climb Up Five Steps | Par 8, Day 112, Walk Outdoors on Flat Ground |
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PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
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Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
"Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability" (NCT02531633)
Timeframe: Day 87, 339, 344, Week 12, 24
Intervention | Scores on scale (Number) |
---|
| Par 1, Week 12, Able to Do Chores | Par 1, Week 12, Get In and Out of a car | Par 1, Week 12, Run Errands and Shop | Par 1, Week 12, Get In and Out of Bed | Par 1, Week 12, Stand Up From a Straight | Par 1, Week 12, Dress yourself | Par 1, Week 12, Shampoo your hair | Par 1, Week 12, Cut your meat | Par 1, Week 12, Lift a Full Cup/Glass to mouth | Par 1, Week 12, Open a New Milk Carton | Par 1, Week 12, Open car doors | Par 1, Week 12, Open Jars Previously Opened | Par 1, Week 12, Turn Faucets On And Off | Par 1, Week 12, Get On and Off The Toilet | Par 1, Week 12, Take a Tub Bath | Par 1, Week 12, Wash and Dry Your Body | Par 1, Week 12, Bend Down Pick Up Clothing-Floor | Par 1, Week 12, Reach-Get Down 5 Lb Obj Above Head | Par 1, Week 12, Climb Up Five Steps | Par 1, Week 12, Walk Outdoors on Flat Ground | Par 1, Week 24, Able to Do Chores | Par 1, Week 24, Get In and Out of a car | Par 1, Week 24, Run Errands and Shop | Par 1, Week 24, Get In and Out of Bed | Par 1, Week 24, Stand Up From a Straight | Par 1, Week 24, Dress yourself | Par 1, Week 24, Shampoo your hair | Par 1, Week 24, Cut your meat | Par 1, Week 24, Lift a Full Cup/Glass to mouth | Par 1, Week 24, Open a New Milk Carton | Par 1, Week 24, Open car doors | Par 1, Week 24, Open Jars Previously Opened | Par 1, Week 24, Turn Faucets On And Off | Par 1, Week 24, Get On and Off The Toilet | Par 1, Week 24, Take a Tub Bath | Par 1, Week 24, Wash and Dry Your Body | Par 1, Week 24, Bend Down Pick Up Clothing-Floor | Par 1, Week 24, Reach-Get Down 5 Lb Obj Above Head | Par 1, Week 24, Climb Up Five Steps | Par 1, Week 24, Walk Outdoors on Flat Ground | Par 1, Day 339, Able to Do Chores | Par 1, Day 339, Get In and Out of a car | Par 1, Day 339, Run Errands and Shop | Par 1, Day 339, Get In and Out of Bed | Par 1, Day 339, Stand Up From a Straight | Par 1, Day 339, Dress yourself | Par 1, Day 339, Shampoo your hair | Par 1, Day 339, Cut your meat | Par 1, Day 339, Lift a Full Cup/Glass to mouth | Par 1, Day 339, Open a New Milk Carton | Par 1, Day 339, Open car doors | Par 1, Day 339, Open Jars Previously Opened | Par 1, Day 339, Turn Faucets On And Off | Par 1, Day 339, Get On and Off The Toilet | Par 1, Day 339, Take a Tub Bath | Par 1, Day 339, Wash and Dry Your Body | Par 1, Day 339, Bend Down Pick Up Clothing-Floor | Par 1, Day 339, Reach-Get Down 5 Lb Obj Above Head | Par 1, Day 339, Climb Up Five Steps | Par 1, Day 339, Walk Outdoors on Flat Ground | Par 2, Week 12, Able to Do Chores | Par 2, Week 12, Get In and Out of a car | Par 2, Week 12, Run Errands and Shop | Par 2, Week 12, Get In and Out of Bed | Par 2, Week 12, Stand Up From a Straight | Par 2, Week 12, Dress yourself | Par 2, Week 12, Shampoo your hair | Par 2, Week 12, Cut your meat | Par 2, Week 12, Lift a Full Cup/Glass to mouth | Par 2, Week 12, Open a New Milk Carton | Par 2, Week 12, Open car doors | Par 2, Week 12, Open Jars Previously Opened | Par 2, Week 12, Turn Faucets On And Off | Par 2, Week 12, Get On and Off The Toilet | Par 2, Week 12, Take a Tub Bath | Par 2, Week 12, Wash and Dry Your Body | Par 2, Week 12, Bend Down Pick Up Clothing-Floor | Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head | Par 2, Week 12, Climb Up Five Steps | Par 2, Week 12, Walk Outdoors on Flat Ground | Par 2, Week 24, Able to Do Chores | Par 2, Week 24, Get In and Out of a car | Par 2, Week 24, Run Errands and Shop | Par 2, Week 24, Get In and Out of Bed | Par 2, Week 24, Stand Up From a Straight | Par 2, Week 24, Dress yourself | Par 2, Week 24, Shampoo your hair | Par 2, Week 24, Cut your meat | Par 2, Week 24, Lift a Full Cup/Glass to mouth | Par 2, Week 24, Open a New Milk Carton | Par 2, Week 24, Open car doors | Par 2, Week 24, Open Jars Previously Opened | Par 2, Week 24, Turn Faucets On And Off | Par 2, Week 24, Get On and Off The Toilet | Par 2, Week 24, Take a Tub Bath | Par 2, Week 24, Wash and Dry Your Body | Par 2, Week 24, Bend Down Pick Up Clothing-Floor | Par 2, Week 24, Reach-Get Down 5 Lb Obj Above Head | Par 2, Week 24, Climb Up Five Steps | Par 2, Week 24, Walk Outdoors on Flat Ground | Par 2, Day 344, Able to Do Chores | Par 2, Day 344, Get In and Out of a car | Par 2, Day 344, Run Errands and Shop | Par 2, Day 344, Get In and Out of Bed | Par 2, Day 344, Stand Up From a Straight | Par 2, Day 344, Dress yourself | Par 2, Day 344, Shampoo your hair | Par 2, Day 344, Cut your meat | Par 2, Day 344, Lift a Full Cup/Glass to mouth | Par 2, Day 344, Open a New Milk Carton | Par 2, Day 344, Open car doors | Par 2, Day 344,Open Jars Previously Opened | Par 2, Day 344, Turn Faucets On And Off | Par 2, Day 344, Get On and Off The Toilet | Par 2, Day 344, Take a Tub Bath | Par 2, Day 344, Wash and Dry Your Body | Par 2, Day 344, Bend Down Pick Up Clothing-Floor | Par 2, Day 344, Reach-Get Down 5 Lb Obj Above Head | Par 2, Day 344, Climb Up Five Steps | Par 2, Day 344, Walk Outdoors on Flat Ground | Par 3, Week 12, Able to Do Chores | Par 3, Week 12, Get In and Out of a car | Par 3, Week 12, Run Errands and Shop | Par 3, Week 12, Get In and Out of Bed | Par 3, Week 12, Stand Up From a Straight | Par 3, Week 12, Dress yourself | Par 3, Week 12, Shampoo your hair | Par 3, Week 12, Cut your meat | Par 3, Week 12, Lift a Full Cup/Glass to mouth | Par 3, Week 12, Open a New Milk Carton | Par 3, Week 12, Open car doors | Par 3, Week 12, Open Jars Previously Opened | Par 3, Week 12, Turn Faucets On And Off | Par 3, Week 12, Get On and Off The Toilet | Par 3, Week 12, Take a Tub Bath | Par 3, Week 12, Wash and Dry Your Body | Par 3, Week 12, Bend Down Pick Up Clothing-Floor | Par 3, Week 12, Reach-Get Down 5 Lb Obj Above Head | Par 3, Week 12, Climb Up Five Steps | Par 3, Week 12, Walk Outdoors on Flat Ground | Par 4, Day 87, Able to Do Chores | Par 4, Day 87, Get In and Out of a car | Par 4, Day 87, Run Errands and Shop | Par 4, Day 87, Get In and Out of Bed | Par 4, Day 87, Stand Up From a Straight | Par 4, Day 87, Dress yourself | Par 4, Day 87, Shampoo your hair | Par 4, Day 87, Cut your meat | Par 4, Day 87, Lift a Full Cup/Glass to mouth | Par 4, Day 87, Open a New Milk Carton | Par 4, Day 87, Open Jars Previously Opened | Par 4, Day 87, Turn Faucets On And Off | Par 4, Day 87, Get On and Off The Toilet | Par 4, Day 87, Take a Tub Bath | Par 4, Day 87, Wash and Dry Your Body | Par 4, Day 87, Bend Down Pick Up Clothing-Floor | Par 4, Day 87, Reach-Get Down 5 Lb Obj Above Head | Par 4, Day 87, Climb Up Five Steps | Par 4, Day 87, Walk Outdoors on Flat Ground |
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PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 3 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 0 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
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Part B: Number of Disease Flares Over Time
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Disease flares (Number) |
---|
| Week 2, n=1,1,0,1,2 | Week 4, n=5,4,4,3,4 | Week 8, n=4,2,3,2,3 | Week 12, n=3,2,2,2,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | 0 | 0 | 0 | 0 |
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Part B: Number of Disease Flares Over Time
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Disease flares (Number) |
---|
| Week 4, n=5,4,4,3,4 | Week 8, n=4,2,3,2,3 | Week 12, n=3,2,2,2,1 | Week 16, n=2,1,1,2,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0 | 1 | 1 | 0 |
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Part B: Number of Disease Flares Over Time
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Disease flares (Number) |
---|
| Week 2, n=1,1,0,1,2 | Week 4, n=5,4,4,3,4 | Week 8, n=4,2,3,2,3 | Week 12, n=3,2,2,2,1 | Week 14, n=0,0,0,1,0 | Week 16, n=2,1,1,2,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | 0 | 0 | 0 | 0 | 1 | 1 |
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Part B: Number of Disease Flares Over Time
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Disease flares (Number) |
---|
| Week 2, n=1,1,0,1,2 | Week 4, n=5,4,4,3,4 | Week 8, n=4,2,3,2,3 | Week 12, n=3,2,2,2,1 | Week 16, n=2,1,1,2,0 | Week 24, n=2,1,0,0,0 | Week 36, n=2,1,0,0,0 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Part B: Number of Disease Flares Over Time
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Disease flares (Number) |
---|
| Week 2, n=1,1,0,1,2 | Week 4, n=5,4,4,3,4 | Week 8, n=4,2,3,2,3 | Week 12, n=3,2,2,2,1 | Week 16, n=2,1,1,2,0 | Week 24, n=2,1,0,0,0 | Week 36, n=2,1,0,0,0 | Week 38, n=1,0,0,0,0 | Week 40, n=1,0,0,0,0 |
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PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 |
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Part B: Number of Participants in Sustained Remission Over Time
Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis. (NCT02531633)
Timeframe: Weeks 4, 8 and 12
Intervention | Participants (Count of Participants) |
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| Week 4,n=1,1,1,0,0 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | 1 |
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Part B: Number of Participants in Sustained Remission Over Time
Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis. (NCT02531633)
Timeframe: Weeks 4, 8 and 12
Intervention | Participants (Count of Participants) |
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| Week 4,n=1,1,1,0,0 | Week 8,n=1,0,1,0,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | 1 | 1 |
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Part B: Number of Participants in Sustained Remission Over Time
Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis. (NCT02531633)
Timeframe: Weeks 4, 8 and 12
Intervention | Participants (Count of Participants) |
---|
| Week 4,n=1,1,1,0,0 | Week 8,n=1,0,1,0,0 | Week 12,n=1,0,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | 1 | 1 | 1 |
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Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category. (NCT02531633)
Timeframe: Baseline (Day 1)
Intervention | Participants (Number) |
---|
| Par 1, Day 1: No change | Par 2, Day 1: Much Better | Par 3, Day 1: Much Better | Par 4, Day 1: Much Better | Par 5, Day 1: Better | Par 6, Day 1: Much Better | Par 7, Day 1: Much Better | Par 8, Day 1: Better | Par 9, Day 1: Much Better | Par 10, Day 1: Better | Par 11, Day 1: Much Better | Par 12, Day 1: Much Better | Par 13, Day 1: Better | Par 14, Day 1: Better | Par 15, Day 1: Much Better | Par 16, Day 1: Much Better | Par 17, Day 1: Much Better | Par 18, Day 1: Much Better |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 1 | 1 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 1 | 1 | 1 | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | 1 | 1 | 1 | 1 | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 1 | 1 | 1 | 1 | 1 | 1 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 1 | 1 | 1 | NA | NA | NA | NA | NA |
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Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category. (NCT02531633)
Timeframe: Baseline (Day 1), Days 103 and 271
Intervention | Participants (Number) |
---|
| Par 1, Day 1: Much Better | Par 2, Day 1: Much Better | Par 2, Day 271: Worse | Par 3, Day 1: Much Better | Par 4, Day 1: Much Better | Par 5,Day 1: Slightly Better | Par 5, Day 103: No change | Par 6, Day 1: Better | Par 7, Day 1: Much Better | Par 8, Day 1: Slightly Better |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | 1 | 1 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | 1 | 1 | 1 | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | 1 | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 1 | 1 | 1 | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | 1 | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Milligram per liter (mg/L) (Mean) |
---|
| Week 2, n=1,1,0,1,2 | Week 4, n=2,1,1,2,2 | Week 8, n=2,1,1,2,1 | Week 12, n=2,1,1,1,0 | Week 16, n=2,0,0,1,0 | Week 24, n=2,0,0,0,0 | Week 36, n=2,0,0,0,0 | Week 38, n=1,0,0,0,0 | Week 40, n=1,0,0,0,0 |
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PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.00 | 0.10 | 0.10 | 0.10 | 0.40 | 1.90 | 0.80 | -0.10 | 0.00 |
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Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Milligram per liter (mg/L) (Mean) |
---|
| Week 2, n=1,1,0,1,2 | Week 4, n=2,1,1,2,2 | Week 8, n=2,1,1,2,1 | Week 12, n=2,1,1,1,0 | Week 14, n=0,0,0,1,0 | Week 16, n=2,0,0,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | -3.70 | -2.35 | 0.55 | 3.90 | -30.20 | -30.70 |
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Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Milligram per liter (mg/L) (Mean) |
---|
| Week 2, n=1,1,0,1,2 | Week 4, n=2,1,1,2,2 | Week 8, n=2,1,1,2,1 | Week 12, n=2,1,1,1,0 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | -0.20 | 0.10 | -0.10 | -0.10 |
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Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Milligram per liter (mg/L) (Mean) |
---|
| Week 4, n=2,1,1,2,2 | Week 8, n=2,1,1,2,1 | Week 12, n=2,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0.10 | 0.30 | 0.10 |
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Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Milligram per liter (mg/L) (Mean) |
---|
| Week 2, n=1,1,0,1,2 | Week 4, n=2,1,1,2,2 | Week 8, n=2,1,1,2,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | -4.20 | -4.20 | -2.10 |
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Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Intervention | mg/L (Mean) |
---|
| Week 4, n=3,3,2,1,2 | Week 8, n=2,1,2,0,2 | Week 12, n=1,1,1,1,1 | Week 16, n=0,1,1,1,0 | Week 24, n=0,1,0,0,0 | Week 36, n=0,1,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | -0.23 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
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Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12
Intervention | Scores on scale (Number) |
---|
| Par 1, Day 30 | Par 2, Day 29 | Par 3, Day 29 | Par 4, Week 12 | Par 4, Day 113 | Par 5, Day 85 | Par 6, Day 65 | Par 7, Week 12 | Par 7, Day 373 | Par 8, Day 64 | Par 9, Day 29 | Par 10, Day 57 | Par 11, Week 12 | Par 11, Day 163 | Par 12, Day 85 | Par 13, Day 59 | Par 14, Day 57 | Par 16, Day 169 | Par 17,Week 12 | Par 17, Day 112 | Par 18, Day 85 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0.163 | 0.163 | -0.042 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0.000 | 0.232 | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | 0.163 | 0.163 | -0.016 | 0.212 | 0.000 | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -0.248 | 0.000 | 0.233 | 0.000 | 0.000 | -0.015 | 0.163 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -0.069 | 0.042 | -0.059 | 0.000 | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Intervention | mm/h (Mean) |
---|
| Week 4, n=3,3,3,1,2 | Week 12, n=1,1,1,1,1 | Week 16, n=0,1,1,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | 8.0 | -6.0 | -4.0 |
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Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Intervention | mm/h (Mean) |
---|
| Week 4, n=3,3,3,1,2 | Week 8, n=2,1,3,0,2 | Week 12, n=1,1,1,1,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | -2.0 | 0.0 | 12.0 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -1.7 | -1.0 | -6.0 |
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Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Intervention | mm/h (Mean) |
---|
| Week 4, n=3,3,3,1,2 | Week 8, n=2,1,3,0,2 | Week 12, n=1,1,1,1,1 | Week 16, n=0,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | -1.0 | -2.0 | 0.0 | 1.0 |
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Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Intervention | mm/h (Mean) |
---|
| Week 4, n=3,3,3,1,2 | Week 8, n=2,1,3,0,2 | Week 12, n=1,1,1,1,1 | Week 16, n=0,1,1,1,0 | Week 24, n=0,1,0,0,0 | Week 36, n=0,1,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | 1.3 | 2.0 | 1.0 | 3.0 | 1.0 | 1.0 |
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Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Millimeter per hour (mm/h) (Mean) |
---|
| Week 4, n=2,1,1,2,2 | Week 12, n=2,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | 4.0 | 4.0 |
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Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Millimeter per hour (mm/h) (Mean) |
---|
| Week 2, n=1,1,0,1,1 | Week 4, n=2,1,1,2,2 | Week 8, n=2,1,0,2,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | -7.0 | -29.5 | -7.0 |
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Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Millimeter per hour (mm/h) (Mean) |
---|
| Week 2, n=1,1,0,1,1 | Week 4, n=2,1,1,2,2 | Week 8, n=2,1,0,2,1 | Week 12, n=2,1,1,1,0 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | 4.0 | 4.0 | 2.0 | 2.0 |
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Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Millimeter per hour (mm/h) (Mean) |
---|
| Week 2, n=1,1,0,1,1 | Week 4, n=2,1,1,2,2 | Week 8, n=2,1,0,2,1 | Week 12, n=2,1,1,1,0 | Week 14, n=0,0,0,1,0 | Week 16, n=2,0,0,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | -14.0 | -5.0 | -6.0 | 10.0 | -19.0 | -18.0 |
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Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Millimeter per hour (mm/h) (Mean) |
---|
| Week 2, n=1,1,0,1,1 | Week 4, n=2,1,1,2,2 | Week 8, n=2,1,0,2,1 | Week 12, n=2,1,1,1,0 | Week 16, n=2,0,0,1,0 | Week 24, n=2,0,0,0,0 | Week 36, n=2,0,0,0,0 | Week 38, n=1,0,0,0,0 | Week 40, n=1,0,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | -1.0 | 0.5 | 3.0 | 0.0 | -0.5 | -1.5 | 6.0 | -1.0 | 1.0 |
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Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported. (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
Intervention | Scores on scale (Number) |
---|
| Par 1, Day 30, I Feel Fatigued | Par 2, Day 29, I Feel Fatigued | Par 3, Day 23, I Feel Fatigued | Par 4, Week 12, I Feel Fatigued | Par 4, Day 113, I Feel Fatigued | Par 5, Week 8, I Feel Fatigued | Par 5, Day 85, I Feel Fatigued | Par 6, Day 65, I Feel Fatigued | Par 7, Week 12, I Feel Fatigued | Par 7, Day 373, I Feel Fatigued | Par 8, Day 64, I Feel Fatigued | Par 9, Day 29, I Feel Fatigued | Par 10, Day 57, I Feel Fatigued | Par 11, Week 12, I Feel Fatigued | Par 11, Day 163, I Feel Fatigued | Par 12, Day 85, I Feel Fatigued | Par 13, Day 59, I Feel Fatigued | Par 14, Day 57, I Feel Fatigued | Par 16, Day 169, I Feel Fatigued | Par 17, Week 12, I Feel Fatigued | Par 17, Day112, I Feel Fatigued | Par 18, Day 85, I Feel Fatigued |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 6 | 6 | -1 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -11 | 0 | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | 0 | 5 | -3 | 0 | 13 | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -3 | -1 | 0 | 2 | -16 | -1 | -3 | -1 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 5 | 6 | -1 | 7 | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24
Intervention | Scores on scale (Number) |
---|
| Par 1, Week 12, I Feel Fatigued | Par 1, Week 24, I Feel Fatigued | Par 1, Day 339, I Feel Fatigued | Par 2, Week 12, I Feel Fatigued | Par 2, Week 24, I Feel Fatigued | Par 2, Day 344, I Feel Fatigued | Par 3, Day 113, I Feel Fatigued | Par 4, Week 12, I Feel Fatigued | Par 5, Week 12, I Feel Fatigued | Par 5, Day 162, I Feel Fatigued | Par 6, Day 91, I Feel Fatigued | Par 7, Day 85, I Feel Fatigued | Par 8, Day 87, I Feel Fatigued |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -7 | -10 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | -5 | -4 | -12 | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | 2 | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -3 | -4 | 3 | 8 | 2 | 6 | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | 2 | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Femtoliter (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | -3.0 | 1.0 | 2.0 |
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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Femtoliter (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | 2.0 | 1.5 | 2.0 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.7 | -0.5 | 0.0 |
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Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category. (NCT02531633)
Timeframe: Weeks 12, 24 and 52
Intervention | Participants (Count of Participants) |
---|
| Week 12,Much Better, n=31,28,24,22,22 | Week 12,Better, n=31,28,24,22,22 | Week 12, Slightly Better, n=31,28,24,22,22 | Week 12,No Change, n=31,28,24,22,22 | Week 12,Slightly Worse, n=31,28,24,22,22 | Week 12,Worse, n=31,28,24,22,22 | Week 12,Much Worse, n=31,28,24,22,22 | Week 24,Much Better, n=23,20,15,17,16 | Week 24,Better, n=23,20,15,17,16 | Week 24, Slightly Better,n=23,20,15,17,16 | Week 24,No Change, n=23,20,15,17,16 | Week 24,Slightly Worse, n=23,20,15,17,16 | Week 24, Worse,n=23,20,15,17,16 | Week 24, Much Worse,n=23,20,15,17,16 | Week 52,Much Better, n=9,5,5,5,4 | Week 52,Better, n=9,5,5,5,4 | Week 52,Slightly Better, n=9,5,5,5,4 | Week 52,No Change, n=9,5,5,5,4 | Week 52,Slightly Worse, n=9,5,5,5,4 | Week 52,Worse, n=9,5,5,5,4 | Week 52,Much Worse, n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 5 | 11 | 3 | 3 | 0 | 0 | 0 | 6 | 6 | 1 | 1 | 1 | 1 | 0 | 3 | 0 | 1 | 0 | 0 | 0 | 0 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 5 | 4 | 8 | 0 | 4 | 1 | 0 | 5 | 6 | 4 | 1 | 1 | 0 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 0 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 7 | 10 | 5 | 3 | 1 | 2 | 0 | 6 | 8 | 2 | 2 | 1 | 1 | 0 | 3 | 2 | 0 | 0 | 0 | 0 | 0 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 11 | 11 | 3 | 3 | 1 | 2 | 0 | 11 | 7 | 2 | 1 | 2 | 0 | 0 | 6 | 2 | 0 | 1 | 0 | 0 | 0 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 2 | 11 | 4 | 4 | 2 | 1 | 0 | 6 | 4 | 0 | 2 | 2 | 1 | 0 | 3 | 1 | 1 | 0 | 0 | 0 | 0 |
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Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24
Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30 millimeters per hour] and CRP [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. (NCT02531633)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | NA |
Part B:SIR 100 mg SC q2w+3 Month Prednisone | NA |
PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA |
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Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare
"Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: Severe Flare including Hospitalizations. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study." (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Participants (Count of Participants) |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0 |
PartB:SIR 100 mg SC q2w+3 Month Prednisone | 0 |
PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0 |
PartB:Placebo SC q2w + 6 Month Prednisone | 0 |
PartB:Placebo SC q2w + 12 Month Prednisone | 0 |
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Part B: Number of Hospitalizations for Disease Flare Over Time
"Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: Severe Flare including Hospitalizations. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study." (NCT02531633)
Timeframe: Up to Week 104
Intervention | Number of hospitalizations (Number) |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0 |
PartB:SIR 100 mg SC q2w+3 Month Prednisone | 0 |
PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0 |
PartB:Placebo SC q2w + 6 Month Prednisone | 0 |
PartB:Placebo SC q2w + 12 Month Prednisone | 0 |
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Part A: Time to First Disease Flare After Clinical Remission
Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented. (NCT02531633)
Timeframe: Week 52
Intervention | Days (Median) |
---|
PartA:SIR 100 mg SC q2w+6 Month Prednisone | NA |
PartA:SIR 100 mg SC q2w+3 Month Prednisone | NA |
PartA:SIR 50 mg SC q4w+6 Month Prednisone | NA |
PartA:Placebo SC q2w + 6 Month Prednisone | NA |
PartA:Placebo SC q2w + 12 Month Prednisone | NA |
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Part B: Time to First Disease Flare for Participants in Sustained Remission
Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented. (NCT02531633)
Timeframe: Week 52
Intervention | Days (Median) |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | NA |
PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA |
PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA |
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Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Millimeters of mercury (Mean) |
---|
| SBP,Week 2,n=37,39,26,24,27 | SBP,Week 4,n=37,37,25,23,27 | SBP,Week 8,n=34,32,24,22,23 | SBP,Week 12,n=32,29,24,22,22 | SBP,Week 16,n=28,26,22,19,19 | SBP,Week 20,n=26,23,19,18,16 | SBP,Week 24,n=23,21,16,17,16 | SBP,Week 28,n=19,18,12,14,14 | SBP,Week 32,n=19,15,10,12,13 | SBP,Week 36,n=15,13,10,12,13 | SBP,Week 40,n=15,11,9,10,10 | SBP,Week 44,n=11,11,6,8,9 | SBP,Week 48,n=9,8,5,8,5 | SBP,Week 52,n=9,5,5,5,4 | DBP,Week 2,n=37,39,26,24,27 | DBP,Week 4,n=37,37,25,23,27 | DBP,Week 8,n=34,32,24,22,23 | DBP,Week 12,n=32,29,24,22,22 | DBP,Week 16,n=28,26,22,19,19 | DBP,Week 20,n=26,23,19,18,16 | DBP,Week 24,n=23,21,16,17,16 | DBP,Week 28,n=19,18,12,14,14 | DBP,Week 32,n=19,15,10,12,13 | DBP,Week 36,n=15,13,10,12,13 | DBP,Week 40,n=15,11,9,10,10 | DBP,Week 44,n=11,11,6,8,9 | DBP,Week 48,n=9,8,5,8,5 | DBP,Week 52,n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | -0.9 | -3.4 | -8.3 | -6.1 | -6.4 | -9.4 | -8.6 | -2.6 | -8.8 | -2.5 | -7.4 | 1.8 | 4.8 | -3.8 | -2.2 | -3.0 | -5.6 | -2.5 | -3.4 | -2.1 | -3.1 | -1.9 | -5.8 | -2.7 | -6.1 | 1.3 | 0.6 | 0.5 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 5.7 | -2.2 | -0.8 | 1.4 | 1.9 | -1.7 | -2.6 | 6.4 | 3.4 | -0.6 | 2.1 | 2.9 | 8.8 | 2.2 | 2.4 | 0.1 | 2.6 | 1.3 | -1.3 | -2.0 | -3.3 | 0.1 | -1.2 | -1.2 | -2.0 | -1.5 | -3.4 | 1.4 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 3.5 | 0.2 | -3.9 | -2.4 | -5.1 | -0.7 | -2.5 | -4.2 | -3.7 | -8.0 | 0.9 | -4.2 | -0.4 | 1.2 | 1.2 | 1.5 | -1.3 | 2.0 | -2.5 | 1.4 | -0.6 | -2.2 | -2.3 | -5.1 | 2.6 | -6.5 | -2.3 | 1.8 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | -0.9 | -0.9 | 0.3 | -2.3 | -6.0 | -6.7 | -5.2 | -8.8 | -10.7 | -6.2 | -11.9 | -12.7 | -13.6 | -8.1 | 0.3 | 1.8 | 2.1 | 1.0 | 0.2 | -0.9 | 1.3 | -3.1 | -4.2 | -0.6 | -6.9 | -2.7 | -5.6 | 0.2 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | -2.1 | -4.7 | -3.5 | -6.2 | -3.0 | -3.4 | -5.6 | -0.1 | -7.4 | -6.8 | -4.8 | 2.7 | -3.6 | 2.2 | -2.3 | -4.1 | -4.0 | -4.7 | -3.1 | -3.2 | -2.7 | -4.3 | -6.9 | -5.6 | -8.0 | -2.5 | -2.0 | 2.2 |
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Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Millimoles per liter (Mean) |
---|
| calcium,Week 2,n=38,39,26,24,26 | calcium,Week 4,n=37,38,25,23,27 | calcium,Week 8,n=34,31,24,22,23 | calcium,Week 12,n=32,28,24,22,21 | calcium,Week 16,n=28,26,22,19,18 | calcium,Week 20,n=25,23,19,18,16 | calcium,Week 24,n=22,21,16,17,16 | calcium,Week 28,n=19,18,12,13,14 | calcium,Week 32,n=19,15,10,12,13 | calcium,Week 36,n=15,12,10,12,13 | calcium,Week 40,n=15,11,9,10,10 | calcium,Week 44,n=11,11,6,8,9 | calcium,Week 48,n=9,8,5,8,5 | calcium,Week 52,n=9,5,5,5,4 | Carbon Dioxide,Week 2,n=38,39,26,24,26 | Carbon Dioxide,Week 4,n=37,38,25,23,27 | Carbon Dioxide,Week 8,n=34,31,24,22,23 | Carbon Dioxide,Week 12,n=32,28,24,22,21 | Carbon Dioxide,Week 16,n=28,26,22,19,18 | Carbon Dioxide,Week 20,n=25,23,19,18,16 | Carbon Dioxide,Week 24,n=22,21,16,17,16 | Carbon Dioxide,Week 28,n=19,18,12,13,14 | Carbon Dioxide,Week 32,n=19,15,10,12,13 | Carbon Dioxide,Week 36,n=15,12,10,12,13 | Carbon Dioxide,Week 40,n=15,11,6,10,10 | Carbon Dioxide,Week 44,n=11,11,6,8,9 | Carbon Dioxide,Week 48,n=9,8,5,8,5 | Carbon Dioxide,Week 52,n=9,5,5,5,4 | Chloride,Week 2,n=38,39,26,24,26 | Chloride,Week 4,n=37,38,25,23,27 | Chloride,Week 8,n=34,31,24,22,23 | Chloride,Week 12,n=32,28,24,22,21 | Chloride,Week 16,n=28,26,22,19,18 | Chloride,Week 20,n=25,23,19,18,16 | Chloride,Week 24,n=22,21,16,17,16 | Chloride,Week 28,n=19,18,12,13,14 | Chloride,Week 32,n=19,15,10,12,13 | Chloride,Week 36,n=15,12,10,12,13 | Chloride,Week 40,n=15,11,9,10,10 | Chloride,Week 44,n=11,11,6,8,9 | Chloride,Week 48,n=9,8,5,8,5 | Chloride,Week 52,n=9,5,5,5,4 | Glucose,Week 2,n=38,39,26,24,26 | Glucose,Week 4,n=37,38,25,23,27 | Glucose,Week 8,n=34,31,24,22,23 | Glucose,Week 12,n=32,28,24,22,21 | Glucose,Week 16,n=28,26,22,19,18 | Glucose,Week 20,n=25,23,19,18,16 | Glucose,Week 24,n=22,21,16,17,16 | Glucose,Week 28,n=19,18,12,13,14 | Glucose,Week 32,n=19,15,10,12,13 | Glucose,Week 36,n=15,12,10,12,13 | Glucose,Week 40,n=15,11,9,10,10 | Glucose,Week 44,n=11,11,6,8,9 | Glucose,Week 48,n=9,8,5,8,5 | Glucose,Week 52,n=9,5,5,5,4 | Phosphate,Week 2,n=38,39,26,24,26 | Phosphate,Week 4,n=37,38,25,23,27 | Phosphate,Week 8,n=34,31,24,22,23 | Phosphate,Week 12,n=32,28,24,22,21 | Phosphate,Week 16,n=28,26,22,19,18 | Phosphate,Week 20,n=25,23,19,18,16 | Phosphate,Week 24,n=22,21,16,17,16 | Phosphate,Week 28,n=19,18,12,13,14 | Phosphate,Week 32,n=19,15,10,12,13 | Phosphate,Week 36,n=15,12,10,12,13 | Phosphate,Week 40,n=15,11,6,10,10 | Phosphate,Week 44,n=11,11,6,8,9 | Phosphate,Week 48,n=9,8,5,8,5 | Phosphate,Week 52,n=9,5,5,5,4 | Potassium,Week 2,n=38,39,26,24,26 | Potassium,Week 4,n=37,38,25,23,27 | Potassium,Week 8,n=34,31,24,22,23 | Potassium,Week 12,n=32,28,24,22,21 | Potassium,Week 16,n=28,26,22,19,18 | Potassium,Week 20,n=25,23,19,18,16 | Potassium,Week 24,n=22,21,16,17,16 | Potassium,Week 28,n=19,18,12,13,14 | Potassium,Week 32,n=19,15,10,12,13 | Potassium,Week 36,n=15,12,10,12,13 | Potassium,Week 40,n=15,11,9,10,10 | Potassium,Week 44,n=11,11,6,8,9 | Potassium,Week 48,n=9,8,5,8,5 | Potassium,Week 52,n=9,5,5,5,4 | Sodium,Week 2,n=38,39,26,24,26 | Sodium,Week 4,n=37,38,25,23,27 | Sodium,Week 8,n=34,31,24,22,23 | Sodium,Week 12,n=32,28,24,22,21 | Sodium,Week 16,n=28,26,22,19,18 | Sodium,Week 20,n=25,23,19,18,16 | Sodium,Week 24,n=22,21,16,17,16 | Sodium,Week 28,n=19,18,12,13,14 | Sodium,Week 32,n=19,15,10,12,13 | Sodium,Week 36,n=15,12,10,12,13 | Sodium,Week 40,n=15,11,9,10,10 | Sodium,Week 44,n=11,11,6,8,9 | Sodium,Week 48,n=9,8,5,8,5 | Sodium,Week 52,n=9,5,5,5,4 | Urea,Week 2,n=38,39,26,24,26 | Urea,Week 4,n=37,38,25,23,27 | Urea,Week 8,n=34,31,24,22,23 | Urea,Week 12,n=32,28,24,22,21 | Urea,Week 16,n=28,26,22,19,18 | Urea,Week 20,n=25,23,19,18,16 | Urea,Week 24,n=22,21,16,17,16 | Urea,Week 28,n=19,18,12,13,14 | Urea,Week 32,n=19,15,10,12,13 | Urea,Week 36,n=15,12,10,12,13 | Urea,Week 40,n=15,11,9,10,10 | Urea,Week 44,n=11,11,6,8,9 | Urea,Week 48,n=9,8,5,8,5 | Urea,Week 52,n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 0.013 | -0.001 | 0.013 | 0.016 | 0.044 | 0.012 | 0.009 | 0.076 | 0.075 | 0.053 | 0.037 | 0.054 | 0.142 | 0.083 | 0.7 | 0.1 | 1.1 | 1.2 | 0.5 | 0.5 | -0.2 | 0.4 | 0.2 | 1.0 | 0.4 | -0.1 | -0.2 | 1.8 | 0.8 | 1.4 | 2.1 | 2.0 | 2.4 | 2.5 | 2.3 | 2.9 | 3.4 | 2.8 | 3.9 | 2.2 | 2.8 | 3.8 | -0.44 | -0.03 | -1.15 | -1.76 | -1.15 | -1.96 | -2.08 | -2.05 | -3.12 | -2.98 | -0.94 | -0.23 | -0.36 | 0.45 | 0.005 | 0.008 | 0.055 | 0.079 | 0.039 | 0.060 | 0.101 | 0.190 | 0.155 | 0.151 | 0.206 | 0.218 | 0.132 | 0.115 | 0.08 | -0.03 | 0.06 | 0.04 | 0.15 | 0.16 | 0.16 | 0.23 | 0.25 | 0.21 | 0.28 | 0.16 | 0.52 | 0.20 | 0.9 | 0.6 | 1.7 | 2.1 | 2.3 | 2.3 | 1.9 | 2.4 | 3.2 | 2.8 | 2.9 | 1.8 | 1.6 | 3.5 | -0.32 | -0.27 | -0.34 | -0.35 | -0.07 | -0.77 | -0.64 | -0.31 | 0.17 | -0.22 | 0.32 | -1.09 | 0.44 | -0.45 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 0.008 | -0.016 | 0.020 | 0.011 | -0.008 | 0.000 | -0.002 | 0.018 | -0.008 | -0.038 | -0.042 | -0.035 | -0.035 | -0.056 | -0.3 | 0.2 | 0.0 | 0.0 | -0.1 | -0.3 | 0.5 | -0.4 | -0.6 | -0.3 | -0.8 | -1.6 | 0.0 | -0.4 | 1.0 | 0.7 | 1.0 | 0.6 | 1.1 | 1.3 | 1.0 | 0.2 | -0.1 | 1.1 | 1.9 | 1.1 | 1.8 | 3.6 | 0.29 | 0.31 | 0.10 | -0.25 | -0.12 | -0.33 | -0.38 | -0.25 | -0.05 | -0.50 | -0.22 | 0.30 | -0.88 | -0.72 | -0.025 | 0.006 | 0.045 | 0.067 | 0.025 | 0.043 | 0.055 | 0.073 | 0.048 | 0.098 | 0.073 | -0.065 | -0.015 | 0.036 | 0.18 | 0.06 | 0.10 | 0.06 | 0.15 | 0.10 | 0.15 | 0.08 | 0.19 | 0.18 | 0.03 | 0.15 | 0.16 | 0.06 | -0.2 | 0.0 | 0.5 | 0.5 | -0.3 | -0.6 | 0.4 | -0.8 | -0.8 | -0.2 | 0.5 | -0.8 | 0.3 | 1.6 | -0.31 | -0.22 | -0.91 | -1.12 | -0.40 | -0.31 | -0.65 | 0.23 | -0.76 | -0.01 | -0.76 | -0.76 | -0.51 | -0.82 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0.006 | 0.008 | 0.049 | 0.072 | 0.050 | 0.070 | 0.064 | 0.066 | 0.044 | 0.055 | 0.016 | 0.025 | 0.028 | 0.076 | 0.6 | 0.2 | 0.3 | 0.6 | 0.5 | -0.1 | 0.4 | 0.4 | 0.8 | 0.3 | 0.9 | 1.6 | 0.5 | 1.2 | 0.6 | 1.6 | 2.4 | 1.8 | 2.3 | 2.0 | 2.7 | 2.8 | 1.9 | 2.4 | 3.6 | 3.4 | 2.1 | 2.2 | -0.46 | -0.35 | -0.58 | -0.63 | 0.33 | -0.46 | -0.44 | -0.32 | -0.48 | -0.35 | -0.33 | -0.05 | -0.93 | -0.94 | -0.004 | -0.011 | 0.091 | 0.154 | 0.139 | 0.160 | 0.163 | 0.090 | 0.101 | 0.068 | -0.007 | 0.025 | -0.054 | -0.036 | -0.03 | -0.04 | 0.05 | 0.15 | 0.03 | 0.07 | -0.01 | 0.07 | 0.01 | -0.07 | -0.03 | -0.13 | 0.06 | -0.16 | 0.0 | 0.4 | 0.9 | 0.5 | 0.6 | 0.6 | 1.0 | 1.2 | -0.3 | 0.6 | 1.2 | 0.4 | 0.8 | 0.4 | -0.16 | -0.61 | -0.99 | -1.20 | -0.52 | -0.70 | -0.22 | -0.42 | -0.64 | -1.43 | -0.78 | -1.05 | -1.58 | -1.22 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0.002 | 0.009 | 0.032 | 0.019 | 0.009 | 0.018 | 0.008 | 0.006 | 0.029 | 0.016 | 0.077 | 0.042 | -0.007 | 0.013 | 0.7 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.4 | -1.6 | -1.0 | -1.1 | -1.5 | -1.7 | -2.6 | -1.1 | 1.1 | 1.8 | 2.5 | 2.9 | 3.0 | 3.3 | 3.4 | 3.9 | 3.4 | 3.8 | 3.3 | 3.8 | 4.6 | 4.8 | -0.03 | -0.10 | -0.29 | -0.64 | -0.71 | -0.66 | -0.72 | -0.91 | -0.74 | -1.14 | -0.99 | -1.39 | -1.39 | -1.51 | 0.056 | 0.071 | 0.088 | 0.122 | 0.113 | 0.070 | 0.132 | 0.156 | 0.164 | 0.111 | 0.221 | 0.142 | 0.029 | 0.049 | 0.03 | -0.13 | 0.01 | -0.12 | 0.01 | 0.04 | 0.05 | 0.12 | 0.16 | 0.16 | 0.24 | 0.16 | 0.21 | 0.22 | 0.3 | 0.7 | 1.1 | 1.8 | 1.0 | 1.0 | 0.9 | 0.9 | 0.7 | 0.5 | 0.1 | 0.5 | -0.3 | 0.7 | 0.05 | -0.09 | -0.36 | -0.65 | -0.56 | -0.30 | -0.48 | -0.45 | -0.16 | 0.06 | -0.17 | -0.46 | -0.18 | -0.26 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | -0.008 | 0.013 | 0.005 | -0.001 | 0.018 | 0.032 | 0.032 | 0.054 | 0.059 | 0.075 | 0.008 | -0.002 | -0.018 | 0.026 | 0.5 | 0.4 | 0.0 | -0.4 | 0.8 | -0.1 | -0.8 | -1.0 | -1.4 | -0.9 | -1.7 | 0.0 | -1.0 | -1.2 | 0.7 | 1.4 | 2.0 | 2.4 | 2.2 | 2.1 | 1.6 | 2.8 | 2.0 | 1.9 | 1.4 | 0.2 | 2.0 | 0.2 | 0.01 | 0.38 | -0.12 | -0.33 | -0.29 | 0.46 | -0.23 | 0.58 | 0.72 | 0.05 | 0.22 | -0.27 | -0.62 | -0.26 | 0.017 | 0.093 | 0.112 | 0.190 | 0.146 | 0.141 | 0.181 | 0.191 | 0.214 | 0.304 | 0.104 | 0.090 | 0.028 | 0.208 | -0.02 | -0.10 | -0.11 | -0.10 | -0.02 | 0.02 | -0.13 | 0.17 | 0.17 | 0.18 | 0.01 | -0.13 | -0.04 | -0.10 | -0.8 | 0.2 | 0.1 | 0.6 | -0.2 | -0.3 | -0.4 | 0.5 | -0.2 | -0.4 | -1.2 | -2.0 | -0.6 | -0.8 | 0.28 | -0.06 | -0.40 | -0.62 | -0.72 | -0.70 | -0.80 | -0.73 | -0.83 | -0.93 | -0.98 | -0.63 | -0.06 | -0.76 |
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Part A: Number of Participants in Sustained Remission at Week 52
Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) [<30 millimeters per hour] and C-reactive Protein (CRP) [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis. (NCT02531633)
Timeframe: Week 52
Intervention | Participants (Count of Participants) |
---|
PartA:SIR 100 mg SC q2w+6 Month Prednisone | 3 |
PartA:SIR 100 mg SC q2w+3 Month Prednisone | 2 |
PartA:SIR 50 mg SC q4w+6 Month Prednisone | 1 |
PartA:Placebo SC q2w + 6 Month Prednisone | 0 |
PartA:Placebo SC q2w + 12 Month Prednisone | 0 |
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Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | International units per liter (Mean) |
---|
| ALT,Week 2,n=38,39,26,24,26 | ALT,Week 4,n=37,38,25,23,27 | ALT,Week 8,n=34,31,24,22,23 | ALT,Week 12,n=32,28,24,22,21 | ALT,Week 16,n=28,26,22,19,18 | ALT,Week 20,n=25,23,19,18,16 | ALT,Week 24,n=22,21,16,17,16 | ALT,Week 28,n=19,18,12,13,14 | ALT,Week 32,n=19,15,10,12,13 | ALT,Week 36,n=15,12,10,12,13 | ALT,Week 40,n=15,11,9,10,10 | ALT,Week 44,n=11,11,6,8,9 | ALT,Week 48,n=9,8,5,8,5 | ALT,Week 52,n=9,5,5,5,4 | ALP,Week 2,n=38,39,26,24,26 | ALP,Week 4,n=37,38,25,23,27 | ALP,Week 8,n=34,31,24,22,23 | ALP,Week 12,n=32,28,24,22,21 | ALP,Week 16,n=28,26,22,19,18 | ALP,Week 20,n=25,23,19,18,16 | ALP,Week 24,n=22,21,16,17,16 | ALP,Week 28,n=19,18,12,13,14 | ALP,Week 32,n=19,15,10,12,13 | ALP,Week 36,n=15,12,10,12,13 | ALP,Week 40,n=15,11,9,10,10 | ALP,Week 44,n=11,11,6,8,9 | ALP,Week 48,n=9,8,5,8,5 | ALP,Week 52,n=9,5,5,5,4 | AST,Week 2,n=38,39,26,24,26 | AST,Week 4,n=37,38,25,23,27 | AST,Week 8,n=34,31,24,22,23 | AST,Week 12,n=32,28,24,22,21 | AST,Week 16,n=28,26,22,19,18 | AST,Week 20,n=25,23,19,18,16 | AST,Week 24,n=22,21,16,17,16 | AST,Week 28,n=19,18,12,13,14 | AST,Week 32,n=19,15,10,12,13 | AST,Week 36,n=15,12,10,12,13 | AST,Week 40,n=15,11,9,10,10 | AST,Week 44,n=11,11,6,8,9 | AST,Week 48,n=9,8,5,8,5 | AST,Week 52,n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 1.8 | -3.1 | -6.8 | -7.0 | -6.6 | -8.1 | -9.4 | -8.9 | -10.0 | -10.0 | -2.1 | -7.0 | 0.2 | 5.3 | -2.6 | 5.3 | 1.6 | -5.3 | -0.3 | -1.0 | -1.8 | 2.9 | 5.2 | 7.3 | 12.3 | 11.9 | 7.2 | -1.5 | 0.4 | -0.7 | -1.6 | 0.1 | 1.0 | 1.4 | -1.3 | -0.1 | 1.2 | 0.2 | 6.7 | 2.3 | 6.4 | 4.3 |
,PartA:Placebo SC q2w + 6 Month Prednisone | -0.6 | -1.2 | -2.8 | -3.3 | -3.5 | 2.3 | -2.8 | -1.9 | -2.0 | -2.8 | 0.1 | -0.4 | -3.5 | -4.4 | -3.0 | -2.2 | 2.9 | 6.6 | 1.1 | 5.9 | 6.9 | 1.6 | -2.3 | -1.8 | -0.2 | 2.8 | 1.5 | 1.0 | -0.3 | -1.0 | 0.1 | 0.5 | 0.2 | 4.3 | 0.6 | 1.1 | 0.6 | 1.3 | 4.7 | 3.5 | 1.3 | -0.2 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 5.3 | 6.6 | 9.5 | 4.4 | 2.2 | 4.9 | 2.5 | 2.9 | 5.0 | 6.0 | 7.3 | 5.5 | 4.5 | 1.6 | -11.4 | -13.4 | -10.4 | -7.0 | -8.0 | -4.4 | -6.2 | -4.3 | -6.1 | -7.3 | -7.4 | -6.2 | -6.5 | -8.0 | 3.7 | 5.9 | 10.6 | 9.0 | 7.0 | 7.7 | 7.6 | 8.1 | 9.2 | 10.8 | 8.7 | 9.2 | 11.8 | 9.2 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 8.2 | 6.6 | 6.0 | 4.7 | 4.1 | 16.1 | 8.3 | 6.7 | 6.6 | 8.7 | 5.3 | 1.8 | 2.3 | 1.3 | -9.3 | -15.5 | -16.8 | -19.2 | -18.2 | -14.4 | -16.3 | -17.6 | -15.9 | -20.3 | -14.5 | -19.4 | -24.4 | -26.0 | 6.1 | 5.4 | 6.4 | 7.6 | 8.5 | 14.6 | 9.8 | 9.0 | 8.8 | 10.6 | 8.9 | 8.1 | 8.1 | 7.1 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 10.1 | 5.2 | 4.7 | 4.0 | 5.2 | 8.6 | 16.4 | 12.1 | 5.1 | 4.5 | 5.4 | 2.7 | 3.6 | 8.8 | -11.4 | -14.2 | -15.3 | -15.0 | -14.6 | -13.3 | -12.5 | -17.5 | -12.6 | -9.6 | -9.9 | -4.0 | -4.4 | -3.6 | 4.5 | 5.0 | 6.7 | 6.5 | 8.0 | 9.0 | 10.5 | 9.4 | 8.0 | 7.6 | 9.1 | 8.3 | 9.8 | 11.6 |
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Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24
Intervention | Scores on scale (Number) |
---|
| Par 1, Week 12 | Par 1, Week 24 | Par 1, Day 339 | Par 2, Week 12 | Par 2, Week 24 | Par 2, Day 344 | Par 3, Day 113 | Par 4, Week 12 | Par 5, Week 12 | Par 5, Day 162 | Par 6, Day 91 | Par 7, Day 85 | Par 8, Day 87 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0.000 | 0.012 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | 0.028 | 0.028 | 0.000 | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | 0.000 | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -0.127 | -0.098 | -0.070 | 0.204 | 0.041 | 0.110 | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | 0.097 | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12
Intervention | Scores on scale (Number) |
---|
| Par 1, Day 30 | Par 2, Day 29 | Par 3, Day 23 | Par 4, Week 12 | Par 4, Day 113 | Par 5, Day 85 | Par 6, Day 65 | Par 7, Week 12 | Par 7, Day 373 | Par 8, Day 64 | Par 9, Day 29 | Par 10, Day 57 | Par 11, Week 12 | Par 11, Day 163 | Par 12, Day 85 | Par 13, Day 59 | Par 14, Day 57 | Par 16, Day 169 | Par 17, Week 12 | Par 17, Day 112 | Par 18, Day 85 |
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PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 9 | 7 | -4 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -42 | 62 | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | 4 | 8 | -2 | -1 | 5 | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 2 | 0 | 1 | -2 | -47 | -1 | 20 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -10 | -12 | -8 | 10 | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24
Intervention | Scores on scale (Number) |
---|
| Par 1, Week 12 | Par 1, Week 24 | Par 1, Day 339 | Par 2, Week 12 | Par 2, Week 24 | Par 2, Day 344 | Par 3, Day 113 | Par 4, Week 12 | Par 5, Week 12 | Par 5, Day 162 | Par 6, Day 91 | Par 7, Day 85 | Par 8, Day 87 |
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PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 4 | 21 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | 9 | -15 | 20 | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | 1 | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -12 | 1 | 8 | 3 | 14 | -1 | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | -4 | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Hematocrit,Week 4,n=3,3,2,1,2 | Hematocrit,Week 12,n=1,1,1,1,1 | Hematocrit,Week 16,n=0,1,1,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | -0.0040 | -0.0010 | -0.0030 |
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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Hematocrit,Week 4,n=3,3,2,1,2 | Hematocrit,Week 8,n=2,1,2,0,2 | Hematocrit,Week 12,n=1,1,1,1,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | -0.0070 | -0.0120 | 0.0030 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -0.0047 | -0.0185 | -0.0120 |
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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Hematocrit,Week 4,n=3,3,2,1,2 | Hematocrit,Week 8,n=2,1,2,0,2 | Hematocrit,Week 12,n=1,1,1,1,1 | Hematocrit,Week 16,n=0,1,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0.0115 | 0.0135 | 0.0470 | 0.0610 |
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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Hematocrit,Week 4,n=3,3,2,1,2 | Hematocrit,Week 8,n=2,1,2,0,2 | Hematocrit,Week 12,n=1,1,1,1,1 | Hematocrit,Week 16,n=0,1,1,1,0 | Hematocrit,Week 24,n=0,1,0,0,0 | Hematocrit,Week 36,n=0,1,0,0,0 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | -0.0057 | 0.0000 | 0.0080 | 0.0060 | 0.0100 | 0.0280 |
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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Hematocrit,Week 2,n=1,1,0,1,2 | Hematocrit,Week 4,n=2,1,1,2,2 | Hematocrit,Week 8,n=2,1,1,2,2 |
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PartB:Placebo SC q2w + 12 Month Prednisone | 0.0235 | 0.0105 | 0.0260 |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | -0.0060 | -0.0080 | -0.0110 |
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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Hematocrit,Week 4,n=2,1,1,2,2 | Hematocrit,Week 8,n=2,1,1,2,2 | Hematocrit,Week 12,n=2,0,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | -0.0250 | -0.0030 | -0.0060 |
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Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Grams per liter (Mean) |
---|
| Albumin,Week 2,n=38,39,26,24,26 | Albumin,Week 4,n=37,38,25,23,27 | Albumin,Week 8,n=34,31,24,22,23 | Albumin,Week 12,n=32,28,24,22,21 | Albumin,Week 16,n=28,26,22,19,18 | Albumin,Week 20,n=25,23,19,18,16 | Albumin,Week 24,n=22,21,16,17,16 | Albumin,Week 28,n=19,18,12,13,14 | Albumin,Week 32,n=19,15,10,12,13 | Albumin,Week 36,n=15,12,10,12,13 | Albumin,Week 40,n=15,11,9,10,10 | Albumin,Week 44,n=11,11,6,8,9 | Albumin,Week 48,n=9,8,5,8,5 | Albumin,Week 52,n=9,5,5,5,4 | Protein,Week 2,n=38,39,26,24,26 | Protein,Week 4,n=37,38,25,23,27 | Protein,Week 8,n=34,31,24,22,23 | Protein,Week 12,n=32,28,24,22,21 | Protein,Week 16,n=28,26,22,19,18 | Protein,Week 20,n=25,23,19,18,16 | Protein,Week 24,n=22,21,16,17,16 | Protein,Week 28,n=19,18,12,13,14 | Protein,Week 32,n=19,15,10,12,13 | Protein,Week 36,n=15,12,10,12,13 | Protein,Week 40,n=15,11,9,10,10 | Protein,Week 44,n=11,11,6,8,9 | Protein,Week 48,n=9,8,5,8,5 | Protein,Week 52,n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | -0.7 | -0.9 | -0.6 | 0.2 | 0.6 | 0.3 | 0.3 | 0.4 | 1.1 | 0.2 | -0.5 | 0.6 | 2.0 | 1.5 | -1.7 | -2.0 | -0.7 | 0.9 | 1.0 | 0.4 | 0.8 | 1.6 | 2.6 | 1.8 | 1.4 | 1.7 | 3.2 | 1.8 |
,PartA:Placebo SC q2w + 6 Month Prednisone | -0.9 | -1.4 | -1.1 | -0.5 | -1.2 | -0.9 | 0.0 | -0.5 | -0.7 | -1.3 | -1.1 | 0.4 | -0.8 | -1.2 | -1.7 | -2.0 | -0.7 | 1.0 | 0.2 | 0.6 | 1.5 | -0.2 | -0.3 | -0.3 | -0.4 | 2.3 | 1.4 | -1.0 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0.9 | 2.0 | 3.1 | 3.4 | 2.8 | 3.9 | 3.8 | 3.5 | 3.6 | 4.3 | 3.9 | 4.1 | 4.4 | 5.2 | -2.4 | -2.4 | -1.6 | -1.3 | -2.0 | -0.4 | -0.9 | -0.8 | -1.5 | -0.8 | -1.5 | -0.4 | -0.1 | 1.0 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0.3 | 0.9 | 1.9 | 2.0 | 1.7 | 1.8 | 1.6 | 1.5 | 2.2 | 3.1 | 3.2 | 3.2 | 3.4 | 3.7 | -2.6 | -2.5 | -1.9 | -1.7 | -2.3 | -1.9 | -1.1 | -2.4 | -1.4 | -0.3 | -0.5 | 0.3 | 0.3 | -0.4 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 0.8 | 1.6 | 2.1 | 3.1 | 2.8 | 2.8 | 3.7 | 2.4 | 2.2 | 2.9 | 2.4 | 2.2 | 1.6 | 4.0 | -1.9 | -1.8 | -2.2 | -0.8 | -1.9 | -1.3 | 0.0 | -2.7 | -2.1 | -0.5 | -2.1 | -2.0 | -1.8 | 0.6 |
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Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Micromoles per liter (Mean) |
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| Bilirubin,Week 2,n=38,39,26,24,26 | Bilirubin,Week 4,n=37,38,25,23,27 | Bilirubin,Week 8,n=34,31,24,22,23 | Bilirubin,Week 12,n=32,28,24,22,21 | Bilirubin,Week 16,n=28,26,22,19,18 | Bilirubin,Week 20,n=25,23,19,18,16 | Bilirubin,Week 24,n=22,21,16,17,16 | Bilirubin,Week 28,n=19,18,12,13,14 | Bilirubin,Week 32,n=19,15,10,12,13 | Bilirubin,Week 36,n=15,12,10,12,13 | Bilirubin,Week 40,n=15,11,6,10,10 | Bilirubin,Week 44,n=11,11,6,8,9 | Bilirubin,Week 48,n=9,8,5,8,5 | Bilirubin,Week 52,n=9,5,5,5,4 | Direct Bilirubin,Week 2,n=38,39,26,24,26 | Direct Bilirubin,Week 4,n=37,38,25,23,27 | Direct Bilirubin,Week 8,n=34,31,24,22,23 | Direct Bilirubin,Week 12,n=32,28,24,22,21 | Direct Bilirubin,Week 16,n=28,26,22,19,18 | Direct Bilirubin,Week 20,n=25,23,19,18,16 | Direct Bilirubin,Week 24,n=22,21,16,17,16 | Direct Bilirubin,Week 28,n=19,18,12,13,14 | Direct Bilirubin,Week 32,n=19,15,10,12,13 | Direct Bilirubin,Week 36,n=15,12,10,12,13 | Direct Bilirubin,Week 40,n=15,11,6,10,10 | Direct Bilirubin,Week 44,n=11,11,6,8,9 | Direct Bilirubin,Week 48,n=9,8,5,8,5 | Direct Bilirubin,Week 52,n=9,5,5,5,4 | Indirect Bilirubin,Week 2,n=38,39,26,24,26 | Indirect Bilirubin,Week 4,n=37,38,25,23,27 | Indirect Bilirubin,Week 8,n=34,31,24,22,23 | Indirect Bilirubin,Week 12,n=32,28,24,22,21 | Indirect Bilirubin,Week 16,n=28,26,22,19,18 | Indirect Bilirubin,Week 20,n=25,23,19,18,16 | Indirect Bilirubin,Week 24,n=22,21,16,17,16 | Indirect Bilirubin,Week 28,n=19,18,12,13,14 | Indirect Bilirubin,Week 32,n=19,15,10,12,13 | Indirect Bilirubin,Week 36,n=15,12,10,12,13 | Indirect Bilirubin,Week 40,n=15,11,6,10,10 | Indirect Bilirubin,Week 44,n=11,11,6,8,9 | Indirect Bilirubin,Week 48,n=9,8,5,8,5 | Indirect Bilirubin,Week 52,n=9,5,5,5,4 | Creatinine,Week 2,n=38,39,26,24,26 | Creatinine,,Week 4,n=37,38,25,23,27 | Creatinine,Week 8,n=34,31,24,22,23 | Creatinine,,Week 12,n=32,28,24,22,21 | Creatinine,,Week 16,n=28,26,22,19,18 | Creatinine,,Week 20,n=25,23,19,18,16 | Creatinine,Week 24,n=22,21,16,17,16 | Creatinine,,Week 28,n=19,18,12,13,14 | Creatinine, Week 32,n=19,15,10,12,13 | Creatinine,,Week 36,n=15,12,10,12,13 | Creatinine,,Week 40,n=15,11,6,10,10 | Creatinine, Week 44,n=11,11,6,8,9 | Creatinine,,Week 48,n=9,8,5,8,5 | Creatinine,,Week 52,n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | -1.0 | -1.5 | -3.2 | -2.9 | -3.3 | -3.1 | -1.7 | -3.2 | -3.0 | -2.1 | -1.9 | -1.2 | -1.8 | 1.8 | -0.3 | -0.6 | -0.8 | -0.6 | -0.8 | -0.9 | -0.8 | -1.0 | -1.2 | -1.2 | -1.4 | -0.7 | -1.2 | -0.5 | -0.7 | -0.9 | -2.4 | -2.3 | -2.5 | -2.2 | -0.9 | -2.2 | -1.8 | -0.8 | -0.5 | -0.6 | -0.6 | 2.3 | 0.28 | 0.48 | 2.43 | 1.46 | 3.37 | 4.73 | 2.63 | 4.07 | 4.10 | 3.62 | 1.55 | 3.96 | 5.72 | 12.23 |
,PartA:Placebo SC q2w + 6 Month Prednisone | -1.1 | -1.8 | -2.3 | -1.0 | -0.9 | -1.4 | -1.1 | -0.8 | -0.8 | -0.9 | -1.1 | -0.1 | -1.1 | -1.0 | 0.0 | -0.2 | -0.1 | -0.1 | -0.1 | -0.2 | -0.4 | -0.5 | -0.2 | -0.2 | 0.0 | 0.0 | 0.0 | -0.4 | -1.1 | -1.6 | -2.2 | -1.0 | -0.8 | -1.2 | -0.8 | -0.3 | -0.6 | -0.8 | -1.1 | -0.1 | -1.1 | -0.6 | -1.65 | -0.64 | -2.93 | -3.09 | -0.14 | -0.18 | -1.14 | -0.28 | 0.59 | 4.56 | 1.67 | 0.23 | 1.43 | 1.78 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 1.5 | 1.9 | 2.8 | 2.8 | 4.4 | 4.3 | 3.0 | 3.7 | 4.0 | 5.3 | 2.9 | 1.8 | 3.8 | 1.6 | -0.1 | 0.1 | 0.1 | 0.1 | 0.4 | 0.1 | 0.0 | -0.1 | 0.3 | 0.3 | -0.4 | -0.4 | -0.3 | -0.8 | 1.6 | 1.9 | 2.7 | 2.7 | 4.0 | 4.2 | 3.0 | 3.8 | 3.7 | 5.0 | 3.3 | 2.2 | 4.0 | 2.4 | 4.10 | 3.03 | 1.48 | -0.84 | 1.16 | 0.33 | -0.45 | 0.46 | -2.52 | -3.82 | -1.45 | -7.06 | -7.15 | -5.10 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 1.8 | 2.4 | 3.0 | 4.3 | 2.7 | 4.7 | 4.9 | 4.4 | 4.2 | 5.2 | 5.1 | 4.4 | 6.7 | 4.8 | 0.1 | 0.3 | 0.2 | 0.3 | 0.3 | 1.4 | 1.0 | 0.7 | 0.5 | 0.7 | 0.6 | 0.8 | 1.2 | 1.0 | 1.7 | 2.1 | 2.8 | 4.0 | 2.4 | 3.3 | 4.0 | 3.7 | 3.7 | 4.5 | 4.5 | 3.5 | 5.4 | 3.8 | 4.96 | 4.00 | 3.26 | 2.88 | 3.87 | -0.87 | 1.58 | 5.00 | 3.88 | 1.09 | 4.87 | 0.03 | 7.21 | 3.56 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 1.9 | 1.8 | 0.9 | 2.7 | 3.9 | 3.6 | 4.8 | 3.1 | 2.7 | 2.3 | 2.6 | 2.5 | 2.2 | 5.0 | 0.1 | 0.1 | 0.0 | 0.2 | 0.3 | 0.4 | 0.4 | 0.1 | 0.1 | -0.1 | -0.3 | 0.2 | -0.6 | -0.2 | 1.8 | 1.8 | 0.9 | 2.5 | 3.6 | 3.2 | 4.4 | 3.0 | 2.6 | 2.4 | 2.9 | 2.3 | 2.8 | 5.2 | 0.71 | 2.56 | 0.95 | 3.28 | 1.27 | -0.09 | 1.86 | -1.33 | -1.33 | 0.88 | -0.88 | -2.38 | 2.80 | 4.20 |
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Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Intervention | Millimeters per hour (Mean) |
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| Week 2,n=37,39,26,24,26 | Week 4,n=36,38,25,22,27 | Week 8,n=33,31,24,22,23 | Week 12,n=32,28,24,22,22 | Week 16,n=28,26,22,19,19 | Week 20,n=26,23,18,18,16 | Week 24,n=23,19,16,17,16 | Week 28,n=19,18,11,14,14 | Week 32,n=19,15,10,12,13 | Week 36,n=15,12,10,12, 13 | Week 40,n=15,11,9,10,10 | Week 44,n=11,11,6,8,8 | Week 48,n=9,8,5,8,5 | Week 52,n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | -9.96 | -5.30 | 1.78 | -2.55 | -2.53 | -5.81 | -3.06 | -1.71 | -2.85 | 0.92 | -2.60 | 2.88 | 8.60 | 1.25 |
,PartA:Placebo SC q2w + 6 Month Prednisone | -1.33 | 7.59 | 6.41 | 20.36 | 14.21 | 10.00 | 7.59 | 1.50 | -2.42 | 0.67 | 9.80 | 4.88 | 4.50 | -4.60 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | -12.78 | -17.41 | -18.76 | -17.89 | -17.17 | -17.07 | -16.84 | -19.94 | -19.80 | -21.25 | -22.27 | -22.18 | -25.63 | -24.60 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | -13.05 | -12.83 | -14.21 | -14.97 | -12.50 | -13.19 | -13.63 | -15.26 | -13.26 | -14.47 | -14.40 | -12.64 | -15.33 | -14.78 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | -14.62 | -14.13 | -15.05 | -14.30 | -15.37 | -14.33 | -14.89 | -16.84 | -14.52 | -14.42 | -11.24 | -12.00 | -14.00 | -12.80 |
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Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Femtoliter (Mean) |
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| Week 2,n=38,39,24,24,25 | Week 4,n=36,37,24,22,27 | Week 8,n=34,29,23,22,21 | Week 12,n=31,28,23,22,22 | Week 16,n=27,26,21,19,19 | Week 20,n=25,23,18,18,16 | Week 24,n=22,21,16,16,16 | Week 28,n=18,18,12,14,13 | Week 32,n=19,15,10,12,13 | Week 36,n=15,12,10,12,12 | Week 40,n=14,11,8,10,10 | Week 44,n=11,10,6,8,9 | Week 48,n=9,8,4,8,5 | Week 52,n=8,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 0.4 | 0.6 | -0.2 | 0.3 | -0.3 | 0.1 | -1.6 | -0.5 | -0.5 | -0.2 | -2.1 | -0.7 | 2.0 | 1.0 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 0.6 | 0.6 | 1.7 | 0.9 | 0.4 | -0.5 | -1.0 | -0.4 | 0.3 | -0.5 | 0.4 | -0.7 | -1.1 | 3.2 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0.5 | 1.1 | 1.8 | 2.0 | 2.2 | 1.8 | 1.1 | 1.4 | 2.0 | 1.6 | 1.8 | 2.5 | 3.3 | 3.2 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0.5 | 0.9 | 1.2 | 0.8 | 1.0 | 1.2 | 1.1 | 0.6 | 0.9 | 1.8 | 0.6 | -0.5 | -0.4 | -0.6 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 0.5 | 1.0 | 1.9 | 2.6 | 3.1 | 2.1 | 2.6 | 2.0 | 1.3 | 0.9 | 2.0 | 1.7 | 2.3 | 1.4 |
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Part A: Change From Baseline in Hematology Parameter-Hematocrit
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Proportion of red blood cells in blood (Mean) |
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| Week 2,n=38,39,24,24,25 | Week 4,n=36,37,24,22,27 | Week 8,n=34,29,23,22,21 | Week 12,n=31,28,23,22,22 | Week 16,n=27,26,21,19,19 | Week 20,n=25,23,18,18,16 | Week 24,n=22,21,16,16,16 | Week 28,n=18,18,12,14,13 | Week 32,n=19,15,10,12,13 | Week 36,n=15,12,10,12,12 | Week 40,n=14,11,8,10,10 | Week 44,n=11,10,6,7,9 | Week 48,n=9,8,4,8,5 | Week 52,n=8,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | -0.0030 | -0.0087 | -0.0159 | -0.0095 | -0.0095 | -0.0062 | -0.0077 | -0.0035 | 0.0025 | 0.0018 | -0.0160 | -0.0037 | 0.0144 | 0.0025 |
,PartA:Placebo SC q2w + 6 Month Prednisone | -0.0063 | -0.0035 | -0.0054 | -0.0118 | -0.0135 | -0.0184 | -0.0133 | -0.0186 | -0.0176 | -0.0198 | -0.0193 | -0.0126 | -0.0216 | -0.0006 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0.0060 | 0.0048 | 0.0054 | 0.0148 | 0.0049 | 0.0066 | 0.0010 | 0.0039 | 0.0027 | 0.0036 | -0.0052 | 0.0054 | -0.0025 | 0.0016 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0.0040 | 0.0059 | 0.0101 | 0.0087 | -0.0037 | -0.0063 | -0.0017 | -0.0089 | -0.0076 | 0.0012 | -0.0115 | -0.0185 | -0.0136 | -0.0135 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 0.0008 | 0.0040 | 0.0019 | 0.0059 | 0.0008 | -0.0015 | 0.0089 | -0.0046 | -0.0060 | -0.0054 | -0.0009 | -0.0097 | -0.0053 | 0.0058 |
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Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Giga cells per liter (Mean) |
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| Eosinophils,Week 2,n=37,36,24,23,25 | Eosinophils,Week 4,n=36,37,24,22,26 | Eosinophils,Week 8,n=34,29,22,22,21 | Eosinophils,Week 12,n=31,28,23,22,22 | Eosinophils,Week 16,n=27,26,20,19,19 | Eosinophils,Week 20,n=25,22,18,17,16 | Eosinophils,Week 24,n=22,21,16,16,16 | Eosinophils,Week 28,n=18,18,11,14,13 | Eosinophils,Week 32,n=19,15,10,12,13 | Eosinophils,Week 36,n=15,12,10,12,12 | Eosinophils,Week 40,n=14,11,8,10,10 | Eosinophils,Week 44,n=11,10,6,7,9 | Eosinophils,Week 48,n=9,8,4,8,5 | Eosinophils,Week 52,n=8,5,5,5,4 | Leukocytes,Week 2,n=37,38,24,24,25 | Leukocytes,Week 4,n=36,37,24,22,26 | Leukocytes,Week 8,n=34,29,23,22,21 | Leukocytes,Week 12,n=31,28,23,22,22 | Leukocytes,Week 16,n=27,26,20,19,19 | Leukocytes,Week 20,n=25,23,18,18,16 | Leukocytes,Week 24,n=22,21,16,16,16 | Leukocytes,Week 28,n=18,18,12,14,13 | Leukocytes,Week 32,n=19,15,10,12,13 | Leukocytes,Week 36,n=15,12,10,12,12 | Leukocytes,Week 40,n=14,11,8,10,10 | Leukocytes,Week 44,n=11,10,6,7,9 | Leukocytes,Week 48,n=9,8,4,8,5 | Leukocytes,Week 52,n=8,5,5,5,4 | Lymphocytes,Week 2,n=37,36,24,23,25 | Lymphocytes,Week 4,n=36,37,24,22,26 | Lymphocytes,Week 8,n=34,29,22,22,21 | Lymphocytes,Week 12,n=31,28,23,22,22 | Lymphocytes,Week 16,n=27,26,20,19,19 | Lymphocytes,Week 20,n=25,22,18,17,16 | Lymphocytes,Week 24,n=22,21,16,16,16 | Lymphocytes,Week 28,n=18,18,11,14,13 | Lymphocytes,Week 32,n=19,15,10,12,13 | Lymphocytes,Week 36,n=15,12,10,12,12 | Lymphocytes,Week 40,n=14,11,8,10,10 | Lymphocytes,Week 44,n=11,10,6,7,9 | Lymphocytes,Week 48,n=9,8,4,8,5 | Lymphocytes,Week 52,n=8,5,5,5,4 | Neutrophils,Week 2,n=37,36,24,23,25 | Neutrophils,Week 4,n=36,37,24,22,26 | Neutrophils,Week 8,n=34,29,22,22,21 | Neutrophils,Week 12,n=31,28,23,22,22 | Neutrophils,Week 16,n=27,26,20,19,19 | Neutrophils,Week 20,n=25,22,18,17,16 | Neutrophils,Week 24,n=22,21,16,16,16 | Neutrophils,Week 28,n=18,18,11,14,13 | Neutrophils,Week 32,n=19,15,10,12,13 | Neutrophils,Week 36,n=15,12,10,12,12 | Neutrophils,Week 40,n=14,11,8,10,10 | Neutrophils,Week 44,n=11,10,6,7,9 | Neutrophils,Week 48,n=9,8,4,8,5 | Neutrophils,Week 52,n=8,5,5,5,4 | Platelets,Week 2,n=37,38,24,23,25 | Platelets,Week 4,n=36,37,24,22,26 | Platelets,Week 8,n=34,29,22,22,21 | Platelets,Week 12,n=31,28,23,22,22 | Platelets,Week 16,n=27,26,20,19,19 | Platelets,Week 20,n=25,22,18,17,16 | Platelets,Week 24,n=22,21,16,16,16 | Platelets,Week 28,n=18,18,11,14,13 | Platelets,Week 32,n=19,15,10,12,13 | Platelets,Week 36,n=15,12,10,12,12 | Platelets,Week 40,n=14,11,8,10,10 | Platelets,Week 44,n=11,10,6,7,9 | Platelets,Week 48,n=9,8,4,8,5 | Platelets,Week 52,n=8,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 0.062 | 0.030 | 0.010 | 0.030 | 0.067 | 0.057 | 0.051 | 0.051 | 0.056 | 0.059 | 0.071 | 0.066 | 0.030 | 0.013 | 0.34 | -0.16 | -0.26 | -1.28 | -0.79 | -1.71 | -1.52 | -1.97 | -2.33 | -2.95 | -2.23 | -3.08 | -3.00 | -3.10 | -0.209 | -0.382 | -0.516 | -0.344 | -0.635 | -0.533 | -0.386 | -0.565 | -0.492 | -0.078 | -0.681 | -0.343 | -0.510 | -0.128 | 0.387 | 0.089 | 0.192 | -1.019 | -0.263 | -1.355 | -1.342 | -1.503 | -2.018 | -3.018 | -1.663 | -2.883 | -2.650 | -2.990 | -4.3 | -5.7 | 15.7 | 4.3 | 13.8 | -0.1 | 20.1 | 13.1 | 10.7 | 20.0 | 5.3 | -3.3 | 0.4 | -17.5 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 0.015 | 0.023 | 0.048 | 0.090 | 0.067 | 0.094 | 0.089 | 0.046 | 0.038 | 0.049 | 0.065 | 0.024 | 0.028 | 0.108 | -0.76 | -1.64 | -1.79 | -2.66 | -2.98 | -3.24 | -2.89 | -3.01 | -3.43 | -3.36 | -3.18 | -2.83 | -2.69 | -3.84 | -0.159 | -0.002 | -0.049 | -0.128 | -0.327 | -0.385 | -0.401 | -0.258 | -0.402 | -0.417 | -0.519 | -1.029 | -0.576 | 0.194 | -0.748 | -1.673 | -1.869 | -2.678 | -2.766 | -2.856 | -2.570 | -2.764 | -3.006 | -3.023 | -2.705 | -1.807 | -2.160 | -4.214 | -1.9 | 2.1 | 14.2 | 17.8 | 12.4 | 14.8 | 6.3 | 15.4 | -1.5 | 13.4 | 5.6 | 11.1 | 14.4 | -18.6 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0.001 | 0.035 | 0.102 | 0.155 | 0.162 | 0.114 | 0.109 | 0.068 | 0.069 | 0.076 | 0.075 | 0.045 | 0.059 | 0.192 | -3.63 | -4.76 | -5.65 | -5.67 | -5.61 | -5.20 | -6.39 | -6.04 | -5.61 | -6.82 | -7.10 | -6.95 | -7.35 | -7.36 | 0.002 | -0.255 | -0.411 | -0.437 | -0.704 | -0.313 | -0.179 | -0.273 | -0.407 | -0.672 | -0.845 | -1.047 | -0.923 | -0.754 | -3.454 | -4.476 | -5.271 | -5.340 | -4.929 | -4.997 | -6.257 | -5.729 | -5.153 | -6.079 | -6.179 | -5.799 | -6.396 | -6.774 | -49.2 | -64.3 | -72.2 | -74.0 | -69.9 | -69.5 | -72.4 | -61.3 | -65.5 | -70.6 | -66.9 | -76.7 | -71.4 | -51.6 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0.019 | 0.043 | 0.056 | 0.077 | 0.097 | 0.166 | 0.210 | 0.163 | 0.244 | 0.282 | 0.191 | 0.144 | 0.091 | 0.151 | -3.12 | -3.66 | -4.04 | -4.68 | -5.21 | -5.24 | -5.14 | -5.46 | -5.71 | -5.76 | -6.14 | -6.25 | -6.88 | -6.66 | 0.015 | 0.027 | -0.191 | -0.215 | -0.450 | -0.616 | -0.399 | -0.614 | -0.602 | -0.625 | -0.929 | -0.915 | -1.258 | -1.253 | -3.208 | -3.791 | -3.949 | -4.590 | -4.933 | -4.867 | -4.985 | -5.076 | -5.357 | -5.444 | -5.416 | -5.432 | -5.628 | -5.520 | -39.0 | -45.9 | -37.3 | -51.2 | -53.8 | -52.2 | -58.0 | -70.2 | -57.6 | -74.1 | -77.4 | -69.5 | -68.3 | -81.9 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 0.010 | 0.012 | 0.054 | 0.090 | 0.117 | 0.136 | 0.109 | 0.120 | 0.092 | 0.153 | 0.104 | 0.165 | 0.233 | 0.172 | -3.32 | -4.07 | -4.42 | -5.23 | -5.36 | -5.40 | -5.01 | -4.58 | -5.27 | -5.58 | -6.46 | -6.17 | -6.48 | -6.38 | -0.041 | 0.057 | -0.067 | -0.081 | -0.153 | -0.439 | -0.073 | -0.192 | -0.476 | -0.430 | -0.570 | -0.198 | 0.118 | -0.286 | -3.367 | -4.106 | -4.354 | -5.250 | -5.358 | -5.168 | -5.030 | -4.469 | -4.840 | -5.265 | -5.916 | -6.185 | -6.790 | -6.256 | -41.1 | -49.0 | -53.3 | -55.4 | -54.8 | -53.5 | -57.5 | -50.6 | -50.8 | -48.6 | -42.0 | -58.2 | -80.8 | -58.6 |
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Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Grams per liter (Mean) |
---|
| MCHC,Week 2,n=32,33,18,22,23 | MCHC,Week 4,n=31,31,19,20,25 | MCHC,Week 8,n=28,24,18,20,20 | MCHC,Week 12,n=25,23,18,20,20 | MCHC,Week 16,n=22,21,17,17,17 | MCHC,Week 20,n=19,18,14,16,14 | MCHC,Week 24,n=16,16,13,15,14 | MCHC,Week 28,n=13,14,10,12,11 | MCHC,Week 32,n=13,11,8,10,11 | MCHC,Week 36,n=10,10,8,10,10 | MCHC,Week 40,n=10,9,7,8,9 | MCHC,Week 44,n=8,8,4,5,8 | MCHC,Week 48,n=6,7,2,6,4 | MCHC,Week 52,n=6,4,3,4,3 | Hemoglobin,Week 2,n=38,39,24,24,25 | Hemoglobin,Week 4,n=36,37,24,22,27 | Hemoglobin,Week 8,n=34,29,23,22,21 | Hemoglobin,Week 12,n=31,28,23,22,22 | Hemoglobin,Week 16,n=27,26,21,19,19 | Hemoglobin,Week 20,n=25,23,18,18,16 | Hemoglobin,Week 24,n=22,21,16,16,16 | Hemoglobin,Week 28,n=18,18,12,14,13 | Hemoglobin,Week 32,n=19,15,10,12,13 | Hemoglobin,Week 36,n=15,12,10,12,12 | Hemoglobin,Week 40,n=14,11,8,10,10 | Hemoglobin,Week 44,n=11,10,6,8,9 | Hemoglobin,Week 48,n=9,8,4,8,5 | Hemoglobin,Week 52,n=8,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 1.2 | 2.4 | 6.7 | 4.9 | 4.5 | 4.6 | 4.9 | -0.4 | 1.4 | 4.2 | 13.9 | 12.1 | 9.3 | 5.0 | -0.9 | -2.1 | -2.8 | -1.4 | -1.7 | -0.6 | -0.9 | -1.5 | 0.8 | 1.3 | -0.4 | 2.8 | 7.6 | 2.8 |
,PartA:Placebo SC q2w + 6 Month Prednisone | -1.1 | 0.1 | 0.6 | 1.3 | 0.9 | 3.4 | 3.0 | 2.8 | 6.7 | 7.9 | 5.1 | 5.2 | 3.8 | 11.3 | -2.4 | -1.0 | -1.4 | -3.2 | -3.8 | -4.6 | -3.1 | -4.4 | -3.0 | -2.6 | -3.4 | -0.3 | -4.6 | 4.4 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0.1 | 2.3 | 6.7 | 6.7 | 8.9 | 10.8 | 14.6 | 9.2 | 8.4 | 6.7 | 11.3 | 9.9 | 11.9 | 18.8 | 2.5 | 2.8 | 4.7 | 8.4 | 5.8 | 7.4 | 7.0 | 5.8 | 5.1 | 4.8 | 3.8 | 6.7 | 4.8 | 8.6 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | -0.5 | 1.6 | 6.1 | 6.5 | 8.3 | 7.7 | 4.7 | 4.5 | 6.9 | 6.9 | 11.5 | 12.5 | 13.3 | 16.5 | 1.2 | 3.0 | 5.9 | 5.8 | 2.6 | 2.0 | 2.2 | 0.3 | 0.9 | 4.4 | 1.3 | 0.0 | 2.4 | 2.9 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 1.9 | 2.6 | 6.4 | 5.9 | 10.2 | 9.0 | 4.9 | 8.9 | 8.8 | 13.5 | 14.4 | 13.5 | 10.5 | 24.0 | 1.3 | 2.5 | 3.1 | 4.7 | 4.2 | 3.3 | 5.4 | 2.8 | 2.0 | 4.0 | 6.3 | 2.3 | 2.8 | 10.4 |
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Part A: Change From Baseline in Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Beats per minute (Mean) |
---|
| Week 2, ,n=37,39,25,24,27 | Week 4,n=37,37,25,22,27 | Week 8,n=34,32,24,22,23 | Week 12,n=32,29,23,22,22 | Week 16,n=28,26,22,19,19 | Week 20,n=26,23,19,18,16 | Week 24,n=23,21,16,17,16 | Week 28,n=19,18,12,14,14 | Week 32,n=19,15,10,12,13 | Week 36,n=15,13,10,12,13 | Week 40,n=15,11,9,10,10 | Week 44,n=11,11,6,8,9 | Week 48,n=9,8,5,8,5 | Week 52,n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | -1.6 | -1.9 | 0.5 | -2.7 | -2.2 | -4.0 | 2.7 | 0.5 | -0.6 | -3.2 | -3.8 | -3.4 | 0.0 | -5.3 |
,PartA:Placebo SC q2w + 6 Month Prednisone | -0.4 | 2.2 | 4.3 | 4.5 | 0.3 | 1.0 | 0.1 | 0.1 | -0.8 | -0.5 | 3.3 | 4.3 | -1.9 | 6.8 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | -2.1 | -1.4 | -3.2 | -1.2 | 0.3 | 0.2 | -3.5 | -1.2 | -4.7 | -5.1 | -3.0 | -3.4 | -9.3 | -11.0 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | -1.9 | 0.2 | -1.1 | -3.8 | -3.4 | -3.0 | -2.1 | -1.4 | -1.3 | -5.9 | -3.9 | -7.1 | -8.2 | -5.0 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 1.8 | -2.4 | -3.1 | -0.8 | -5.3 | -0.7 | 0.7 | -3.5 | -2.2 | -4.5 | -3.4 | -8.3 | -7.2 | -4.0 |
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Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Intervention | Milligrams per liter (Mean) |
---|
| Week 2,n=38,39,26,24,26 | Week 4,n=37,38,25,23,27 | Week 8,n=34,31,24,22,23 | Week 12,n=32,28,24,21,21 | Week 16,n=28,26,22,19,18 | Week 20,n=26,23,19,18,16 | Week 24,n=23,20,16,17,16 | Week 28,n=19,18,12,14,14 | Week 32,n=19,15,10,12,13 | Week 36,n=15,12,10,12,13 | Week 40,n=15,11,8,10,10 | Week 44,n=11,11,6,8,9 | Week 48,n=9,7,5,8,5 | Week 52,n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 1.07 | 0.76 | 7.86 | 4.04 | 6.99 | 2.35 | 6.54 | 0.22 | 4.37 | 1.64 | 2.77 | 5.13 | 8.10 | -1.65 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 1.27 | 4.91 | 10.00 | 14.81 | 10.53 | 5.32 | 5.07 | 1.87 | 2.61 | 5.73 | 6.27 | 2.80 | 6.31 | 0.64 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | -8.81 | -9.01 | -9.94 | -9.96 | -10.43 | -11.67 | -13.19 | -13.42 | -14.47 | -16.28 | -17.67 | -17.47 | -23.39 | -7.26 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | -5.07 | -4.39 | -4.98 | -5.08 | -4.35 | -4.50 | -4.38 | -5.28 | -4.85 | -4.72 | -4.72 | -5.35 | -5.91 | -6.00 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | -5.15 | -4.09 | -4.19 | -4.22 | -4.48 | -4.78 | -5.14 | -6.33 | -7.15 | -7.08 | -4.69 | -1.90 | -2.20 | -2.20 |
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Part A: Change From Baseline in Temperature
Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Celsius (Mean) |
---|
| Week 2, ,n=37,39,26,24,27 | Week 4,n=37,37,25,23,27 | Week 8,n=34,32,23,22,23 | Week 12,n=32,29,24,22,22 | Week 16,n=28,26,22,19,19 | Week 20,n=26,23,19,18,16 | Week 24,n=23,21,16,17,16 | Week 28,n=19,18,12,13,14 | Week 32,n=19,15,10,12,13 | Week 36,n=15,13,9,12,13 | Week 40,n=15,11,9,10,10 | Week 44,n=11,11,6,8,9 | Week 48,n=9,8,5,8,5 | Week 52,n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 0.10 | 0.11 | 0.19 | 0.09 | 0.09 | 0.05 | 0.04 | -0.06 | 0.01 | -0.08 | -0.05 | -0.08 | -0.08 | -0.08 |
,PartA:Placebo SC q2w + 6 Month Prednisone | -0.16 | -0.10 | 0.04 | -0.15 | -0.21 | -0.07 | -0.26 | -0.16 | -0.13 | -0.09 | -0.05 | 0.00 | -0.01 | 0.02 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | -0.04 | 0.01 | -0.09 | -0.11 | -0.05 | -0.05 | -0.11 | -0.07 | -0.07 | -0.11 | -0.03 | -0.06 | -0.05 | -0.32 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | -0.11 | -0.12 | -0.04 | -0.08 | -0.08 | 0.03 | 0.03 | 0.03 | -0.01 | -0.09 | 0.08 | -0.14 | -0.22 | -0.08 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 0.03 | 0.04 | -0.07 | 0.01 | 0.04 | -0.12 | -0.11 | -0.09 | 0.28 | -0.10 | 0.18 | -0.03 | -0.14 | 0.14 |
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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Proportion of red blood cells in blood (Mean) |
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| Hematocrit,Week 2,n=1,1,0,1,2 | Hematocrit,Week 4,n=2,1,1,2,2 | Hematocrit,Week 8,n=2,1,1,2,2 | Hematocrit,Week 12,n=2,0,1,1,0 | Hematocrit,Week 14,n=0,0,0,1,0 | Hematocrit,Week 16,n=2,0,0,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | 0.0250 | -0.0060 | -0.0040 | -0.0420 | -0.0080 | 0.0080 |
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Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Intervention | mg/L (Mean) |
---|
| Week 4, n=3,3,2,1,2 | Week 8, n=2,1,2,0,2 | Week 12, n=1,1,1,1,1 | Week 16, n=0,1,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0.05 | 0.00 | 0.00 | 0.00 |
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Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Intervention | mg/L (Mean) |
---|
| Week 4, n=3,3,2,1,2 | Week 8, n=2,1,2,0,2 | Week 12, n=1,1,1,1,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | -0.55 | 0.95 | 0.70 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -0.30 | -0.05 | -0.90 |
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Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Intervention | mg/L (Mean) |
---|
| Week 4, n=3,3,2,1,2 | Week 12, n=1,1,1,1,1 | Week 16, n=0,1,1,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | 6.10 | -0.80 | -0.70 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Micromoles per liter (Mean) |
---|
| Bilirubin,Week 2,n=1,1,0,1,2 | Bilirubin,Week 4,n=2,1,1,2,2 | Bilirubin,Week 8,n=2,1,1,2,2 | Bilirubin,Week 12,n=2,0,1,1,0 | Bilirubin,Week 16,n=2,0,0,1,0 | Bilirubin,Week 24,n=2,0,0,0,0 | Bilirubin,Week 36,n=2,0,0,0,0 | Bilirubin,Week 38,n=1,0,0,0,0 | Bilirubin,Week 40,n=1,0,0,0,0 | Direct Bilirubin,Week 2,n=1,1,0,1,2 | Direct Bilirubin,Week 4,n=2,1,1,2,2 | Direct Bilirubin,Week 8,n=2,1,1,2,1 | Direct Bilirubin,Week 12,n=2,0,1,1,0 | Direct Bilirubin,Week 16,n=2,0,0,1,0 | Direct Bilirubin,Week 24,n=2,0,0,0,0 | Direct Bilirubin,Week 36,n=2,0,0,0,0 | Direct Bilirubin,Week 38,n=1,0,0,0,0 | Direct Bilirubin,Week 40,n=1,0,0,0,0 | Indirect Bilirubin,Week 2,n=1,1,0,1,2 | Indirect Bilirubin,Week 4,n=2,1,1,2,2 | Indirect Bilirubin,Week 8,n=2,1,1,2,1 | Indirect Bilirubin,Week 12,n=2,0,1,1,0 | Indirect Bilirubin,Week 16,n=2,0,0,1,0 | Indirect Bilirubin,Week 24,n=2,0,0,0,0 | Indirect Bilirubin,Week 36,n=2,0,0,0,0 | Indirect Bilirubin,Week 38,n=1,0,0,0,0 | Indirect Bilirubin,Week 40,n=1,0,0,0,0 | Creatinine,Week 2,n=1,1,0,1,2 | Creatinine,Week 4,n=2,1,1,2,2 | Creatinine,Week 8,n=2,1,1,2,1 | Creatinine,Week 12,n=2,0,1,1,0 | Creatinine,Week 16,n=2,0,0,1,0 | Creatinine,Week 24,n=2,0,0,0,0 | Creatinine,Week 36,n=2,0,0,0,0 | Creatinine,Week 38,n=1,0,0,0,0 | Creatinine,Week 40,n=1,0,0,0,0 |
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PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.0 | 5.0 | -1.0 | 0.0 | 5.0 | -2.0 | 1.0 | 0.0 | 2.0 | 0.0 | 1.0 | 0.0 | 0.0 | 1.0 | 0.0 | -1.0 | 0.0 | 0.0 | 0.0 | 4.0 | -1.0 | 0.0 | 4.0 | -2.0 | 2.0 | 0.0 | 2.0 | -3.50 | -11.05 | -8.40 | -11.90 | -12.80 | -9.75 | -15.05 | -19.40 | -20.30 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Micromoles per liter (Mean) |
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| Bilirubin,Week 2,n=1,1,0,1,2 | Bilirubin,Week 4,n=2,1,1,2,2 | Bilirubin,Week 8,n=2,1,1,2,2 | Bilirubin,Week 12,n=2,0,1,1,0 | Bilirubin,Week 14,n=0,0,0,1,0 | Bilirubin,Week 16,n=2,0,0,1,0 | Direct Bilirubin,Week 2,n=1,1,0,1,2 | Direct Bilirubin,Week 4,n=2,1,1,2,2 | Direct Bilirubin,Week 8,n=2,1,1,2,1 | Direct Bilirubin,Week 12,n=2,0,1,1,0 | Direct Bilirubin,Week 14,n=0,0,0,1,0 | Direct Bilirubin,Week 16,n=2,0,0,1,0 | Indirect Bilirubin,Week 2,n=1,1,0,1,2 | Indirect Bilirubin,Week 4,n=2,1,1,2,2 | Indirect Bilirubin,Week 8,n=2,1,1,2,1 | Indirect Bilirubin,Week 12,n=2,0,1,1,0 | Indirect Bilirubin,Week 14,n=0,0,0,1,0 | Indirect Bilirubin,Week 16,n=2,0,0,1,0 | Creatinine,Week 2,n=1,1,0,1,2 | Creatinine,Week 4,n=2,1,1,2,2 | Creatinine,Week 8,n=2,1,1,2,1 | Creatinine,Week 12,n=2,0,1,1,0 | Creatinine,Week 14,n=0,0,0,1,0 | Creatinine,Week 16,n=2,0,0,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | 2.0 | 1.0 | 1.0 | -2.0 | 0.0 | 2.0 | 2.0 | 1.0 | 1.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | -2.0 | 0.0 | 2.0 | 1.80 | -1.30 | 0.45 | -0.90 | 0.80 | 4.40 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Micromoles per liter (Mean) |
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| Bilirubin,Week 4,n=2,1,1,2,2 | Bilirubin,Week 8,n=2,1,1,2,2 | Bilirubin,Week 12,n=2,0,1,1,0 | Direct Bilirubin,Week 4,n=2,1,1,2,2 | Direct Bilirubin,Week 8,n=2,1,1,2,1 | Direct Bilirubin,Week 12,n=2,0,1,1,0 | Indirect Bilirubin,Week 4,n=2,1,1,2,2 | Indirect Bilirubin,Week 8,n=2,1,1,2,1 | Indirect Bilirubin,Week 12,n=2,0,1,1,0 | Creatinine,Week 4,n=2,1,1,2,2 | Creatinine,Week 8,n=2,1,1,2,1 | Creatinine,Week 12,n=2,0,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0.0 | 2.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.0 | 0.0 | 2.70 | 9.70 | 4.40 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Micromoles per liter (Mean) |
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| Bilirubin,Week 2,n=1,1,0,1,2 | Bilirubin,Week 4,n=2,1,1,2,2 | Bilirubin,Week 8,n=2,1,1,2,2 | Direct Bilirubin,Week 2,n=1,1,0,1,2 | Direct Bilirubin,Week 4,n=2,1,1,2,2 | Direct Bilirubin,Week 8,n=2,1,1,2,1 | Indirect Bilirubin,Week 2,n=1,1,0,1,2 | Indirect Bilirubin,Week 4,n=2,1,1,2,2 | Indirect Bilirubin,Week 8,n=2,1,1,2,1 | Creatinine,Week 2,n=1,1,0,1,2 | Creatinine,Week 4,n=2,1,1,2,2 | Creatinine,Week 8,n=2,1,1,2,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | -1.0 | 1.0 | 2.0 | 0.0 | 0.0 | 0.0 | -1.0 | 1.0 | 2.0 | 3.10 | 2.20 | 0.00 |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | 0.0 | -2.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | -2.0 | 0.0 | -6.20 | -12.40 | -8.00 |
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Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12
Intervention | Scores on scale (Number) |
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| Par 1, Day 30, Physical Functioning | Par 1, Day 30, Role Physical | Par 1, Day 30, Bodily Pain | Par 1, Day 30, General health | Par 1, Day 30, Vitality | Par 1, Day 30, Social Functioning | Par 1, Day 30, Role emotional | Par 1, Day 30, Mental health | Par 1, Day 30, Physical Component Summary | Par 1, Day 30, Mental Component Summary | Par 2, Day 29, Physical Functioning | Par 2, Day 29, Role Physical | Par 2, Day 29, Bodily Pain | Par 2, Day 29, General health | Par 2, Day 29, Vitality | Par 2, Day 29, Social Functioning | Par 2, Day 29, Role emotional | Par 2, Day 29, Mental health | Par 2, Day 29, Physical Component Summary | Par 2, Day 29, Mental Component Summary | Par 3, Day 23, Physical Functioning | Par 3, Day 23, Role Physical | Par 3, Day 23, Bodily Pain | Par 3, Day 23, General health | Par 3, Day 23, Vitality | Par 3, Day 23, Social Functioning | Par 3, Day 23, Role emotional | Par 3, Day 23, Mental health | Par 3, Day 23, Physical Component Summary | Par 3, Day 23, Mental Component Summary | Par 4, Week 12, Physical Functioning | Par 4, Week 12, Role Physical | Par 4, Week 12, Bodily Pain | Par 4, Week 12, General health | Par 4, Week 12, Vitality | Par 4, Week 12, Social Functioning | Par 4, Week 12, Role emotional | Par 4, Week 12, Mental health | Par 4, Week 12, Physical Component Summary | Par 4, Week 12, Mental Component Summary | Par 4, Day 113, Physical Functioning | Par 4, Day 113, Role Physical | Par 4, Day 113, Bodily Pain | Par 4, Day 113, General health | Par 4, Day 113, Vitality | Par 4, Day 113, Social Functioning | Par 4, Day 113, Role emotional | Par 4, Day 113, Mental health | Par 4, Day 113, Physical Component Summary | Par 4, Day 113, Mental Component Summary | Par 5, Week 8, Physical Functioning | Par 5, Week 8, Role Physical | Par 5, Week 8, Bodily Pain | Par 5, Week 8, General health | Par 5, Week 8, Vitality | Par 5, Week 8, Social Functioning | Par 5, Week 8, Role emotional | Par 5, Week 8, Mental health | Par 5, Week 8, Physical Component Summary | Par 5, Week 8, Mental Component Summary | Par 5, Day 85, Physical Functioning | Par 5, Day 85, Role Physical | Par 5, Day 85, Bodily Pain | Par 5, Day 85, General health | Par 5, Day 85, Vitality | Par 5, Day 85, Social Functioning | Par 5, Day 85, Role emotional | Par 5, Day 85, Mental health | Par 5, Day 85, Physical Component Summary | Par 5, Day 85, Mental Component Summary | Par 6, Day 65, Physical Functioning | Par 6, Day 65, Role Physical | Par 6, Day 65, Bodily Pain | Par 6, Day 65, General health | Par 6, Day 65, Vitality | Par 6, Day 65, Social Functioning | Par 6, Day 65, Role emotional | Par 6, Day 65, Mental health | Par 6, Day 65, Physical Component Summary | Par 6, Day 65, Mental Component Summary | Par 7, Week 12, Physical Functioning | Par 7, Week 12, Role Physical | Par 7, Week 12, Bodily Pain | Par 7, Week 12, General health | Par 7, Week 12, Vitality | Par 7, Week 12, Social Functioning | Par 7, Week 12, Role emotional | Par 7, Week 12, Mental health | Par 7, Week 12, Physical Component Summary | Par 7, Week 12, Mental Component Summary | Par 7, Day 373, Physical Functioning | Par 7, Day 373, Role Physical | Par 7, Day 373, Bodily Pain | Par 7, Day 373, General health | Par 7, Day 373, Vitality | Par 7, Day 373, Social Functioning | Par 7, Day 373, Role emotional | Par 7, Day 373, Mental health | Par 7, Day 373, Physical Component Summary | Par 7, Day 373, Mental Component Summary | Par 8, Day 64, Physical Functioning | Par 8, Day 64, Role Physical | Par 8, Day 64, Bodily Pain | Par 8, Day 64, General health | Par 8, Day 64, Vitality | Par 8, Day 64, Social Functioning | Par 8, Day 64, Role emotional | Par 8, Day 64, Mental health | Par 8, Day 64, Physical Component Summary | Par 8, Day 64, Mental Component Summary | Par 9, Day 29, Physical Functioning | Par 9, Day 29, Role Physical | Par 9, Day 29, Bodily Pain | Par 9, Day 29, General health | Par 9, Day 29, Vitality | Par 9, Day 29, Social Functioning | Par 9, Day 29, Role emotional | Par 9, Day 29, Mental health | Par 9, Day 29, Physical Component Summary | Par 9, Day 29, Mental Component Summary | Par 10, Day 57, Physical Functioning | Par 10, Day 57, Role Physical | Par 10, Day 57, Bodily Pain | Par 10, Day 57, General health | Par 10, Day 57, Vitality | Par 10, Day 57, Social Functioning | Par 10, Day 57, Role emotional | Par 10, Day 57, Mental health | Par 10, Day 57, Physical Component Summary | Par 10, Day 57, Mental Component Summary | Par 11, Week 12, Physical Functioning | Par 11, Week 12, Role Physical | Par 11, Week 12, Bodily Pain | Par 11, Week 12, General health | Par 11, Week 12, Vitality | Par 11, Week 12, Social Functioning | Par 11, Week 12, Role emotional | Par 11, Week 12, Mental health | Par 11, Week 12, Physical Component Summary | Par 11, Week 12, Mental Component Summary | Par 11, Day 163, Physical Functioning | Par 11, Day 163, Role Physical | Par 11, Day 163, Bodily Pain | Par 11, Day 163, General health | Par 11, Day 163, Vitality | Par 11, Day 163, Social Functioning | Par 11, Day 163, Role emotional | Par 11, Day 163, Mental health | Par 11, Day 163, Physical Component Summary | Par 11, Day 163, Mental Component Summary | Par 12, Day 85, Physical Functioning | Par 12, Day 85, Role Physical | Par 12, Day 85, Bodily Pain | Par 12, Day 85, General health | Par 12, Day 85, Vitality | Par 12, Day 85, Social Functioning | Par 12, Day 85, Role emotional | Par 12, Day 85, Mental health | Par 12, Day 85, Physical Component Summary | Par 12, Day 85, Mental Component Summary | Par 13, Day 59, Physical Functioning | Par 13, Day 59, Role Physical | Par 13, Day 59, Bodily Pain | Par 13, Day 59, General health | Par 13, Day 59, Vitality | Par 13, Day 59, Social Functioning | Par 13, Day 59, Role emotional | Par 13, Day 59, Mental health | Par 13, Day 59, Physical Component Summary | Par 13, Day 59, Mental Component Summary | Par 14, Day 57, Physical Functioning | Par 14, Day 57, Role Physical | Par 14, Day 57, Bodily Pain | Par 14, Day 57, General health | Par 14, Day 57, Vitality | Par 14, Day 57, Social Functioning | Par 14, Day 57, Role emotional | Par 14, Day 57, Mental health | Par 14, Day 57, Physical Component Summary | Par 14, Day 57, Mental Component Summary | Par 15, Day 169, Physical Functioning | Par 15, Day 169, Role Physical | Par 15, Day 169, Bodily Pain | Par 15, Day 169, General health | Par 15, Day 169, Vitality | Par 15, Day 169, Social Functioning | Par 15, Day 169, Role emotional | Par 15, Day 169, Mental health | Par 15, Day 169, Physical Component Summary | Par 15, Day 169, Mental Component Summary | Par 16, Week 12, Physical Functioning | Par 16, Week 12, Role Physical | Par 16, Week 12, Bodily Pain | Par 16, Week 12, General health | Par 16, Week 12, Vitality | Par 16, Week 12, Social Functioning | Par 16, Week 12, Role emotional | Par 16, Week 12, Mental health | Par 16, Week 12, Physical Component Summary | Par 16, Week 12, Mental Component Summary | Par 16, Day 112, Physical Functioning | Par 16, Day 112, Role Physical | Par 16, Day 112, Bodily Pain | Par 16, Day 112, General health | Par 16, Day 112, Vitality | Par 16, Day 112, Social Functioning | Par 16, Day 112, Role emotional | Par 16, Day 112, Mental health | Par 16, Day 112, Physical Component Summary | Par 16, Day 112, Mental Component Summary | Par 17, Day 85, Physical Functioning | Par 17, Day 85, Role Physical | Par 17, Day 85, Bodily Pain | Par 17, Day 85, General health | Par 17, Day 85, Vitality | Par 17, Day 85, Social Functioning | Par 17, Day 85, Role emotional | Par 17, Day 85, Mental health | Par 17, Day 85, Physical Component Summary | Par 17, Day 85, Mental Component Summary |
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PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 5 | 6.25 | 28 | 0 | -6.25 | 0 | 0 | 0 | 5.1 | -2.52 | 0 | 12.5 | 28 | -20 | -6.25 | 0 | 0 | 0 | 2.71 | -2.21 | -10 | -25 | -10 | 0 | 6.25 | -12.5 | 0 | 5 | -6.51 | 3.01 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -5.01 | -18.75 | -32 | 10 | 12.5 | -37.5 | 0 | 15 | -7.54 | 3.62 | 4.99 | 50 | 33 | 5 | 6.25 | 25 | 50 | 0 | 7.93 | 8.48 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0 | 6.25 | 16 | 0 | -6.25 | 0 | 0 | -5 | -3.33 | -2.88 | 15 | 6.25 | 16 | 8 | 0 | 0 | 0 | -15 | 7.95 | -6.1 | 5 | -6.25 | -22 | 0 | -12.5 | 0 | 25 | -15 | -3.24 | 0.02 | 10 | 6.25 | 0 | -3 | 0 | 0 | 0 | -10 | 3.22 | -3.68 | 0 | 12.5 | 0 | -5 | 0 | 12.5 | 0 | 0 | 0.95 | 0.83 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -5 | 0 | -16 | 10 | 0 | 0 | 0 | 5 | -2.26 | 2.26 | 0 | 0 | 0 | 8 | 6.25 | 0 | 0 | 10 | -0.12 | 3.18 | 25 | 6.25 | 49 | 10 | 0 | 0 | 0 | -5 | 12.88 | -5.75 | 15 | 18.75 | 0 | 0 | 6.25 | 0 | 0 | 0 | 4.88 | -1.45 | 15 | 0 | 0 | 10 | 0 | -12.5 | 0 | 25 | 0.77 | 3.61 | -5 | 0 | 10 | -10 | -6.25 | -12.5 | 16.67 | 0 | -2.1 | 1.1 | 5 | -6.25 | 10 | -22 | -6.25 | -12.5 | 8.33 | 10 | -3.17 | 1.62 | 0 | 6.25 | 0 | 0 | -6.25 | 12.5 | 8.33 | 0 | -0.01 | 1.88 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -29.99 | -18.75 | 0 | -13 | -6.25 | -25 | 0 | 5 | -9.37 | 1.44 | -15.01 | 6.25 | 0 | -8 | 0 | -37.5 | 9 | 10 | -3.64 | -0.4 | -5 | -6.25 | -11 | -5 | 6.25 | 0 | -16.67 | 5 | -2.76 | 0.13 | 5 | -12.5 | 0 | 0 | 0 | -12.5 | 0 | -25 | 2.16 | -7.59 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24
Intervention | Scores on scale (Number) |
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| Par 1, Week 12, Physical Functioning | Par 1, Week 12, Role Physical | Par 1, Week 12, Bodily Pain | Par 1, Week 12, General Health | Par 1, Week 12, Vitality | Par 1, Week 12, Social Functioning | Par 1, Week 12, Role Emotional | Par 1, Week 12, Mental Health | Par 1, Week 12, Physical Component Summary | Par 1, Week 12, Mental Component Summary | Par 1, Week 24, Physical Functioning | Par 1, Week 24, Role Physical | Par 1, Week 24, Bodily Pain | Par 1, Week 24, General Health | Par 1, Week 24, Vitality | Par 1, Week 24, Social Functioning | Par 1, Week 24, Role Emotional | Par 1, Week 24, Mental Health | Par 1, Week 24, Physical Component Summary | Par 1, Week 24, Mental Component Summary | Par 1, Day 339, Physical Functioning | Par 1, Day 339, Role Physical | Par 1, Day 339, Bodily Pain | Par 1, Day 339, General Health | Par 1, Day 339, Vitality | Par 1, Day 339, Social Functioning | Par 1, Day 339, Role Emotional | Par 1, Day 339, Mental Health | Par 1, Day 339, Physical Component Summary | Par 1, Day 339, Mental Component Summary | Par 2, Week 12, Physical Functioning | Par 2, Week 12, Role Physical | Par 2, Week 12, Bodily Pain | Par 2, Week 12, General Health | Par 2, Week 12, Vitality | Par 2, Week 12, Social Functioning | Par 2, Week 12, Role Emotional | Par 2, Week 12, Mental Health | Par 2, Week 12, Physical Component Summary | Par 2, Week 12, Mental Component Summary | Par 2, Week 24, Physical Functioning | Par 2, Week 24, Role Physical | Par 2, Week 24, Bodily Pain | Par 2, Week 24, General Health | Par 2, Week 24, Vitality | Par 2, Week 24, Social Functioning | Par 2, Week 24, Role Emotional | Par 2, Week 24, Mental Health | Par 2, Week 24, Physical Component Summary | Par 2, Week 24, Mental Component Summary | Par 2, Day 344, Physical Functioning | Par 2, Day 344, Role Physical | Par 2, Day 344, Bodily Pain | Par 2, Day 344, General Health | Par 2, Day 344, Vitality | Par 2, Day 344, Social Functioning | Par 2, Day 344, Role Emotional | Par 2, Day 344, Mental Health | Par 2, Day 344, Physical Component Summary | Par 2, Day 344, Mental Component Summary | Par 3, Day 113, Physical Functioning | Par 3, Day 113, Role Physical | Par 3, Day 113, Bodily Pain | Par 3, Day 113, General Health | Par 3, Day 113, Vitality | Par 3, Day 113, Social Functioning | Par 3, Day 113, Role Emotional | Par 3, Day 113, Mental Health | Par 3, Day 113, Physical Component Summary | Par 3, Day 113, Mental Component Summary | Par 4, Week 12, Physical Functioning | Par 4, Week 12, Role Physical | Par 4, Week 12, Bodily Pain | Par 4, Week 12, General Health | Par 4, Week 12, Vitality | Par 4, Week 12, Social Functioning | Par 4, Week 12, Role Emotional | Par 4, Week 12, Mental Health | Par 4, Week 12, Physical Component Summary | Par 4, Week 12, Mental Component Summary | Par 5, Week 12, Physical Functioning | Par 5, Week 12, Role Physical | Par 5, Week 12, Bodily Pain | Par 5, Week 12, General Health | Par 5, Week 12, Vitality | Par 5, Week 12, Social Functioning | Par 5, Week 12, Role Emotional | Par 5, Week 12, Mental Health | Par 5, Week 12, Physical Component Summary | Par 5, Week 12, Mental Component Summary | Par 5, Day 162, Physical Functioning | Par 5, Day 162, Role Physical | Par 5, Day 162, Bodily Pain | Par 5, Day 162, General Health | Par 5, Day 162, Vitality | Par 5, Day 162, Social Functioning | Par 5, Day 162, Role Emotional | Par 5, Day 162, Mental Health | Par 5, Day 162, Physical Component Summary | Par 5, Day 162, Mental Component Summary | Par 6, Day 91, Physical Functioning | Par 6, Day 91, Role Physical | Par 6, Day 91, Bodily Pain | Par 6, Day 91, General Health | Par 6, Day 91, Vitality | Par 6, Day 91, Social Functioning | Par 6, Day 91, Role Emotional | Par 6, Day 91, Mental Health | Par 6, Day 91, Physical Component Summary | Par 6, Day 91, Mental Component Summary | Par 7, Day 85, Physical Functioning | Par 7, Day 85, Role Physical | Par 7, Day 85, Bodily Pain | Par 7, Day 85, General Health | Par 7, Day 85, Vitality | Par 7, Day 85, Social Functioning | Par 7, Day 85, Role Emotional | Par 7, Day 85, Mental Health | Par 7, Day 85, Physical Component Summary | Par 7, Day 85, Mental Component Summary | Par 8, Day 87, Physical Functioning | Par 8, Day 87, Role Physical | Par 8, Day 87, Bodily Pain | Par 8, Day 87, General Health | Par 8, Day 87, Vitality | Par 8, Day 87, Social Functioning | Par 8, Day 87, Role Emotional | Par 8, Day 87, Mental Health | Par 8, Day 87, Physical Component Summary | Par 8, Day 87, Mental Component Summary |
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PartB:Placebo SC q2w + 12 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 10 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -10.01 | -6.25 | -22 | 10 | -12.5 | NA | NA | 5 | -4.79 | 1.82 | 0 | 6.25 | 21 | 0 | 0 | 12.5 | 16.66 | 5 | 1.52 | 4.54 |
,PartB:Placebo SC q2w + 6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 5 | -18.75 | -16 | 10 | 6.25 | -25 | -16.66 | -5 | -0.34 | -5.35 | 10.01 | -18.75 | -16 | -7 | -12.5 | -25 | -33.33 | 5 | -1.62 | -8.24 | -15 | -25 | 22 | 0 | -6.25 | 0 | 0 | 20 | -5.17 | 5.95 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | -10 | 0 | 0 | -5 | -6.25 | NA | 0 | -5 | -1.72 | -1.05 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -10 | -12.5 | -39 | 0 | -6.25 | 0 | -8.33 | 10 | -8.76 | 3.29 | -4.99 | -12.5 | 1 | -5 | 0 | 0 | -16.67 | 5 | -2.09 | -0.76 | 9.99 | 37.5 | 23 | 5 | 6.25 | 0 | 0 | 0 | 9.98 | -2.78 | 4.99 | 50 | 49 | 10 | 0 | 12.5 | NA | -10 | 15.7 | -5.84 | 24.99 | 50 | 33 | 5 | -6.25 | 12.5 | 0 | -20 | 17.37 | -10.18 | -5.01 | 37.5 | 11 | 10 | -6.25 | 12.5 | 0 | -15 | 8.12 | -4.89 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 168 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 15 | 6.25 | 33 | -5 | 0 | 0 | 0 | 5 | 6.28 | -1.59 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Millimoles per liter (Mean) |
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| Calcium,Week 4,n=3,3,2,1,2 | Calcium,Week 12,n=1,1,1,1,1 | Calcium,Week 16,n=0,1,1,1,0 | Carbon Dioxide,Week 4,n=3,3,2,1,2 | Carbon Dioxide,Week 12,n=1,1,1,1,1 | Carbon Dioxide,Week 16,n=0,1,1,1,0 | Chloride,Week 4,n=3,3,2,1,2 | Chloride,Week 12,n=1,1,1,1,1 | Chloride,Week 16,n=0,1,1,1,0 | Glucose,Week 4,n=3,3,2,1,2 | Glucose,Week 12,n=1,1,1,1,1 | Glucose,Week 16,n=0,1,1,1,0 | Phosphate,Week 4,n=3,3,2,1,2 | Phosphate,Week 12,n=1,1,1,1,1 | Phosphate,Week 16,n=0,1,1,1,0 | Potassium,Week 4,n=3,3,2,1,2 | Potassium,Week 12,n=1,1,1,1,1 | Potassium,Week 16,n=0,1,1,1,0 | Sodium,Week 4,n=3,3,2,1,2 | Sodium,Week 12,n=1,1,1,1,1 | Sodium,Week 16,n=0,1,1,1,0 | Urea,Week 4,n=3,3,2,1,2 | Urea,Week 12,n=1,1,1,1,1 | Urea,Week 16,n=0,1,1,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | 0.120 | 0.000 | 0.060 | -1.0 | 0.0 | 0.0 | -4.0 | -2.0 | -1.0 | 0.70 | -0.50 | 2.10 | 0.050 | 0.250 | 0.000 | 0.40 | 0.00 | -0.20 | -3.0 | 0.0 | 0.0 | 0.00 | -1.00 | 0.50 |
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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Proportion of red blood cells in blood (Mean) |
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| Hematocrit,Week 2,n=1,1,0,1,2 | Hematocrit,Week 4,n=2,1,1,2,2 | Hematocrit,Week 8,n=2,1,1,2,2 | Hematocrit,Week 12,n=2,0,1,1,0 | Hematocrit,Week 16,n=2,0,0,1,0 | Hematocrit,Week 24,n=2,0,0,0,0 | Hematocrit,Week 36,n=2,0,0,0,0 | Hematocrit,Week 38,n=1,0,0,0,0 | Hematocrit,Week 40,n=1,0,0,0,0 |
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PartB:SIR 100 mg SC q2w+6 Month Prednisone | -0.0080 | 0.0030 | 0.0115 | 0.0125 | 0.0000 | 0.0040 | 0.0005 | -0.0050 | -0.0140 |
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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Giga cells per liter (Mean) |
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| Eosinophils,Week 4,n=3,3,2,1,2 | Eosinophils,Week 12,n=1,1,1,1,1 | Eosinophils,Week 16,n=0,1,1,1,0 | Leukocytes,Week 4,n=3,3,2,1,2 | Leukocytes,Week 12,n=1,1,1,1,1 | Leukocytes,Week 16,n=0,1,1,1,0 | Lymphocytes,Week 4,n=3,3,2,1,2 | Lymphocytes,Week 12,n=1,1,1,1,1 | Lymphocytes,Week 16,n=0,1,1,1,0 | Neutrophils ,Week 4,n=3,3,2,1,2 | Neutrophils ,Week 12,n=1,1,1,1,1 | Neutrophils ,Week 16,n=0,1,1,1,0 | Platelets,Week 4,n=3,3,2,1,2 | Platelets,Week 12,n=1,1,1,1,1 | Platelets,Week 16,n=0,1,1,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | -0.030 | 0.070 | -0.050 | -0.40 | -1.50 | -1.30 | -0.960 | 0.380 | -0.520 | 0.390 | -1.770 | -0.210 | 26.0 | -8.0 | -19.0 |
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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Giga cells per liter (Mean) |
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| Eosinophils,Week 4,n=3,3,2,1,2 | Eosinophils,Week 8,n=2,1,2,0,2 | Eosinophils,Week 12,n=1,1,1,1,1 | Leukocytes,Week 4,n=3,3,2,1,2 | Leukocytes,Week 8,n=2,1,2,0,2 | Leukocytes,Week 12,n=1,1,1,1,1 | Lymphocytes,Week 4,n=3,3,2,1,2 | Lymphocytes,Week 8,n=2,1,2,0,2 | Lymphocytes,Week 12,n=1,1,1,1,1 | Neutrophils ,Week 4,n=3,3,2,1,2 | Neutrophils ,Week 8,n=2,1,2,0,2 | Neutrophils ,Week 12,n=1,1,1,1,1 | Platelets,Week 4,n=3,3,2,1,2 | Platelets,Week 8,n=2,1,2,0,2 | Platelets,Week 12,n=1,1,1,1,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | 0.415 | 0.330 | 0.030 | 1.30 | 0.65 | -0.70 | 0.015 | -0.180 | -0.610 | 0.815 | 0.500 | -0.140 | -14.0 | 31.5 | 14.0 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -0.110 | -0.070 | -0.120 | 0.40 | 0.25 | -1.30 | 0.293 | 0.470 | -0.210 | 0.183 | -0.205 | -0.750 | 15.0 | 17.5 | 27.0 |
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Part A: Cumulative Prednisone Dose Over Time
Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Intervention | Milligrams (Mean) |
---|
| Week 2, n= 40,39,26,27,26 | Week 4,n=40,39,26,25,27 | Week 8,n=37, 37,26,23,26 | Week 12,n=34,32,24,22,24 | Week 16,n=32,30,24,22,22 | Week 20,n=29,27,21,24,19 | Week 24,n=30,25,19,18,17 | Week 28,n=24,23,15,17,15 | Week 32,n=19,21,13,15,18 | Week 36,n=19,17,14,13,14 | Week 40,n=18,15,11,13,12 | Week 44,n=17,13,10,12,13 | Week 48,n=10,16,9,8,11 | Week 52,n=11,10,6,7,6 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 430.846 | 751.407 | 1129.077 | 1462.917 | 1729.977 | 2041.632 | 2299.471 | 2387.800 | 2404.500 | 2717.696 | 2963.865 | 2954.760 | 3167.898 | 3603.229 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 432.815 | 705.480 | 1161.391 | 1379.409 | 1672.795 | 1646.177 | 1917.444 | 2141.294 | 2531.417 | 2617.817 | 2960.144 | 2783.542 | 2859.208 | 3157.054 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 464.923 | 741.115 | 987.730 | 1063.773 | 1182.288 | 1339.546 | 1495.015 | 1575.549 | 1716.863 | 1803.919 | 2023.342 | 1481.115 | 1601.656 | 2418.213 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 439.575 | 701.100 | 1086.676 | 1344.441 | 1545.602 | 1690.302 | 1878.458 | 2000.813 | 2216.000 | 2321.711 | 2003.264 | 2051.603 | 1821.325 | 2974.295 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 424.577 | 701.192 | 1014.731 | 1208.167 | 1348.750 | 1475.786 | 1626.342 | 1797.533 | 1859.346 | 1705.214 | 1842.500 | 1980.733 | 1562.333 | 2556.222 |
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Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 12, 24, 36, 52
Intervention | Scores on scale (Mean) |
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| Baseline, n=42,38,25,23,27 | Week 12, n=31,28,24,22,22 | Week 24, n=23,20,15,17,16 | Week 36, n=15,13,10,12,13 | Week 52, n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 65.1 | 65.5 | 61.5 | 61.6 | 70.0 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 62.1 | 63.3 | 64.9 | 68.3 | 60.2 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 65.6 | 64.2 | 70.6 | 73.9 | 80.6 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 67.0 | 74.3 | 74.6 | 79.5 | 79.9 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 57.0 | 68.4 | 65.1 | 66.9 | 78.4 |
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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Giga cells per liter (Mean) |
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| Eosinophils,Week 4,n=3,3,2,1,2 | Eosinophils,Week 8,n=2,1,2,0,2 | Eosinophils,Week 12,n=1,1,1,1,1 | Eosinophils,Week 16,n=0,1,1,1,0 | Leukocytes,Week 4,n=3,3,2,1,2 | Leukocytes,Week 8,n=2,1,2,0,2 | Leukocytes,Week 12,n=1,1,1,1,1 | Leukocytes,Week 16,n=0,1,1,1,0 | Lymphocytes,Week 4,n=3,3,2,1,2 | Lymphocytes,Week 8,n=2,1,2,0,2 | Lymphocytes,Week 12,n=1,1,1,1,1 | Lymphocytes,Week 16,n=0,1,1,1,0 | Neutrophils ,Week 4,n=3,3,2,1,2 | Neutrophils ,Week 8,n=2,1,2,0,2 | Neutrophils ,Week 12,n=1,1,1,1,1 | Neutrophils ,Week 16,n=0,1,1,1,0 | Platelets,Week 4,n=3,3,2,1,2 | Platelets,Week 8,n=2,1,2,0,2 | Platelets,Week 12,n=1,1,1,1,1 | Platelets,Week 16,n=0,1,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | -0.050 | 0.020 | -0.190 | -0.180 | 0.50 | 0.90 | 0.80 | 0.30 | 0.370 | 0.205 | 0.190 | 0.340 | 0.180 | 0.600 | 0.820 | 0.230 | 10.5 | 10.0 | 14.0 | 15.0 |
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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Giga cells per liter (Mean) |
---|
| Eosinophils,Week 4,n=3,3,2,1,2 | Eosinophils,Week 8,n=2,1,2,0,2 | Eosinophils,Week 12,n=1,1,1,1,1 | Eosinophils,Week 16,n=0,1,1,1,0 | Eosinophils,Week 24,n=0,1,0,0,0 | Eosinophils,Week 36,n=0,1,0,0,0 | Leukocytes,Week 4,n=3,3,2,1,2 | Leukocytes,Week 8,n=2,1,2,0,2 | Leukocytes,Week 12,n=1,1,1,1,1 | Leukocytes,Week 16,n=0,1,1,1,0 | Leukocytes,Week 24,n=0,1,0,0,0 | Leukocytes,Week 36,n=0,1,0,0,0 | Lymphocytes,Week 4,n=3,3,2,1,2 | Lymphocytes,Week 8,n=2,1,2,0,2 | Lymphocytes,Week 12,n=1,1,1,1,1 | Lymphocytes,Week 16,n=0,1,1,1,0 | Lymphocytes,Week 24,n=0,1,0,0,0 | Lymphocytes,Week 36,n=0,1,0,0,0 | Neutrophils ,Week 4,n=3,3,2,1,2 | Neutrophils ,Week 8,n=2,1,2,0,2 | Neutrophils ,Week 12,n=1,1,1,1,1 | Neutrophils ,Week 16,n=0,1,1,1,0 | Neutrophils ,Week 24,n=0,1,0,0,0 | Neutrophils ,Week 36,n=0,1,0,0,0 | Platelets,Week 4,n=3,3,2,1,2 | Platelets,Week 8,n=2,1,2,0,2 | Platelets,Week 12,n=1,1,1,1,1 | Platelets,Week 16,n=0,1,1,1,0 | Platelets,Week 24,n=0,1,0,0,0 | Platelets,Week 36,n=0,1,0,0,0 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | -0.013 | 0.020 | -0.120 | -0.200 | -0.100 | -0.240 | 0.30 | 0.10 | -1.60 | -0.50 | -0.60 | -1.10 | 0.077 | 0.090 | 0.140 | -0.040 | 0.000 | -0.240 | 0.333 | 0.010 | -1.440 | -0.220 | -0.350 | -0.420 | -6.0 | -25.0 | -20.0 | -4.0 | -20.0 | -16.0 |
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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Giga cells per liter (Mean) |
---|
| Eosinophils,Week 2,n=1,1,0,1,2 | Eosinophils,Week 4,n=2,1,1,2,2 | Eosinophils,Week 8,n=2,1,1,2,1 | Leukocytes,Week 2,n=1,1,0,1,2 | Leukocytes,Week 4,n=2,1,1,2,2 | Leukocytes,Week 8,n=2,1,1,2,1 | Lymphocytes,Week 2,n=1,1,0,1,2 | Lymphocytes,Week 4,n=2,1,1,2,2 | Lymphocytes,Week 8,n=2,1,1,2,1 | Neutrophils ,Week 2,n=1,1,0,1,2 | Neutrophils ,Week 4,n=2,1,1,2,2 | Neutrophils ,Week 8,n=2,1,1,2,2 | Platelets ,Week 2,n=1,1,0,1,2 | Platelets,Week 4,n=2,1,1,2,2 | Platelets,Week 8,n=2,1,1,2,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | -0.010 | 0.035 | 0.045 | -2.30 | -1.45 | -0.95 | -0.160 | -0.115 | -0.275 | -2.210 | -1.420 | -0.790 | -20.5 | -42.0 | -40.0 |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | -0.110 | -0.210 | -0.180 | 0.30 | -0.30 | 0.00 | 0.000 | -0.340 | 0.160 | 0.510 | 0.400 | 0.060 | 4.0 | 6.0 | -6.0 |
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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Giga cells per liter (Mean) |
---|
| Eosinophils,Week 4,n=2,1,1,2,2 | Eosinophils,Week 8,n=2,1,1,2,1 | Eosinophils,Week 12,n=2,0,1,1,0 | Leukocytes,Week 4,n=2,1,1,2,2 | Leukocytes,Week 8,n=2,1,1,2,1 | Leukocytes,Week 12,n=2,0,1,1,0 | Lymphocytes,Week 4,n=2,1,1,2,2 | Lymphocytes,Week 8,n=2,1,1,2,1 | Lymphocytes,Week 12,n=2,0,1,1,0 | Neutrophils ,Week 4,n=2,1,1,2,2 | Neutrophils ,Week 8,n=2,1,1,2,2 | Neutrophils ,Week 12,n=2,0,1,1,0 | Platelets,Week 4,n=2,1,1,2,2 | Platelets,Week 8,n=2,1,1,2,1 | Platelets,Week 12,n=2,0,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | -0.010 | 0.040 | 0.030 | 0.20 | 0.60 | 0.90 | -0.010 | 0.050 | 0.300 | 0.230 | 0.620 | 0.630 | -1.0 | 2.0 | 52.0 |
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Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 12, 24, 36, 52
Intervention | Scores on scale (Mean) |
---|
| Baseline, n=42,38,25,23,27 | Week 12, n=31,28,24,22,22 | Week 24, n=23,20,15,17,16 | Week 36, n=15,13,10,12,13 | Week 52, n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 0.7554 | 0.7069 | 0.7301 | 0.7506 | 0.8068 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 0.7429 | 0.7228 | 0.7323 | 0.6950 | 0.7864 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0.6681 | 0.7024 | 0.7217 | 0.7454 | 0.7628 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0.7918 | 0.7866 | 0.7485 | 0.8011 | 0.8210 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 0.6912 | 0.7452 | 0.7135 | 0.7774 | 0.8092 |
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Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items. (NCT02531633)
Timeframe: Baseline (Week 0), Weeks 12, 24, 36, 52
Intervention | Scores on scale (Mean) |
---|
| Baseline, n=42,38,25,23,27 | Week 12, n=31,28,24,22,22 | Week 24, n=23,20,15,17,16 | Week 36, n=15,13,10,12,13 | Week 52, n=9,5,5,5,4 |
---|
PartA:Placebo SC q2w + 12 Month Prednisone | 34.1 | 35.5 | 36.0 | 37.5 | 41.0 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 38.0 | 38.5 | 36.2 | 40.9 | 44.0 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 34.2 | 32.7 | 36.5 | 38.4 | 43.0 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 38.7 | 40.2 | 38.1 | 41.4 | 42.1 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 31.1 | 34.3 | 31.2 | 36.9 | 40.4 |
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Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
"Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability." (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 12, 24, 36 and 52
Intervention | Scores on scale (Mean) |
---|
| Baseline, n=19,14,13,9,12 | Week 12, n=12,8,12,9,9 | Week 24, n=10, 7,7,7,9 | Week 36, n=6,5,4,4,7 | Week 52, n=5,2,3,1,2 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 0.8646 | 0.9306 | 0.9583 | 1.0000 | 0.1875 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 0.8889 | 0.5694 | 0.9107 | 0.5625 | 0.0000 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 1.1250 | 1.0938 | 0.8750 | 0.8250 | 0.3125 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0.6776 | 0.3229 | 0.5875 | 0.5208 | 0.3000 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 0.9615 | 0.7292 | 0.9821 | 0.6250 | 0.1667 |
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Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
"The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Data for NRS scores over time for part A is reported." (NCT02531633)
Timeframe: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Intervention | Scores on scale (Mean) |
---|
| Baseline, n=42,38,25,23,27 | Week 2, n=38,38,25,21,27 | Week 4, n=36,37,24,22,27 | Week 8, n=34,30,24,21,23 | Week 12, n=31,28,24,22,22 | Week 16, n=27,25,22,19,19 | Week 20, n=26,23,19,18,15 | Week 24, n=23,20,15,17,16 | Week 28, n=18,17,11,13,14 | Week 32, n=19,14,9,12,12 | Week 36, n=15,13,10,12,13 | Week 40, n=15,11,9,10,10 | Week 44, n=11,11,6,8,8 | Week 48, n=9,8,5,7,5 | Week 52, n=9,5,5,5,4 |
---|
PartA:Placebo SC q2w + 12 Month Prednisone | 2.6 | 2.6 | 1.8 | 3.3 | 2.0 | 2.7 | 2.7 | 3.5 | 2.9 | 3.1 | 1.9 | 2.6 | 3.0 | 4.0 | 1.0 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 2.6 | 2.6 | 2.4 | 2.1 | 2.3 | 2.4 | 1.4 | 2.4 | 2.3 | 2.6 | 2.3 | 1.9 | 1.3 | 1.6 | 2.2 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 2.5 | 2.8 | 3.1 | 2.9 | 3.6 | 3.3 | 2.9 | 2.5 | 2.8 | 1.9 | 2.0 | 2.0 | 1.9 | 0.8 | 0.8 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 1.8 | 1.3 | 1.7 | 1.8 | 1.7 | 1.4 | 1.7 | 2.4 | 2.6 | 2.1 | 1.6 | 2.0 | 2.1 | 1.9 | 1.3 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 3.1 | 2.8 | 3.3 | 3.0 | 3.3 | 3.0 | 3.6 | 3.3 | 3.6 | 2.9 | 2.9 | 3.1 | 2.2 | 2.6 | 2.8 |
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Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
"The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor)." (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Intervention | Scores on scale (Mean) |
---|
| Baseline, n=42,39,25,26,27 | Week 2, n=38,38,25,21,27 | Week 4, n=36,37,24,22,27 | Week 8, n=34,30,24,21,23 | Week 12, n=31,28,24,22,22 | Week 16, n=27,25,22,19,19 | Week 20, n=26,23,19,18,15 | Week 24, n=23,20,15,17,16 | Week 28, n=18,17,11,13,14 | Week 32, n=19,14,9,12,12 | Week 36, n=15,13,10,12,13 | Week 40, n=15,11,9,10,10 | Week 44, n=11,11,6,8,8 | Week 48, n=9,8,5,7,5 | Week 52, n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 3.64 | 3.52 | 2.62 | 2.90 | 2.75 | 2.76 | 2.90 | 3.34 | 2.74 | 2.88 | 2.62 | 3.00 | 3.49 | 4.48 | 2.13 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 3.60 | 3.45 | 3.01 | 2.85 | 3.20 | 2.86 | 2.45 | 2.85 | 2.68 | 2.43 | 2.68 | 2.24 | 2.18 | 1.86 | 2.44 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 3.72 | 3.51 | 3.75 | 3.87 | 3.80 | 3.82 | 3.20 | 2.33 | 3.09 | 2.22 | 2.66 | 2.35 | 2.19 | 1.03 | 0.46 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 2.96 | 2.59 | 2.43 | 1.97 | 1.97 | 1.95 | 2.60 | 2.63 | 2.44 | 2.01 | 1.46 | 2.05 | 2.28 | 1.81 | 1.10 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 4.24 | 3.73 | 3.81 | 3.44 | 3.95 | 3.39 | 4.17 | 3.83 | 4.18 | 3.02 | 2.79 | 3.20 | 2.17 | 2.30 | 2.76 |
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Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
"The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 (none) to 10 (extremely active)." (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Intervention | Scores on scale (Mean) |
---|
| Baseline, n=42,39,25,26,27 | Week 2, n=36,35,25,20,26 | Week 4, n=33,32,23,21,25 | Week 8, n=33,28,23,20,21 | Week 12, n=29,25,23,18,21 | Week 16, n=26,23,21,16,19 | Week 20, n=25,23,18,17,15 | Week 24, n=20,20,15,15,15 | Week 28, n=17,17,11,12,13 | Week 32, n=19,14,8,11,12 | Week 36, n=13,11,10,11,13 | Week 40, n=13,9,8,9,10 | Week 44, n=10,9,6,8,7 | Week 48, n=7,7,5,6,5 | Week 52, n=9,5,5,4,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 3.25 | 1.76 | 1.02 | 1.14 | 1.47 | 0.67 | 1.27 | 1.37 | 0.85 | 0.89 | 0.75 | 0.57 | 0.87 | 1.60 | 1.80 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 3.05 | 1.85 | 0.92 | 0.79 | 1.28 | 1.39 | 0.83 | 1.48 | 0.88 | 1.26 | 0.56 | 0.52 | 0.58 | 0.78 | 1.35 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 2.95 | 1.52 | 1.44 | 1.30 | 1.81 | 1.54 | 1.42 | 0.68 | 1.43 | 0.67 | 1.12 | 0.77 | 1.07 | 0.31 | 0.10 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 2.33 | 1.09 | 0.81 | 1.09 | 1.08 | 0.74 | 0.71 | 0.82 | 0.76 | 0.83 | 0.48 | 0.38 | 0.31 | 0.27 | 0.31 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 2.94 | 1.83 | 1.55 | 1.35 | 1.64 | 1.87 | 1.16 | 1.50 | 1.18 | 1.40 | 0.61 | 0.36 | 0.43 | 0.30 | 0.32 |
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Part A: Number of Disease Flares Over Time
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Intervention | Disease flares (Number) |
---|
| Week 2, n=38, 39,26,25,27 | Week 4, n=37,37,25,23,27 | Week 8, n=34,32,24,23,23 | Week 12, n=32,29,24,22,22 | Week 16, n=28,26,22,19,19 | Week 20, n=26,23,19,18,16 | Week 24, n=23,21,16,17,16 | Week 28, n=19,18,12,14,14 | Week 32, n=19,15,10,12,13 | Week 36, n=15,13,10,12,13 | Week 40, n=15,11,9,10,10 | Week 44, n=11,11,6,8,9 | Week 48, n=9,8,5,8,5 | Week 52, n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 2 | 2 | 5 | 4 | 4 | 3 | 5 | 5 | 6 | 6 | 5 | 7 | 3 | 4 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 0 | 0 | 1 | 4 | 9 | 10 | 11 | 11 | 10 | 10 | 8 | 6 | 7 | 7 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 2 | 4 | 6 | 9 | 9 | 9 | 9 | 8 | 8 | 8 | 7 | 8 | 4 | 2 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 1 | 3 | 2 | 4 | 4 | 4 | 6 | 5 | 5 | 3 | 2 | 1 | 1 | 1 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 2 | 3 | 3 | 4 | 5 | 6 | 8 | 8 | 5 | 5 | 5 | 3 | 1 | 1 |
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Part A: Number of Hospitalizations for Disease Flare Over Time
Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Intervention | Number of Hospitalizations (Number) |
---|
| Week 2, n=38, 39,26,25,27 | Week 4, n=37,37,25,23,27 | Week 8, n=34,32,24,23,23 | Week 12, n=32,29,24,22,22 | Week 16, n=28,26,22,19,19 | Week 20, n=26,23,19,18,16 | Week 24, n=23,21,16,17,16 | Week 28, n=19,18,12,14,14 | Week 32, n=19,15,10,12,13 | Week 36, n=15,13,10,12,13 | Week 40, n=15,11,9,10,10 | Week 44, n=11,11,6,8,9 | Week 48, n=9,8,5,8,5 | Week 52, n=9,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0 | 0 | 0 | 2 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Millimoles per liter (Mean) |
---|
| Calcium,Week 4,n=3,3,2,1,2 | Calcium,Week 8,n=2,1,2,0,2 | Calcium,Week 12,n=1,1,1,1,1 | Carbon Dioxide,Week 4,n=3,3,2,1,2 | Carbon Dioxide,Week 8,n=2,1,2,0,2 | Carbon Dioxide,Week 12,n=1,1,1,1,1 | Chloride,Week 4,n=3,3,2,1,2 | Chloride,Week 8,n=2,1,2,0,2 | Chloride,Week 12,n=1,1,1,1,1 | Glucose,Week 4,n=3,3,2,1,2 | Glucose,Week 8,n=2,1,2,0,2 | Glucose,Week 12,n=1,1,1,1,1 | Phosphate,Week 4,n=3,3,2,1,2 | Phosphate,Week 8,n=2,1,2,0,2 | Phosphate,Week 12,n=1,1,1,1,1 | Potassium,Week 4,n=3,3,2,1,2 | Potassium,Week 8,n=2,1,2,0,2 | Potassium,Week 12,n=1,1,1,1,1 | Sodium,Week 4,n=3,3,2,1,2 | Sodium,Week 8,n=2,1,2,0,2 | Sodium,Week 12,n=1,1,1,1,1 | Urea,Week 4,n=3,3,2,1,2 | Urea,Week 8,n=2,1,2,0,2 | Urea,Week 12,n=1,1,1,1,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | -0.040 | 0.020 | 0.000 | -3.0 | -1.5 | -3.0 | 0.5 | 0.5 | -2.0 | -0.40 | 0.55 | 0.20 | -0.025 | -0.075 | -0.100 | -0.10 | -0.10 | -0.40 | -1.0 | -1.0 | -4.0 | -0.25 | 0.50 | -2.50 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.067 | 0.010 | 0.020 | 0.0 | -0.5 | 1.0 | 0.7 | -2.0 | -2.0 | -0.10 | 0.15 | 0.00 | 0.050 | 0.150 | 0.050 | -0.27 | -0.25 | -0.20 | 0.3 | -2.5 | -2.0 | -0.83 | -0.50 | -0.50 |
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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Millimoles per liter (Mean) |
---|
| Calcium,Week 4,n=3,3,2,1,2 | Calcium,Week 8,n=2,1,2,0,2 | Calcium,Week 12,n=1,1,1,1,1 | Calcium,Week 16,n=0,1,1,1,0 | Carbon Dioxide,Week 4,n=3,3,2,1,2 | Carbon Dioxide,Week 8,n=2,1,2,0,2 | Carbon Dioxide,Week 12,n=1,1,1,1,1 | Carbon Dioxide,Week 16,n=0,1,1,1,0 | Chloride,Week 4,n=3,3,2,1,2 | Chloride,Week 8,n=2,1,2,0,2 | Chloride,Week 12,n=1,1,1,1,1 | Chloride,Week 16,n=0,1,1,1,0 | Glucose,Week 4,n=3,3,2,1,2 | Glucose,Week 8,n=2,1,2,0,2 | Glucose,Week 12,n=1,1,1,1,1 | Glucose,Week 16,n=0,1,1,1,0 | Phosphate,Week 4,n=3,3,2,1,2 | Phosphate,Week 8,n=2,1,2,0,2 | Phosphate,Week 12,n=1,1,1,1,1 | Phosphate,Week 16,n=0,1,1,1,0 | Potassium,Week 4,n=3,3,2,1,2 | Potassium,Week 8,n=2,1,2,0,2 | Potassium,Week 12,n=1,1,1,1,1 | Potassium,Week 16,n=0,1,1,1,0 | Sodium,Week 4,n=3,3,2,1,2 | Sodium,Week 8,n=2,1,2,0,2 | Sodium,Week 12,n=1,1,1,1,1 | Sodium,Week 16,n=0,1,1,1,0 | Urea,Week 4,n=3,3,2,1,2 | Urea,Week 8,n=2,1,2,0,2 | Urea,Week 12,n=1,1,1,1,1 | Urea,Week 16,n=0,1,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0.060 | 0.050 | 0.160 | 0.180 | 0.0 | 0.5 | 0.0 | 1.0 | -2.5 | -2.5 | -4.0 | -5.0 | -0.80 | -0.85 | 0.30 | 0.30 | -0.125 | -0.250 | 0.000 | 0.000 | 0.10 | 0.00 | 0.40 | -0.10 | -3.0 | -3.5 | -4.0 | -4.0 | -0.50 | -0.75 | 0.00 | -0.50 |
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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Millimoles per liter (Mean) |
---|
| Calcium,Week 4,n=3,3,2,1,2 | Calcium,Week 8,n=2,1,2,0,2 | Calcium,Week 12,n=1,1,1,1,1 | Calcium,Week 16,n=0,1,1,1,0 | Calcium,Week 24,n=0,1,0,0,0 | Calcium,Week 36,n=0,1,0,0,0 | Carbon Dioxide,Week 4,n=3,3,2,1,2 | Carbon Dioxide,Week 8,n=2,1,2,0,2 | Carbon Dioxide,Week 12,n=1,1,1,1,1 | Carbon Dioxide,Week 16,n=0,1,1,1,0 | Carbon Dioxide,Week 24,n=0,1,0,0,0 | Carbon Dioxide,Week 36,n=0,1,0,0,0 | Chloride,Week 4,n=3,3,2,1,2 | Chloride,Week 8,n=2,1,2,0,2 | Chloride,Week 12,n=1,1,1,1,1 | Chloride,Week 16,n=0,1,1,1,0 | Chloride,Week 24,n=0,1,0,0,0 | Chloride,Week 36,n=0,1,0,0,0 | Glucose,Week 4,n=3,3,2,1,2 | Glucose,Week 8,n=2,1,2,0,2 | Glucose,Week 12,n=1,1,1,1,1 | Glucose,Week 16,n=0,1,1,1,0 | Glucose,Week 24,n=0,1,0,0,0 | Glucose,Week 36,n=0,1,0,0,0 | Phosphate,Week 4,n=3,3,2,1,2 | Phosphate,Week 8,n=2,1,2,0,2 | Phosphate,Week 12,n=1,1,1,1,1 | Phosphate,Week 16,n=0,1,1,1,0 | Phosphate,Week 24,n=0,1,0,0,0 | Phosphate,Week 36,n=0,1,0,0,0 | Potassium,Week 4,n=3,3,2,1,2 | Potassium,Week 8,n=2,1,2,0,2 | Potassium,Week 12,n=1,1,1,1,1 | Potassium,Week 16,n=0,1,1,1,0 | Potassium,Week 24,n=0,1,0,0,0 | Potassium,Week 36,n=0,1,0,0,0 | Sodium,Week 4,n=3,3,2,1,2 | Sodium,Week 8,n=2,1,2,0,2 | Sodium,Week 12,n=1,1,1,1,1 | Sodium,Week 16,n=0,1,1,1,0 | Sodium,Week 24,n=0,1,0,0,0 | Sodium,Week 36,n=0,1,0,0,0 | Urea,Week 4,n=3,3,2,1,2 | Urea,Week 8,n=2,1,2,0,2 | Urea,Week 12,n=1,1,1,1,1 | Urea,Week 16,n=0,1,1,1,0 | Urea,Week 24,n=0,1,0,0,0 | Urea,Week 36,n=0,1,0,0,0 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | -0.093 | -0.060 | 0.040 | 0.040 | -0.040 | -0.020 | -2.7 | -4.0 | -2.0 | 0.0 | 1.0 | -2.0 | 0.3 | -1.0 | 0.0 | 1.0 | 1.0 | 0.0 | 0.33 | 0.60 | 2.80 | 1.40 | 1.10 | 2.10 | -0.033 | -0.100 | -0.250 | 0.100 | 0.050 | -0.150 | 0.03 | -0.30 | -0.20 | -0.10 | -0.10 | -0.20 | -1.0 | 2.0 | 1.0 | 0.0 | 3.0 | 1.0 | -0.50 | 0.00 | -1.50 | 0.00 | -0.50 | -1.00 |
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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Millimoles per liter (Mean) |
---|
| Calcium,Week 2,n=1,1,0,1,2 | Calcium,Week 4,n=2,1,1,2,2 | Calcium,Week 8,n=2,1,1,2,1 | Carbon Dioxide,Week 2,n=1,1,0,1,2 | Carbon Dioxide,Week 4,n=2,1,1,2,2 | Carbon Dioxide,Week 8,n=2,1,1,2,1 | Chloride,Week 2,n=1,1,0,1,2 | Chloride,Week 4,n=2,1,1,2,2 | Chloride,Week 8,n=2,1,1,2,1 | Glucose,Week 2,n=1,1,0,1,2 | Glucose,Week 4,n=2,1,1,2,2 | Glucose,Week 8,n=2,1,1,2,1 | Phosphate,Week 2,n=1,1,0,1,2 | Phosphate,Week 4,n=2,1,1,2,2 | Phosphate,Week 8,n=2,1,1,2,1 | Potassium,Week 2,n=1,1,0,1,2 | Potassium,Week 4,n=2,1,1,2,2 | Potassium,Week 8,n=2,1,1,2,1 | Sodium,Week 2,n=1,1,0,1,2 | Sodium,Week 4,n=2,1,1,2,2 | Sodium,Week 8,n=2,1,1,2,1 | Urea,Week 2,n=1,1,0,1,2 | Urea,Week 4,n=2,1,1,2,2 | Urea,Week 8,n=2,1,1,2,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | 0.040 | 0.000 | 0.020 | -1.0 | -3.5 | -1.0 | 1.0 | 1.5 | 3.0 | 1.25 | -0.05 | 0.20 | 0.000 | -0.050 | -0.050 | 0.10 | 0.00 | 0.10 | 1.0 | 0.5 | 2.0 | 0.75 | 0.25 | 0.50 |
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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Millimoles per liter (Mean) |
---|
| Calcium,Week 4,n=2,1,1,2,2 | Calcium,Week 8,n=2,1,1,2,1 | Calcium,Week 12,n=2,1,1,1,0 | Carbon Dioxide,Week 4,n=2,1,1,2,2 | Carbon Dioxide,Week 8,n=2,1,1,2,1 | Carbon Dioxide,Week 12,n=2,1,1,1,0 | Chloride,Week 4,n=2,1,1,2,2 | Chloride,Week 8,n=2,1,1,2,1 | Chloride,Week 12,n=2,1,1,1,0 | Glucose,Week 4,n=2,1,1,2,2 | Glucose,Week 8,n=2,1,1,2,1 | Glucose,Week 12,n=2,1,1,1,0 | Phosphate,Week 4,n=2,1,1,2,2 | Phosphate,Week 8,n=2,1,1,2,1 | Phosphate,Week 12,n=2,1,1,1,0 | Potassium,Week 4,n=2,1,1,2,2 | Potassium,Week 8,n=2,1,1,2,1 | Potassium,Week 12,n=2,1,1,1,0 | Sodium,Week 4,n=2,1,1,2,2 | Sodium,Week 8,n=2,1,1,2,1 | Sodium,Week 12,n=2,1,1,1,0 | Urea,Week 4,n=2,1,1,2,2 | Urea,Week 8,n=2,1,1,2,1 | Urea,Week 12,n=2,1,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | -0.080 | 0.000 | 0.000 | 2.0 | 1.0 | 2.0 | 6.0 | 2.0 | -1.0 | -0.70 | 0.10 | 0.00 | 0.000 | 0.150 | 0.050 | 0.20 | 0.50 | 0.30 | 3.0 | 0.0 | -2.0 | 1.50 | 3.00 | 1.50 |
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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Millimoles per liter (Mean) |
---|
| Calcium,Week 2,n=1,1,0,1,2 | Calcium,Week 4,n=2,1,1,2,2 | Calcium,Week 8,n=2,1,1,2,1 | Calcium,Week 12,n=2,1,1,1,0 | Carbon Dioxide,Week 2,n=1,1,0,1,2 | Carbon Dioxide,Week 4,n=2,1,1,2,2 | Carbon Dioxide,Week 8,n=2,1,1,2,1 | Carbon Dioxide,Week 12,n=2,1,1,1,0 | Chloride,Week 2,n=1,1,0,1,2 | Chloride,Week 4,n=2,1,1,2,2 | Chloride,Week 8,n=2,1,1,2,1 | Chloride,Week 12,n=2,1,1,1,0 | Glucose,Week 2,n=1,1,0,1,2 | Glucose,Week 4,n=2,1,1,2,2 | Glucose,Week 8,n=2,1,1,2,1 | Glucose,Week 12,n=2,1,1,1,0 | Phosphate,Week 2,n=1,1,0,1,2 | Phosphate,Week 4,n=2,1,1,2,2 | Phosphate,Week 8,n=2,1,1,2,1 | Phosphate,Week 12,n=2,1,1,1,0 | Potassium,Week 2,n=1,1,0,1,2 | Potassium,Week 4,n=2,1,1,2,2 | Potassium,Week 8,n=2,1,1,2,1 | Potassium,Week 12,n=2,1,1,1,0 | Sodium,Week 2,n=1,1,0,1,2 | Sodium,Week 4,n=2,1,1,2,2 | Sodium,Week 8,n=2,1,1,2,1 | Sodium,Week 12,n=2,1,1,1,0 | Urea,Week 2,n=1,1,0,1,2 | Urea,Week 4,n=2,1,1,2,2 | Urea,Week 8,n=2,1,1,2,1 | Urea,Week 12,n=2,1,1,1,0 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | 0.000 | -0.100 | -0.140 | NA | -5.0 | -3.0 | -4.0 | NA | 2.0 | 1.0 | 0.0 | NA | 0.20 | 0.40 | 0.00 | 0.00 | -0.100 | -0.250 | -0.200 | NA | -0.20 | -0.20 | 0.00 | NA | -2.0 | -1.0 | -1.0 | NA | -2.50 | -1.00 | -2.00 | NA |
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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Millimoles per liter (Mean) |
---|
| Calcium,Week 2,n=1,1,0,1,2 | Calcium,Week 4,n=2,1,1,2,2 | Calcium,Week 8,n=2,1,1,2,1 | Calcium,Week 12,n=2,1,1,1,0 | Calcium,Week 14,n=0,0,0,1,0 | Calcium,Week 16,n=2,0,0,1,0 | Carbon Dioxide,Week 2,n=1,1,0,1,2 | Carbon Dioxide,Week 4,n=2,1,1,2,2 | Carbon Dioxide,Week 8,n=2,1,1,2,1 | Carbon Dioxide,Week 12,n=2,1,1,1,0 | Carbon Dioxide,Week 14,n=0,0,0,1,0 | Carbon Dioxide,Week 16,n=2,0,0,1,0 | Chloride,Week 2,n=1,1,0,1,2 | Chloride,Week 4,n=2,1,1,2,2 | Chloride,Week 8,n=2,1,1,2,1 | Chloride,Week 12,n=2,1,1,1,0 | Chloride,Week 14,n=0,0,0,1,0 | Chloride,Week 16,n=2,0,0,1,0 | Glucose,Week 2,n=1,1,0,1,2 | Glucose,Week 4,n=2,1,1,2,2 | Glucose,Week 8,n=2,1,1,2,1 | Glucose,Week 12,n=2,1,1,1,0 | Glucose,Week 14,n=0,0,0,1,0 | Glucose,Week 16,n=2,0,0,1,0 | Phosphate,Week 2,n=1,1,0,1,2 | Phosphate,Week 4,n=2,1,1,2,2 | Phosphate,Week 8,n=2,1,1,2,1 | Phosphate,Week 12,n=2,1,1,1,0 | Phosphate,Week 14,n=0,0,0,1,0 | Phosphate,Week 16,n=2,0,0,1,0 | Potassium,Week 2,n=1,1,0,1,2 | Potassium,Week 4,n=2,1,1,2,2 | Potassium,Week 8,n=2,1,1,2,1 | Potassium,Week 12,n=2,1,1,1,0 | Potassium,Week 14,n=0,0,0,1,0 | Potassium,Week 16,n=2,0,0,1,0 | Sodium,Week 2,n=1,1,0,1,2 | Sodium,Week 4,n=2,1,1,2,2 | Sodium,Week 8,n=2,1,1,2,1 | Sodium,Week 12,n=2,1,1,1,0 | Sodium,Week 14,n=0,0,0,1,0 | Sodium,Week 16,n=2,0,0,1,0 | Urea,Week 2,n=1,1,0,1,2 | Urea,Week 4,n=2,1,1,2,2 | Urea,Week 8,n=2,1,1,2,1 | Urea,Week 12,n=2,1,1,1,0 | Urea,Week 14,n=0,0,0,1,0 | Urea,Week 16,n=2,0,0,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | 0.100 | 0.050 | -0.020 | -0.040 | 0.000 | 0.140 | -2.0 | -1.5 | -1.0 | -3.0 | 1.0 | -1.0 | 0.0 | 0.5 | 1.0 | 1.0 | 1.0 | 0.0 | 1.30 | -0.05 | 0.30 | -0.10 | -0.10 | -0.20 | -0.300 | 0.050 | -0.075 | 0.200 | 0.250 | 0.300 | 0.00 | -0.30 | -0.30 | 0.10 | 0.00 | -0.10 | -2.0 | 0.5 | -0.5 | 2.0 | 2.0 | 0.0 | 0.50 | 1.50 | -0.25 | 0.00 | 1.00 | 1.50 |
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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Millimoles per liter (Mean) |
---|
| Calcium,Week 2,n=1,1,0,1,2 | Calcium,Week 4,n=2,1,1,2,2 | Calcium,Week 8,n=2,1,1,2,1 | Calcium,Week 12,n=2,1,1,1,0 | Calcium,Week 16,n=2,0,0,1,0 | Calcium,Week 24,n=2,0,0,0,0 | Calcium,Week 36,n=2,0,0,0,0 | Calcium,Week 38,n=1,0,0,0,0 | Calcium,Week 40,n=1,0,0,0,0 | Carbon Dioxide,Week 2,n=1,1,0,1,2 | Carbon Dioxide,Week 4,n=2,1,1,2,2 | Carbon Dioxide,Week 8,n=2,1,1,2,1 | Carbon Dioxide,Week 12,n=2,1,1,1,0 | Carbon Dioxide,Week 16,n=2,0,0,1,0 | Carbon Dioxide,Week 24,n=2,0,0,0,0 | Carbon Dioxide,Week 36,n=2,0,0,0,0 | Carbon Dioxide,Week 38,n=1,0,0,0,0 | Carbon Dioxide,Week 40,n=1,0,0,0,0 | Chloride,Week 2,n=1,1,0,1,2 | Chloride,Week 4,n=2,1,1,2,2 | Chloride,Week 8,n=2,1,1,2,1 | Chloride,Week 12,n=2,1,1,1,0 | Chloride,Week 16,n=2,0,0,1,0 | Chloride,Week 24,n=2,0,0,0,0 | Chloride,Week 36,n=2,0,0,0,0 | Chloride,Week 38,n=1,0,0,0,0 | Chloride,Week 40,n=1,0,0,0,0 | Glucose,Week 2,n=1,1,0,1,2 | Glucose,Week 4,n=2,1,1,2,2 | Glucose,Week 8,n=2,1,1,2,1 | Glucose,Week 12,n=2,1,1,1,0 | Glucose,Week 16,n=2,0,0,1,0 | Glucose,Week 24,n=2,0,0,0,0 | Glucose,Week 36,n=2,0,0,0,0 | Glucose,Week 38,n=1,0,0,0,0 | Glucose,Week 40,n=1,0,0,0,0 | Phosphate,Week 2,n=1,1,0,1,2 | Phosphate,Week 4,n=2,1,1,2,2 | Phosphate,Week 8,n=2,1,1,2,1 | Phosphate,Week 12,n=2,1,1,1,0 | Phosphate,Week 16,n=2,0,0,1,0 | Phosphate,Week 24,n=2,0,0,0,0 | Phosphate,Week 36,n=2,0,0,0,0 | Phosphate,Week 38,n=1,0,0,0,0 | Phosphate,Week 40,n=1,0,0,0,0 | Potassium,Week 2,n=1,1,0,1,2 | Potassium,Week 4,n=2,1,1,2,2 | Potassium,Week 8,n=2,1,1,2,1 | Potassium,Week 12,n=2,1,1,1,0 | Potassium,Week 16,n=2,0,0,1,0 | Potassium,Week 24,n=2,0,0,0,0 | Potassium,Week 36,n=2,0,0,0,0 | Potassium,Week 38,n=1,0,0,0,0 | Potassium,Week 40,n=1,0,0,0,0 | Sodium,Week 2,n=1,1,0,1,2 | Sodium,Week 4,n=2,1,1,2,2 | Sodium,Week 8,n=2,1,1,2,1 | Sodium,Week 12,n=2,1,1,1,0 | Sodium,Week 16,n=2,0,0,1,0 | Sodium,Week 24,n=2,0,0,0,0 | Sodium,Week 36,n=2,0,0,0,0 | Sodium,Week 38,n=1,0,0,0,0 | Sodium,Week 40,n=1,0,0,0,0 | Urea,Week 2,n=1,1,0,1,2 | Urea,Week 4,n=2,1,1,2,2 | Urea,Week 8,n=2,1,1,2,1 | Urea,Week 12,n=2,1,1,1,0 | Urea,Week 16,n=2,0,0,1,0 | Urea,Week 24,n=2,0,0,0,0 | Urea,Week 36,n=2,0,0,0,0 | Urea,Week 38,n=1,0,0,0,0 | Urea,Week 40,n=1,0,0,0,0 |
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PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.060 | 0.070 | 0.120 | 0.110 | 0.000 | 0.040 | -0.050 | -0.020 | -0.020 | 3.0 | 3.5 | 2.5 | 3.5 | 0.5 | 3.0 | 1.5 | 1.0 | -2.0 | -1.0 | -2.5 | -3.0 | -2.5 | -1.0 | -2.0 | 0.5 | -1.0 | 0.0 | 0.80 | 0.95 | 0.70 | 0.60 | 0.55 | 0.65 | 0.35 | 0.50 | 3.60 | 0.050 | -0.125 | 0.025 | -0.025 | -0.050 | 0.050 | -0.025 | 0.000 | 0.000 | 0.10 | 0.20 | 0.10 | 0.25 | 0.00 | 0.40 | 0.20 | 0.00 | -0.30 | 0.0 | -0.5 | -2.0 | -1.0 | -1.5 | -0.5 | 2.0 | -1.0 | 2.0 | -1.00 | 1.25 | 2.00 | -0.50 | 1.25 | 0.00 | 0.00 | 1.50 | 1.50 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Micromoles per liter (Mean) |
---|
| Bilirubin,Week 4,n=3,3,2,1,2 | Bilirubin,Week 8,n=2,1,2,0,2 | Bilirubin,Week 12,n=1,1,1,1,1 | Bilirubin,Week 16,n=0,1,1,1,0 | Bilirubin,Week 24,n=0,1,0,0,0 | Bilirubin,Week 36,n=0,1,0,0,0 | Direct Bilirubin,Week 4,n=3,3,2,1,2 | Direct Bilirubin,Week 8,n=2,1,2,0,2 | Direct Bilirubin,Week 12,n=1,1,1,1,1 | Direct Bilirubin,Week 16,n=0,1,1,1,0 | Direct Bilirubin,Week 24,n=0,1,0,0,0 | Direct Bilirubin,Week 36,n=0,1,0,0,0 | Indirect Bilirubin,Week 4,n=3,3,2,1,2 | Indirect Bilirubin,Week 8,n=2,1,2,0,2 | Indirect Bilirubin,Week 12,n=1,1,1,1,1 | Indirect Bilirubin,Week 16,n=0,1,1,1,0 | Indirect Bilirubin,Week 24,n=0,1,0,0,0 | Indirect Bilirubin,Week 36,n=0,1,0,0,0 | Creatinine,Week 4,n=3,3,2,1,2 | Creatinine,Week 8,n=2,1,2,0,2 | Creatinine,Week 12,n=1,1,1,1,1 | Creatinine,Week 16,n=0,1,1,1,0 | Creatinine,Week 24,n=0,1,0,0,0 | Creatinine,Week 36,n=0,1,0,0,0 |
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PartBSIR 100 mg SC q2w+3 Month Prednisone | 1.3 | 2.0 | -2.0 | -2.0 | -2.0 | -4.0 | 0.0 | 2.0 | 2.0 | 0.0 | 0.0 | 0.0 | 1.3 | 0.0 | -4.0 | -2.0 | -2.0 | -4.0 | -0.63 | -18.60 | -27.40 | -19.50 | -27.40 | -21.20 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Micromoles per liter (Mean) |
---|
| Bilirubin,Week 4,n=3,3,2,1,2 | Bilirubin,Week 8,n=2,1,2,0,2 | Bilirubin,Week 12,n=1,1,1,1,1 | Bilirubin,Week 16,n=0,1,1,1,0 | Direct Bilirubin,Week 4,n=3,3,2,1,2 | Direct Bilirubin,Week 8,n=2,1,2,0,2 | Direct Bilirubin,Week 12,n=1,1,1,1,1 | Direct Bilirubin,Week 16,n=0,1,1,1,0 | Indirect Bilirubin,Week 4,n=3,3,2,1,2 | Indirect Bilirubin,Week 8,n=2,1,2,0,2 | Indirect Bilirubin,Week 12,n=1,1,1,1,1 | Indirect Bilirubin,Week 16,n=0,1,1,1,0 | Creatinine,Week 4,n=3,3,2,1,2 | Creatinine,Week 8,n=2,1,2,0,2 | Creatinine,Week 12,n=1,1,1,1,1 | Creatinine,Week 16,n=0,1,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | -5.0 | -4.0 | 2.0 | -2.0 | 0.0 | 0.0 | 0.0 | 0.0 | -5.0 | -4.0 | 2.0 | -2.0 | -1.30 | -5.25 | 5.30 | 5.30 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Micromoles per liter (Mean) |
---|
| Bilirubin,Week 4,n=3,3,2,1,2 | Bilirubin,Week 8,n=2,1,2,0,2 | Bilirubin,Week 12,n=1,1,1,1,1 | Direct Bilirubin,Week 4,n=3,3,2,1,2 | Direct Bilirubin,Week 8,n=2,1,2,0,2 | Direct Bilirubin,Week 12,n=1,1,1,1,1 | Indirect Bilirubin,Week 4,n=3,3,2,1,2 | Indirect Bilirubin,Week 8,n=2,1,2,0,2 | Indirect Bilirubin,Week 12,n=1,1,1,1,1 | Creatinine,Week 4,n=3,3,2,1,2 | Creatinine,Week 8,n=2,1,2,0,2 | Creatinine,Week 12,n=1,1,1,1,1 |
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PartBPlacebo SC q2w + 12 Month Prednisone | -8.0 | -6.0 | -8.0 | -2.0 | -2.0 | -2.0 | -6.0 | -4.0 | -6.0 | 3.95 | -5.75 | -19.50 |
,PartBSIR 100 mg SC q2w+6 Month Prednisone | 0.7 | 3.0 | 4.0 | 0.0 | 1.0 | 2.0 | 0.7 | 2.0 | 2.0 | -7.07 | -8.40 | -6.20 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Micromoles per liter (Mean) |
---|
| Bilirubin,Week 4,n=3,3,2,1,2 | Bilirubin,Week 12,n=1,1,1,1,1 | Bilirubin,Week 16,n=0,1,1,1,0 | Direct Bilirubin,Week 4,n=3,3,2,1,2 | Direct Bilirubin,Week 12,n=1,1,1,1,1 | Direct Bilirubin,Week 16,n=0,1,1,1,0 | Indirect Bilirubin,Week 4,n=3,3,2,1,2 | Indirect Bilirubin,Week 12,n=1,1,1,1,1 | Indirect Bilirubin,Week 16,n=0,1,1,1,0 | Creatinine,Week 4,n=3,3,2,1,2 | Creatinine,Week 12,n=1,1,1,1,1 | Creatinine,Week 16,n=0,1,1,1,0 |
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PartBPlacebo SC q2w + 6 Month Prednisone | 0.0 | 4.0 | 4.0 | 0.0 | 0.0 | 0.0 | 0.0 | 4.0 | 4.0 | -0.90 | 9.70 | 5.30 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Grams per liter (Mean) |
---|
| Albumin,Week 4,n=3,3,2,1,2 | Albumin,Week 8,n=2,1,2,0,2 | Albumin,Week 12,n=1,1,1,1,1 | Albumin,Week 16,n=0,1,1,1,0 | Albumin,Week 24,n=0,1,0,0,0 | Albumin,Week 36,n=0,1,0,0,0 | Protein,Week 4,n=3,3,2,1,2 | Protein,Week 8,n=2,1,2,0,2 | Protein,Week 12,n=1,1,1,1,1 | Protein,Week 16,n=0,1,1,1,0 | Protein,Week 24,n=0,1,0,0,0 | Protein,Week 36,n=0,1,0,0,0 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | -1.3 | -2.0 | -1.0 | -2.0 | -1.0 | -2.0 | -2.7 | -2.0 | -2.0 | -2.0 | -1.0 | -2.0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Grams per liter (Mean) |
---|
| Albumin,Week 4,n=3,3,2,1,2 | Albumin,Week 12,n=1,1,1,1,1 | Albumin,Week 16,n=0,1,1,1,0 | Protein,Week 4,n=3,3,2,1,2 | Protein,Week 12,n=1,1,1,1,1 | Protein,Week 16,n=0,1,1,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | 0.0 | 3.0 | 0.0 | 0.0 | 1.0 | -1.0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Grams per liter (Mean) |
---|
| Albumin,Week 4,n=3,3,2,1,2 | Albumin,Week 8,n=2,1,2,0,2 | Albumin,Week 12,n=1,1,1,1,1 | Protein,Week 4,n=3,3,2,1,2 | Protein,Week 8,n=2,1,2,0,2 | Protein,Week 12,n=1,1,1,1,1 |
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PartB:Placebo SC q2w + 12 Month Prednisone | -2.5 | -1.5 | 0.0 | -5.0 | -1.5 | 2.0 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -0.3 | 1.5 | 3.0 | -0.3 | 1.5 | 3.0 |
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Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Intervention | Participants (Count of Participants) |
---|
| Week 2, n=38, 39,26,25,27 | Week 4, n=37,37,25,23,27 | Week 8, n=34,32,24,23,23 | Week 12, n=32,29,24,22,22 | Week 16, n=28,26,22,19,19 | Week 20, n=26,23,19,18,16 | Week 24, n=23,21,16,17,16 | Week 28, n=19,18,12,14,14 | Week 32, n=19,15,10,12,13 | Week 36, n=15,13,10,12,13 | Week 40, n=15,11,9,10,10 | Week 44, n=11,11,6,8,9 | Week 48, n=9,8,5,8,5 | Week 52, n=9,5,5,5,4 |
---|
PartA:Placebo SC q2w + 12 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Giga cells per liter (Mean) |
---|
| Eosinophils,Week 2,n=1,1,0,1,2 | Eosinophils,Week 4,n=2,1,1,2,2 | Eosinophils,Week 8,n=2,1,1,2,1 | Eosinophils,Week 12,n=2,0,1,1,0 | Eosinophils,Week 14,n=0,0,0,1,0 | Eosinophils,Week 16,n=2,0,0,1,0 | Leukocytes,Week 2,n=1,1,0,1,2 | Leukocytes,Week 4,n=2,1,1,2,2 | Leukocytes,Week 8,n=2,1,1,2,1 | Leukocytes,Week 12,n=2,0,1,1,0 | Leukocytes,Week 14,n=0,0,0,1,0 | Leukocytes,Week 16,n=2,0,0,1,0 | Lymphocytes,Week 2,n=1,1,0,1,2 | Lymphocytes,Week 4,n=2,1,1,2,2 | Lymphocytes,Week 8,n=2,1,1,2,1 | Lymphocytes,Week 12,n=2,0,1,1,0 | Lymphocytes,Week 14,n=0,0,0,1,0 | Lymphocytes,Week 16,n=2,0,0,1,0 | Neutrophils ,Week 2,n=1,1,0,1,2 | Neutrophils ,Week 4,n=2,1,1,2,2 | Neutrophils ,Week 8,n=2,1,1,2,2 | Neutrophils ,Week 12,n=2,0,1,1,0 | Neutrophils ,Week 14,n=0,0,0,1,0 | Neutrophils ,Week 16,n=2,0,0,1,0 | Platelets ,Week 2,n=1,1,0,1,2 | Platelets,Week 4,n=2,1,1,2,2 | Platelets,Week 8,n=2,1,1,2,1 | Platelets,Week 12,n=2,0,1,1,0 | Platelets,Week 14,n=0,0,0,1,0 | Platelets,Week 16,n=2,0,0,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | 0.000 | -0.030 | -0.120 | -0.160 | -0.290 | -0.270 | 2.60 | 0.60 | 0.10 | -0.60 | 0.40 | -0.30 | -0.400 | -0.035 | -0.185 | -0.190 | 0.490 | 0.540 | 3.010 | 0.740 | 0.485 | -0.320 | 0.590 | -0.050 | -27.0 | -33.5 | -20.5 | 12.0 | -31.0 | -97.0 |
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Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | trillion cells per liter (Mean) |
---|
| Week 2,n=38,39,24,24,25 | Week 4,n=36,37,24,22,27 | Week 8,n=34,29,23,22,21 | Week 12,n=31,28,23,22,22 | Week 16,n=27,26,21,19,19 | Week 20,n=25,23,18,18,16 | Week 24,n=22,21,16,16,16 | Week 28,n=18,18,12,14,13 | Week 32,n=19,15,10,12,13 | Week 36,n=15,12,10,12,12 | Week 40,n=14,11,8,10,10 | Week 44,n=11,10,6,7,9 | Week 48,n=9,8,4,8,5 | Week 52,n=8,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | -0.07 | -0.14 | -0.17 | -0.11 | -0.11 | -0.08 | -0.01 | -0.02 | 0.04 | 0.03 | -0.10 | -0.03 | 0.04 | -0.05 |
,PartA:Placebo SC q2w + 6 Month Prednisone | -0.10 | -0.09 | -0.16 | -0.20 | -0.19 | -0.20 | -0.11 | -0.18 | -0.22 | -0.21 | -0.22 | -0.10 | -0.20 | -0.18 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0.02 | -0.01 | -0.04 | 0.05 | -0.07 | -0.03 | -0.06 | -0.04 | -0.09 | -0.04 | -0.16 | -0.10 | -0.23 | -0.18 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0.01 | 0.01 | 0.04 | 0.03 | -0.09 | -0.13 | -0.09 | -0.14 | -0.13 | -0.08 | -0.16 | -0.18 | -0.14 | -0.16 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | -0.01 | -0.01 | -0.08 | -0.07 | -0.14 | -0.12 | -0.04 | -0.16 | -0.13 | -0.10 | -0.09 | -0.17 | -0.18 | -0.02 |
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Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | Picograms (Mean) |
---|
| Week 2,n=38,39,24,24,25 | Week 4,n=36,37,24,22,27 | Week 8,n=34,29,23,22,21 | Week 12,n=31,28,23,22,22 | Week 16,n=27,26,21,19,19 | Week 20,n=25,23,18,18,16 | Week 24,n=22,21,16,16,16 | Week 28,n=18,18,12,14,13 | Week 32,n=19,15,10,12,13 | Week 36,n=15,12,10,12,12 | Week 40,n=14,11,8,10,10 | Week 44,n=11,10,6,8,9 | Week 48,n=9,8,4,8,5 | Week 52,n=8,5,5,5,4 |
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PartA:Placebo SC q2w + 12 Month Prednisone | 0.22 | 0.36 | 0.49 | 0.47 | 0.22 | 0.39 | -0.08 | -0.20 | -0.14 | 0.15 | 0.44 | 0.77 | 1.32 | 0.80 |
,PartA:Placebo SC q2w + 6 Month Prednisone | 0.12 | 0.25 | 0.60 | 0.44 | 0.24 | 0.14 | -0.04 | 0.21 | 0.68 | 0.68 | 0.71 | 0.30 | 0.14 | 1.84 |
,PartA:SIR 100 mg SC q2w+3 Month Prednisone | 0.29 | 0.58 | 1.20 | 1.43 | 1.59 | 1.69 | 1.80 | 1.48 | 1.57 | 1.29 | 1.75 | 1.83 | 2.25 | 2.70 |
,PartA:SIR 100 mg SC q2w+6 Month Prednisone | 0.13 | 0.53 | 0.96 | 0.94 | 1.16 | 1.24 | 0.97 | 0.91 | 1.01 | 1.42 | 1.30 | 1.16 | 1.36 | 1.44 |
,PartA:SIR 50 mg SC q4w+6 Month Prednisone | 0.42 | 0.55 | 1.16 | 1.38 | 1.83 | 1.48 | 1.34 | 1.47 | 1.27 | 1.39 | 1.91 | 1.63 | 1.73 | 2.24 |
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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Femtoliter (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0.0 | 0.0 | -1.0 | 0.0 |
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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Femtoliter (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 | Week 24,n=0,1,0,0,0 | Week 36,n=0,1,0,0,0 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | 1.3 | 1.0 | 2.0 | 1.0 | 3.0 | 4.0 |
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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Femtoliter (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | 0.5 | 0.5 | 2.0 |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | 1.0 | 1.0 | -1.0 |
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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Femtoliter (Mean) |
---|
| Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,0,1,1,0 |
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PartB:SIR 50 mg SC q4w+6 Month Prednisone | 1.0 | 0.0 | 0.0 |
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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Femtoliter (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,0,1,1,0 | Week 14,n=0,0,0,1,0 | Week 16,n=2,0,0,1,0 |
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PartB:Placebo SC q2w + 6 Month Prednisone | 0.0 | -1.5 | -2.5 | -6.0 | -5.0 | -4.0 |
[back to top]
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Femtoliter (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,1 | Week 12,n=2,0,1,1,0 | Week 16,n=2,0,0,1,0 | Week 24,n=2,0,0,0,0 | Week 36,n=2,0,0,0,0 | Week 38,n=1,0,0,0,0 | Week 40,n=1,0,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | -2.0 | 1.5 | 1.5 | 2.5 | 0.5 | 1.5 | 2.5 | 0.0 | -2.0 |
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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Trillion cells per liter (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | 0.10 | 0.00 | -0.10 |
[back to top]
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Trillion cells per liter (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | -0.20 | -0.20 | -0.10 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -0.03 | -0.15 | -0.10 |
[back to top]
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Trillion cells per liter (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0.10 | 0.10 | 0.60 | 0.70 |
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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Trillion cells per liter (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 | Week 24,n=0,1,0,0,0 | Week 36,n=0,1,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | -0.10 | 0.00 | 0.10 | 0.10 | 0.00 | 0.10 |
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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Trillion cells per liter (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,2 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | 0.25 | 0.10 | 0.15 |
[back to top]
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Trillion cells per liter (Mean) |
---|
| Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,2 | Week 12,n=2,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | -0.30 | 0.00 | 0.00 |
[back to top]
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Trillion cells per liter (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,2 | Week 12,n=2,1,1,1,0 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | -0.10 | -0.10 | 0.00 | NA |
[back to top]
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Trillion cells per liter (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,2 | Week 12,n=2,1,1,1,0 | Week 14,n=0,0,0,1,0 | Week 16,n=2,0,0,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | 0.30 | 0.00 | 0.05 | -0.20 | 0.10 | -0.20 |
[back to top]
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Trillion cells per liter (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,2 | Week 12,n=2,1,1,1,0 | Week 16,n=2,0,0,1,0 | Week 24,n=2,0,0,0,0 | Week 36,n=2,0,0,0,0 | Week 38,n=1,0,0,0,0 | Week 40,n=1,0,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | 0.00 | 0.00 | 0.10 | 0.10 | 0.00 | 0.00 | -0.05 | 0.00 | 0.00 |
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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Picograms (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | -1.00 | 2.20 | 1.30 |
[back to top]
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Picograms (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | 0.00 | 1.10 | 1.80 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | -0.33 | -0.15 | -0.10 |
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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Picograms (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | -0.25 | 0.00 | 0.70 | -0.20 |
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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Picograms (Mean) |
---|
| Week 4,n=3,3,2,1,2 | Week 8,n=2,1,2,0,2 | Week 12,n=1,1,1,1,1 | Week 16,n=0,1,1,1,0 | Week 24,n=0,1,0,0,0 | Week 36,n=0,1,0,0,0 |
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PartB:SIR 100 mg SC q2w+3 Month Prednisone | -0.47 | -0.60 | -0.50 | -0.80 | -0.80 | -0.20 |
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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Picograms (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,2 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | 0.60 | 1.00 | 0.70 |
[back to top]
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Picograms (Mean) |
---|
| Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,2 | Week 12,n=2,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0.20 | 0.30 | 0.30 |
[back to top]
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Picograms (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,2 | Week 12,n=2,1,1,1,0 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | 0.20 | 0.60 | 1.30 | NA |
[back to top]
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Picograms (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,2 | Week 12,n=2,1,1,1,0 | Week 14,n=0,0,0,1,0 | Week 16,n=2,0,0,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | -0.20 | -0.05 | -0.45 | 0.00 | -0.90 | -0.10 |
[back to top]
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Picograms (Mean) |
---|
| Week 2,n=1,1,0,1,2 | Week 4,n=2,1,1,2,2 | Week 8,n=2,1,1,2,2 | Week 12,n=2,1,1,1,0 | Week 16,n=2,0,0,1,0 | Week 24,n=2,0,0,0,0 | Week 36,n=2,0,0,0,0 | Week 38,n=1,0,0,0,0 | Week 40,n=1,0,0,0,0 |
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PartB:SIR 100 mg SC q2w+6 Month Prednisone | -1.10 | 0.30 | 0.30 | 0.25 | 0.00 | 0.10 | 0.25 | -0.40 | 0.40 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | International units per liter (Mean) |
---|
| ALT,Week 4,n=2,1,1,2,2 | ALT,Week 8,n=2,1,1,2,2 | ALT,Week 12,n=2,0,1,1,0 | ALP,Week 4,n=2,1,1,2,2 | ALP,Week 8,n=2,1,1,2,2 | ALP,Week 12,n=2,0,1,1,0 | AST,Week 4,n=2,1,1,2,2 | AST,Week 8,n=2,1,1,2,2 | AST,Week 12,n=2,0,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | 0.0 | 1.0 | 4.0 | -4.0 | -3.0 | 2.0 | 0.0 | -3.0 | -1.0 |
[back to top]
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | International units per liter (Mean) |
---|
| ALT,Week 2,n=1,1,0,1,2 | ALT,Week 4,n=2,1,1,2,2 | ALT,Week 8,n=2,1,1,2,2 | ALP,Week 2,n=1,1,0,1,2 | ALP,Week 4,n=2,1,1,2,2 | ALP,Week 8,n=2,1,1,2,2 | AST,Week 2,n=1,1,0,1,2 | AST,Week 4,n=2,1,1,2,2 | AST,Week 8,n=2,1,1,2,2 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | 4.0 | 4.0 | 2.0 | -2.0 | -9.0 | -16.0 | 0.0 | 0.0 | -2.0 |
,PartB:Placebo SC q2w + 12 Month Prednisone | 72.5 | 51.5 | 31.5 | -5.0 | -7.0 | -12.0 | 44.5 | 23.0 | 14.0 |
[back to top]
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | International units per liter (Mean) |
---|
| ALT,Week 2,n=1,1,0,1,2 | ALT,Week 4,n=2,1,1,2,2 | ALT,Week 8,n=2,1,1,2,2 | ALT,Week 12,n=2,0,1,1,0 | ALT,Week 16,n=2,0,0,1,0 | ALT,Week 24,n=2,0,0,0,0 | ALT,Week 36,n=2,0,0,0,0 | ALT,Week 38,n=1,0,0,0,0 | ALT,Week 40,n=1,0,0,0,0 | ALP,Week 2,n=1,1,0,1,2 | ALP,Week 4,n=2,1,1,2,2 | ALP,Week 8,n=2,1,1,2,2 | ALP,Week 12,n=2,0,1,1,0 | ALP,Week 16,n=2,0,0,1,0 | ALP,Week 24,n=2,0,0,0,0 | ALP,Week 36,n=2,0,0,0,0 | ALP,Week 38,n=1,0,0,0,0 | ALP,Week 40,n=1,0,0,0,0 | AST,Week 2,n=1,1,0,1,2 | AST,Week 4,n=2,1,1,2,2 | AST,Week 8,n=2,1,1,2,2 | AST,Week 12,n=2,0,1,1,0 | AST,Week 16,n=2,0,0,1,0 | AST,Week 24,n=2,0,0,0,0 | AST,Week 36,n=2,0,0,0,0 | AST,Week 38,n=1,0,0,0,0 | AST,Week 40,n=1,0,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | 1.0 | -1.5 | 2.5 | -3.0 | -1.0 | -2.5 | -4.5 | -9.0 | -9.0 | 7.0 | 5.5 | 7.0 | 5.0 | -0.5 | 2.5 | 2.0 | 7.0 | 18.0 | 0.0 | -4.5 | 1.5 | -4.0 | -3.0 | -3.5 | -4.5 | -7.0 | -7.0 |
[back to top]
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | International units per liter (Mean) |
---|
| ALT,Week 2,n=1,1,0,1,2 | ALT,Week 4,n=2,1,1,2,2 | ALT,Week 8,n=2,1,1,2,2 | ALT,Week 12,n=2,0,1,1,0 | ALT,Week 14,n=0,0,0,1,0 | ALT,Week 16,n=2,0,0,1,0 | ALP,Week 2,n=1,1,0,1,2 | ALP,Week 4,n=2,1,1,2,2 | ALP,Week 8,n=2,1,1,2,2 | ALP,Week 12,n=2,0,1,1,0 | ALP,Week 14,n=0,0,0,1,0 | ALP,Week 16,n=2,0,0,1,0 | AST,Week 2,n=1,1,0,1,2 | AST,Week 4,n=2,1,1,2,2 | AST,Week 8,n=2,1,1,2,2 | AST,Week 12,n=2,0,1,1,0 | AST,Week 14,n=0,0,0,1,0 | AST,Week 16,n=2,0,0,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | 3.0 | 4.0 | 4.5 | -3.0 | 2.0 | 2.0 | -17.0 | -9.0 | -4.5 | 8.0 | -15.0 | -9.0 | 3.0 | -0.5 | 2.0 | -2.0 | 0.0 | 1.0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | International units per liter (Mean) |
---|
| ALT,Week 4,n=3,3,2,1,2 | ALT,Week 8,n=2,1,2,0,2 | ALT,Week 12,n=1,1,1,1,1 | ALP,Week 4,n=3,3,2,1,2 | ALP,Week 8,n=2,1,2,0,2 | ALP,Week 12,n=1,1,1,1,1 | AST,Week 4,n=3,3,2,1,2 | AST,Week 8,n=2,1,2,0,2 | AST,Week 12,n=1,1,1,1,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | 1.0 | -1.5 | 2.0 | 0.0 | -3.0 | -10.0 | -1.5 | 0.0 | 2.0 |
,PartB:SIR 100 mg SC q2w+6 Month Prednisone | 2.3 | 9.0 | 3.0 | -0.7 | 1.5 | -1.0 | 0.7 | 10.5 | 1.0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | International units per liter (Mean) |
---|
| ALT,Week 4,n=3,3,2,1,2 | ALT,Week 12,n=1,1,1,1,1 | ALT,Week 16,n=0,1,1,1,0 | ALP,Week 4,n=3,3,2,1,2 | ALP,Week 12,n=1,1,1,1,1 | ALP,Week 16,n=0,1,1,1,0 | AST,Week 4,n=3,3,2,1,2 | AST,Week 12,n=1,1,1,1,1 | AST,Week 16,n=0,1,1,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | 103.0 | 0.0 | 1.0 | 81.0 | -11.0 | -10.0 | 24.0 | 0.0 | 2.0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | International units per liter (Mean) |
---|
| ALT,Week 4,n=3,3,2,1,2 | ALT,Week 8,n=2,1,2,0,2 | ALT,Week 12,n=1,1,1,1,1 | ALT,Week 16,n=0,1,1,1,0 | ALT,Week 24,n=0,1,0,0,0 | ALT,Week 36,n=0,1,0,0,0 | ALP,Week 4,n=3,3,2,1,2 | ALP,Week 8,n=2,1,2,0,2 | ALP,Week 12,n=1,1,1,1,1 | ALP,Week 16,n=0,1,1,1,0 | ALP,Week 24,n=0,1,0,0,0 | ALP,Week 36,n=0,1,0,0,0 | AST,Week 4,n=3,3,2,1,2 | AST,Week 8,n=2,1,2,0,2 | AST,Week 12,n=1,1,1,1,1 | AST,Week 16,n=0,1,1,1,0 | AST,Week 24,n=0,1,0,0,0 | AST,Week 36,n=0,1,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+3 Month Prednisone | 2.7 | 13.0 | 8.0 | -5.0 | 0.0 | -4.0 | 0.0 | -1.0 | 0.0 | 4.0 | 2.0 | 4.0 | 2.0 | 7.0 | -1.0 | -4.0 | -1.0 | -3.0 |
[back to top]
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | International units per liter (Mean) |
---|
| ALT,Week 4,n=3,3,2,1,2 | ALT,Week 8,n=2,1,2,0,2 | ALT,Week 12,n=1,1,1,1,1 | ALT,Week 16,n=0,1,1,1,0 | ALP,Week 4,n=3,3,2,1,2 | ALP,Week 8,n=2,1,2,0,2 | ALP,Week 12,n=1,1,1,1,1 | ALP,Week 16,n=0,1,1,1,0 | AST,Week 4,n=3,3,2,1,2 | AST,Week 8,n=2,1,2,0,2 | AST,Week 12,n=1,1,1,1,1 | AST,Week 16,n=0,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | -8.0 | -9.5 | -4.0 | -6.0 | 0.5 | -1.0 | 17.0 | 3.0 | -5.0 | -6.0 | 2.0 | 0.0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Grams per liter (Mean) |
---|
| Albumin,Week 4,n=2,1,1,2,2 | Albumin,Week 8,n=2,1,1,2,1 | Albumin,Week 12,n=2,0,1,1,0 | Protein,Week 4,n=2,1,1,2,2 | Protein,Week 8,n=2,1,1,2,1 | Protein,Week 12,n=2,0,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | -1.0 | 0.0 | 1.0 | -2.0 | 2.0 | 2.0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Grams per liter (Mean) |
---|
| Albumin,Week 2,n=1,1,0,1,2 | Albumin,Week 4,n=2,1,1,2,2 | Albumin,Week 8,n=2,1,1,2,1 | Protein,Week 2,n=1,1,0,1,2 | Protein,Week 4,n=2,1,1,2,2 | Protein,Week 8,n=2,1,1,2,1 |
---|
PartB:Placebo SC q2w + 12 Month Prednisone | 3.5 | 3.0 | 2.0 | 1.5 | -0.5 | 0.0 |
,PartB:SIR 100 mg SC q2w+3 Month Prednisone | -1.0 | 0.0 | 0.0 | -1.0 | 0.0 | 0.0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Grams per liter (Mean) |
---|
| Albumin,Week 2,n=1,1,0,1,2 | Albumin,Week 4,n=2,1,1,2,2 | Albumin,Week 8,n=2,1,1,2,1 | Albumin,Week 12,n=2,0,1,1,0 | Albumin,Week 16,n=2,0,0,1,0 | Albumin,Week 24,n=2,0,0,0,0 | Albumin,Week 36,n=2,0,0,0,0 | Albumin,Week 38,n=1,0,0,0,0 | Albumin,Week 40,n=1,0,0,0,0 | Protein,Week 2,n=1,1,0,1,2 | Protein,Week 4,n=2,1,1,2,2 | Protein,Week 8,n=2,1,1,2,1 | Protein,Week 12,n=2,0,1,1,0 | Protein,Week 16,n=2,0,0,1,0 | Protein,Week 24,n=2,0,0,0,0 | Protein,Week 36,n=2,0,0,0,0 | Protein,Week 38,n=1,0,0,0,0 | Protein,Week 40,n=1,0,0,0,0 |
---|
PartB:SIR 100 mg SC q2w+6 Month Prednisone | -1.0 | 0.0 | 1.0 | 1.0 | -0.5 | -0.5 | -1.0 | -2.0 | -2.0 | 0.0 | 1.0 | 3.0 | 2.5 | 1.0 | 0.5 | 1.5 | 1.0 | 0.0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Intervention | Grams per liter (Mean) |
---|
| Albumin,Week 2,n=1,1,0,1,2 | Albumin,Week 4,n=2,1,1,2,2 | Albumin,Week 8,n=2,1,1,2,1 | Albumin,Week 12,n=2,0,1,1,0 | Albumin,Week 14,n=0,0,0,1,0 | Albumin,Week 16,n=2,0,0,1,0 | Protein,Week 2,n=1,1,0,1,2 | Protein,Week 4,n=2,1,1,2,2 | Protein,Week 8,n=2,1,1,2,1 | Protein,Week 12,n=2,0,1,1,0 | Protein,Week 14,n=0,0,0,1,0 | Protein,Week 16,n=2,0,0,1,0 |
---|
PartB:Placebo SC q2w + 6 Month Prednisone | 5.0 | 0.0 | -2.0 | -4.0 | 0.0 | 2.0 | 8.0 | -0.5 | -2.5 | -4.0 | -5.0 | -2.0 |
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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Intervention | Grams per liter (Mean) |
---|
| Albumin,Week 4,n=3,3,2,1,2 | Albumin,Week 8,n=2,1,2,0,2 | Albumin,Week 12,n=1,1,1,1,1 | Albumin,Week 16,n=0,1,1,1,0 | Protein,Week 4,n=3,3,2,1,2 | Protein,Week 8,n=2,1,2,0,2 | Protein,Week 12,n=1,1,1,1,1 | Protein,Week 16,n=0,1,1,1,0 |
---|
PartB:SIR 50 mg SC q4w+6 Month Prednisone | 1.0 | 1.0 | 5.0 | 5.0 | 1.0 | 2.5 | 9.0 | 12.0 |
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Number of Participants With a Grade 3 or Higher Toxicity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
The Primary Outcome measures toxicity, with particular attention to Events of Clinical Interest when adding MK-3475 to standard RCHOP therapy. The sample size of 30 patients will permit the estimation of a 40% incidence of grade 3-5 clinically relevant toxicity. (NCT02541565)
Timeframe: Up to 90 days after completion of study treatment
Intervention | Participants (Count of Participants) |
---|
Treatment (Pembrolizumab, Combination Chemotherapy) | 13 |
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Terminal Plasma Half-Life (t1/2) of Obinutuzumab
(NCT02550652)
Timeframe: Day 0, Week 24, Week 52
Intervention | day (Mean) |
---|
| Day 0 | Week 24 | Week 52 |
---|
OBINUTUZUMAB 1000MG and MMF | 13.1 | 20.5 | 22.1 |
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Volume of Distribution Under Steady State (Vss) of Obinutuzumab
(NCT02550652)
Timeframe: Day 0, Week 24, Week 52
Intervention | L (Mean) |
---|
| Day 0 | Week 24 | Week 52 |
---|
OBINUTUZUMAB 1000MG and MMF | 3.67 | 3.67 | 3.67 |
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Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52
Anti-dsDNA antibodies are a group of anti-nuclear antibodies targeting double stranded DNA. (NCT02550652)
Timeframe: Baseline and Week 52
Intervention | log IU/mL (Mean) |
---|
OBINUTUZUMAB 1000MG and MMF | -0.810 |
PLACEBO and MMF | -0.080 |
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Change From Baseline in C4 Levels at Week 52
Complement C4 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases. (NCT02550652)
Timeframe: Baseline, Week 52
Intervention | g/L (Mean) |
---|
OBINUTUZUMAB 1000MG and MMF | 0.101 |
PLACEBO and MMF | 0.003 |
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Change From Baseline in Complement Component 3 (C3) Levels at Week 52
Complement C3 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases. (NCT02550652)
Timeframe: Baseline and Week 52
Intervention | g/L (Mean) |
---|
OBINUTUZUMAB 1000MG and MMF | 0.311 |
PLACEBO and MMF | 0.108 |
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Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52
Percentage of participants with normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. (NCT02550652)
Timeframe: From baseline to Week 52
Intervention | percentage of participants (Number) |
---|
OBINUTUZUMAB 1000MG and MMF | 34.9 |
PLACEBO and MMF | 22.6 |
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Percentage of Participants Who Achieve Protocol Defined CRR at Week 24
CRR defined as normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. (NCT02550652)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
OBINUTUZUMAB 1000MG and MMF | 23.8 |
PLACEBO and MMF | 24.2 |
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Percentage of Participants Who Achieve Protocol Defined Modified CRR (mCRR1) at Week 52
mCRR1 has got two components only, i.e. serum Creatinine and urinary protein to creatinine ratio. mCRR1 is defined by attainment of normalization of serum creatinine as evidenced by 1.) serum creatinine ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine ≤ the ULN range of central laboratory values and 2.) Urinary protein to creatinine ratio <0.5. (NCT02550652)
Timeframe: Week 52
Intervention | percentage of participants (Number) |
---|
OBINUTUZUMAB 1000MG and MMF | 39.7 |
PLACEBO and MMF | 25.8 |
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Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52
OR includes both CRR and partial renal response (PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then urine protein:creatinine ratio of <1.0. 2. If baseline protein:creatinine ratio is > 3.0, then urine protein:creatinine ratio of <3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or <10 RBCs/HPF. (NCT02550652)
Timeframe: From baseline to Week 52
Intervention | percentage of participants (Number) |
---|
OBINUTUZUMAB 1000MG and MMF | 55.6 |
PLACEBO and MMF | 35.5 |
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Percentage of Participants Who Achieve Protocol Defined Partial Renal Response (PRR) at Week 52
PRR defined as serum creatinine ≤15% above baseline value, no urinary red cell casts and either RBCs/HPF ≤ 50% above baseline or < 10 RBCs/HPF, 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then a urine protein:creatinine ratio of < 1.0. 2. If baseline protein:creatinine ratio is > 3.0, then a urine protein:creatinine ratio of < 3.0. (NCT02550652)
Timeframe: From baseline to Week 52
Intervention | percentage of participants (Number) |
---|
OBINUTUZUMAB 1000MG and MMF | 55.6 |
PLACEBO and MMF | 33.9 |
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Percentage of Participants Who Achieve Protocol Defined Second mCRR (mCRR2) at Week 52
mCRR2 is defined by normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts), and urinary protein to creatinine ratio <0.5. Normalization of serum creatinine as evidenced by the following: Serum creatinine ≤15% above baseline if baseline (Day 1) serum creatinine is above the normal range of the central laboratory values or ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. (NCT02550652)
Timeframe: Week 52
Intervention | percentage of participants (Number) |
---|
OBINUTUZUMAB 1000MG and MMF | 44.4 |
PLACEBO and MMF | 33.9 |
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Percentage of Participants Who Achieve Protocol Defined Third mCRR (mCRR3) at Week 52
mCRR3 is defined by normalization of serum creatine as evidenced by serum creatinine ≤ the ULN range of central laboratory values and urinary protein to creatinine ratio < 0.5. (NCT02550652)
Timeframe: Week 52
Intervention | percentage of participants (Number) |
---|
OBINUTUZUMAB 1000MG and MMF | 46.0 |
PLACEBO and MMF | 38.7 |
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Percentage of Participants With Anti-Drug Antibody (ADA) to Obinutuzumab
Antibodies are a blood protein produced in response to and counteracting a specific antigen. (NCT02550652)
Timeframe: From baseline up to Week 104
Intervention | percentage of participants (Number) |
---|
OBINUTUZUMAB 1000MG and MMF | 9.38 |
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Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab
(NCT02550652)
Timeframe: Week 0, Week 24, Week 52
Intervention | ug/mL*day (Mean) |
---|
| Week 0-24 | Week 24-52 | Week 0-52 |
---|
OBINUTUZUMAB 1000MG and MMF | 10595 | 15811 | 26406 |
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Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score
Each VAS had a range from 0-100 with higher scores indicating greater symptom impact on global health status. (NCT02550652)
Timeframe: Baseline (Day 1), Weeks 4, 12, 24, 36, 52
Intervention | score on scale (Mean) |
---|
| Baseline | Week 4 | Week 12 | Week 24 | Week 36 | Week 52 |
---|
OBINUTUZUMAB 1000MG and MMF | 41.3 | -14.4 | -19.9 | -25.0 | -24.8 | -25.4 |
,PLACEBO and MMF | 39.4 | -8.7 | -11.6 | -20.8 | -19.6 | -23.3 |
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Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab
(NCT02550652)
Timeframe: Week 0, Week 24, Week 52
Intervention | ug/mL (Mean) |
---|
| Week 0-24 | Week 24-52 | Week 0-52 |
---|
OBINUTUZUMAB 1000MG and MMF | 559 | 605 | 605 |
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Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels
CD19+ B cell is a B-lymphocyte with a transmembrane protein that is encoded by the gene CD19. (NCT02550652)
Timeframe: Baseline, Week 2, Week 4, Week 12, Week 24, Week 52
Intervention | Percent change of cells/uL (Mean) |
---|
| Week 2 | Week 4 | Week 12 | Week 24 | Week 52 |
---|
OBINUTUZUMAB 1000MG and MMF | -97.469 | -98.777 | -97.045 | -96.628 | -98.620 |
,PLACEBO and MMF | 39.293 | -5.186 | 0.661 | -11.446 | 37.695 |
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Percentage of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs), Infections and Serious infections. (NCT02550652)
Timeframe: From Baseline up to Week 104
Intervention | percentage of participants (Number) |
---|
| Adverse Events | Grade 3 AEs | Grade 4 AEs | Grade 5 AEs | Serious Adverse Events | Infections | Serious infections |
---|
OBINUTUZUMAB 1000MG and MMF | 90.6 | 29.7 | 10.9 | 1.6 | 25.0 | 75.0 | 7.8 |
,PLACEBO and MMF | 88.5 | 24.6 | 13.1 | 6.6 | 29.5 | 62.3 | 18.0 |
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Percentage of Participants With First Protocol Defined CRR Over the Course of 52 Weeks
CRR included normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the ULN range of central laboratory values if baseline serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. Percentage of participants with response at various time points were measured using Kaplan Meier method. (NCT02550652)
Timeframe: From Baseline to Week 52
Intervention | percentage of participants (Number) |
---|
| Week 12 | Week 24 | Week 36 | Week 52 |
---|
OBINUTUZUMAB 1000MG and MMF | 10 | 26 | 36 | 50 |
,PLACEBO and MMF | 10 | 28 | 35 | 40 |
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Percentage of Participants With First Protocol Defined Overall Response Over the Course of 52 Weeks
OR includes both CRR and partial renal response(PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in upcr, with one of these conditions met: 1. If baseline upcr is ≤3.0, then upcr of <1.0. 2. If baseline pcr is > 3.0, then upcr of <3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or <10 RBCs/HPF. Percentage of participants with response at various time points were measured using Kaplan Meier method. (NCT02550652)
Timeframe: From baseline to Week 52
Intervention | percentage of participants (Number) |
---|
| Week 12 | Week 24 | Week 36 | Week 52 |
---|
OBINUTUZUMAB 1000MG and MMF | 26 | 57 | 63 | 75 |
,PLACEBO and MMF | 19 | 41 | 51 | 58 |
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Systemic Clearance of Obinutuzumab
(NCT02550652)
Timeframe: Day 0, Week 24, Week 52
Intervention | L/day (Mean) |
---|
| Day 0 | Week 24 | Week 52 |
---|
OBINUTUZUMAB 1000MG and MMF | 0.255 | 0.147 | 0.137 |
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Number of Participants With Adverse Events Graded According to CTC (Phase II)
"The toxicity profile will be further assessed based on phase II patients. Overall toxicity incidence of maximum tolerated dose level of the Intent to treat (ITT) group of subjects is summarized.~39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group." (NCT02561273)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
| grade 3,4 neutropenia | grade 3, 4 leukopenia | grade 3, 4 anemia | grade 3, 4 thrombocytopenia | grade 3, 4 lymphopenia | grade 3, 4 febrile neutropenia | grade 3, 4 diarrhea | grade 3, 4 Peripheral sensory neuropathy | grade 3, 4 fatigue | grade 3, 4 nausea | grade 3, 4 anorexia | grade 3, 4 vomiting | grade 3, 4 mucositis oral | grade 3, 4 Rash maculo-papular | grade 3, 4 hypotension | grade 3, 4 back pain |
---|
Treatment (Combination Chemotherapy, Lenalidomide) | 27 | 25 | 17 | 17 | 18 | 15 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
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Complete Response Rate (Phase II)
A success is defined to be an objective status of CR after completion of 6 cycles of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A 95% confidence interval for the true overall CR rate will be calculated according to the method of Duffy and Santner. (NCT02561273)
Timeframe: Up to the completion of course 6 (18 weeks)
Intervention | percentage of participants (Number) |
---|
Treatment (Combination Chemotherapy, Lenalidomide) | 49 |
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Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I) within the first cycle of study treatment. (NCT02561273)
Timeframe: 21 days
Intervention | milligrams (Number) |
---|
Treatment (Combination Chemotherapy, Lenalidomide) | 10 |
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Overall Response Rate
The ORR will be estimated by the total number of patients who achieve a PR or CR at the end of six cycles of treatment divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true ORR will be calculated. (NCT02561273)
Timeframe: Up to the completion of course 6 (18 weeks)
Intervention | percentage of participants (Number) |
---|
Treatment (Combination Chemotherapy, Lenalidomide) | 69 |
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Overall Survival
The distribution of overall survival will be estimated using the method of Kaplan-Meier. (NCT02561273)
Timeframe: Time from registration to death due to any cause, assessed up to 1 year
Intervention | percentage of participants (Number) |
---|
Treatment (Combination Chemotherapy, Lenalidomide) | 89 |
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Progression-free Survival
The distribution of PFS will be estimated using the method of Kaplan-Meier. The PFS rate at 2 years will be estimated. A 2-year PFS rate of 60% will be considered of interest. (NCT02561273)
Timeframe: Time from registration to progression or death due to any cause, assessed up to 2 years
Intervention | percentage of participants (Number) |
---|
Treatment (Combination Chemotherapy, Lenalidomide) | 55 |
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Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I)
Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized. (NCT02561273)
Timeframe: Up to 6 cycles of treatment (approximately 5 months)
Intervention | Participants (Count of Participants) |
---|
| grade 3,4 neutropenia | grade 3, 4 anemia | grade 3, 4 thrombocytopenia | grade 3,4 neutropenia fever | grade 3, 4 diarrhea | grade 3, 4 hyperglycemia | grade 3, 4 hypokalemia | grade 3, 4 hypotension | grade 3, 4 hyperbilirubinemia | grade 3, 4 mucositis | grade 3,4 nausea | grade 3,4 vomiting |
---|
10 mg Lenalidomide Participants | 5 | 3 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,15 mg Lenalidomide Participants | 4 | 3 | 3 | 0 | 2 | 2 | 1 | 1 | 1 | 2 | 2 | 1 |
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Change in Lund-Kennedy Endoscopic Scores
"Characteristics of each sinonasal cavity are assessed endoscopically to provide a score based on polyp disease, mucosal edema/crusting/scarring and nasal secretions. A score is provided for the left and right. The scores are totaled to provide a number between 0 and 20.~Polyps: 0 = absence of polyp; 1 = polyps in middle meatus only; 2 = polyps beyond middle meatus Edema: 0 = absent; 1 = mild; 2 = severe Discharge: 0 = no discharge; 1 = clear, thin discharge; 2 = thick, purulent discharge Scarring: 0 = absent; 1 = mild; 2 = severe Crusting: 0 = absent; 1 = mild; 2 = severe~This scoring system has since been the instrument of choice to endoscopically evaluate outcomes of interventions in non-neoplastic sinonasal disease prospectively over time in research and clinical practice. The higher the score, the worse the outcome. Endoscopy scores from the 3 study groups are compared for the average unit change between baseline and day 119." (NCT02562924)
Timeframe: 119 days
Intervention | score on a scale (Mean) |
---|
Budesonide Rinse Group | -8.0 |
MEDIHONEY® Rinse Alone Group | -1.5 |
MEDIHONEY® and Budesonide Rinse Group | -6.9 |
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Change in SNOT-22 Nasal Symptom Scores
"The SNOT-22 consists of 22 questions; items 1 to 12 represent the physical problems associated with rhinosinusitis, items 13 to 18 represent the functional limitations, and items 20 to 22 represent the emotional consequences. Each question is scored by the patient from 0 (no problem) to 5 (the problem is as bad as it can be).~The first seven questions relate to nasal symptoms. The nasal symptoms score is calculated by summing the scores for these first seven questions. The range is 0 to 35. Higher scores reflect more severe quality of life impairment as subjectively reported by the patient. The nasal symptom scores from the 3 study groups are compared for the average change in score from baseline to day 119." (NCT02562924)
Timeframe: 119 days
Intervention | score on a scale (Mean) |
---|
Budesonide Rinse Group | -10.0 |
MEDIHONEY® Rinse Alone Group | -5.3 |
MEDIHONEY® and Budesonide Rinse Group | -11.7 |
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Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score
The SNOT-22 consists of 22 questions; items 1 to 12 represent the physical problems associated with rhinosinusitis, items 13 to 18 represent the functional limitations, and items 20 to 22 represent the emotional consequences. Each question is scored by the patient from 0 (no problem) to 5 (the problem is as bad as it can be). The overall score can theoretically range from 0 to 110, with higher scores reflecting more severe quality of life impairment as subjectively reported by the patient. Overall SNOT-22 scores from the 3 study groups are compared for the average change in score from baseline to day 119. (NCT02562924)
Timeframe: 119 days
Intervention | score on a scale (Mean) |
---|
Budesonide Rinse Group | -22.8 |
MEDIHONEY® Rinse Alone Group | -15.3 |
MEDIHONEY® and Budesonide Rinse Group | -25.6 |
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Treatment Success
Treatment success was defined as the percentage of participants with stable low disease activity (LDA) (DAS28-ESR score ≤ 3.2) at Week 24 post-randomization, who did not suffer a flare due to RA and who showed no confirmed adrenal insufficiency that required replacement therapy. DAS28 has the following standardized cut-offs for disease activity and remission: DAS28 > 5.1 = high disease activity; DAS28 between 3.2 and 5.1 = moderate disease activity; DAS28 ≤ 3.2 = low disease activity; DAS28 ≤ 2.6 = remission. (NCT02573012)
Timeframe: Week 24
Intervention | Percentage of Participants (Number) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 64.9 |
Tocilizumab+Prednisone (Constant Dose) | 77.3 |
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Changes From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Score
The WPAI:SHP is a 6-item questionnaire to measure performance impairment of work and regular daily activity and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score range from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicate greater impairment and less productivity. A positive change in score indicates impairment, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline and Week 24
Intervention | Score on a scale (Mean) |
---|
| Percent work time missed due to problem | Percent impairment while working due to problem | Percent overall work impairment due to problem | Percent activity impairment due to problem |
---|
Tocilizumab+Prednisone (Constant Dose) | 0.572 | -5.584 | -6.191 | -4.190 |
,Tocilizumab+Prednisone (Tapering Dose) | 4.535 | -0.851 | 6.219 | 3.398 |
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Cumulative Prednisone Exposure (Dose)
"In Post-randomization prednisone arm, Cumulative dose = (number of capsules taken during week 1 to 4 * 1 mg) + (3/4 * number of capsules taken during week 5 to 8 * 1 mg) + (1/2 * number of capsules taken during week 9 to 12 * 1 mg) + (1/4 * number of capsules taken during week 13 to 16 * 1 mg). In continued arm, cumulative dose = (1/4 * number of capsule taken * 5 mg).~Cumulative prednisone dose is defined as cumulative blinded prednisone + cumulative flare rescue prednisone." (NCT02573012)
Timeframe: Randomization to 24 weeks
Intervention | mg (Mean) |
---|
| Cumulative blinded prednisone dose | Cumulative flare rescue prednisone dose | Cumulative prednisone dose |
---|
Tocilizumab+Prednisone (Constant Dose) | 769.459 | 121.875 | 777.136 |
,Tocilizumab+Prednisone (Tapering Dose) | 267.099 | 98.519 | 287.405 |
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Number of Administrations of Flare Rescue Medication
Proportion of participants who received courses of RA flare rescue medication by number of courses received. (NCT02573012)
Timeframe: Randomization to 24 weeks
Intervention | Percentage of Participants (Number) |
---|
| 0 courses | 1 course | 2 courses | 3 courses | >3 courses |
---|
Tocilizumab+Prednisone (Constant Dose) | 93.8 | 3.9 | 1.6 | 0.8 | 0 |
,Tocilizumab+Prednisone (Tapering Dose) | 79.4 | 15.3 | 4.6 | 0 | 0.8 |
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Percentage of Participants Who Maintain LDA (DAS28 ESR Score <=3.2) or Remission (DAS28 ESR Score <2.6) and the Percentage of Participants Who Maintain the Baseline Disease Activity Level
"The proportion of participants who maintained LDA and the proportion of participants who maintained the baseline disease activity level at Week 24.~LDA was defined as DAS28 ESR score <= 3.2. Remission was defined as DAS28 ESR score <= 2.6. Participants who maintained the baseline activity was defined as DAS28-ESR at Week 24 <= DAS28-ESR at baseline." (NCT02573012)
Timeframe: Randomization to Week 24
Intervention | Percentage of Participants (Number) |
---|
| LDA at baseline | LDA at Week 24 | Baseline DAS28-ESR ≤ 2.6 | Remission at Week 24 | Maintained baseline activity at Week 24 |
---|
Tocilizumab+Prednisone (Constant Dose) | 96.9 | 83.1 | 76.6 | 81.6 | 54.7 |
,Tocilizumab+Prednisone (Tapering Dose) | 97.7 | 73.4 | 78.6 | 61.2 | 36.6 |
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Time to First RA Flare
The mean time of onset for the first RA flare since randomization. (NCT02573012)
Timeframe: Randomization to 24 weeks
Intervention | Weeks (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 15.64 |
Tocilizumab+Prednisone (Constant Dose) | 12.11 |
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Percentage of Participants With >=1 Flare
Percentage of participants with >=1 flare (NCT02573012)
Timeframe: 24 weeks
Intervention | Percentage of Participants (Number) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 26.0 |
Tocilizumab+Prednisone (Constant Dose) | 10.9 |
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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Tender 68 Joint Counts
Count of tender joints based on 68 assessed joints. (NCT02573012)
Timeframe: Baseline to Week 24
Intervention | Tender joints (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 0.793 |
Tocilizumab+Prednisone (Constant Dose) | -0.330 |
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Changes From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Final Score
The RAID is a participant-completed questionnaire specific for RA consisting of a 0-10 rating for pain, functional disability, fatigue, sleep, physical well-being, emotional well-being and coping. Scores are weighted to produce a final numerical result. A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline and Week 24
Intervention | Score on a scale (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 0.469 |
Tocilizumab+Prednisone (Constant Dose) | -0.220 |
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Percentage of Participants Who Permanently Discontinue Study Treatment Due to Insufficient Flare Control
Percentage of participants who permanently discontinue study treatment due to insufficient flare control (NCT02573012)
Timeframe: 24 weeks
Intervention | Percentage of Participants (Number) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 0 |
Tocilizumab+Prednisone (Constant Dose) | 0.8 |
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Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index is calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter (cm) visual analog scale (VAS) + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 100 mm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores range from 0 to 76, with higher scores indicating increased disease activity. A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline and Week 24
Intervention | Score on a scale (Least Squares Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 2.663 |
Tocilizumab+Prednisone (Constant Dose) | 0.321 |
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Time to First Administration of Flare Rescue Medication
Time of onset of first administration of RA flare rescue medication since randomization date (NCT02573012)
Timeframe: Randomization to 24 weeks
Intervention | Weeks (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 13.59 |
Tocilizumab+Prednisone (Constant Dose) | 8.76 |
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Change From Baseline in Disease Activity Score in 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24 Post-randomization
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint count, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100-millimeter (mm) visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline to Week 24
Intervention | Score on a scale (Least Squares Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 0.538 |
Tocilizumab+Prednisone (Constant Dose) | -0.075 |
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Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 24
The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count based on a 28-joint assessment, patient and physician global assessment of disease activity according to 100-mm visual analog scale (VAS) and level of C-reactive protein in milligrams per deciliter (mg/dL, normal <1 mg/dl). The total SDAI score range is 0-86, where higher scores indicate increased disease activity. A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Randomization to Week 24
Intervention | Score on a scale (Least Squares Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 2.511 |
Tocilizumab+Prednisone (Constant Dose) | 0.248 |
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Percentage of Participants With >=1 Administration of Flare Rescue Medication
The proportion of participants with at least one administration of RA flare rescue medication. (NCT02573012)
Timeframe: Randomization to 24 weeks
Intervention | Percentage of Participants (Number) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 20.6 |
Tocilizumab+Prednisone (Constant Dose) | 6.3 |
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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Patient's Global Assessment of Disease Activity
The ACR patient's global assessment of disease activity is scored on a visual analog scale (VAS) from 0 (symptom-free and no arthritis symptoms) to 100 mm (maximum arthritis disease activity). A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline to Week 24
Intervention | cm (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 0.280 |
Tocilizumab+Prednisone (Constant Dose) | -0.153 |
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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Patient's Assessment of Pain
The ACR patient's assessment of pain is scored on a visual analog scale (VAS) from 0 (no pain) to 100 mm (unbearable pain). A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline to Week 24
Intervention | mm (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 4.648 |
Tocilizumab+Prednisone (Constant Dose) | -8.010 |
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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: High Sensitivity C-Reactive Protein (hsCRP)
Change from baseline in the acute phase reactant hsCRP (NCT02573012)
Timeframe: Baseline to Week 24
Intervention | mg/dL (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | -0.135 |
Tocilizumab+Prednisone (Constant Dose) | -0.040 |
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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Health Assessment Questionnaire-Disability Index (HAQ-DI)
A measure of self-perceived disability containing 20 questions in eight categories and including additional section about aid from other people and devices needed to correct the disabilities. Scores range from 0 to 3, with higher scores indicating worse disability. (NCT02573012)
Timeframe: Baseline to Week 24
Intervention | Score on a scale (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 0.167 |
Tocilizumab+Prednisone (Constant Dose) | -0.087 |
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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Erythrocyte Sedimentation Rate (ESR)
Change from baseline in the acute phase reactant ESR (NCT02573012)
Timeframe: Baseline to Week 24
Intervention | mm/hr (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 1.517 |
Tocilizumab+Prednisone (Constant Dose) | -0.679 |
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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Physician's Global Assessment of Disease Activity
The ACR physician's global assessment of disease activity is scored on a visual analog scale (VAS) from 0 (symptom-free and no arthritis symptoms) to 100 mm (maximum arthritis disease activity). A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline to Week 24
Intervention | cm (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 0.345 |
Tocilizumab+Prednisone (Constant Dose) | -0.248 |
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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Swollen 66 Joint Counts
Count of swollen joints based upon 66 assessed joints. (NCT02573012)
Timeframe: Baseline to Week 24
Intervention | Swollen joints (Mean) |
---|
Tocilizumab+Prednisone (Tapering Dose) | 0.129 |
Tocilizumab+Prednisone (Constant Dose) | -0.107 |
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Percentage of Visits With RA Flares
(NCT02573012)
Timeframe: Randomization to 24 weeks
Intervention | Percentage of visits with flares (Number) |
---|
| 1 Visit | 2 Visits | 3 Visits | >3 Visits |
---|
Tocilizumab+Prednisone (Constant Dose) | 7.0 | 3.9 | 0 | 0 |
,Tocilizumab+Prednisone (Tapering Dose) | 16.0 | 6.9 | 2.3 | 0.8 |
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Observed Serum Rituximab Concentration
"Predose time point was any time prior to dose for Cycle 1 and within 5 hour prior to dose for other cycles (Cycles 2,5,8) during induction phase and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 mg/hour. If no infusion-related or hypersensitivity reaction occurs, increase the infusion rate in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour." (NCT02596971)
Timeframe: Predose, 0.5h postinfusion on D1 of Cy1,2,5,8 (1Cy: 21 days); at 120 days and 1 year after last rituximab dose or at treatment discontinuation (up to 4 years)
Intervention | ug/mL (Median) |
---|
| C1 - Cmax after dosing C1 | C1 - Ctrough after dosing C1 | C8 - Cmax after dosing C8 | C8 - Ctrough after dosing C8 |
---|
Atezo-R-CHOP Cohort (Expansion Phase) | 159 | 26.1 | 229 | 105.5 |
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Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
"Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was any time prior to dose for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported." (NCT02596971)
Timeframe: Baseline up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
| Baseline | Induction Cycle 2 Day 1 | Atezolizumab Day 120 Follow up | Atezo PK and Immunogenicity Follow Up (1YR) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 2.4 | 0 | 0 | 0 |
,Atezo-G-CHOP Cohort (Safety Run-In Phase) | 0 | 0 | 0 | 0 |
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Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
"Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was any time prior to dose for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported." (NCT02596971)
Timeframe: Baseline up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
| Baseline | Induction Cycle 2 Day 1 | Consolidation Cycle 16 | Atezolizumab Day 120 Follow up | Atezo PK and Immunogenicity Follow Up (1YR) |
---|
Atezo-R-CHOP Cohort (Expansion Phase) | 14.3 | 2.6 | 5.9 | 9.1 | 5.6 |
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Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Induction: Predose (any time prior to dose) on D1 of Cy1,5,8 (1Cy: 21 days); Maintenance: at 120 days and 1 year of last rituximab dose or at treatment discontinuation (up to 4 years) (NCT02596971)
Timeframe: Baseline up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
| Baseline | Induction Cycle 1 Day 1 | Induction Cycle 5 Day 1 | Induction Cycle 8 Day 1 | Rituximab Day 120 Follow up | Rituximab 1 Year Follow up | Study Drug Completion or Early Discontinuation |
---|
Atezo-R-CHOP Cohort (Expansion Phase) | 14.3 | 0 | 0 | 0 | 0 | 0 | 0 |
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Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Induction: Predose (any time prior to dose) on D1 of Cy1,5,6 (1Cy: 21/28 days); Maintenance: Predose (any time prior to dose) on D1 of Month 1; at 120 days and 1 year of last obinutuzumab dose or at treatment discontinuation (up to 4 years) (NCT02596971)
Timeframe: Baseline up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
| Induction Cycle 1 Day 1 | Induction Cycle 5 Day 1 | Induction Cycle 6 Day 1 | Maintenance Month 1 | Study Drug Completion or Early Discontinuation | Obinutuzumab Day 120 Follow up |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 2.4 | 0 | 0 | 0 | 0 | 0 |
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Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria
Tumor response assessment was performed by IRC according to modified Lugano classification using PET/CT scan. OR defined as a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake =mediastinum), or 3 (uptake ] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
Intervention | percentage of participants (Number) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 90.0 |
Atezo-R-CHOP Cohort (Expansion Phase) | 87.5 |
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Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT02596971)
Timeframe: Baseline up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 100 |
Atezo-G-CHOP Cohort (Safety Run-In Phase) | 100 |
Atezo-R-CHOP Cohort (Expansion Phase) | 100 |
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Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria
CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. (NCT02596971)
Timeframe: Baseline up to approximately 4 years (assessed at Baseline, 6 to 8 weeks after Day [D] 1 of Cycle [Cy] 6 or 8 (1Cy: 21 or 28 days), then every 2 months up to 24 months, at 35 days of last dose, and at every 3 months post-treatment follow-up [up 4 years])
Intervention | percentage of participants (Number) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 80.0 |
Atezo-R-CHOP Cohort (Expansion Phase) | 75.0 |
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Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria
Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [=] mediastinum), or 3 (uptake less than [<] mediastinum but =liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. All PET evaluable 1L FL and 1L DLBCL participants with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
Intervention | percentage of participants (Number) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 75 |
Atezo-R-CHOP Cohort (Expansion Phase) | 77.5 |
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Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria
Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake =mediastinum), or 3 (uptake NCT02596971)
Timeframe: Up to approximately 6 months
Intervention | percentage of participants (Number) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 87.5 |
Atezo-R-CHOP Cohort (Expansion Phase) | 77.5 |
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Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria
Complete response according to modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. (NCT02596971)
Timeframe: Up to approximately 6 months
Intervention | percentage of participants (Number) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 80.0 |
Atezo-R-CHOP Cohort (Expansion Phase) | 75.0 |
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Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria
Complete response according to the modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
Intervention | percentage of participants (Number) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 75.0 |
Atezo-R-CHOP Cohort (Expansion Phase) | 77.5 |
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Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria
Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake =mediastinum), or 3 (uptake ] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
Intervention | percentage of participants (Number) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 95.0 |
Atezo-R-CHOP Cohort (Expansion Phase) | 87.5 |
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Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria
Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
Intervention | percentage of participants (Number) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 95.0 |
Atezo-R-CHOP Cohort (Expansion Phase) | 87.5 |
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Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria
Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
Intervention | percentage of participants (Number) |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 90.0 |
Atezo-R-CHOP Cohort (Expansion Phase) | 90.0 |
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Observed Serum Atezolizumab Concentration
"Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was within 5 hour prior to dose for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes." (NCT02596971)
Timeframe: Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)
Intervention | ug/mL (Median) |
---|
| Cycle 2 - Cmax after 1st infusion | C2 - Cmin before 2nd infusion | C6 - Cmin after 6th infusion |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 275 | 83 | 256 |
,Atezo-G-CHOP Cohort (Safety Run-In Phase) | 424 | 94 | 195 |
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Observed Serum Atezolizumab Concentration
"Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was within 5 hour prior to dose for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes." (NCT02596971)
Timeframe: Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)
Intervention | ug/mL (Median) |
---|
| Cycle 2 - Cmax after 1st infusion | C2 - Cmin before 2nd infusion | C8 - Cmax after 7th infusion | C8 - Cmin before 8th infusion |
---|
Atezo-R-CHOP Cohort (Expansion Phase) | 332 | 82.1 | 486.5 | 184 |
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Observed Serum Obinutuzumab Concentration
"Predose time point was any time prior to dose for Cycle (Cy) 1 and within 5 hour prior to dose for other cycles (Cy 2,5,6) and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 milligrams per hour (mg/hour). If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour." (NCT02596971)
Timeframe: Induction: Predose, 0.5 hour (h) postinfusion on Day (D) 1 of Cy1,2,5,6 (1Cy: 21/28 days); Maintenance: Predose, 0.5h postinfusion on Day 1 of Month 1,3,7,15,23; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)
Intervention | ug/mL (Median) |
---|
| C1 Cmax after 1st infusion | C1 Cmin after the last infusion on C1 | C6 - Cmax after last dosing of induction | C6 - Cmin after last dosing of induction |
---|
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 329 | 322 | 544 | 203 |
,Atezo-G-CHOP Cohort (Safety Run-In Phase) | 400 | 399 | 659 | 245 |
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Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were to be categorized as SAE. AEs of special interest included any opportunistic infections, serious post injection systemic reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B virus infection or reactivation, severe mucocutaneous reactions (e.g., toxic epidermal necrolysis and stevens-johnson syndrome), cytopenias and cardiovascular events. Participants with SAEs and AESI were to be summarized. No serious adverse events (SAEs) or adverse events of special interest (AESI) reported. (NCT02613910)
Timeframe: Up to Week 156
Intervention | Participants (Number) |
---|
| Any SAE | Any AESI |
---|
Ofatumumab | 0 | 0 |
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Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs and those with AEs leading to permanent discontinuation of ofatumumab SC (AELD) were to be summarized. Safety Population consists of all participants enrolled in the study. No safety events were reported for the one participant enrolled. (NCT02613910)
Timeframe: Up to Week 60
Intervention | Participants (Number) |
---|
Ofatumumab | 0 |
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Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities
12-lead ECG was planned to be taken on Baseline (Week 0) and at Follow-up visit (Week 60). No clinically significant ECG abnormalities were noted for the one participant. (NCT02613910)
Timeframe: Up to Week 60
Intervention | Participants (Number) |
---|
Ofatumumab | 0 |
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Number of Participants With Injection Site Reactions
Number of participants with injection site reactions were planned to be summarized. No cases of injection site reaction were reported for the one participant. (NCT02613910)
Timeframe: Up to Week 60
Intervention | Participants (Number) |
---|
Ofatumumab | 0 |
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Number of Participants With Vital Signs of Clinical Concern
Participants with vitals signs of clinical concern were planned to be summarized. No vital signs of clinical concerns were present for the one participant. (NCT02613910)
Timeframe: Up to Week 60
Intervention | Participants (Number) |
---|
Ofatumumab | 0 |
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Number of Participants With Severe Adverse Events
Severity is a category utilized for rating the intensity of an adverse event. Participants with severe AEs were to be summarized. No serious adverse events (SAEs) were reported for the one participant enrolled. (NCT02613910)
Timeframe: Up to Week 60
Intervention | Participants (Number) |
---|
Ofatumumab | 0 |
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Number of Participants With Post-injection Systemic Reactions
All serious post-injection systemic reactions were planned to be monitored closely throughout the study and number of participants with post-injection systemic reactions was to be summarized. No cases of post-injection systemic reactions were reported for the one participant. (NCT02613910)
Timeframe: Up to Week 60
Intervention | Participants (Number) |
---|
Ofatumumab | 0 |
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Number of Participants With Laboratory Results of Potential Clinical Concern
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of clinical chemistry parameters; and at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of hematology parameters. No laboratory values of potential clinical concern were identified for this one participant. (NCT02613910)
Timeframe: Up to Week 156
Intervention | Participants (Number) |
---|
Ofatumumab | 0 |
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Number of Participants With Infections
All infections were planned to be monitored closely throughout the study and participants with infections were to be summarized. No cases of infection were reported for the one participant. (NCT02613910)
Timeframe: Up to Week 60
Intervention | Participants (Number) |
---|
Ofatumumab | 0 |
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Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4])
Area under the serum concentration-time curve from time zero (Day 1) to final time point measured after the first administration (Week 1) until Week 4 (AUC(W1-W4)). PK blood samples for this endpoint were drawn at Day 1 (before and after the first infusion), Day 8 ± 1 (7 days after first infusion), Day 15 ± 1 (14 days after first infusion), Day 22 ± 2 (before and after completion of the second infusion). (NCT02617485)
Timeframe: Baseline to Week 4
Intervention | (μg*day)/mL (Mean) |
---|
MabionCD20 | 1559.51 |
MabThera | 1509.79 |
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Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26])
Area under the serum concentration-time curve from time zero to final time point measured from Week 13 until Week 26 (AUC[W13-W26]). PK blood samples for this endpoint were drawn at Day 85 ± 4 (before and after completion of the fifth infusion), Day 106 ± 4 (before and after completion of sixth infusion), Day 127 ± 4 (before and after completion of the seventh infusion), Day 148 ± 4 (before and after completion of the eight infusion), Day 155 ± 4 (one week after last infusion) and Day 176 ± 4 (one month after last infusion). (NCT02617485)
Timeframe: Week 13 to Week 26
Intervention | (μg*day)/mL (Mean) |
---|
MabionCD20 | 16498.9 |
MabThera | 15647.4 |
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AUC (W1-W26)
Area under the serum concentration-time curve measured after the first administration (Week 1) until Week 26 (AUC(1-26)) (NCT02617485)
Timeframe: Week 1 until Week 26
Intervention | (μg*day)/mL (Mean) |
---|
MabionCD20 | 28413.6 |
MabThera | 26955.3 |
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AUC (W1-W26) B-cell
Area under the serum concentration-time curve of CD19+ B cell counts, measured from the first administration to the final time point at Week 26 (AUC(1-26) B-cell). (NCT02617485)
Timeframe: baseline to Week 26
Intervention | cells*days/mL blood (Mean) |
---|
MabionCD20 | 3395.82 |
MabThera | 10476.2 |
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Ctrough (Before 8th Infusion)
Trough serum concentration measured at the end of a dosing interval at steady state, taken directly before eighth infusion. (NCT02617485)
Timeframe: Week 22
Intervention | μg/mL (Mean) |
---|
MabionCD20 | 102.246 |
MabThera | 90.61 |
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Adverse Events
Percentage of patients with at least one AE in a given category. Data from the entire follow-up are included (Period 1 and Period 2). (NCT02617485)
Timeframe: from baseline to Week 46
Intervention | percent (Number) |
---|
| all AEs | TEAEs | TESAEs | severe TEAEs | related TEAEs | related severe TEAEs | related TESAEs | TEAEs leading to death | related TEAEs leading to death |
---|
MabionCD20 | 71.0 | 71.0 | 19.0 | 40.0 | 53.0 | 29.0 | 13.0 | 8.0 | 2.0 |
,MabThera | 67.5 | 65.0 | 12.5 | 22.5 | 42.5 | 22.5 | 5.0 | 0 | 0 |
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Efficacy Assessment at Week 26
An efficacy assessment was made after 8 treatment cycles (at Week 26) based on tumour responses classified according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). Response was assessed based on clinical, radiologic (CT scan) and pathologic (bone marrow) criteria. Possible efficacy responses were: complete response, partial response, stable disease, and progressive disease. Efficacy reported here includes all patients included in the ITT set. (NCT02617485)
Timeframe: Week 26
Intervention | Participants (Count of Participants) |
---|
| Complete | Partial | Stable disease | Progressive disease | Missing |
---|
MabionCD20 | 34 | 42 | 10 | 10 | 4 |
,MabThera | 14 | 18 | 4 | 2 | 2 |
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Cmax (Post 5th and 8th Infusion)
Maximum serum drug concentration (Cmax) at steady state after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 (5th infusion) and Week 22 (8th infusion)
Intervention | μg/mL (Mean) |
---|
| 5th infusion | 8th infusion |
---|
MabionCD20 | 273.356 | 296.784 |
,MabThera | 266.439 | 296.462 |
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T1/2 (Post 5th and 8th Infusions)
Elimination half-life at steady state after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 to Week 16 and Week 22 to Week 26
Intervention | days (Mean) |
---|
| 5th infusion | 8th infusion |
---|
MabionCD20 | 14.801 | 18.301 |
,MabThera | 15.217 | 16.997 |
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Kel (Post 5th and 8th Infusions)
Elimination Rate Constant at steady stade after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 (5th infusion) and Week 22 (8th infusion)
Intervention | 1/day (Mean) |
---|
| 5th infusion | 8th infusion |
---|
MabionCD20 | 0.05663 | 0.04335 |
,MabThera | 0.05418 | 0.04379 |
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CLss (Post 5th and 8th Infusions)
Clearance at steady state after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 to Week 16 and Week 22 to Week 26
Intervention | mL/day (Mean) |
---|
| 5th infusion | 8th infusion |
---|
MabionCD20 | 198.701 | 179.168 |
,MabThera | 206.905 | 191.272 |
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Immunogenicity
Percentage of patients with positive ADA or NAb results in a given category. Data pertain to the entire follow-up period (from Baseline to Week 46). (NCT02617485)
Timeframe: from baseline to Week 46
Intervention | participants (Number) |
---|
| Treatment-induced ADA | Persistent ADA | Transient ADA | Treatment-boosted ADA | NAb positive |
---|
MabionCD20 | 6 | 4 | 2 | 0 | 0 |
,MabThera | 1 | 1 | 0 | 0 | 0 |
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PSA Response in the Standard Treatment Arm and Experimental Treatment Arm
"PSA response measured according to Prostate Cancer Working Group 2 (PCWG2).~The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm." (NCT02685267)
Timeframe: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), Day 231, and every 21 days through study completion (an average of 1 year)
Intervention | Participants (Count of Participants) |
---|
Docetaxel/Prednisone | 2 |
Docetaxel/Prednisone + Enzalutamide | 3 |
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Overall Survival
(NCT02685267)
Timeframe: At both 1 year and 2 years from treatment start
Intervention | Participants (Count of Participants) |
---|
Docetaxel/Prednisone | 2 |
Docetaxel/Prednisone + Enzalutamide | 4 |
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Progression-free Survival (Radiographic or Per PCWG2 Criteria)
The primary endpoint of the study is progression-free survival (PFS), defined as the time from randomization to disease progression. Progression will be evaluated using a combination of RECIST and Prostate Cancer Working Group 2 guidelines. (NCT02685267)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Docetaxel/Prednisone | 0 |
Docetaxel/Prednisone + Enzalutamide | 0 |
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Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP
Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP (17-Hydroxyprogesterone). The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed 17-OHP values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of 17-OHP when compared to baseline (0). (NCT02716818)
Timeframe: 24 weeks
Intervention | Z-score (Mean) |
---|
Chronocort® | -0.403 |
Standard Glucocorticoid Therapy | -0.172 |
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Number of Participants With 17-OHP and A4 Levels in the Optimal Range at 9:00 at Week 24 Visit
"17-OHP and A4 levels at 09:00 at the week 24 visit, as a responder analysis (i.e. the number of participants achieving results in the optimal range).~Optimal range for 17-OHP (male) = 1.2* - 6.7 nmol/L (female) = 1.2* - 8.6 Optimal range for A4 (male) = 1.4 - 5.2 nmol/L (female) = 1.0 - 7.0 nmol/L~* = There is no lower reference range available for 17-OHP, hence the lower limit of the optimal range was used in the derivation of the average Standard Deviation Score. This enabled calculation of an 'unsigned' SDS score which was used to assess potential over-treatment as well as under-treatment." (NCT02716818)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
Chronocort - 09:00h Response - 17-OHP | 30 |
Chronocort - 09:00h Response - A4 | 25 |
Standard Glucocorticoid Therapy - 09:00h Response - 17-OHP | 30 |
Standard Glucocorticoid Therapy - 09:00h Response - A4 | 30 |
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Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass)
Changes relative to Standard glucocorticoid therapy in body composition (DEXA) (fat mass and lean mass) - measured at all sites except Germany. (NCT02716818)
Timeframe: Baseline and 24 weeks
Intervention | kilograms (Mean) |
---|
Chronocort - DEXA - Fat Mass | -0.575 |
Standard Glucocorticoid Therapy - DEXA - Fat Mass | 0.445 |
Chronocort - DEXA - Lean Mass | 0.640 |
Standard Glucocorticoid Therapy - DEXA - Lean Mass | 0.234 |
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Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Bone Mineral Density) - Measured at All Sites Except Germany.
Changes relative to Standard glucocorticoid therapy in body composition (DEXA - bone mineral density only) - measured at all sites except Germany. (NCT02716818)
Timeframe: Baseline and 24 weeks
Intervention | g/cm^2 (Mean) |
---|
Chronocort - DEXA - Bone Mineral Density | -0.001 |
Standard Glucocorticoid Therapy - DEXA - Bone Mineral Density | -0.008 |
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17-OHP and A4 by Individual Baseline Treatment Strata.
17-OHP and A4 by individual baseline treatment strata presented in the same manner as the primary endpoint (using 24-hour SDS profile at 24 weeks). Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP and A4. This secondary efficacy variable was calculated as follows: the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP and A4. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed 17-OHP and A4 values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of 17-OHP and A4 when compared to baseline (0). (NCT02716818)
Timeframe: 24 weeks
Intervention | Z-score (Mean) |
---|
Pre-Baseline - Hydrocortisone - 17-OHP | -0.248 |
Pre-Baseline - Prednisone/Prednisolone - 17-OHP | -0.061 |
Pre-Baseline - Dexamethasone - 17-OHP | -0.245 |
Pre-Baseline - Chronocort vs. Hydrocortisone - 17-OHP | -0.431 |
Pre-Baseline - Chronocort vs. Prednisone/Prednisolone - 17-OHP | -0.320 |
Pre-Baseline - Chronocort vs. Dexamethasone - 17-OHP | -0.565 |
Pre-Baseline - Hydrocortisone - A4 | -0.211 |
Pre-Baseline - Prednisone/Prednisolone - A4 | 0.100 |
Pre-Baseline - Dexamethasone - A4 | 0.368 |
Pre-Baseline - Chronocort vs. Hydrocortisone - A4 | 0.015 |
Pre-Baseline - Chronocort vs. Prednisone/Prednisolone - A4 | 0.328 |
Pre-Baseline - Chronocort vs. Dexamethasone - A4 | -0.092 |
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Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4
Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for A4 (androstenedione). This secondary efficacy variable was calculated as follows: the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of A4. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed A4 values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of A4 when compared to baseline (0). (NCT02716818)
Timeframe: 24 weeks
Intervention | Z-score (Mean) |
---|
Chronocort® | 0.113 |
Standard Glucocorticoid Therapy | -0.041 |
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Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment. (NCT02741271)
Timeframe: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Intervention | hr (Median) |
---|
Pooled MF/F 100/10 mcg and MF 100 mcg | 1.47 |
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Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the change from baseline in total daily short-acting beta-agonist (SABA) use (puffs per day) was averaged and assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms. This secondary analysis of the change from baseline used the cLDA method without multiple imputation.A model-based MAR approach was used for missing data. (NCT02741271)
Timeframe: Baseline and Weeks 1-12 (Averaged)
Intervention | Puffs per day (Mean) |
---|
| Baseline | Change from Baseline Over Weeks 1-12 (Average) |
---|
MF MDI 100 mcg BID | 0.13 | -0.02 |
,MF/F MDI 100/10 mcg BID | 0.25 | -0.12 |
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Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment
The key secondary objective was to determine the onset of action for the efficacy of MF/F MDI 100/10 mcg BID, compared with MF MDI 100 mcg BID. The post-dose AM % predicted FEV1 was averaged sequentially, and the change from baseline on Day 1 was assessed. This key secondary endpoint was controlled for multiplicity in a step-down fashion, based on trial success defined as a statistically significant improvement in the primary endpoint for MF/F vs MF. Missing data were imputed using control-based multiple imputations with the cLDA model. (NCT02741271)
Timeframe: Baseline and Day 1, measured at 4 hr, 2 hr and 60, 30, 15, and 5 min, post-dose time points
Intervention | Percent predicted FEV1 (Mean) |
---|
| Baseline | Change from Baseline (4 hr post-dose on Day 1) | Change from Baseline (2 hr post-dose on Day 1) | Change from Baseline (60 min post-dose on Day 1) | Change from Baseline (30 min post-dose on Day 1) | Change from Baseline (15 min post-dose on Day 1) | Change from Baseline (5 min post-dose on Day 1) |
---|
MF MDI 100 mcg BID | 78.48 | 5.68 | 5.87 | 4.92 | 3.05 | 1.38 | 0.95 |
,MF/F MDI 100/10 mcg BID | 79.21 | 11.61 | 12.71 | 11.05 | 9.56 | 8.00 | 5.20 |
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Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants using SABA rescue medication in Weeks 1-12 (individually) of the double-blind treatment period was assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms. (NCT02741271)
Timeframe: Baseline and Weeks 1-12 (Averaged)
Intervention | Participants (Number) |
---|
| Baseline | Weeks 1-12 |
---|
MF MDI 100 mcg BID | 17 | 45 |
,MF/F MDI 100/10 mcg BID | 23 | 41 |
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Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE. (NCT02741271)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
MF/F MDI 100/10 mcg BID | 0 |
MF MDI 100 mcg BID | 3 |
Total | 3 |
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Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE)
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE. (NCT02741271)
Timeframe: Up to 26 weeks
Intervention | Participants (Count of Participants) |
---|
MF/F MDI 100/10 mcg BID | 37 |
MF MDI 100 mcg BID | 52 |
Total | 89 |
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Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment
This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 4 hours post-dose on Day 1 and Week 12 compared to Baseline. Baseline was the average of 30 and 0 minutes pre-dose % predicted FEV1 values. The AUC was calculated over the scheduled timepoints of 0 min, 5 min, 15 min, 30 min, 60 min, 2 hr and 4 hr post-dose. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC. (NCT02741271)
Timeframe: Baseline, Day 1 and Week 12
Intervention | Percent predicted FEV1 (Mean) |
---|
| Baseline | Change from Baseline on Day 1 | Change from Baseline at Week 12 |
---|
MF MDI 100 mcg BID | 78.48 | 2.70 | 4.87 |
,MF/F MDI 100/10 mcg BID | 79.21 | 7.13 | 7.56 |
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Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60
This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 60 minutes post-dose (at 0, 5, 15, 30 and 60 minutes) and averaged across study visits in the Treatment Period (Day 1, Week 1, Week 4, Week 8 and Week 12) compared to Baseline. Baseline was the average of % predicted FEV1 values at 30 min and 0 min pre-dose. At each visit, the area under the curve is calculated over the post-dose timepoints. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC. (NCT02741271)
Timeframe: Baseline, and average of Day 1, Weeks 1, 4, 8, and 12
Intervention | Percent predicted FEV1 (Mean) |
---|
| Baseline | Change from Baseline |
---|
MF MDI 100 mcg BID | 78.48 | 3.96 |
,MF/F MDI 100/10 mcg BID | 79.21 | 8.99 |
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Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment
The change from baseline in AM pre-dose % predicted FEV1 with MF/F MDI 100/10 mcg BID vs MF MDI 100 mcg BID averaged over 12 weeks treatment was assessed. This secondary analysis of the change from baseline used the cLDA method without multiple imputation. A model-based MAR approach was used for missing data. (NCT02741271)
Timeframe: Baseline and Weeks 4, 8, and 12 (Averaged)
Intervention | Percent predicted FEV1 (Mean) |
---|
| Baseline | Change from Baseline (Weeks 4, 8, and 12) |
---|
MF MDI 100 mcg BID | 78.22 | 0.44 |
,MF/F MDI 100/10 mcg BID | 79.21 | 1.51 |
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Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants whose use of SABA rescue medication increased in Weeks 1-12 (individually) of the double-blind treatment period was assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for relief of asthma symptoms. (NCT02741271)
Timeframe: Weeks 1-12 (Averaged)
Intervention | Participants (Number) |
---|
MF/F MDI 100/10 mcg BID | 24 |
MF MDI 100 mcg BID | 34 |
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Maximum Plasma Concentration (Cmax) of Mometsone Furoate
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment. (NCT02741271)
Timeframe: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Intervention | pg/mL (Geometric Mean) |
---|
Pooled MF/F 100/10 mcg and MF 100 mcg | 16 |
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Lund Kennedy Endoscopy Score Over Time
The Lund-Kennedy score is a validated scale by which clinicians grade the endoscopic appearance of the sinonasal cavity for sinusitis patients. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. Higher scores represent a worse endoscopic appearance. (NCT02748070)
Timeframe: Baseline, 1, week, 1 month, 3 months, and 6 months
Intervention | score on a scale (Mean) |
---|
| Baseline | 1 week | 1 month | 3 months | 6 months |
---|
Placebo | 3.8 | 5.3 | 3.8 | 2.4 | 1.8 |
,Prednisone | 2.9 | 5.9 | 3.5 | 1.9 | 1.3 |
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Sino-nasal Outcome Test (SNOT-22) Over Time
SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients. (NCT02748070)
Timeframe: Baseline, 1, week, 1 month, 3 months, and 6 months
Intervention | score on a scale (Mean) |
---|
| Baseline | 1 week | 1 month | 3 months | 6 months |
---|
Placebo | 42.9 | 38.5 | 28.6 | 20.3 | 25.2 |
,Prednisone | 43.8 | 39.7 | 26.6 | 28.3 | 34.2 |
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Percentage of Participants With Overall Survival
Overall survival is defined as survival of death from any cause. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization
Intervention | percentage of participants (Number) |
---|
| Overall Survival at 6 Months | Overall Survival at 12 Months |
---|
Prednisone | 82.7 | 73.2 |
,Sirolimus | 81.9 | 76.3 |
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Percentage of Participants With Complete or Partial Response (CR/PR) to Acute GVHD Treatment
"Scoring of CR/PR is in comparison to the participant's acute GVHD status at randomization. Complete response (CR) is defined as staging of 0 for in all target organs for GVHD - skin, GI tract, and liver. Partial response (PR) is defined as improvement in some target organ(s) without worsening in others. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are considered failures for this endpoint. Organ staging is defined below:~Skin stage:~0: No rash~Rash <25% of body surface area (BSA)~Rash on 25-50% of BSA~Rash on >50% of BSA~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level):~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus" (NCT02806947)
Timeframe: Days 28 and 56 Post-randomization
Intervention | Participants (Count of Participants) |
---|
| CR/PR at Day 2872566668 | CR/PR at Day 2872566669 | CR/PR at Day 5672566669 | CR/PR at Day 5672566668 |
---|
| Yes | No |
---|
Sirolimus | 35 |
Prednisone | 46 |
Prednisone | 17 |
Sirolimus | 34 |
Prednisone | 50 |
Sirolimus | 19 |
Prednisone | 13 |
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Percentage of Participants With Non-relapse Mortality
Non-relapse mortality is defined as death due to any cause other than relapse of the underlying malignancy. The cumulative incidence of non-relapse mortality is described, with malignancy relapse treated as a competing risk. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization
Intervention | percentage of participants (Number) |
---|
| Non-relapse Mortality at 6 Months | Non-relapse Mortality at 12 Months |
---|
Prednisone | 9.4 | 14.2 |
,Sirolimus | 12.7 | 16.5 |
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Percentage of Participants With Malignancy Relapse
The cumulative incidence of relapse of the primary malignancy is described, with death treated as a competing risk. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization
Intervention | percentage of participants (Number) |
---|
| Malignancy Relapse at 6 Months | Malignancy Relapse at 12 Months |
---|
Prednisone | 12.5 | 15.7 |
,Sirolimus | 14.5 | 21.9 |
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Acute GVHD Response
"Acute GVHD response is classified as CR, PR, mixed response (MR), no response (NR), and progression and scored by comparison to acute GVHD status at randomization. MR is defined as improvement in some organ(s) with worsening in another, progression as worsening in some organ(s) without improvement in others, and NR as absence of any improvement or worsening. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are classified as NR. Organ staging is defined as:~Skin stage:~0: No rash~Rash <25% of body surface area (BSA)~Rash 25-50% of BSA~Rash >50% of BSA~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level in mg/dL):~0: <2~2-3~3.01-6~6.01-15.0~>15~GI stage:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus" (NCT02806947)
Timeframe: Days 28 and 56 Post-randomization
Intervention | Participants (Count of Participants) |
---|
| Acute GVHD Response at Day 2872566669 | Acute GVHD Response at Day 2872566668 | Acute GVHD Response at Day 5672566669 | Acute GVHD Response at Day 5672566668 |
---|
| Complete Response (CR) | Partial Response (PR) | Mixed Response (MR) | No Response (NR) | Progression |
---|
Prednisone | 39 |
Sirolimus | 5 |
Prednisone | 7 |
Sirolimus | 1 |
Prednisone | 5 |
Sirolimus | 16 |
Prednisone | 11 |
Sirolimus | 2 |
Prednisone | 1 |
Sirolimus | 30 |
Prednisone | 48 |
Sirolimus | 4 |
Prednisone | 2 |
Sirolimus | 0 |
Prednisone | 0 |
Sirolimus | 19 |
Prednisone | 10 |
Prednisone | 3 |
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Percentage of Participants With Chronic GVHD
Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. The cumulative incidence of chronic GVHD is described, with death and malignancy relapse treated as competing risks. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization
Intervention | percentage of participants (Number) |
---|
| Chronic GVHD at 6 Months | Chronic GVHD at 12 Months |
---|
Prednisone | 31.2 | 40.6 |
,Sirolimus | 25.7 | 31.4 |
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Proportion of Participants With Event-free Survival
Event-free survival is defined as freedom from acute GVHD progression, chronic GVHD, malignancy relapse, and death. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization
Intervention | percentage of participants (Number) |
---|
| Event-free Survival at 6 Months | Event-free Survival at 12 Months |
---|
Prednisone | 43.7 | 31.2 |
,Sirolimus | 47.3 | 35.9 |
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Percentage of Participants With Treatment Failure
"Treatment failure is defined as either no response (NR) or progression and scored by comparison to acute GVHD status at randomization. Progression is defined as worsening in some target organ(s) without improvement in others and NR is defined as absence of any improvement or worsening in target organs. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are classified as NR. Organ staging is defined as:~Skin stage:~0: No rash~Rash <25% of body surface area (BSA)~Rash 25-50% of BSA~Rash >50% of BSA~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level in mg/dL):~0: <2~2-3~3.01-6~6.01-15.0~>15~GI stage:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus" (NCT02806947)
Timeframe: Days 28 and 56 Post-randomization
Intervention | Participants (Count of Participants) |
---|
| Treatment Failure at Day 2872566668 | Treatment Failure at Day 2872566669 | Treatment Failure at Day 5672566668 | Treatment Failure at Day 5672566669 |
---|
| No | Yes |
---|
Sirolimus | 18 |
Prednisone | 12 |
Sirolimus | 36 |
Prednisone | 51 |
Sirolimus | 19 |
Prednisone | 13 |
Sirolimus | 34 |
Prednisone | 50 |
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Percentage of Participants With Serious Infections
The cumulative incidence of serious infections (Grade 2 or 3 per BMT CTN MOP) is described, with death treated as a competing risk. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization
Intervention | percentage of participants (Number) |
---|
| Seirious Infections at 6 Months | Seirious Infections at 12 Months |
---|
Prednisone | 43.8 | 51.8 |
,Sirolimus | 30.4 | 39.6 |
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Percentage of Participants With Disease-free Survival
Disease-free survival is defined as freedom from death and relapse of the underlying malignancy. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization
Intervention | percentage of participants (Number) |
---|
| Disease-free Survival at 6 Months | Disease-free Survival at 12 Months |
---|
Prednisone | 78.1 | 70.2 |
,Sirolimus | 72.8 | 61.6 |
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Percentage of Participants With GVHD-free Survival
GVHD-free survival is defined as freedom from acute GVHD, chronic GVHD, and death. The proportion of participants alive and free of both acute and chronic GVHD are described at 6 and 12 months post-randomization. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization
Intervention | percentage of participants (Number) |
---|
| GVHD-free Survival at 6 Months | GVHD-free Survival at 12 Months |
---|
Prednisone | 46.0 | 46.0 |
,Sirolimus | 45.3 | 50.9 |
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Number of HES Flares Per Participant Per Year
The rate of HES flares for each participant was calculated as the number of observed HES flares divided by the time (expressed in years) between randomization and either the week 32 visit date if available, or the study withdrawal date. Negative binomial generalized linear model including Baseline OCS dose, region, treatment and observed time (offset variable). Wilcoxon test stratified by Baseline OCS (0-<=20mg/day, >20mg/day prednisone or equivalent) and region. Adjusted mean and 95% CI rate/year has been presented. (NCT02836496)
Timeframe: Up to Week 32
Intervention | Flares per participant per year (Mean) |
---|
Placebo | 1.46 |
Mepolizumab 300 mg SC | 0.50 |
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Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period
Percentage of participants who experienced >=1 HES flare during the 32-Week treatment period or who withdrew from the study has been presented. A HES flare is defined as a HES related clinical manifestation based on a physician-documented change in clinical signs or symptoms which resulted in need for an increase in the maintenance Oral Corticosteroid (OCS) dose by at least 10 mg per day for 5 days or an increase in or addition of any cytotoxic or immunosuppressive HES therapy. HES flare is also defined as receipt of two or more courses of blinded active OCS during the treatment period. Intent-to-treat (ITT) Population comprises of all randomized participants. This population was based on the treatment to which the participants were randomized. Any participant who received a treatment randomization number were considered to be randomized. (NCT02836496)
Timeframe: Up to Week 32
Intervention | Percentage of participants (Number) |
---|
Placebo | 56 |
Mepolizumab 300 mg SC | 28 |
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Number of Participants With Change From Baseline in Fatigue Severity Based on Brief Fatigue Inventory (BFI) in Item 3 (Worst Level of Fatigue During Past 24 Hours) at Week 32 by Category
"The change from Baseline in fatigue severity (worst level of fatigue during past 24 hours) at Week 32 was calculated using the mean of the 7 daily assessments of BFI item 3 up to and including the date of the Week 32 visit as the Week 32 assessment, and the mean of the 7 daily assessments of BFI item 3 up to but not including the date of first dose of study treatment as the Baseline assessment. Wilcoxon Rank Sum test stratified by Baseline fatigue severity (severe defined as BFI item 3>=7 and not severe defined as BFI item 3<7), Baseline OCS (0-<=20mg/day and >20mg/day prednisone or equivalent) and region. Participants with missing change from Baseline at Week 32 were included in the worst category (>=4 point increase)." (NCT02836496)
Timeframe: Baseline (Week 0) and at Week 32
Intervention | Participants (Count of Participants) |
---|
| >=4 point increase (>=3.5) | 3 point increase (>=2.5 to <3.5) | 2 point increase (>=1.5 to <2.5) | 1 point increase (>=0.5 to <1.5) | No change (>-0.5 to <0.5) | 1 point reduction (>-1.5 to <=-0.5) | 2 point reduction (>-2.5 to <=-1.5) | 3 point reduction (>-3.5 to <=-2.5) | >=4 point reduction (<=-3.5) |
---|
Mepolizumab 300 mg SC | 5 | 0 | 5 | 6 | 9 | 11 | 7 | 2 | 9 |
,Placebo | 7 | 4 | 4 | 9 | 14 | 5 | 3 | 5 | 3 |
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Time to First HES Flare
The time to first HES flare was calculated as (onset date of first HES flare minus date of first dose of study treatment) plus 1. Probability of first flare (by week 4, 8, 12, 16, 20, 24, 28, and 32) and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method. (NCT02836496)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28 and 32
Intervention | Probability expressed as percentage (Number) |
---|
| Flares by Week 4 | Flares by Week 8 | Flares by Week 12 | Flares by Week 16 | Flares by Week 20 | Flares by Week 24 | Flares by Week 28 | Flares by Week 32 |
---|
Mepolizumab 300 mg SC | 5.6 | 7.4 | 9.3 | 13.0 | 13.0 | 14.8 | 20.5 | 26.3 |
,Placebo | 7.4 | 14.9 | 26.2 | 33.8 | 41.3 | 48.9 | 50.8 | 52.7 |
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Percentage of Participants Who Experienced a HES Flare or Who Withdrew From the Study During Week 20 Through Week 32
HES flare during Week 20 through Week 32 was defined as a HES flare starting or ongoing on or after the date of the Week 20 visit up to and including the date of the Week 32 visit. Percentage of participants who experienced >=1 HES flare during Week 20 through Week 32 or who withdrew from the study has been presented. (NCT02836496)
Timeframe: Week 20 to Week 32
Intervention | Percentage of participants (Number) |
---|
Placebo | 35 |
Mepolizumab 300 mg SC | 17 |
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PSA Response Rate, Defined as >= 50% Decline in PSA From Baseline Maintained for at Least 3 Weeks and Measured by the Same Laboratory, and Without Evidence of Other Disease Progression Documented at Time of Confirmatory Values
The response rate will be compared to a historical response rate of 20% using the exact binomial test for a single proportion. Confidence intervals for the response rate will be calculated using Wilson's method. (NCT02844582)
Timeframe: Up to 18 months.
Intervention | Participants (Count of Participants) |
---|
Treatment (Cabazitaxel, Prednisone) | 0 |
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Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03
Incidence of adverse events, serious adverse events, and discontinuations, described and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCT02844582)
Timeframe: Up to 28 days after discontinuation of study drug
Intervention | participants (Number) |
---|
| Back pain | Diarrhea | Fatigue | Hot flashes | Neutrophil count decreased | Non-cardiac chest pain | Pain | Renal and urinary disorders - Other, specify | White blood cell decreased |
---|
Treatment (Cabazitaxel, Prednisone) | 1 | 1 | 2 | 1 | 2 | 1 | 1 | 1 | 2 |
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Number of Participants Without Biochemical Failure at 2 Years
Prostate-specific antigen progression (i.e. biochemical failure) will be defined per the American Urological Association guidelines (i.e. confirmed prostate-specific antigen post-radical prostatectomy >= 0.2 ng/mL). We will report the number of patients without biochemical failure at 2 years. (NCT02849990)
Timeframe: At 2 years
Intervention | participants (Number) |
---|
Treatment (Neoadjuvant Chemotherapy) | 18 |
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Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment
The near pathologic complete response will be defined as =< 5 mm of residual tumor as assessed on prostatectomy specimens after 3 months of treatment. (NCT02849990)
Timeframe: At 3 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Neoadjuvant Chemotherapy) | 6 |
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Number of Patients With Pathologic T3 Disease After 3 Months of Treatment.
The presence of T3 disease (e.g. extraprostatic tumor not invading adjacent structures) will be determine from the prostatectomy specimen after 3 months of treament. (NCT02849990)
Timeframe: At 3 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Neoadjuvant Chemotherapy) | 18 |
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Overall Survival (OS)
Will will report the number of participants alive at 2-years following enrollment. (NCT02849990)
Timeframe: At 2 years
Intervention | Participants (Count of Participants) |
---|
Treatment (Neoadjuvant Chemotherapy) | 20 |
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Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment
Pathologic complete response is defined as no evidence of cancer on fully submitted prostatectomy specimens using standard surgical pathology assessments (i.e. H&E assessment will be used for the purpose of defining pathologic complete response per protocol) at 3 months. (NCT02849990)
Timeframe: At 3 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Neoadjuvant Chemotherapy) | 1 |
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The Proportion of Men Who Receive Adjuvant Radiation Therapy
Patients that received radiation following prostatetomy (NCT02849990)
Timeframe: Up to 1 year post prostatectomy
Intervention | Participants (Count of Participants) |
---|
Treatment (Neoadjuvant Chemotherapy) | 7 |
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Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported. (NCT02855359)
Timeframe: Up to 183 days
Intervention | Participants (Count of Participants) |
---|
| Alanine aminotransferase increased | Hypoalbuminemia | Alkaline phosphatase increased | Aspartate aminotransferase increased | Blood bilirubin increased | Hypercalcemia | Hypocalcemia | Hyperglycemia | Hypoglycemia | Hypermagnesemia | Hypomagnesemia | Hypophosphatemia | Hypokalemia | Hypernatremia | Hyponatremia | Hyperuricemia | Anemia | Leukopenia | Lymphopenia | Neutropenia | Thrombocytopenia |
---|
Denintuzumab Mafodotin + RCHOP | 4 | 4 | 8 | 9 | 4 | 0 | 5 | 11 | 4 | 4 | 4 | 5 | 7 | 1 | 12 | 1 | 12 | 13 | 13 | 11 | 13 |
,Denintuzumab Mafodotin + RCHP | 3 | 3 | 5 | 5 | 0 | 3 | 5 | 8 | 1 | 0 | 4 | 5 | 6 | 1 | 4 | 0 | 10 | 10 | 9 | 9 | 10 |
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Part A and Part B Outcome Measure: Incidence of Adverse Events
Part A data only; study did not progress to Part B. (NCT02855359)
Timeframe: 54.7 weeks
Intervention | Participants (Count of Participants) |
---|
| Any Treatment-emergent adverse event (TEAE) | Any Grade 3-5 TEAE | Any Treatment-related Adverse Event (AE) | Any DM treatment-related AE | Any RCHOP/RCHP treatment-related AE | Any AE with Outcome of Death | Any Serious Adverse Event (SAE) | Any Treatment-Related SAE | Any DM Treatment-Related SAE |
---|
Denintuzumab Mafodotin + RCHOP | 13 | 12 | 13 | 13 | 13 | 1 | 4 | 3 | 2 |
,Denintuzumab Mafodotin + RCHP | 11 | 11 | 10 | 9 | 10 | 2 | 5 | 4 | 2 |
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Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2]
4-year bPFS rate is defined as the probability of biochemical progression free and survival at 4 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 4-year mark are censored at date of last disease evaluation. (NCT02903368)
Timeframe: At 4 years post RP
Intervention | percentage of subjects (Number) |
---|
Arm 2A: AAPL Adjuvant Therapy (Part 2) | 67 |
Arm 2B: Observation (Part 2) | 61 |
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Rate of Freedom From Further Anti-cancer Therapy at 2-years Post RP (Part 2)
Defined as the probability of freedom from further anti-cancer therapy at 2-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 2-year mark are censored at date of last follow-up. (NCT02903368)
Timeframe: At 2-years post RP
Intervention | percentage of subjects (Number) |
---|
Arm 2A: AAPL Adjuvant Therapy (Part 2) | 90 |
Arm 2B: Observation (Part 2) | 80 |
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Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1)
Prostate specific antigen (PSA) was measured on day 1 of each cycle during the neoadjuvant therapy. PSA nadir was defined as the lowest PSA value prior to Radical Prostatectomy (RP). Number and percent of participants with nadir PSA < 0.2 ng/mL were reported. (NCT02903368)
Timeframe: Assessed on day 1 of each cycle (1 cycle=28 +/- 2 days), up to 6 months from the initiation of neoadjuvant therapy.
Intervention | Participants (Count of Participants) |
---|
Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 55 |
Arm 1B: APL Neoadjuvant Therapy (Part 1) | 58 |
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Combined pCR or MRD Rate [Part 1]
Pathological response, defined as achieving either pCR or MRD at radical prostatectomy (RP). Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm. (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
Intervention | Participants (Count of Participants) |
---|
Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 12 |
Arm 1B: APL Neoadjuvant Therapy (Part 1) | 12 |
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Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL. (NCT02903368)
Timeframe: At 12-months post-RP
Intervention | score on 0-100 scale (Mean) |
---|
| Urinary Irritative | Urinary Incontinence | Bowel | Sexual | Hormonal |
---|
Arm 2A: AAPL Adjuvant Therapy (Part 2) | 91 | 75 | 95 | 16 | 68 |
,Arm 2B: Observation (Part 2) | 91 | 74 | 94 | 26 | 86 |
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Frequency of Presenting Intraductal Carcinoma at RP (Part 1)
Intraductal carcinoma was evaluated by central pathology review of specimens at Radical Prostatectomy (RP). (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
Intervention | Participants (Count of Participants) |
---|
Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 15 |
Arm 1B: APL Neoadjuvant Therapy (Part 1) | 19 |
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Frequency of Presenting Intra-operative Complications Following RP (Part 1)
Intra-operative complications were collected via questionnaire following Radical Prostatectomy. (NCT02903368)
Timeframe: Assessed post-RP, at 6 months from the initiation of neoadjuvant therapy.
Intervention | Participants (Count of Participants) |
---|
Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 1 |
Arm 1B: APL Neoadjuvant Therapy (Part 1) | 1 |
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Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2]
2-year bPFS rate is defined as the probability of biochemical progression free and survival at 2 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 2-year mark are censored at date of last disease evaluation. (NCT02903368)
Timeframe: At 2 years post RP
Intervention | percentage of subjects (Number) |
---|
Arm 2A: AAPL Adjuvant Therapy (Part 2) | 90 |
Arm 2B: Observation (Part 2) | 80 |
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Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2]
3-year bPFS rate is defined as the probability of biochemical progression free and survival at 3 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 3-year mark are censored at date last disease evaluation. (NCT02903368)
Timeframe: At 3 years post RP
Intervention | percentage of subjects (Number) |
---|
Arm 2A: AAPL Adjuvant Therapy (Part 2) | 81 |
Arm 2B: Observation (Part 2) | 72 |
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Frequency of Positive Surgical Margins at RP (Part 1)
Pathologic specimens were centrally reviewed and counted for positive surgical margins at the time of Radical Prostatectomy (RP). (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
Intervention | Participants (Count of Participants) |
---|
Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 4 |
Arm 1B: APL Neoadjuvant Therapy (Part 1) | 7 |
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Rate of Freedom From Further Anti-cancer Therapy at 3-years Post RP (Part 2)
Defined as the probability of freedom from further anti-cancer therapy at 3-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 3-year mark are censored at date of last follow-up. (NCT02903368)
Timeframe: At 3 years post RP
Intervention | percentage of subjects (Number) |
---|
Arm 2A: AAPL Adjuvant Therapy (Part 2) | 83 |
Arm 2B: Observation (Part 2) | 72 |
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Rate of Freedom From Further Anti-cancer Therapy at 4-years Post RP (Part 2)
Defined as the probability of freedom from further anti-cancer therapy at 4-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 4-year mark are censored at date of last follow-up. (NCT02903368)
Timeframe: At 4-years post RP
Intervention | percentage of subjects (Number) |
---|
Arm 2A: AAPL Adjuvant Therapy (Part 2) | 78 |
Arm 2B: Observation (Part 2) | 67 |
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Rate of pCR at RP (Part 1)
Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen at radical prostatectomy (RP). (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
Intervention | Participants (Count of Participants) |
---|
Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 7 |
Arm 1B: APL Neoadjuvant Therapy (Part 1) | 6 |
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Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL. (NCT02903368)
Timeframe: At 24-months post-RP
Intervention | score on 0-100 scale (Mean) |
---|
| Urinary Irritative | Urinary Incontinence | Bowel | Sexual | Hormonal |
---|
Arm 2A: AAPL Adjuvant Therapy (Part 2) | 92 | 75 | 95 | 31 | 88 |
,Arm 2B: Observation (Part 2) | 93 | 76 | 97 | 26 | 90 |
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Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL. (NCT02903368)
Timeframe: At 6-months post-RP
Intervention | Score on 0-100 (Mean) |
---|
| Urinary Irritative | Urinary Incontinence | Bowel | Sexual | Hormonal |
---|
Arm 2A: AAPL Adjuvant Therapy (Part 2) | 90 | 63 | 95 | 17 | 68 |
,Arm 2B: Observation (Part 2) | 92 | 72 | 96 | 14 | 83 |
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Percentage of Participants With Recurrence of Focal Segmental Glomerulosclerosis (rFSGS) or Death or Graft Loss or Lost to Follow-up Through 3 Months Post Transplant
rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS. (NCT02921789)
Timeframe: At 3 Months post transplant
Intervention | Percentage of participants (Number) |
---|
SOC Regimen | 31.3 |
Bleselumab Regimen | 18.5 |
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Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant
rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS. (NCT02921789)
Timeframe: At 6 and 12 Months post transplant
Intervention | Percentage of participants (Number) |
---|
| Month 6 | Month 12 |
---|
Bleselumab Regimen | 18.5 | 23.1 |
,SOC Regimen | 31.3 | 35.5 |
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Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant
All episodes of kidney dysfunction based on clinical signs and symptoms were evaluated for possible BPAR. BPAR was confirmed if participants Banff criteria >=1. (NCT02921789)
Timeframe: At 3, 6 and 12 Months post transplant
Intervention | Percentage of participants (Number) |
---|
| Month 3 | Month 6 | Month 12 |
---|
Bleselumab Regimen | 26.9 | 26.9 | 29.2 |
,SOC Regimen | 20.0 | 20.0 | 24.1 |
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Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant
Percentage of participants with biopsy-proven rFSGS determined by a blinded central review of images from electron microscopy (EM) and slides for light microscopy (LM) by an independent pathologist. (NCT02921789)
Timeframe: At 3, 6 and 12 Months post transplant
Intervention | Percentage of participants (Number) |
---|
| Month 3 | Month 6 | Month 12 |
---|
Bleselumab Regimen | 31.8 | 30.4 | 29.2 |
,SOC Regimen | 35.7 | 36.7 | 36.7 |
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Percentage of Participants With Efficacy Failure Through 12 Months Post Transplant
Efficacy failure was defined as BPAR, death, graft loss or lost to follow-up through 12 months post transplant. (NCT02921789)
Timeframe: 12 Months post transplant
Intervention | Percentage of participants (Number) |
---|
SOC Regimen | 32.3 |
Bleselumab Regimen | 32.0 |
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CT Scan Changes
CT scan of the sinuses, Lund Mackay score to access severity of sinus disease on CT scan. Scored on scale 0-20 with lower score better. (NCT02927834)
Timeframe: 4 week post treatment
Intervention | score out of total 20 (Mean) |
---|
Antibiotic Only | 10.33 |
Augmentin With 6 Day Steroid | 11 |
Augmentin With 21 Day Steroid | 11.83 |
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Nasal Endoscopy
Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better (NCT02927834)
Timeframe: 4 weeks post treatment
Intervention | score out of total 12 (Mean) |
---|
Antibiotic Only | 2.55 |
Augmentin With 6 Day Steroid | 3.00 |
Augmentin With 21 Day Steroid | 2.16 |
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Sinonasal Outcome Test (SNOT 20)
Sinonasal outcome test to access nasal/sinus symptoms. 20 questions, each question scored 0-5. 0 meaning no symptoms, 5 worse. 0- 100 total with lower number meaning better outcome (NCT02927834)
Timeframe: 4 weeks post treatment
Intervention | Score out of total 100 (Mean) |
---|
Antibiotic Only | 50.33 |
Augmentin With 6 Day Steroid | 53.14 |
Augmentin With 21 Day Steroid | 37 |
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Nonrelapse Mortality (NRM)
Defined as the proportion of subjects who died due to causes other than malignancy relapse. (NCT02953678)
Timeframe: From baseline to Months 6, 9, 12, and 24
Intervention | percentage of participants (Number) |
---|
| 6 months | 9 months | 12 months | 24 months |
---|
Ruxolitinib in Combination With Corticosteroids | 44.4 | 48.2 | 52.9 | 64.8 |
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Relapse Rate
Defined as the percentage of participants whose underlying malignancy relapsed. (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Intervention | percentage of participants (Number) |
---|
Ruxolitinib in Combination With Corticosteroids | 7.0 |
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Overall Response Rate (ORR) at Day 28
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). (NCT02953678)
Timeframe: From baseline to Day 28
Intervention | Participants (Count of Participants) |
---|
| Responders - CR | Responders - VGPR | Responders - PR |
---|
Ruxolitinib in Combination With Corticosteroids | 19 | 7 | 13 |
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Failure-free Survival (FFS)
Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD). (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Intervention | days (Median) |
---|
Ruxolitinib in Combination With Corticosteroids | 85.0 |
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Overall Survival (OS)
Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause. (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
Intervention | days (Median) |
---|
Ruxolitinib in Combination With Corticosteroids | 232.0 |
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Overall Response Rate (ORR)
Defined as the percentage of participants demonstrating a CR, VGPR, or PR. (NCT02953678)
Timeframe: From baseline to days 14, 56, and 100
Intervention | percentage of participants (Number) |
---|
| Day 14 | Day 56 | Day 100 |
---|
Ruxolitinib in Combination With Corticosteroids | 62.0 | 36.6 | 32.4 |
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Percentage of Participants With Six-month Duration of Response (DOR)
Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit. (NCT02953678)
Timeframe: From Baseline up to 6 months
Intervention | percentage of participants (Number) |
---|
Ruxolitinib in Combination With Corticosteroids | 68.2 |
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Percentage of Participants With Three-month DOR
Defined as the time from first response until GVHD progression or death. DOR was assessed when all participants who were on the study completed the Day 84 visit. (NCT02953678)
Timeframe: From Baseline up to 3 months
Intervention | percentage of participants (Number) |
---|
Ruxolitinib in Combination With Corticosteroids | 84.5 |
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Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE was an AE that was reported for the first time, or worsening of a pre-existing event after the first dose of study drug (until 30 days after the last dose of study drug). Severity of AEs was described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). Grade 3 and above would constitute a severe, life-threatening, or death event. (NCT02953678)
Timeframe: From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
Intervention | Participants (Count of Participants) |
---|
| TEAEs | Serious TEAEs | Grade 3 or Higher TEAEs |
---|
Ruxolitinib in Combination With Corticosteroids | 71 | 59 | 69 |
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Weight-Based Dose Requirement
Weight-based dose requirements to reach therapeutic goal pre- and post-conversion (NCT02953873)
Timeframe: Baseline to 3 months post conversion
Intervention | mg/kg (Median) |
---|
| Pre-Conversion | Post-Conversion |
---|
Conversion Arm | 0.11 | 0.16 |
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Total Daily Dose
Difference in Total Daily Dose necessary for steady state therapeutic goal (NCT02953873)
Timeframe: Baseline to 3 months post conversion
Intervention | mg (Median) |
---|
| Pre-Conversion Tacrolimus Dose | Post-Conversion Tacrolimus Dose |
---|
Conversion Arm | 10 | 15 |
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Number of Days to Reach Therapeutic Trough Goal
Days to reach therapeutic goal after conversion (NCT02953873)
Timeframe: Baseline to 3 months post conversion
Intervention | number of days (Median) |
---|
| Homozygous CYP3A5 1 expressors | Heterozygous CYP3A5 1 expressors | CYP3A5 1 non-expressors |
---|
Conversion Arm | 15 | 10 | 15 |
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Dose-normalized Trough
Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL® (NCT02953873)
Timeframe: Baseline to 3 months post-conversion
Intervention | ng/dL (Median) |
---|
| Pre-Conversion Dose Trough | Post-Conversion Dose Trough |
---|
Conversion Arm | 0.59 | 0.44 |
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Dose Modifications
Number of dose modifications from baseline to 3 months post-conversion. (NCT02953873)
Timeframe: Baseline to 3 months post conversion
Intervention | number of dose modifications (Median) |
---|
| Homozygous CYP3A5 1 expressors | Heterozygous CYP3A5 1 expressors | CYP3A5 1 non expressers |
---|
Conversion Arm | 1 | 2 | 4 |
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Self-reported Medication Adherence From Baseline to 6 Months.
Percent of subjects reporting high medication adherence at baseline compared to 6 months post-conversion, using the Morisky Medication Adherence scale (MMAS). The MMAS rates medication adherence on a scale of 0 to 8. 0 is high adherence, 1-2 is medium adherence, and greater than or equal to 3 is low adherence. (NCT02954198)
Timeframe: 6 months post conversion
Intervention | % of participants (Number) |
---|
| Baseline | 6 months post-conversion |
---|
Control: Envarsus + MMF | 80 | 59 |
,Intervention: Envarsus + Everoliumus | 45 | 47 |
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Subject Specific Change on Medication Side Effect Scale
Examine subject specific change on a validated Medication Side Effect Scale at the time of the conversion versus six months post-conversion, compared between the two arms. Side effect burden scale is from 0 to 180. A lower score is less side effect burden, a higher score is more side effect burden. (NCT02954198)
Timeframe: Baseline to 6 months post conversion
Intervention | units on a scale (Mean) |
---|
| Baseline | 6 month post-conversion |
---|
Control: Envarsus + MMF | 71 | 93 |
,Intervention: Envarsus + Everoliumus | 37 | 38 |
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Percent of Participants Who Experienced Kidney Transplant Graft Loss
Measure and compare time-to-event analysis between the two arms graft loss (time to event analysis) (NCT02954198)
Timeframe: Baseline to 6 months post conversion
Intervention | Participants (Count of Participants) |
---|
Control: Envarsus + MMF | 0 |
Intervention: Envarsus + Everoliumus | 0 |
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Percent of Participants Experiencing Acute Allograft Rejection
Estimate the composite of treatment failure rate, defined as acute allograft rejection with a Banff grade 1A or higher, graft loss, or death at six months post-conversion, in patients converted to a once-daily immunosuppressant regimen of Envarsus®, everolimus, and prednisone versus patients converted to a twice-daily regimen of Envarsus®, MMF, and prednisone. (NCT02954198)
Timeframe: Baseline to 6 months post conversion
Intervention | Participants (Count of Participants) |
---|
Control: Envarsus + MMF | 0 |
Intervention: Envarsus + Everoliumus | 0 |
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Number of Participants With Disease Flare
Disease relapse was defined as the recurrence of signs or symptoms of GCA (e.g., cranial or PMR) that required treatment intensification, regardless of the ESR and CRP levels. (NCT02955147)
Timeframe: 52 weeks
Intervention | Participants (Count of Participants) |
---|
Ustekinumab Plus Prednisone | 7 |
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Percentage of Patients in Glucocorticoid-free Remission
The primary study endpoint, prednisone-free remission, was defined as: 1) absence of relapse from the time that remission was achieved through week 52; 2) normalization of ESR (<40 mm/hour) and CRP (<10 mg/L); and, 3) adherence to the protocol prednisone taper. (NCT02955147)
Timeframe: 52 weeks
Intervention | Participants (Count of Participants) |
---|
Ustekinumab Plus Prednisone | 3 |
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Cumulative Prednisone Dose
(NCT02955147)
Timeframe: 52 weeks
Intervention | mg of prednisone (Mean) |
---|
Ustekinumab Plus Prednisone | 2289 |
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Number of Participants With at Least One Adverse Event
(NCT02955147)
Timeframe: 52 weeks
Intervention | Participants (Count of Participants) |
---|
Ustekinumab Plus Prednisone | 12 |
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Final Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days
(NCT02959944)
Timeframe: 24 weeks (Cumulatively up to 12 July 2021)
Intervention | percentage of participants (Number) |
---|
Ibrutinib + Prednisone | 41.1 |
Placebo + Prednisone | 45.9 |
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Final Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits
"Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment.~The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores." (NCT02959944)
Timeframe: Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021)
Intervention | percentage of participants (Number) |
---|
Ibrutinib + Prednisone | 43.2 |
Placebo + Prednisone | 30.6 |
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Final Analysis: Response Rate at 24 Weeks
"Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks.~Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site." (NCT02959944)
Timeframe: 24 weeks (Cumulatively up to 12 July 2021)
Intervention | percentage of participants (Number) |
---|
Ibrutinib + Prednisone | 47.4 |
Placebo + Prednisone | 54.1 |
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Final Analysis: Response Rate at 48 Weeks
"Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks.~Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site." (NCT02959944)
Timeframe: 48 weeks (Cumulatively up to 12 July 2021)
Intervention | percentage of participants (Number) |
---|
Ibrutinib + Prednisone | 41.1 |
Placebo + Prednisone | 36.7 |
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Primary Analysis: Duration of Response (DOR) for Participants Who Had PR or CR at Any Time
Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology. (NCT02959944)
Timeframe: Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020)
Intervention | months (Median) |
---|
Ibrutinib + Prednisone | 19.8 |
Placebo + Prednisone | 10.0 |
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Primary Analysis: Overall Survival (OS)
OS was defined as the time of randomization until the time of death due to any cause, in months. (NCT02959944)
Timeframe: Median time on study (cumulatively up to 30 March 2020) was 19.8 months and 18.4 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively.
Intervention | months (Median) |
---|
Ibrutinib + Prednisone | NA |
Placebo + Prednisone | NA |
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Primary Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days
(NCT02959944)
Timeframe: 24 weeks (Cumulatively up to 30 March 2020)
Intervention | percentage of participants (Number) |
---|
Ibrutinib + Prednisone | 40.0 |
Placebo + Prednisone | 45.9 |
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Primary Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits
"Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment.~The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores." (NCT02959944)
Timeframe: Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020)
Intervention | percentage of participants (Number) |
---|
Ibrutinib + Prednisone | 38.9 |
Placebo + Prednisone | 26.5 |
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Primary Analysis: Response Rate at 24 Weeks
"Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks.~Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site." (NCT02959944)
Timeframe: 24 weeks (Cumulatively up to 30 March 2020)
Intervention | percentage of participants (Number) |
---|
Ibrutinib + Prednisone | 47.4 |
Placebo + Prednisone | 54.1 |
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Primary Analysis: Response Rate at 48 Weeks
"Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks.~Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site." (NCT02959944)
Timeframe: 48 weeks (Cumulatively up to 30 March 2020)
Intervention | percentage of participants (Number) |
---|
Ibrutinib + Prednisone | 41.1 |
Placebo + Prednisone | 36.7 |
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Final Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD
The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. (NCT02959944)
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021)
Intervention | proportion of participants (Number) |
---|
| 3 Months | 6 Months | 9 Months | 12 Months | 15 Months | 18 Months | 21 Months | 24 Months |
---|
Ibrutinib + Prednisone | 0.042 | 0.218 | 0.318 | 0.406 | 0.439 | 0.450 | 0.495 | 0.495 |
,Placebo + Prednisone | 0.021 | 0.219 | 0.326 | 0.359 | 0.359 | 0.369 | 0.391 | 0.391 |
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Final Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants
The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. (NCT02959944)
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021)
Intervention | proportion of participants (Number) |
---|
| 3 Months | 6 Months | 9 Months | 12 Months | 15 Months | 18 Months | 21 Months | 24 Months |
---|
Ibrutinib + Prednisone | 0.011 | 0.143 | 0.222 | 0.280 | 0.314 | 0.349 | 0.372 | 0.406 |
,Placebo + Prednisone | 0.000 | 0.136 | 0.221 | 0.264 | 0.274 | 0.285 | 0.307 | 0.307 |
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Final Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone
AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug. (NCT02959944)
Timeframe: From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 12 July 2021), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months.
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Any Grade ≥ 3 TEAE | Any Ibrutinib-/Placebo-Related TEAE | Any Grade ≥ 3 Ibrutinib-/Placebo-Related TEAE | Any Corticosteroid-Related TEAE | Any Grade ≥ 3 Corticosteroid-Related TEAE | Any TEAE Leading to Discontinuation (DC) of Any Treatment | Any TEAE Leading to DC of Ibrutinib/Placebo | Any TEAE Leading to DC of Corticosteroid | Any Treatment Emergent SAE (TESAE) | Any Grade ≥ 3 TESAE | Any Treatment-Related TESAE | Any Ibrutinib/Placebo Treatment-Related TESAE | Any Corticosteroid Treatment-Related TESAE | Any Fatal TEAE |
---|
Ibrutinib + Prednisone | 93 | 64 | 67 | 35 | 72 | 34 | 23 | 22 | 10 | 49 | 46 | 29 | 26 | 26 | 12 |
,Placebo + Prednisone | 95 | 64 | 57 | 27 | 76 | 35 | 28 | 27 | 9 | 47 | 45 | 27 | 18 | 26 | 6 |
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Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD
The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. (NCT02959944)
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 30 March 2020)
Intervention | proportion of participants (Number) |
---|
| 3 Months | 6 Months | 9 Months | 12 Months | 15 Months | 18 Months |
---|
Ibrutinib + Prednisone | 0.042 | 0.229 | 0.318 | 0.392 | 0.419 | 0.419 |
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Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD
The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. (NCT02959944)
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 30 March 2020)
Intervention | proportion of participants (Number) |
---|
| 3 Months | 6 Months | 9 Months | 12 Months | 15 Months | 18 Months | 21 Months | 24 Months |
---|
Placebo + Prednisone | 0.021 | 0.216 | 0.322 | 0.356 | 0.356 | 0.356 | 0.425 | 0.425 |
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Primary Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants
The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. (NCT02959944)
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24 (cumulatively up to 30 March 2020)
Intervention | proportion of participants (Number) |
---|
| 3 Months | 6 Months | 9 Months | 12 Months | 15 Months | 18 Months | 21 Months | 24 Months |
---|
Ibrutinib + Prednisone | 0.011 | 0.142 | 0.220 | 0.256 | 0.285 | 0.313 | 0.376 | 0.421 |
,Placebo + Prednisone | 0.000 | 0.134 | 0.207 | 0.241 | 0.241 | 0.241 | 0.268 | 0.268 |
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Primary Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone
AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug. (NCT02959944)
Timeframe: From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 30 March 2020), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months.
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Any Grade ≥ 3 TEAE | Any Ibrutinib-/Placebo-Related TEAE | Any Grade ≥ 3 Ibrutinib-/Placebo-Related TEAE | Any Corticosteroid-Related TEAE | Any Grade ≥ 3 Corticosteroid-Related TEAE | Any TEAE Leading to Discontinuation (DC) of Any Treatment | Any TEAE Leading to DC of Ibrutinib/Placebo | Any TEAE Leading to DC of Corticosteroid | Any Treatment Emergent SAE (TESAE) | Any Grade ≥ 3 TESAE | Any Treatment-Related TESAE | Any Ibrutinib/Placebo Treatment-Related TESAE | Any Corticosteroid Treatment-Related TESAE | Any Fatal TEAE |
---|
Ibrutinib + Prednisone | 93 | 60 | 66 | 32 | 71 | 32 | 21 | 21 | 8 | 46 | 43 | 27 | 24 | 24 | 10 |
,Placebo + Prednisone | 95 | 64 | 58 | 28 | 77 | 36 | 24 | 23 | 8 | 48 | 46 | 28 | 19 | 27 | 7 |
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Final Analysis: DOR for Participants Who Had PR or CR at Any Time
Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology. (NCT02959944)
Timeframe: Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021)
Intervention | months (Median) |
---|
Ibrutinib + Prednisone | 19.1 |
Placebo + Prednisone | 10.2 |
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Final Analysis: OS
OS was defined as the time of randomization until the time of death due to any cause, in months. (NCT02959944)
Timeframe: Median time on study (cumulatively up to 12 July 2021) was 33.1 months and 32.5 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively.
Intervention | months (Median) |
---|
Ibrutinib + Prednisone | NA |
Placebo + Prednisone | NA |
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Objective Response Rate (ORR) Cohorts B and C Per BICR
"Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment.~Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).~Confidence-interval based on Clopper Pearson method." (NCT02985957)
Timeframe: From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
Intervention | Percent of Participants (Number) |
---|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 12.5 |
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 20.0 |
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Objective Response Rate (ORR) Cohort D
"In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment.~Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).~Confidence-interval based on Clopper Pearson method." (NCT02985957)
Timeframe: From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
Intervention | Percent of Participants (Number) |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 8.9 |
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 15.2 |
Cohort D Arm 3: Ipilimumab 3 mg/kg | 4.3 |
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 11.1 |
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Overall Survival (OS) Cohorts B and C
"Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From first dose to the date of death due to any cause (assessed up to approximately 61 months)
Intervention | Months (Median) |
---|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 19.75 |
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 15.21 |
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The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
The number of participants with an change in laboratory values from baseline Grade in Cohort D. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Intervention | Participants (Number) |
---|
| Hemoglobin | Platelet Count | Leukocytes | Lymphocytes (Absolute) | Absolute Neutrophil Count | Alkaline Phosphatase | Aspartate Aminotransferase | Alanine Aminotransferase | Bilirubin, Total | Creatinine | Amylase, Total | Lipase, Total | Hypernatremia | Hyponatremia | Hyperkalemia | Hypokalemia | Hypercalcemia | Hypocalcemia |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 23 | 9 | 6 | 20 | 7 | 23 | 16 | 19 | 3 | 18 | 12 | 14 | 4 | 21 | 7 | 3 | 2 | 11 |
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The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
The number of participants with an change in laboratory values from baseline Grade in Cohort D. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Intervention | Participants (Number) |
---|
| Hemoglobin | Platelet Count | Leukocytes | Lymphocytes (Absolute) | Absolute Neutrophil Count | Alkaline Phosphatase | Aspartate Aminotransferase | Alanine Aminotransferase | Bilirubin, Total | Creatinine | Amylase, Total | Lipase, Total | Hypernatremia | Hyponatremia | Hyperkalemia | Hypokalemia | Hypercalcemia | Hypocalcemia | Hyperglycemia | Hypoglycemia |
---|
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 34 | 7 | 7 | 21 | 7 | 18 | 18 | 21 | 1 | 13 | 15 | 15 | 3 | 9 | 8 | 8 | 5 | 21 | 9 | 0 |
,Cohort D Arm 3: Ipilimumab 3 mg/kg | 13 | 2 | 2 | 7 | 2 | 9 | 4 | 3 | 0 | 1 | 1 | 6 | 1 | 6 | 0 | 3 | 1 | 12 | 3 | 0 |
,Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 42 | 14 | 23 | 36 | 19 | 7 | 11 | 6 | 3 | 14 | 3 | 7 | 3 | 10 | 7 | 7 | 1 | 17 | 5 | 1 |
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The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Intervention | Participants (Number) |
---|
| Hemoglobin | Platelet Count | Leukocytes | Lymphocytes (Absolute) | Absolute Neutrophil Count | Alkaline Phosphatase | Aspartate Aminotransferase | Alanine Aminotransferase | Bilirubin, Total | Creatinine | Amylase, Total | Lipase, Total | Hypernatremia | Hyponatremia | Hyperkalemia | Hypokalemia | Hypercalcemia | Hypocalcemia | Hyperglycemia | Hypoglycemia |
---|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 6 | 3 | 1 | 9 | 0 | 7 | 9 | 5 | 3 | 5 | 8 | 6 | 1 | 8 | 1 | 3 | 0 | 4 | 0 | 0 |
,Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 23 | 8 | 7 | 17 | 6 | 15 | 17 | 14 | 0 | 8 | 6 | 3 | 0 | 15 | 5 | 7 | 0 | 12 | 2 | 0 |
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Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C
The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations. (NCT02985957)
Timeframe: At baseline and at Week 4 of Cycle 2.
Intervention | Score on a scale (Mean) |
---|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 0.0083 |
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | -0.0074 |
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The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
"The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.~TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal" (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Intervention | Participants (Count of Participants) |
---|
| TSH > ULN | TSH > ULN WITH TSH <= ULN AT BASELINE | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | TSH > ULN WITH FT3/FT4 TEST MISSING | TSH < LLN | TSH = LLN AT BASELINE | TSH ULN | TSH TSH < LLN WITH FT3/FT4 TEST MISSING | | |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 12 | 10 | 8 | 4 | 0 | 21 | 21 | 9 | 12 | 0 |
,Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 20 | 16 | 12 | 7 | 1 | 22 | 20 | 9 | 11 | 2 |
,Cohort D Arm 3: Ipilimumab 3 mg/kg | 1 | 1 | 0 | 1 | 0 | 7 | 6 | 1 | 5 | 1 |
,Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 11 | 6 | 3 | 5 | 3 | 6 | 5 | 3 | 3 | 0 |
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The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
"The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.~TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal" (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Intervention | Participants (Count of Participants) |
---|
| TSH > ULN | TSH > ULN WITH TSH <= ULN AT BASELINE | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | TSH > ULN WITH FT3/FT4 TEST MISSING | TSH < LLN | TSH = LLN AT BASELINE | TSH ULN | TSH TSH < LLN WITH FT3/FT4 TEST MISSING | | |
---|
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 5 | 3 | 4 | 1 | 0 | 7 | 6 | 4 | 2 | 1 |
,Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 13 | 7 | 6 | 4 | 3 | 10 | 10 | 8 | 1 | 1 |
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The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
"The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.~ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal" (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Intervention | Participants (Count of Participants) |
---|
| ALT OR AST > 3XULN | ALT OR AST> 5XULN | ALT OR AST> 10XULN | ALT OR AST > 20XULN | TOTAL BILIRUBIN > 2XULN |
---|
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 0 | 0 | 0 | 0 | 0 |
,Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 2 | 2 | 2 | 2 | 2 |
,Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 5 | 2 | 1 | 1 | 0 |
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The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Intervention | Participants (Count of Participants) |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 38 |
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 44 |
Cohort D Arm 3: Ipilimumab 3 mg/kg | 15 |
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 32 |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | 6 |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 | 16 |
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The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
"The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.~ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal" (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Intervention | Participants (Count of Participants) |
---|
| ALT OR AST > 3XULN | ALT OR AST> 5XULN | ALT OR AST> 10XULN | ALT OR AST > 20XULN | TOTAL BILIRUBIN > 2XULN | ALP>1.5XULN | CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>1.5XULN WITHIN 1 DAY | CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>1.5XULN WITHIN 30 DAYS | CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>2XULN WITHIN 1 DAY | CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>2XULN WITHIN 30 DAYS |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 6 | 3 | 1 | 0 | 2 | 22 | 1 | 1 | 1 | 1 |
,Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 8 | 5 | 3 | 1 | 0 | 24 | 0 | 0 | 0 | 0 |
,Cohort D Arm 3: Ipilimumab 3 mg/kg | 0 | 0 | 0 | 0 | 0 | 14 | 0 | 0 | 0 | 0 |
,Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 1 | 0 | 0 | 0 | 0 | 17 | 0 | 0 | 0 | 0 |
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The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Intervention | Participants (Count of Participants) |
---|
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 1 |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 17 |
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 18 |
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The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Intervention | Participants (Count of Participants) |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 16 |
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 26 |
Cohort D Arm 3: Ipilimumab 3 mg/kg | 7 |
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 13 |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | 2 |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 | 6 |
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The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Intervention | Participants (Count of Participants) |
---|
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 2 |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 45 |
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 45 |
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The Number of Participants Experiencing Adverse Events (AEs) in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Intervention | Participants (Count of Participants) |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 69 |
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 71 |
Cohort D Arm 3: Ipilimumab 3 mg/kg | 37 |
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 69 |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | 10 |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 | 25 |
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Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C
"Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.~Radiographic progression per Investigator assessment:~Bone disease progression by Prostate Cancer Working Group (PCWG2)~Non-bone soft tissue disease progression by RECIST v1.1~Clinical progression per investigator assessment:~Need for palliative radiation therapy involving more than one site, OR~Surgery of kyphoplasty to any neoplastic lesion, OR~Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Intervention | Months (Median) |
---|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 4.34 |
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 3.71 |
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Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D
"Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.~Radiographic progression per Investigator assessment:~Bone disease progression by Prostate Cancer Working Group (PCWG2)~Non-bone soft tissue disease progression by RECIST v1.1~Clinical progression per investigator assessment:~Need for palliative radiation therapy involving more than one site, OR~Surgery of kyphoplasty to any neoplastic lesion, OR~Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)
Intervention | Months (Median) |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 2.53 |
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 3.68 |
Cohort D Arm 3: Ipilimumab 3 mg/kg | 2.66 |
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 5.85 |
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Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D
The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations. (NCT02985957)
Timeframe: At baseline and 4 weeks after first dose.
Intervention | Score on a scale (Mean) |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 0.0032 |
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | -0.0328 |
Cohort D Arm 3: Ipilimumab 3 mg/kg | 0.0113 |
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 0.0219 |
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Radiographic Progression-Free Survival (rPFS) for Cohort D
"Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first.~The following progressive diseases were collected, documented and assessed as below:~Radiographic progression per BICR assessment~Bone disease progression by (Prostate Cancer Working Group) PCWG2~Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)
Intervention | Months (Median) |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 3.94 |
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 4.17 |
Cohort D Arm 3: Ipilimumab 3 mg/kg | 3.48 |
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 7.92 |
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Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR
"Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first.~The following progressive diseases were collected, documented and assessed as below:~Radiographic progression per retrospective Blinded Independent Central Review (BICR) assessment~Bone disease progression by Prostate Cancer Working Group (PCWG2)~Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Intervention | Months (Median) |
---|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 7.59 |
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 5.36 |
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Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C
"The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.~Confidence-interval based on Clopper Pearson method." (NCT02985957)
Timeframe: From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Intervention | Percent of Participants (Number) |
---|
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 17.6 |
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 10.0 |
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Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D
"The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.~Confidence-interval based on Clopper Pearson method." (NCT02985957)
Timeframe: From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Intervention | Percent of Participants (Number) |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 12.3 |
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 16.2 |
Cohort D Arm 3: Ipilimumab 3 mg/kg | 5.3 |
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 23.0 |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | 25.0 |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 | 16.0 |
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Overall Survival (OS) Cohort D
"Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From randomization to the date of death due to any cause (assessed up to approximately 61 months)
Intervention | Months (Median) |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 15.9 |
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 13.47 |
Cohort D Arm 3: Ipilimumab 3 mg/kg | 18.46 |
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 14.78 |
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The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Intervention | Participants (Count of Participants) |
---|
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 1 |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 17 |
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 33 |
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The Number of Participants Who Died in Cohort D
Death due to any cause. (NCT02985957)
Timeframe: From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).
Intervention | Participants (Count of Participants) |
---|
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W | 47 |
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 44 |
Cohort D Arm 3: Ipilimumab 3 mg/kg | 14 |
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 31 |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | 6 |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 | 17 |
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The Number of Participants Who Died in Cohorts A, B and C
Death due to any cause. (NCT02985957)
Timeframe: From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months).
Intervention | Participants (Count of Participants) |
---|
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 2 |
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 39 |
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 39 |
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The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Intervention | Participants (Number) |
---|
| Hemoglobin | Platelet Count | Leukocytes | Lymphocytes (Absolute) | Absolute Neutrophil Count | Alkaline Phosphatase | Aspartate Aminotransferase | Alanine Aminotransferase | Bilirubin, Total | Creatinine | Amylase, Total | Lipase, Total | Hypernatremia | Hyponatremia | Hyperkalemia | Hypokalemia | Hypercalcemia | Hypocalcemia |
---|
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity
"WBC=White Blood Cell~TEAE=Treatment-Emergent Adverse Event" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)
Intervention | Participants (Count of Participants) |
---|
| Any Treatment-Emergent Infection | Any Serious Treatment-Emergent Infection | Any Severe Treatment-Emergent Infection | Any Treatment-Emergent Infection Leading to Study Withdrawal | Any Treatment-Emergent Life-threatening Infection | Any Treatment-Emergent Infection Leading to Death | Any TEAE Associated with Hepatic Abnormalities | Any TEAE Associated with Low WBC Counts | Any TEAE Associated with hypersensitivity |
---|
Avacopan Group | 113 | 22 | 12 | 4 | 1 | 1 | 22 | 31 | 68 |
,Prednisone Group | 124 | 25 | 10 | 5 | 2 | 2 | 19 | 39 | 70 |
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Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period
"The median time to relapse was not estimable because of small number of relapsed subjects.~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 52
Intervention | percentage of participants (Number) |
---|
Prednisone Group | 21.0 |
Avacopan Group | 10.1 |
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Percentage of Subjects Achieving Sustained Disease Remission at Week 52
"Sustained remission at Week 52 was defined as:~Disease remission at Week 26 as defined above;~Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;~No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee." (NCT02994927)
Timeframe: Week 52
Intervention | percentage of participants (Number) |
---|
Prednisone Group | 54.9 |
Avacopan Group | 65.7 |
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Percentage of Subjects Achieving Disease Remission at Week 26
"Disease remission at Week 26 was defined as:~Achieving a BVAS of 0 as determined by the Adjudication Committee;~No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;~No BVAS >0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment)." (NCT02994927)
Timeframe: Week 26
Intervention | percentage of participants (Number) |
---|
Prednisone Group | 70.1 |
Avacopan Group | 72.3 |
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Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC
"AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;~The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
Prednisone Group | 68.9 |
Avacopan Group | 62.7 |
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Number of Subjects With Clinically Significant ECG Changes From Baseline
"Clinical significance was assessed by the individual reading of the ECGs~ECG=Electrocardiogram" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)
Intervention | Participants (Count of Participants) |
---|
Prednisone Group | 8 |
Avacopan Group | 12 |
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Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study
"BVAS=Birmingham Vasculitis Activity Score;~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)
Intervention | Participants (Count of Participants) |
---|
Prednisone Group | 33 |
Avacopan Group | 16 |
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Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study
"The median time to relapse was not estimable because of small number of relapsed subjects.~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 52
Intervention | percentage of participants (Number) |
---|
Prednisone Group | 12.2 |
Avacopan Group | 7.5 |
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Change From Baseline in Vital Signs (4/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | kilogram(s) (Mean) |
---|
| Weight (Week 26) | Weight (Week 52) |
---|
Avacopan Group | 1.93 | 2.59 |
,Prednisone Group | 3.33 | 3.27 |
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Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs
"AEs=Adverse events~SAEs=Serious adverse events~TEAE=Treatment-emergent adverse event" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)
Intervention | Number (Number) |
---|
| Number of subjects with at least one TEAE | Number of TEAEs | Number of subjects with SAEs | Number of SAEs | Subjects with TEAE leading to discontinuation |
---|
Avacopan Group | 164 | 1779 | 70 | 116 | 27 |
,Prednisone Group | 161 | 2139 | 74 | 166 | 28 |
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Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator
AE=Adverse Event (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)
Intervention | Participants (Count of Participants) |
---|
| Relationship of avacopan/placebo to an AE | Relationship of glucocorticoid use to an AE | Relationship of cyclophosphamide IV use to an AE | Relationship of oral cyclophosphamide use to an AE | Relationship of rituximab use to an AE | Relationship of azathioprine use to an AE | Relationship of mycophenolate use to an AE |
---|
Avacopan Group | 100 | 107 | 31 | 8 | 50 | 28 | 6 |
,Prednisone Group | 103 | 131 | 30 | 4 | 61 | 35 | 9 |
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In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks
"BVAS=Birmingham Vasculitis Activity Score~MCP-1=monocyte chemoattractant protein-1" (NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | Percentage change (Least Squares Mean) |
---|
| Week 26 | Week 52 |
---|
Avacopan Group | -67 | -73 |
,Prednisone Group | -64 | -71 |
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In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks
"Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.~eGFR=estimated glomerular filtration rate~BVAS=Birmingham Vasculitis Activity Score~MDRD=Modification of Diet in Renal Disease" (NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | Change in eGFR (mL/min/1.73 m^2) (Least Squares Mean) |
---|
| Week 26 | Week 52 |
---|
Avacopan Group | 5.8 | 7.3 |
,Prednisone Group | 2.9 | 4.1 |
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In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks
"BVAS=Birmingham Vasculitis Activity Score~UACR=Urinary albumin:creatinine ratio" (NCT02994927)
Timeframe: Baseline, Week 4, 26 and 52
Intervention | Percentage change (Least Squares Mean) |
---|
| Week 4 | Week 26 | Week 52 |
---|
Avacopan Group | -40 | -63 | -74 |
,Prednisone Group | 0 | -70 | -77 |
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Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI
"GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;~GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;~The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health)." (NCT02994927)
Timeframe: Baseline, Week 13 and 26
Intervention | Glucocorticoid Toxicity Index (Least Squares Mean) |
---|
| GTI-CWS (Week 13) | GTI-CWS (Week 26) | GTI-AIS (Week 13) | GTI-AIS (Week 26) |
---|
Avacopan Group | 25.7 | 39.7 | 9.9 | 11.2 |
,Prednisone Group | 36.6 | 56.6 | 23.2 | 23.4 |
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Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points
VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health). (NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | score on a scale (Least Squares Mean) |
---|
| Week 26 | Week 52 |
---|
Avacopan Group | 1.06 | 1.17 |
,Prednisone Group | 0.97 | 1.15 |
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Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index
"SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2)~EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels~The SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health)." (NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | Change from baseline (Least Squares Mean) |
---|
| SF-36v2: Physical Component Score (Week 26) | SF-36v2: Physical Component Score (Week 52) | SF-36v2: Physical Functioning (Week 26) | SF-36v2: Physical Functioning (Week 52) | SF-36v2: Role Physical (Week 26) | SF-36v2: Role Physical (Week 52) | SF-36v2: Bodily Pain (Week 26) | SF-36v2: Bodily Pain (Week 52) | SF-36v2: General Health Perception (Week 26) | SF-36v2: General Health Perception (Week 52) | SF-36v2: Mental Component Score (Week 26) | SF-36v2: Mental Component Score (Week 52) | SF-36v2: Mental Health (Week 26) | SF-36v2: Mental Health (Week 52) | SF-36v2: Role Emotional (Week 26) | SF-36v2: Role Emotional (Week 52) | SF-36v2: Social Functioning (Week 26) | SF-36v2: Social Functioning (Week 52) | SF-36v2: Vitality (Week 26) | SF-36v2: Vitality (Week 52) | EQ-5D-5L VAS Score (Week 26) | EQ-5D-5L VAS Score (Week 52) | EQ-5D-5L Index Score (Week 26) | EQ-5D-5L Index Score (Week 52) |
---|
Avacopan Group | 4.445 | 4.980 | 7.31 | 9.55 | 16.78 | 17.12 | 14.75 | 16.12 | 3.12 | 5.84 | 4.849 | 6.394 | 8.29 | 10.89 | 7.32 | 9.38 | 14.50 | 18.06 | 12.03 | 14.36 | 9.1 | 13.0 | 0.0229 | 0.0474 |
,Prednisone Group | 1.344 | 2.626 | 1.88 | 4.82 | 7.52 | 12.27 | 9.82 | 11.87 | -2.89 | -0.17 | 3.271 | 4.694 | 6.84 | 9.66 | 1.40 | 4.14 | 11.09 | 13.56 | 6.42 | 10.48 | 5.5 | 7.1 | -0.0010 | -0.0038 |
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Change From Baseline in Vital Signs (5/5)
BMI=Body Mass Index (NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | kilogram(s)/ square meter (Mean) |
---|
| BMI (Week 26) | BMI (Week 52) |
---|
Avacopan Group | 0.67 | 0.94 |
,Prednisone Group | 1.13 | 1.12 |
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Change From Baseline in Vital Signs (3/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | degree Celsius (Mean) |
---|
| Temperature (Week 26) | Temperature (Week 52) |
---|
Avacopan Group | -0.11 | -0.11 |
,Prednisone Group | -0.03 | 0.04 |
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Change From Baseline in Vital Signs (2/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | beats/min (Mean) |
---|
| Pulse Rate (Week 26) | Pulse Rate (Week 52) |
---|
Avacopan Group | 0.9 | -0.3 |
,Prednisone Group | 2.2 | -1.3 |
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Change From Baseline in Vital Signs (1/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | mmHg (Mean) |
---|
| Systolic Blood Pressure (Week 26) | Systolic Blood Pressure (Week 52) | Diastolic Blood Pressure (Week 26) | Diastolic Blood Pressure (Week 52) |
---|
Avacopan Group | -2.6 | -1.0 | 0.5 | 1.4 |
,Prednisone Group | -2.5 | -2.4 | 2.7 | 1.4 |
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | mg/dL (Mean) |
---|
| Creatinine (Week 26) | Creatinine (Week 52) | Urea Nitrogen (Week 26) | Urea Nitrogen (Week 52) | Protein (Week 26) | Protein (Week 52) | Cholesterol (Week 26) | Cholesterol (Week 52) | LDL Cholesterol (Week 26) | LDL Cholesterol (Week 52) | Bilirubin (Week 26) | Bilirubin (Week 52) |
---|
Avacopan Group | -0.195 | -0.244 | -11.0 | -11.9 | 220 | 250 | 7.4 | 9.3 | 12.0 | 11.9 | 0.078 | 0.057 |
,Prednisone Group | -0.105 | -0.200 | -9.4 | -7.8 | 50 | 160 | 19.0 | 13.8 | 22.7 | 21.7 | 0.065 | 0.053 |
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | U/L (Mean) |
---|
| Lactate Dehydrogenase (Week 26) | Lactate Dehydrogenase (Week 52) | Alkaline Phosphatase (Week 26) | Alkaline Phosphatase (Week 52) | Creatine Kinase (Week 26) | Creatine Kinase (Week 52) | Alanine Aminotransferase (Week 26) | Alanine Aminotransferase (Week 52) | Aspartate Aminotransferase (Week 26) | Aspartate Aminotransferase (Week 52) |
---|
Avacopan Group | -6.1 | -10.7 | -3.9 | -4.0 | 76.8 | 76.3 | -6.1 | -7.2 | 2.5 | 2.0 |
,Prednisone Group | 2.3 | -8.6 | -0.6 | 0.8 | 47.6 | 57.6 | -6.8 | -8.2 | 1.9 | 0.5 |
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | percentage of red blood cells (Mean) |
---|
| Hematocrit (Week 26) | Hematocrit (Week 52) |
---|
Avacopan Group | 2.7 | 3.2 |
,Prednisone Group | 2.6 | 3.0 |
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | g/dL (Mean) |
---|
| Hemoglobin (Week 26) | Hemoglobin (Week 52) |
---|
Avacopan Group | 1.10 | 1.27 |
,Prednisone Group | 1.07 | 1.20 |
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | 10^12 cells/L (Mean) |
---|
| Erythrocytes (Week 26) | Erythrocytes (Week 52) |
---|
Avacopan Group | 0.252 | 0.279 |
,Prednisone Group | 0.226 | 0.244 |
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | 10^9 cells/L (Mean) |
---|
| Eosinophils (Week 26) | Eosinophils (Week 52) | Basophils (Week 26) | Basophils (Week 52) | Monocytes (Week 26) | Monocytes (Week 52) | Platelets (Week 26) | Platelets (Week 52) |
---|
Avacopan Group | 0.07 | 0.07 | -0.00 | -0.01 | -0.04 | -0.01 | -77.1 | -73.8 |
,Prednisone Group | 0.07 | 0.05 | -0.01 | -0.01 | 0.01 | 0.01 | -73.9 | -75.5 |
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
Intervention | 10^3 cells/μL (Mean) |
---|
| Leukocytes (Week 26) | Leukocytes (Week 52) | Neutrophils (Week 26) | Neutrophils (Week 52) | Lymphocytes (Week 26) | Lymphocytes (Week 52) |
---|
Avacopan Group | -5.94 | -5.62 | -5.24 | -4.95 | -0.84 | -0.82 |
,Prednisone Group | -5.69 | -5.54 | -5.10 | -4.89 | -0.62 | -0.67 |
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Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Total Percentage
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
Intervention | percentage of participants (Number) |
---|
High Group for PDL1 % of Total Cells | 75 |
Low Group for PDL1 % of Total Cells | 20 |
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Percentage of Participants Who Responded During Induction and Continued Into Consolidation Therapy (Database Cutoff Date: 02-Aug-2018)
The percentage of participants who achieved a partial response (PR) or complete response (CR) at the end of Induction and continued into consolidation period in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined in outcome #1. PR was defined as a partial metabolic response and radiographic evidence showing ≥ 50% decrease in sum of perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites, no new lesions, spleen must have regressed > 50% in length beyond normal, and residual bone marrow involvement improved from baseline. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis was rejected if the lower limit of the confidence interval for the rate of subjects who continue consolidation therapy out of all subjects. (NCT03003520)
Timeframe: From first dose of study drug to completion of at least one cycle in the Consolidation Period (Day 1 up to Week 52)
Intervention | percentage of participants (Number) |
---|
DUR + R-CHOP | 67.6 |
DUR + R2-CHOP | 66.7 |
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Participants With Treatment Emergent Adverse Events (TEAE)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild (no limitation in activity or intervention); - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); - Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); - Grade 4 = Life-threatening; - Grade 5 = Death. Relation to IP is determined by the investigator. (NCT03003520)
Timeframe: From the date of the first dose of study drug to within 90 days after the last dose of durvalumab or 28 days after the last dose of any investigational product (IP) whichever is greater. (Up to approximately 72 weeks)
Intervention | Participants (Count of Participants) |
---|
| >= 1 Treatment-emergent adverse event (TEAE) | >=1 TEAE related to durvalumab | >=1 TEAE related to R-CHOP | >=1 TEAE related to durvalumab or any other IP | >=1 TEAE severity grade 3-4 | >=1 TEAE severity grade 3-4 related to durvalumab | >=1 TEAE severity grade 3-4 related to R-CHOP | >=1 TEAE severity grade 3-4 related to any IP | >=1 TEAE severity grade 5 | >=1 TEAE severity grade 5 related to any IP | >=1 serious TEAE | >=1 serious TEAE related to durvalumab | >=1 serious TEAE related to R-CHOP | >=1 serious TEAE related to any IP | >=1 leading to discontinuation of durvalumab | >=1 leading to discontinuation of R-CHOP | >=1 leading to discontinuation of any IP | >=1 leading to interruption of durvalumab | >=1 leading to interruption of R-CHOP | >=1 leading to interruption of any IP | >=1 leading to infusion interruption of durvalumab | >=1 leading to dose reduction of vincristine |
---|
DUR + R-CHOP | 43 | 33 | 40 | 41 | 37 | 18 | 27 | 31 | 3 | 0 | 23 | 10 | 10 | 14 | 13 | 4 | 13 | 15 | 12 | 18 | 2 | 4 |
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Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Percentage of Tumor Cells
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
Intervention | percentage of participants (Number) |
---|
High Group for PDL1 % of Tumor Cells | 64 |
Low Group for PDL1 % of Tumor Cells | 56 |
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Percentage of Participants Who Achieved a Complete Response (CR) at the End of Induction Therapy
The primary efficacy analysis evaluated the complete response rate (CRR) at the end of the induction therapy in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined as a complete metabolic response and radiographic evidence showing target nodes/nodal masses regressed to ≤ 1.5 cm in longest diameter, no new lesions, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis for the primary endpoint was rejected if the lower limit of the confidence interval for the complete response rate at the completion of the induction therapy in the efficacy evaluable population is above 55%. (NCT03003520)
Timeframe: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
Intervention | percentage of participants (Number) |
---|
DUR + R-CHOP | 54.1 |
DUR + R2-CHOP | 66.7 |
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Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for the Interferon Gamma Score (IFNG-Score) From Ribonucleic Acid (RNA)-Sequencing Data
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
Intervention | percentage of participants (Number) |
---|
High Group for RNA IFN Gamma Score | 43 |
Low Group for RNA IFN Gamma Score | 60 |
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Participants With Treatment Emergent Adverse Events (TEAE)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild (no limitation in activity or intervention); - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); - Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); - Grade 4 = Life-threatening; - Grade 5 = Death. Relation to IP is determined by the investigator. (NCT03003520)
Timeframe: From the date of the first dose of study drug to within 90 days after the last dose of durvalumab or 28 days after the last dose of any investigational product (IP) whichever is greater. (Up to approximately 72 weeks)
Intervention | Participants (Count of Participants) |
---|
| >= 1 Treatment-emergent adverse event (TEAE) | >=1 TEAE related to durvalumab | >=1 TEAE related to R-CHOP | >=1 TEAE related to lenalidomide | >=1 TEAE related to durvalumab or any other IP | >=1 TEAE severity grade 3-4 | >=1 TEAE severity grade 3-4 related to durvalumab | >=1 TEAE severity grade 3-4 related to R-CHOP | >=1 TEAE severity grade 3-4 related to lenalidomid | >=1 TEAE severity grade 3-4 related to any IP | >=1 TEAE severity grade 5 | >=1 TEAE severity grade 5 related to any IP | >=1 serious TEAE | >=1 serious TEAE related to durvalumab | >=1 serious TEAE related to R-CHOP | >=1 serious TEAE related to lenalidomide | >=1 serious TEAE related to any IP | >=1 leading to discontinuation of durvalumab | >=1 leading to discontinuation of R-CHOP | >=1 leading to discontinuation of lenalidomide | >=1 leading to discontinuation of any IP | >=1 leading to interruption of durvalumab | >=1 leading to interruption of R-CHOP | >=1 leading to interruption of lenalidomide | >=1 leading to interruption of any IP | >=1 leading to infusion interruption of durvalumab | >=1 leading to dose reduction of vincristine | >=1 leading to dose reduction of lenalidomide |
---|
DUR + R2-CHOP | 3 | 3 | 3 | 3 | 3 | 3 | 1 | 3 | 2 | 3 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 1 | 2 | 3 | 0 | 1 | 1 |
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Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) CD8 T-Cell Density
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
Intervention | percentage of participants (Number) |
---|
High Group for CD8 Density | 67 |
Low Group for CD8 Density | 64 |
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Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate
"Response was determined by having no detectable disease by multiparameter flow cytometry (MFC-). For Ph+ subjects, complete molecular response (CMR) by BCR-ABL RT-PCR was assigned when MFC was undetectable.~When no measurable residual disease was detected by MFC (MFC-) per EuroFlow criteria, high-throughput sequencing-based MRD testing (HTS; ClonoSEQ) was performed." (NCT03023046)
Timeframe: Within 4 cycles of study therapy
Intervention | Participants (Count of Participants) | Participants (Count of Participants) |
---|
| MFC-72545885 | MFC-72545886 | CMR72545885 | HTS-72545885 | HTS-72545886 |
---|
| Achieve within 4 cycles | Not achieved within 4 cycles |
---|
Ph+ Subjects | 20 |
Ph- Subjects | 9 |
Ph+ Subjects | 11 |
Ph+ Subjects | 17 |
Ph+ Subjects | 8 |
Ph- Subjects | 6 |
Ph+ Subjects | 16 |
Ph- Subjects | 16 |
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Overall Survival
Alive at 2 years after enrollment (NCT03023046)
Timeframe: Up to 2 years
Intervention | Percentage of Participants (Number) |
---|
Treatment (Chemotherapy) | 70 |
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Number of Participants With Morphological Complete Response Rate
Morphological complete remission (CR) was determined by bone marrow aspirate morphology and defined as <5% blasts by morphology, absolute neutrophil count >1000/uL, and platelet count >100,000/uL. (NCT03023046)
Timeframe: Within 4 cycles of study therapy
Intervention | Participants (Count of Participants) |
---|
Ph+ Subjects | 27 |
Ph- Subjects | 20 |
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Number of Participants With Adverse Events
Grade 1 or higher non-hematologic adverse events will be assessed by Common Terminology Criteria for Adverse Events version 5.0. (NCT03023046)
Timeframe: Within 28 days of the last dose of the study drugs
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy) | 44 |
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Event-free Survival
Events were defined as any of the following: (1) unable to achieve either morphologic complete remission (CR) or MRD- by MFC, (2) relapse after CR, (3) MRD recurrence after achieving MRD-, or (4) death from any cause. (NCT03023046)
Timeframe: Up to 2 years
Intervention | Percentage of Participants (Number) |
---|
Treatment (Chemotherapy) | 32 |
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Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels
"AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone.~C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)" (NCT03023891)
Timeframe: baseline and 4-8 hours after drug administration
Intervention | ng*min/mL (Mean) |
---|
| Visit 1: baseline | Visit 2: 4-8 hours post prednisone |
---|
Prednisone | 493.89 | 449.41 |
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Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels
"AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone.~Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2)." (NCT03023891)
Timeframe: baseline and 4-8 hours after drug administration
Intervention | μU*min/mL (Mean) |
---|
| Visit 1: baseline | Visit 2: 4-8 hours post prednisone |
---|
Prednisone | 5415.87 | 5466.55 |
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White Blood Cell Counts
White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2) (NCT03023891)
Timeframe: baseline and within 4 and 8 hours after drug administration
Intervention | x10^3 cells/mL (Mean) |
---|
| Visit 1: baseline | Visit 2: 4 to 8 hours post prednisone |
---|
Prednisone | 5.26 | 6.99 |
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Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose
"AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration.~Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)" (NCT03023891)
Timeframe: baseline and 4-8 hours after drug administration
Intervention | mg*min/dL (Mean) |
---|
| Visit 1: baseline | Visit 2: 4-8 hours post prednisone |
---|
Prednisone | 13530.56 | 20273.75 |
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Number of Patients With Durable Tumor and Symptomatic Response
Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 6 months. (NCT03043105)
Timeframe: From baseline to the time point when a patient achieves treatment response for 24 weeks.
Intervention | Participants (Count of Participants) |
---|
TCP Treatment Group | 12 |
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Overall Survival
Overall survival, defined as the time to patients' death, is measured. (NCT03043105)
Timeframe: From date of randomization until the date of death from any cause, assessed up to 36 months.
Intervention | months (Mean) |
---|
TCP Treatment Group | 32.16 |
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Progression-free Survival
Progression-free survival (PFS) is defined as the time to death or treatment failure. Treatment failure is defined as: sustained increase in grade ≥2 disease-related symptoms persisting ≥12 weeks; new disease-related grade ≥3 symptoms; sustained >1 point increase in ECOG-PS persisting for ≥12 weeks; radiological progression; or initiation of another treatment for MCD. (NCT03043105)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Intervention | months (Mean) |
---|
TCP Treatment Group | 23.32 |
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Change in SF-36 Score
SF-36 score is a self-administered scoring system which reflects a patient's general health status. SF-36 contains 8 dimensions, including physical functioning, role physical, role emotional, vitality, mental health, social functioning, bodily pain, and general health. Each dimension ranges from 0 to 100. Higher scores mean better outcome. SF-36 score at baseline was compared with SF-36 score at 24 weeks. (NCT03043105)
Timeframe: From baseline to 24 weeks after treatment.
Intervention | score on a scale (Mean) |
---|
| physical functioning | role physical | role emotional | vitality | mental health | social functioning | bodily pain | general health |
---|
TCP Treatment Group | 15.1 | 26.7 | 19.6 | 11.1 | 8.5 | 13.6 | 15.8 | 9.1 |
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Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (Intent-To-Treat (ITT) Population)
Radiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Disease progression for soft tissue is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the sum of diameters of target lesions; progression of non target lesions; the appearance of one or more new lesions. Disease progression for bone lesions is defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. rPFS will be analyzed in the Intent-to-Treat (ITT) population. (NCT03072238)
Timeframe: Up to approximately 31 months
Intervention | Months (Median) |
---|
Placebo + Abiraterone | 16.6 |
Ipatasertib + Abiraterone | 19.2 |
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Plasma Concentrations of Abiraterone at Specified Timepoints
Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants. (NCT03072238)
Timeframe: Pre-dose at steady state in Cycle 1, Day 15 and Cycle 3 Day 1 (each cycle length= 28 days)
Intervention | ng/mL (Geometric Mean) |
---|
| Cycle 1 Day 15 | Cycle 3 Day 1 |
---|
Ipatasertib + Abiraterone | 9.40 | 9.55 |
,Placebo + Abiraterone | 11.2 | 10.4 |
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Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (PTEN Loss Population)
Radiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Disease progression for soft tissue is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the sum of diameters of target lesions; progression of non target lesions; the appearance of one or more new lesions. Disease progression for bone lesions is defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. rPFS will be analyzed in participants with phosphatase and tensin homolog (PTEN) - loss tumors (using the Ventana PTEN immunohistochemistry (IHC) assay). (NCT03072238)
Timeframe: Up to approximately 31 months
Intervention | Months (Median) |
---|
Placebo + Abiraterone | 16.5 |
Ipatasertib + Abiraterone | 18.5 |
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Plasma Concentrations of Ipatasertib at Specified Timepoints
Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants. (NCT03072238)
Timeframe: 1-3 hours post-dose (Cycle 1, Day 1; Cycle 1 Day 15 and Cycle 3 Day 1) and pre-dose at steady state (Cycle 1 Day 15, Cycle 3 Day 1, Cycle 6 Day 1) (each cycle length= 28 days)
Intervention | ng/mL (Geometric Mean) |
---|
| Cycle 1 Day 1 Post-dose | Cycle 1 Day 15 Pre-dose | Cycle 1 Day 15 Post-dose | Cycle 3 Day 1 Pre-dose | Cycle 3 Day 1 Post-dose | Cycle 6 Day 1 Pre-dose |
---|
Ipatasertib + Abiraterone | 212 | 46.8 | 247 | 35.4 | 207 | 46.1 |
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To Evaluate Progression-free Survival on the Combination of Docetaxel Plus Apalutamide
"Progression free survival (PFS) is defined as the time from treatment initiation until the occurrence of one of the following:~A participant was considered to have progressed by bone scan if~the first bone scan with greater than or equal to (≥) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from study drug initiation and was confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline);~the first bone scan with ≥2 new lesions compared to baseline was observed in ≥12 weeks from study drug initiation and the new lesions were verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline);~Progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) by RECIST v. 1.1; or~Death from any cause." (NCT03093272)
Timeframe: Disease was evaluated radiologically at baseline and every 12 weeks on treatment; PFS follow up was up to 9.4 months
Intervention | months (Number) |
---|
| Participant 1 | Participant 2 | Participant 3 | Participant 4 | Participant 5 | Participant 6 | Participant 7 | Participant 8 | Participant 9 |
---|
Apalutamide Combined With Docetaxel | 5.6 | NA | 5.6 | 8.1 | 1.8 | 4.8 | 5.1 | NA | 9.4 |
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Serum PSA Change From Baseline to 12 Weeks on Treatment
The maximum percent PSA change (rise or fall) from baseline to after 12 weeks on study. For patients who discontinue on or before the 12 week assessment or for whom the 12 week assessment is missing, the last observation prior to the week 12 assessment will be utilized. Patients with no post-baseline PSA data will be excluded from the summary. (NCT03093272)
Timeframe: PSA was measured on Cycle 1 Day 1 (Baseline) and at 12 weeks on treatment.
Intervention | percent (Median) |
---|
Apalutamide Combined With Docetaxel | 13.0 |
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Maximum Blood Concentration (Cmax) for Docetaxel Pharmacokinetic Analysis
The pharmacokinetic (PK) parameters of the first 9 patients enrolled at Dana-Farber Cancer Institute will be determined using noncompartmental methods with WinNonLin version 5.2. Maximum blood concentration (Cmax) will be determined by visual inspection. Due to the premature termination of the study, only 9 patients were evaluated. The PK samples were collected on Days 1 and 2 of the first two treatment cycles. (NCT03093272)
Timeframe: Cycle 1, 2: During infusion at pre-dose, 15 minutes and 30 minutes post-dose, end of dose, and 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post dose.
Intervention | ng/mL (Mean) |
---|
| Cycle 1 | Cycle 2 |
---|
Apalutamide Combined With Docetaxel | 2415 | 1641 |
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Area Under the Curve (AUC) for Docetaxel Pharmacokinetic Analysis
The area under the blood concentration-time curve (linear trapezoidal rule) will be determined between 0-24 hours (AUC0-24). The PK samples were collected during the first two days of cycles 1 and 2. (NCT03093272)
Timeframe: Cycle 1, 2: During infusion at pre-dose, 15 minutes and 30 minutes post-dose, end of dose, and 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post dose.
Intervention | ng•h/mL (Mean) |
---|
| Cycle 1 | Cycle 2 |
---|
Apalutamide Combined With Docetaxel | 3406 | 3095 |
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Overall Survival
Overall Survival (OS) is defined as the time from trial treatment start to death due to any cause, or censored at date last known alive. (NCT03093272)
Timeframe: Measured from end of study treatment to death due to any cause; OS measured as 22.4 months
Intervention | months (Number) |
---|
| Participant 1 | Participant 2 | Participant 3 | Participant 4 | Participant 5 | Participant 6 | Participant 7 | Participant 8 | Participant 9 |
---|
Apalutamide Combined With Docetaxel | 22.4 | 4.2 | 21.2 | 16.8 | 1.8 | 9.0 | 10.1 | 5.9 | 12.2 |
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Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy
CR rate was estimated by the proportion of evaluable patients achieving CR after CHEP-BV induction therapy, along with the 95% exact binomial confidence interval. (NCT03113500)
Timeframe: Up to the end of the CHEP-BV treatment
Intervention | percentage of response rate (Number) |
---|
Treatment (CHEP-BV) | 79 |
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Overall Survival at 1 Year
Overall survival (OS) was measured from enrollment to death from any cause. OS was estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. (NCT03113500)
Timeframe: The time from enrollment to death from any cause assessed up to 1 year.
Intervention | percentage of survival probability (Number) |
---|
Treatment (CHEP-BV) | 91 |
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Incidence Rate of aGVHD Flares
(NCT03139604)
Timeframe: up to day 100
Intervention | participants (Number) |
---|
Itacitinib Plus Corticosteroids | 42 |
Placebo Plus Corticosteroids | 48 |
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Failure-free Survival
Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD) (NCT03139604)
Timeframe: 6 months from randomization
Intervention | proportion of participants (Number) |
---|
Itacitinib Plus Corticosteroids | 44.29 |
Placebo Plus Corticosteroids | 40.00 |
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Duration of Response
Defined as the interval from first response until GVHD progression or death. (NCT03139604)
Timeframe: Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months
Intervention | days (Median) |
---|
Itacitinib Plus Corticosteroids | 587 |
Placebo Plus Corticosteroids | NA |
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Time to Response
Defined as the interval from treatment initiation to first response (NCT03139604)
Timeframe: End of Study, total particpation expected to average 24 months
Intervention | days (Mean) |
---|
Itacitinib Plus Corticosteroids | 9.9 |
Placebo Plus Corticosteroids | 10.1 |
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Number of Treatment-emergent Adverse Events With INCB39110
Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment (NCT03139604)
Timeframe: 30-35 days after end of treatment, approximately 24 months
Intervention | participants (Number) |
---|
Itacitinib Plus Corticosteroids | 208 |
Placebo Plus Corticosteroids | 214 |
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Cmin of Itacitinib When Administered in Combination With Corticosteroids
Defined as minimum observed plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28
Intervention | nM (Mean) |
---|
Itacitinib Plus Corticosteroids | 72.5 |
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Cmax of Itacitinib When Administered in Combination With Corticosteroids
Defined as maximum observed plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28
Intervention | nM (Mean) |
---|
Itacitinib Plus Corticosteroids | 796 |
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CL/F of Itacitinib When Administered in Combination With Corticosteroids
Defined as oral dose clearance. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28
Intervention | L/h (Mean) |
---|
Itacitinib Plus Corticosteroids | 104 |
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AUC of Itacitinib When Administered in Combination With Corticosteroids
Defined as area under the concentration-time curve. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28
Intervention | nM*h (Mean) |
---|
Itacitinib Plus Corticosteroids | 6720 |
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Proportion of Subjects Who Discontinue Corticosteroids
Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated (NCT03139604)
Timeframe: Days 28, 56, 100, and 180
Intervention | participants (Number) |
---|
| Day 28 | Day 56 | Day 100 | Day 180 |
---|
Itacitinib Plus Corticosteroids | 3 | 16 | 39 | 39 |
,Placebo Plus Corticosteroids | 3 | 11 | 45 | 45 |
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Objective Response Rate
(NCT03139604)
Timeframe: Days 14, 56 and 100
Intervention | participants (Number) |
---|
| Day 14 | Day 56 | Day 100 |
---|
Itacitinib Plus Corticosteroids | 170 | 138 | 92 |
,Placebo Plus Corticosteroids | 160 | 124 | 96 |
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Nonrelapse Mortality
Defined as the percentage of participants who died due to causes other than malignancy relapse. (NCT03139604)
Timeframe: Month 6,9,12 and 24
Intervention | participants (Number) |
---|
| 6 Months | 9 Months | 12 Months | 24 Months |
---|
Itacitinib Plus Corticosteroids | 36 | 46 | 51 | 56 |
,Placebo Plus Corticosteroids | 37 | 45 | 52 | 52 |
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Incidence Rate of cGVHD
(NCT03139604)
Timeframe: Days 180 and 365
Intervention | participants (Number) |
---|
| Day 180 | Day 365 |
---|
Itacitinib Plus Corticosteroids | 25 | 43 |
,Placebo Plus Corticosteroids | 36 | 58 |
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Tmax of Itacitinib When Administered in Combination With Corticosteroids
Defined as time to maximum plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28
Intervention | hrs (Median) |
---|
Itacitinib Plus Corticosteroids | 2.1 |
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Relapse Rate of Malignant and Nonmalignant Hematologic Disease
Defined as the proportion of subjects whose underlying hematologic disease relapses (NCT03139604)
Timeframe: Randomization through end of Study, study duration expected to average 24 months
Intervention | percentage (Number) |
---|
Itacitinib Plus Corticosteroids | 12.4 |
Placebo Plus Corticosteroids | 11.4 |
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Overall Survival (OS)
Defined as the interval from study enrollment to death due to any cause. (NCT03139604)
Timeframe: End of Study up to approximately 24 months
Intervention | days (Median) |
---|
Itacitinib Plus Corticosteroids | 365 |
Placebo Plus Corticosteroids | 348.5 |
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Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). (NCT03139604)
Timeframe: Day 28
Intervention | Percentage of Participants (Number) |
---|
Itacitinib Plus Corticosteroids | 74.0 |
Placebo Plus Corticosteroids | 66.4 |
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Proportion of Subjects Who Discontinue Immunosuppressive Medications
Summary statistics of subjects discontinuing immunosuppressive medications will be calculated (NCT03139604)
Timeframe: Days 56 and 100
Intervention | participants (Number) |
---|
| Day 56 | Day 100 |
---|
Itacitinib Plus Corticosteroids | 12 | 11 |
,Placebo Plus Corticosteroids | 10 | 8 |
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Incidence Rate of Secondary Graft Failure
Defined as > 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (< 0.5 × 109/L) and/or thrombocytopenia (< 20 × 109/L) within 2 months of transplantion (NCT03139604)
Timeframe: Randomization through end of Study, study duration expected to average 24 months
Intervention | participants (Number) |
---|
Itacitinib Plus Corticosteroids | 2 |
Placebo Plus Corticosteroids | 0 |
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Number of Participants With AEs Leading to Any Dose Reduction or Delays Until End of the Study
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of Participants with AEs leading to any dose reduction or delays from start of the treatment until end of the study were reported. (NCT03150056)
Timeframe: Up to 3 years and 11 months
Intervention | Participants (Count of Participants) |
---|
| Dose reduction | Dose delay |
---|
GSK525762 40 mg+Abiraterone 1000 mg | 0 | 4 |
,GSK525762 60 mg Alternate+Abiraterone 1000 mg | 1 | 2 |
,GSK525762 60 mg Alternate+Enzalutamide 160 mg | 7 | 12 |
,GSK525762 60 mg+Abiraterone 1000 mg | 4 | 5 |
,GSK525762 60 mg+Enzalutamide 160 mg | 10 | 15 |
,GSK525762 80 mg+Enzalutamide 160 mg | 7 | 8 |
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61
Intervention | Scores on a scale (Mean) |
---|
| Week 1 Day 1,n=1,0,0,0,2,0 | Week 2 Day 1,n=6,1,2,4,4,8 | Week 3 Day 1,n=6,0,1,4,3,7 | Week 4 Day 1,n=6,1,2,3,6,10 | Week 5 Day 1,n=3,0,1,3,5,9 | Week 9 Day 1,n=2,0,1,2,3,6 | Week 13 Day 1,n=1,1,1,1,2,3 | Week 17 Day 1,n=1,1,1,1,1,3 | Week 33 Day 1,n=0,0,1,0,1,2 |
---|
GSK525762 60 mg+Enzalutamide 160 mg | 4.2 | 0.0 | 2.8 | 1.4 | 0.0 | -30.6 | -8.3 | 0.0 | 0.0 |
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Cmax of Abiraterone
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
| Week 1 Day 1, n=10,5,4 | Week 3 Day 1, n=4,4,2 |
---|
GSK525762 40 mg+Abiraterone 1000 mg | 122.496 | 146.924 |
,GSK525762 60 mg Alternate+Abiraterone 1000 mg | 63.369 | 87.554 |
,GSK525762 60 mg+Abiraterone 1000 mg | 77.962 | 149.673 |
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Ctrough of Enzalutamide
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25
Intervention | Microgram per milliliter (Geometric Mean) |
---|
| Week 1 Day 1, Pre-dose, n=9,20,18 | Week 3 Day 1, Pre-dose, n=9,19,13 | Week 5 Day 1, Pre-dose, n=10,15,18 | Week 9 Day 1, Pre-dose, n=6,6,13 | Week 17 Day 1, Pre-dose, n=4,2,4 | Week 25 Day 1, Pre-dose, n=2,2,2 |
---|
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 14.546 | 11.497 | 12.561 | 12.056 | 10.267 | 13.791 |
,GSK525762 60 mg+Enzalutamide 160 mg | 13.313 | 10.902 | 9.814 | 8.064 | 12.568 | 13.069 |
,GSK525762 80 mg+Enzalutamide 160 mg | 13.066 | 10.385 | 10.026 | 10.021 | 8.621 | 10.103 |
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Number of Participants With AEs Leading to Any Dose Reduction or Delays
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to any dose reduction or delays have been presented. (NCT03150056)
Timeframe: Up to 21.3 months
Intervention | Participants (Count of Participants) |
---|
| Dose reduction | Dose delay |
---|
GSK525762 40 mg+Abiraterone 1000 mg | 0 | 4 |
,GSK525762 60 mg Alternate+Abiraterone 1000 mg | 1 | 2 |
,GSK525762 60 mg Alternate+Enzalutamide 160 mg | 7 | 12 |
,GSK525762 60 mg+Abiraterone 1000 mg | 4 | 5 |
,GSK525762 60 mg+Enzalutamide 160 mg | 10 | 15 |
,GSK525762 80 mg+Enzalutamide 160 mg | 7 | 8 |
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Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment Until End of the Study
Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs from start of the treatment until end of the study were reported. (NCT03150056)
Timeframe: Up to 3 years and 11 months
Intervention | Participants (Count of Participants) |
---|
GSK525762 60 mg+Abiraterone 1000 mg | 6 |
GSK525762 60 mg Alternate+Abiraterone 1000 mg | 2 |
GSK525762 40 mg+Abiraterone 1000 mg | 2 |
GSK525762 80 mg+Enzalutamide 160 mg | 3 |
GSK525762 60 mg+Enzalutamide 160 mg | 8 |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 4 |
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Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Until End of the Study
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function. Number of Participants With any AEs and SAEs collected from start of the treatment until end of the study were reported. (NCT03150056)
Timeframe: Up to 3 years and 11 months
Intervention | Participants (Count of Participants) |
---|
| Any AEs | Any SAEs |
---|
GSK525762 40 mg+Abiraterone 1000 mg | 4 | 0 |
,GSK525762 60 mg Alternate+Abiraterone 1000 mg | 6 | 2 |
,GSK525762 60 mg Alternate+Enzalutamide 160 mg | 21 | 7 |
,GSK525762 60 mg+Abiraterone 1000 mg | 10 | 4 |
,GSK525762 60 mg+Enzalutamide 160 mg | 22 | 6 |
,GSK525762 80 mg+Enzalutamide 160 mg | 10 | 1 |
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Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
Performance status assessments were based on 6-point ECOG scale (from 0 to 5), where 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work); 2=ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5=dead. Data for worst case post-Baseline is presented. (NCT03150056)
Timeframe: Up to 21.3 months
Intervention | Participants (Count of Participants) |
---|
| 0 | 1 | 2 | 3 | 4 | 5 |
---|
GSK525762 40 mg+Abiraterone 1000 mg | 0 | 3 | 0 | 1 | 0 | 0 |
,GSK525762 60 mg Alternate+Abiraterone 1000 mg | 0 | 4 | 2 | 0 | 0 | 0 |
,GSK525762 60 mg Alternate+Enzalutamide 160 mg | 1 | 13 | 6 | 1 | 0 | 0 |
,GSK525762 60 mg+Abiraterone 1000 mg | 2 | 7 | 1 | 0 | 0 | 0 |
,GSK525762 60 mg+Enzalutamide 160 mg | 1 | 16 | 3 | 1 | 0 | 0 |
,GSK525762 80 mg+Enzalutamide 160 mg | 2 | 5 | 3 | 0 | 0 | 0 |
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61
Intervention | Scores on a scale (Mean) |
---|
| Week 2 Day 1,n=6,1,2,4,4,8 | Week 3 Day 1,n=6,0,1,4,3,7 | Week 4 Day 1,n=6,1,2,3,6,10 | Week 5 Day 1,n=3,0,1,3,5,9 | Week 9 Day 1,n=2,0,1,2,3,6 | Week 13 Day 1,n=1,1,1,1,2,3 | Week 17 Day 1,n=1,1,1,1,1,3 | Week 21 Day 1,n=0,0,1,1,0,2 |
---|
GSK525762 80 mg+Enzalutamide 160 mg | -2.1 | -4.2 | 5.6 | -5.6 | -20.8 | 0.0 | 0.0 | 0.0 |
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61
Intervention | Scores on a scale (Mean) |
---|
| Week 1 Day 1,n=1,0,0,0,2,0 | Week 2 Day 1,n=6,1,2,4,4,8 | Week 3 Day 1,n=6,0,1,4,3,7 | Week 4 Day 1,n=6,1,2,3,6,10 | Week 5 Day 1,n=3,0,1,3,5,9 | Week 9 Day 1,n=2,0,1,2,3,6 | Week 13 Day 1,n=1,1,1,1,2,3 | Week 17 Day 1,n=1,1,1,1,1,3 |
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GSK525762 60 mg+Abiraterone 1000 mg | 8.3 | -8.3 | -8.3 | -8.3 | -8.3 | -12.5 | -25.0 | -25.0 |
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Cmax of Enzalutamide
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25
Intervention | Microgram per milliliter (Geometric Mean) |
---|
GSK525762 80 mg+Enzalutamide 160 mg | NA |
GSK525762 60 mg+Enzalutamide 160 mg | NA |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | NA |
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Circulating Tumor Cells (CTC) Response Rate
CTC response rate is defined as the percentage of participants with a CTC conversion to <5/7.5 mL blood at nadir (confirmed by a second consecutive value obtained four or more weeks later) for participants with unfavourable CTC (>=5/7.5 mL) at Baseline. CI was computed using exact two sided 95% CI. (NCT03150056)
Timeframe: Up to 21.3 months
Intervention | Percentage of participants (Number) |
---|
GSK525762 60 mg+Abiraterone 1000 mg | 0 |
GSK525762 60 mg Alternate+Abiraterone 1000 mg | 0 |
GSK525762 80 mg+Enzalutamide 160 mg | 33 |
GSK525762 60 mg+Enzalutamide 160 mg | 8 |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 0 |
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AUC(0-tau) of Enzalutamide
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25
Intervention | Hours*microgram per milliliter (Geometric Mean) |
---|
GSK525762 80 mg+Enzalutamide 160 mg | NA |
GSK525762 60 mg+Enzalutamide 160 mg | NA |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | NA |
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Ctrough of Abiraterone
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
| Week 1 Day 1, n=9,2,3 | Week 3 Day 1, n=2,4,1 |
---|
GSK525762 40 mg+Abiraterone 1000 mg | 11.263 | 21.800 |
,GSK525762 60 mg Alternate+Abiraterone 1000 mg | 4.636 | 7.697 |
,GSK525762 60 mg+Abiraterone 1000 mg | 7.603 | 15.114 |
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Prostate-specific Antigen (PSA) Response Rate at Week 4
PSA Response Rate is defined as percentage of participants achieving >=30% decrease from Baseline PSA after 4 weeks of study treatment. The CI was calculated using exact two sided 95% CI for the percentage of participants with Baseline PSA values who show >=30% reduction in PSA at >=4 weeks post-Baseline. (NCT03150056)
Timeframe: Week 4
Intervention | Percentage of participants (Number) |
---|
GSK525762 60 mg+Abiraterone 1000 mg | 0 |
GSK525762 60 mg Alternate+Abiraterone 1000 mg | 17 |
GSK525762 40 mg+Abiraterone 1000 mg | 0 |
GSK525762 80 mg+Enzalutamide 160 mg | 0 |
GSK525762 60 mg+Enzalutamide 160 mg | 0 |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 0 |
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Radiographic Progression-free Survival (rPFS)
rPFS is defined as the time from study treatment start until the first date of either disease progression or death due to any cause. The date of disease progression is defined as the earliest date of disease progression as assessed by the investigator using PCWG3-modified RECIST, version 1.1 or progression on bone scan. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. (NCT03150056)
Timeframe: Up to 21.3 montths
Intervention | Days (Median) |
---|
GSK525762 60 mg+Abiraterone 1000 mg | 53.0 |
GSK525762 60 mg Alternate+Abiraterone 1000 mg | NA |
GSK525762 40 mg+Abiraterone 1000 mg | NA |
GSK525762 80 mg+Enzalutamide 160 mg | 416.0 |
GSK525762 60 mg+Enzalutamide 160 mg | 141.0 |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 330.0 |
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Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function. (NCT03150056)
Timeframe: Up to 21.3 months
Intervention | Participants (Count of Participants) |
---|
| Any AEs | Any SAEs |
---|
GSK525762 40 mg+Abiraterone 1000 mg | 4 | 0 |
,GSK525762 60 mg Alternate+Abiraterone 1000 mg | 6 | 2 |
,GSK525762 60 mg Alternate+Enzalutamide 160 mg | 21 | 7 |
,GSK525762 60 mg+Abiraterone 1000 mg | 10 | 4 |
,GSK525762 60 mg+Enzalutamide 160 mg | 22 | 6 |
,GSK525762 80 mg+Enzalutamide 160 mg | 10 | 1 |
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Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment
Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs have been presented. (NCT03150056)
Timeframe: Up to 21.3 months
Intervention | Participants (Count of Participants) |
---|
GSK525762 60 mg+Abiraterone 1000 mg | 6 |
GSK525762 60 mg Alternate+Abiraterone 1000 mg | 2 |
GSK525762 40 mg+Abiraterone 1000 mg | 2 |
GSK525762 80 mg+Enzalutamide 160 mg | 3 |
GSK525762 60 mg+Enzalutamide 160 mg | 8 |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 4 |
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Tmax of Enzalutamide
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25
Intervention | Hours (Median) |
---|
GSK525762 80 mg+Enzalutamide 160 mg | NA |
GSK525762 60 mg+Enzalutamide 160 mg | NA |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | NA |
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Tmax of Abiraterone
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3
Intervention | Hours (Median) |
---|
| Week 1 Day 1, n=10,5,4 | Week 3 Day 1, n=4,4,2 |
---|
GSK525762 40 mg+Abiraterone 1000 mg | 0.750 | 3.017 |
,GSK525762 60 mg Alternate+Abiraterone 1000 mg | 1.083 | 2.000 |
,GSK525762 60 mg+Abiraterone 1000 mg | 1.133 | 1.000 |
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Disease Control Rate at Week 24
Disease control rate (DCR) is defined as the percentage of participants with >=1 post-Baseline disease assessment who showed either a confirmed complete response (CR), partial response (PR) or stable disease (SD) observed at >=24 weeks per prostate cancer working group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; where CR: disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter in the short axis; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive diseases. Confidence interval (CI) was computed using exact two sided 95% CI. (NCT03150056)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
GSK525762 60 mg+Abiraterone 1000 mg | 0 |
GSK525762 60 mg Alternate+Abiraterone 1000 mg | 40 |
GSK525762 40 mg+Abiraterone 1000 mg | 50 |
GSK525762 80 mg+Enzalutamide 160 mg | 40 |
GSK525762 60 mg+Enzalutamide 160 mg | 11 |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 29 |
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61
Intervention | Scores on a scale (Mean) |
---|
| Week 2 Day 1,n=6,1,2,4,4,8 | Week 4 Day 1,n=6,1,2,3,6,10 | Week 13 Day 1,n=1,1,1,1,2,3 | Week 17 Day 1,n=1,1,1,1,1,3 |
---|
GSK525762 60 mg Alternate+Abiraterone 1000 mg | 16.7 | 16.7 | 8.3 | -16.7 |
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Time to Disease Progression
Time to disease progression is defined as the time from date of first dose of study treatment to date of disease progression defined as one or more of the following criteria: 1. Radiographic progression by PCWG3-modified RECIST version 1.1 for participants with measurable disease, 2. Bone progression on bone scan according to the PCGW3 criteria, 3. PSA progression according to the PCWG3 criteria accompanied by any one of the following: investigator-defined clinical progression or either of the above RECIST version 1.1 radiographic progression or bone progression. (NCT03150056)
Timeframe: Up to 21.3 months
Intervention | Days (Median) |
---|
GSK525762 60 mg+Abiraterone 1000 mg | 88.0 |
GSK525762 60 mg Alternate+Abiraterone 1000 mg | NA |
GSK525762 40 mg+Abiraterone 1000 mg | NA |
GSK525762 80 mg+Enzalutamide 160 mg | 87.0 |
GSK525762 60 mg+Enzalutamide 160 mg | 86.0 |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 84.0 |
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Objective Response Rate
Objective response rate (ORR) is defined as the percentage of participants with a confirmed CR or PR at any time as per PCWG3-modified RECIST version 1.1; where CR: Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis and PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. (NCT03150056)
Timeframe: Up to 21.3 months
Intervention | Percentage of participants (Number) |
---|
GSK525762 60 mg+Abiraterone 1000 mg | 0 |
GSK525762 60 mg Alternate+Abiraterone 1000 mg | 0 |
GSK525762 40 mg+Abiraterone 1000 mg | 0 |
GSK525762 80 mg+Enzalutamide 160 mg | 0 |
GSK525762 60 mg+Enzalutamide 160 mg | 0 |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 0 |
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61
Intervention | Scores on a scale (Mean) |
---|
| Week 2 Day 1,n=6,1,2,4,4,8 | Week 3 Day 1,n=6,0,1,4,3,7 | Week 4 Day 1,n=6,1,2,3,6,10 | Week 5 Day 1,n=3,0,1,3,5,9 | Week 9 Day 1,n=2,0,1,2,3,6 | Week 13 Day 1,n=1,1,1,1,2,3 | Week 17 Day 1,n=1,1,1,1,1,3 | Week 21 Day 1,n=0,0,1,1,0,2 | Week 25 Day 1,n=0,0,1,0,0,1 | Week 33 Day 1,n=0,0,1,0,1,2 | Week 37 Day 1,n=0,0,1,0,0,3 | Week 41 Day 1,n=0,0,1,0,0,0 | Week 45 Day 1,n=0,0,1,0,0,1 | Week 49 Day 1,n=0,0,1,0,0,2 | Week 61 Day 1,n=0,0,1,0,0,1 |
---|
GSK525762 40 mg+Abiraterone 1000 mg | -12.5 | -16.7 | 0.0 | 8.3 | -8.3 | 0.0 | 16.7 | 16.7 | 0.0 | 8.3 | 0.0 | 8.3 | -8.3 | 16.7 | 16.7 |
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61
Intervention | Scores on a scale (Mean) |
---|
| Week 2 Day 1,n=6,1,2,4,4,8 | Week 3 Day 1,n=6,0,1,4,3,7 | Week 4 Day 1,n=6,1,2,3,6,10 | Week 5 Day 1,n=3,0,1,3,5,9 | Week 9 Day 1,n=2,0,1,2,3,6 | Week 13 Day 1,n=1,1,1,1,2,3 | Week 17 Day 1,n=1,1,1,1,1,3 | Week 21 Day 1,n=0,0,1,1,0,2 | Week 25 Day 1,n=0,0,1,0,0,1 | Week 29 Day 1,n=0,0,0,0,0,2 | Week 33 Day 1,n=0,0,1,0,1,2 | Week 37 Day 1,n=0,0,1,0,0,3 | Week 45 Day 1,n=0,0,1,0,0,1 | Week 49 Day 1,n=0,0,1,0,0,2 | Week 61 Day 1,n=0,0,1,0,0,1 |
---|
GSK525762 60 mg Alternate+Enzalutamide 160 mg | -1.0 | -1.2 | 2.5 | -0.0 | -12.5 | 0.0 | -11.1 | -4.2 | -8.3 | -8.3 | -8.3 | -2.8 | 0.0 | -8.3 | -16.7 |
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AUC(0-tau) of Abiraterone
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
| Week 1 Day 1, n=5,1,1 | Week 3 Day 1, n=1,2,1 |
---|
GSK525762 40 mg+Abiraterone 1000 mg | 1405.809 | 2185.039 |
,GSK525762 60 mg Alternate+Abiraterone 1000 mg | 148.871 | 595.686 |
,GSK525762 60 mg+Abiraterone 1000 mg | 432.368 | 1361.627 |
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Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50)
PSA50 response rate is defined as percentage of participants with a decrease of >=50% in the PSA concentration from the Baseline PSA value determined at least 12 weeks after start of treatment and confirmed >=4 weeks later by an additional PSA evaluation. (NCT03150056)
Timeframe: Up to 21.3 months
Intervention | Percentage of participants (Number) |
---|
GSK525762 60 mg+Abiraterone 1000 mg | 0 |
GSK525762 60 mg Alternate+Abiraterone 1000 mg | 0 |
GSK525762 40 mg+Abiraterone 1000 mg | 0 |
GSK525762 80 mg+Enzalutamide 160 mg | 0 |
GSK525762 60 mg+Enzalutamide 160 mg | 0 |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 0 |
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Composite Response Rate
Composite response rate was defined as the percentage of participants with one of the following: a) Response based on PCWG3-modified RECIST version 1.1, b) PSA decrease of >=50% from Baseline at Week 12 and thereafter, or c) Circulating Tumor-cell Count Conversion from unfavorable (>=5/7.5 milliliter [mL]) at Baseline to favorable (<5/7.5 mL) confirmed by a second assessment at least 4 weeks later. If a participant met at least one of the above requirements, then that participant was considered a composite responder. CI was computed using exact two sided 95% CI. (NCT03150056)
Timeframe: Up to 21.3 months
Intervention | Percentage of participants (Number) |
---|
GSK525762 60 mg+Abiraterone 1000 mg | 0 |
GSK525762 60 mg Alternate+Abiraterone 1000 mg | 0 |
GSK525762 40 mg+Abiraterone 1000 mg | 0 |
GSK525762 80 mg+Enzalutamide 160 mg | 10 |
GSK525762 60 mg+Enzalutamide 160 mg | 5 |
GSK525762 60 mg Alternate+Enzalutamide 160 mg | 0 |
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Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24
Treatment failure was a participant meeting at least 1 of these criteria in at least 1 eye: New active, inflammatory lesions relative to Day 1/Baseline (all visits starting Week (Wk) 6); Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (change of Grade 0 to Grade 2+/Grade 0.5+ to Grade 3+) (all visits after Wk 6) relative to best state (RBS) achieved in Anterior Chamber (AC) cell grade (Standardization of Uveitis Nomenclature [SUN] criteria)[AC cell grades range from 0 (0 cells) to 4+ (>50 cells), higher scores=severe uveitis]; Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (all visits after Wk 6) RBS achieved in Vitreous Haze (VH) grade (National Eye Institute [NEI]/SUN criteria)[VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), higher scores=severe uveitis]; Worsening of best corrected visual acuity (BCVA) by ≥15 letters RBS achieved (all visits starting Wk 6), measured by an eye chart, fewer correct letters=severe uveitis. (NCT03207815)
Timeframe: Week 6 through Week 24
Intervention | percentage of participants (Number) |
---|
Filgotinib | 37.5 |
Placebo | 67.6 |
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Time to Development of Macular Edema in At Least One Eye on or After Week 6
Time in weeks until the development of Macular edema or Week 52 or EOT or ET. Macular edema is determined by OCT and is defined as central retinal thickness ≥ 300 microns if using Cirrus machine, or ≥ 315 microns if using Spectralis machine. (NCT03207815)
Timeframe: Week 6 through Week 52
Intervention | weeks (Median) |
---|
Filgotinib | 7.8 |
Placebo | 12.3 |
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Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
The number of AC cells observed within a 1 mm × 1 mm slit beam were recorded for each eye. The reported number was used to determine the grade according to the SUN criteria. AC cell grades range from 0 (0 cells in field) to 4+ (>50 cells in field), with higher scores indicating more cells visible in the AC and greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement. (NCT03207815)
Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
Intervention | score (Mean) |
---|
| Left Eye: Best State Prior to Week 6 | Right Eye: Best State Prior to Week 6 | Left Eye: Change From Best State at Week 52/EOT/ET | Right Eye: Change From Best State at Week 52/EOT/ET |
---|
Filgotinib | 0.0 | 0.0 | 0.2 | 0.2 |
,Placebo | 0.1 | 0.1 | 0.6 | 0.7 |
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Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
BCVA is the best possible vision that an eye can achieve with the set of glasses or contact lenses. A refraction test was performed to measure the appropriate lens strength to focus light on the retina. Using the appropriate corrective lenses based on that visit's refraction, participant's BCVA was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. In the ETDRS system, 15 letters is equal to a change in 3 lines of visual acuity. If the participant is unable to read letters on a testing chart, visual acuity is described as ranging from ability to count fingers, recognize hand movements, or light perception. The smaller BVCA score indicates greater severity of uveitis. A positive change from best state value obtained prior to Week 6 indicates improvement. (NCT03207815)
Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
Intervention | logMAR (Mean) |
---|
| Left Eye: Best State Prior to Week 6 | Right Eye: Best State Prior to Week 6 | Left Eye: Change From Best State at Week 52/EOT/ET | Right Eye: Change From Best State at Week 52/EOT/ET |
---|
Filgotinib | 0.09 | 0.09 | 0.03 | -0.01 |
,Placebo | 0.07 | 0.12 | 0.05 | 0.07 |
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Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET)
Grading of VH was based on the publication from the NEI which has also been adapted by the SUN working group. VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), with higher scores indicating greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement. (NCT03207815)
Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
Intervention | score (Mean) |
---|
| Left Eye: Best State Prior to Week 6 | Right Eye: Best State Prior to Week 6 | Left Eye: Change From Best State at Week 52/EOT/ET | Right Eye: Change From Best State at Week 52/EOT/ET |
---|
Filgotinib | 0.3 | 0.3 | 0.1 | 0.1 |
,Placebo | 0.2 | 0.3 | 0.3 | 0.2 |
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Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
Central retinal thickness is measured by optical coherence tomography (OCT). Central retinal thickness is defined as the thickness of the retina in the center of the foveal pit (1 mm subfield). The larger central retinal thickness value indicates greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement. (NCT03207815)
Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
Intervention | log microns (Mean) |
---|
| Left Eye: Best State Prior to Week 6 | Right Eye: Best State Prior to Week 6 | Left Eye: Change From Best State at Week 52/EOT/ET | Right Eye: Change From Best State at Week 52/EOT/ET |
---|
Filgotinib | 2.45 | 2.47 | 0.01 | 0.01 |
,Placebo | 2.46 | 2.44 | 0.04 | 0.03 |
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Plasma Concentration of Filgotinib
(NCT03207815)
Timeframe: Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time
Intervention | nanograms per millilitre (ng/ml) (Mean) |
---|
| Day 1 Postdose | Week 4 Predose | Week 6 Predose | Week 12 Postdose | Week 24 Single Anytime | Week 36 Single Anytime | Week 52 Single Anytime | Early Termination Single Anytime |
---|
Filgotinib | 748.5 | 173.3 | 133.9 | 1088.7 | 397.5 | 295.7 | 195.2 | 434.8 |
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Time to Treatment Failure on or After Week 6
Treatment failure was a participant meeting at least 1 of these criteria in at least 1 eye: New active, inflammatory lesions relative to Day 1/Baseline (all visits starting Wk 6); Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (change of Grade 0 to Grade 2+/Grade 0.5+ to Grade 3+) (all visits after Wk 6) relative to best state (RBS) achieved in AC cell grade (SUN criteria) [AC cell grades range from 0 (0 cells) to 4+ (>50 cells), higher scores=severe uveitis]; Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (all visits after Wk 6) RBS achieved in VH grade (NEI/SUN criteria) [VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), higher scores=severe uveitis]; Worsening of BCVA by ≥15 letters RBS achieved (all visits starting Wk 6), measured by an eye chart, fewer correct letters=severe uveitis. (NCT03207815)
Timeframe: Week 6 through Week 52
Intervention | weeks (Median) |
---|
Filgotinib | NA |
Placebo | 22.0 |
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The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy
The study will provide a point estimate and 95% confidence interval of the proportion of patients with pathologic stage =< pT2N0 at prostatectomy for each arm. Patient characteristics will be summarized using descriptive statistics for each arm. (NCT03279250)
Timeframe: At the time of radical prostatectomy
Intervention | Participants (Count of Participants) |
---|
Arm A (LHRHa, Apalutamide) | 13 |
Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | 12 |
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Number of Participants With Incidence of Adverse Events
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Incidence of serious adverse events and 95% confidence interval will be provided overall as well as for each major affected organ category. (NCT03279250)
Timeframe: From screening up to 4 weeks post-surgery, an average of 7 months
Intervention | Participants (Count of Participants) |
---|
| Serious | Non Serious |
---|
Arm A (LHRHa, Apalutamide) | 1 | 34 |
,Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | 2 | 34 |
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Number of Participants With Acute Cellular Rejection Between Study and Control Groups
Acute Cellular Rejection of liver graft was determined by liver biopsy using Banff criteria. The decision to perform liver biopsy was as per treating physician based on patient's clinical course and blood chemisteries. Protocol bioopsies were not performed. (NCT03304626)
Timeframe: Post-Transplant day 4 to week 24
Intervention | Participants (Count of Participants) |
---|
Study Group | 1 |
Control Group | 1 |
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Rate of New Onset Diabetes After Transplant
Rates of new onset diabetes in patients who did not have diabetes prior to liver transplant (NCT03304626)
Timeframe: Post-Transplant day 4 to week 24
Intervention | Participants (Count of Participants) |
---|
Study Group | 0 |
Control Group | 3 |
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Number of Participants With Adrenal Suppression
"This outcomes was measured in Budesonide group only. Serum cortisol levels after 12 weeks of Budesonide use were checked to see if they fall below the adrenal suppression threshold of 3microgram/dl. If these were below 3 microgram/dl then patient is considered to have developed adrenal suppression.~Second measure used to check for adrenal suppression was Cosyntorpin stimulation test. One-time, low-dose, cosyntropin stimulation test at week 12 was performed by administering cosyntropin at a dose of 0.5 µg/1.73 m2 of the body surface area and checking the serum cortisol levels at baseline and at 30 minutes after cosyntropin injection. A serum cortisol value of <11 µg/dL after cosyntropin stimulation was used to define adrenal suppression. Participant meeting any of these criteria was said to have developed adrenal suppression" (NCT03304626)
Timeframe: Post-Transplant week 12
Intervention | Participants (Count of Participants) |
---|
Study Group | 2 |
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Number of Participants With Adverse Events
"Rates of adverse events~All cause mortality~Graft failure~Acute cellular rejection~New Onset Diabetes after Transplant~Rates of bacterial, fungal or viral infections~Other adverse events including ascites, pleural effusion, kidney injury, biliary stricture" (NCT03304626)
Timeframe: Post-Transplant day 4 to week 24
Intervention | Participants (Count of Participants) |
---|
Study Group | 10 |
Control Group | 6 |
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Number of Participants With Laboratory Values Change From Baseline
Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (Up to 34 months)
Intervention | Participants (Number) |
---|
| Hemoglobin Grade 0 | Hemoglobin Grade 1 | Hemoglobin Grade 2 | Platelet Grade 0 | Platelet Grade 1 | Leukocytes Grade 0 | Leukocytes Grade 1 | Leukocytes Grade 2 | Lymphocytes Grade 0 | Lymphocytes Grade 1 | Lymphocytes Grade 2 | Lymphocytes Grade 3 | Neutrophil Grade 0 | Neutrophil Grade 1 | Neutrophil Grade 2 | Alkaline Phosphatase Grade 0 | Alkaline Phosphatase Grade 1 | Alkaline Phosphatase Grade 2 | Alkaline Phosphatase Grade 3 | Aspartate Aminotransferase Grade 0 | Aspartate Aminotransferase Grade 1 | Alanine Aminotransferase Grade 0 | Alanine Aminotransferase Grade 1 | Bilirubin Grade 0 | Bilirubin Grade 1 | Creatinine Grade 0 | Creatinine Grade 1 |
---|
Arm A1 | 23 | 38 | 8 | 35 | 4 | 38 | 10 | 1 | 24 | 10 | 3 | 1 | 35 | 3 | 1 | 25 | 13 | 9 | 1 | 52 | 5 | 47 | 4 | 4 | 1 | 30 | 7 |
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Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease (NCT03338790)
Timeframe: Up to approximately 36 months
Intervention | Percentage of participants (Number) |
---|
| Overall | Homologous Recombination Deficiency (HRD+) |
---|
Arm A1 | 10.3 | 17.2 |
,Arm A2 | 15.4 | 25.0 |
,Arm B | 40.0 | 36.8 |
,Arm C | 11.1 | 20.0 |
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Prostate-Specific Antigen Response Rate (RR-PSA)
Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result (NCT03338790)
Timeframe: Up to approximately 36 months
Intervention | Percentage of participants (Number) |
---|
| Overall | Homologous Recombination Deficiency (HRD+) |
---|
Arm A1 | 11.9 | 18.2 |
,Arm A2 | 27.3 | 41.9 |
,Arm B | 46.9 | 50.0 |
,Arm C | 34.1 | 50.0 |
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Number of Deaths
Number of deaths in all treated participants (NCT03338790)
Timeframe: Up to 36 months
Intervention | Deaths (Number) |
---|
Arm A1 | 59 |
Arm A2 | 42 |
Arm B | 44 |
Arm C | 28 |
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Number of Participants With Adverse Events (AEs)
Number of Participants with any grade adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and immune-mediated AEs using the Common Toxicity Criteria Grade for Adverse Events (CTCAE V4) (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (Up to 34 months)
Intervention | Participants (Number) |
---|
| Adverse Events (AEs) | Serious Adverse Events (SAEs) | AEs leading to discontinuation | Immune-mediated AEs (Pneumonitis) | Immune-mediated AEs (Diarrhea/Colitis) | Immune-mediated AEs (Hepatitis) | Immune-mediated AEs (Nephritis/Renal Dysfunction) | Immune-mediated AEs (Rash) | Immune-mediated AEs (Hypersensitivity/Infusion Reactions) |
---|
Arm A1 | 88 | 47 | 39 | 1 | 4 | 8 | 2 | 5 | 0 |
,Arm A2 | 71 | 37 | 26 | 2 | 4 | 7 | 3 | 5 | 1 |
,Arm B | 83 | 41 | 33 | 8 | 1 | 3 | 0 | 9 | 1 |
,Arm C | 49 | 20 | 18 | 0 | 0 | 2 | 0 | 10 | 3 |
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Number of Participants With Laboratory Abnormalities in Specific Liver Tests
"Number of participants with laboratory abnormalities in specific liver tests based on SI conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:~ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN~Total bilirubin > 2 x ULN~ALP > 1.5 x ULN~Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN~Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN~Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN~Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN" (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (up to 34 months)
Intervention | Participants (Number) |
---|
| ALT or AST > 3xULN | ALT or AST > 5xULN | ALT or AST > 10xULN | ALT or AST > 20xULN | TOTAL BILIRUBIN > 2xULN | ALP > 1.5xULN | Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 1.5xULN within one day | Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 1.5xULN within 30 days | Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 2xULN within one day | Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 2xULN within 30 days |
---|
Arm A1 | 19 | 11 | 2 | 0 | 3 | 49 | 3 | 4 | 2 | 2 |
,Arm A2 | 23 | 14 | 5 | 1 | 1 | 34 | 1 | 1 | 1 | 1 |
,Arm B | 6 | 3 | 1 | 1 | 1 | 34 | 0 | 0 | 0 | 0 |
,Arm C | 4 | 3 | 0 | 0 | 0 | 21 | 1 | 1 | 0 | 0 |
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Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
"Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:~TSH value > ULN and~with baseline TSH value <= ULN~with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test~with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test~with FT3/FT4 missing within 2-week window after the abnormal TSH test.~TSH < LLN and~with baseline TSH value >= LLN~with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test~with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test~with FT3/FT4 missing within 2-week window after the abnormal TSH test" (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (Up to 34 months)
Intervention | Participants (Number) |
---|
| TSH > ULN | TSH > ULN with TSH <= ULN at baseline | TSH > ULN with at least one FT3/FT4 test value < LLN | TSH > ULN with all other FT3/FT4 test values >= LLN | TSH > ULN with FT3/FT4 test missing | TSH < LLN | TSH < LLN with TSH >= LLN at baseline | TSH < LLN with at least one FT3/FT4 test value > ULN | TSH < LLN with all other FT3/FT4 test values <= ULN | TSH < LLN with FT3/FT4 test missing |
---|
Arm A1 | 22 | 17 | 10 | 10 | 2 | 16 | 13 | 5 | 8 | 3 |
,Arm A2 | 17 | 12 | 6 | 9 | 2 | 12 | 11 | 5 | 4 | 3 |
,Arm B | 12 | 7 | 7 | 3 | 2 | 25 | 19 | 2 | 11 | 12 |
,Arm C | 17 | 12 | 5 | 10 | 2 | 8 | 8 | 7 | 0 | 1 |
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Number of Participants With Laboratory Values Change From Baseline
Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (Up to 34 months)
Intervention | Participants (Number) |
---|
| Hemoglobin Grade 0 | Hemoglobin Grade 1 | Hemoglobin Grade 2 | Platelet Grade 0 | Platelet Grade 1 | Leukocytes Grade 0 | Leukocytes Grade 1 | Lymphocytes Grade 0 | Lymphocytes Grade 1 | Lymphocytes Grade 2 | Neutrophil Grade 0 | Neutrophil Grade 2 | Alkaline Phosphatase Grade 0 | Alkaline Phosphatase Grade 1 | Alkaline Phosphatase Grade 2 | Alkaline Phosphatase Grade 3 | Aspartate Aminotransferase Grade 0 | Aspartate Aminotransferase Grade 1 | Alanine Aminotransferase Grade 0 | Alanine Aminotransferase Grade 1 | Bilirubin Grade 0 | Bilirubin Grade 1 | Creatinine Grade 0 | Creatinine Grade 1 |
---|
Arm C | 8 | 12 | 2 | 13 | 0 | 13 | 2 | 14 | 2 | 3 | 7 | 1 | 8 | 6 | 0 | 0 | 9 | 4 | 4 | 1 | 3 | 0 | 3 | 2 |
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Number of Participants With Laboratory Values Change From Baseline
Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (Up to 34 months)
Intervention | Participants (Number) |
---|
| Hemoglobin Grade 0 | Hemoglobin Grade 1 | Hemoglobin Grade 2 | Platelet Grade 0 | Platelet Grade 1 | Leukocytes Grade 0 | Leukocytes Grade 1 | Leukocytes Grade 2 | Lymphocytes Grade 0 | Lymphocytes Grade 1 | Lymphocytes Grade 2 | Lymphocytes Grade 3 | Neutrophil Grade 0 | Neutrophil Grade 1 | Alkaline Phosphatase Grade 0 | Alkaline Phosphatase Grade 1 | Alkaline Phosphatase Grade 2 | Alkaline Phosphatase Grade 3 | Aspartate Aminotransferase Grade 0 | Aspartate Aminotransferase Grade 1 | Alanine Aminotransferase Grade 0 | Alanine Aminotransferase Grade 1 | Bilirubin Grade 0 | Creatinine Grade 0 | Creatinine Grade 1 |
---|
Arm A2 | 21 | 28 | 3 | 32 | 1 | 34 | 6 | 0 | 30 | 8 | 3 | 0 | 26 | 4 | 33 | 4 | 1 | 3 | 49 | 4 | 48 | 3 | 12 | 30 | 5 |
,Arm B | 30 | 20 | 2 | 10 | 0 | 28 | 4 | 1 | 28 | 0 | 5 | 0 | 37 | 1 | 13 | 13 | 2 | 0 | 28 | 6 | 13 | 3 | 2 | 13 | 5 |
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Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL)
Complete response based on the modified National Comprehensive Cancer Network (NCCN) criteria was defined as: less than 5 percent (%) blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets greater than (>)100*10^9 cells/liter (L) and absolute neutrophil count (ANC) >1.0*10^9 cells/L. This outcome measure was planned to be analyzed for specified arm only. (NCT03384654)
Timeframe: Up to 2 cycles, that is, up to 56 days (each cycle of 28-days)
Intervention | Percentage of participants (Number) |
---|
Cohort 1: B-cell ALL (1-17 Years) | 0 |
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Overall Response Rate (ORR)
For ALL participants, ORR was defined as percentage of participants who achieved CR or CR with only partial hematological recovery(CRi) as per NCCN criteria. CR for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets >100*10^9 cells/L and ANC >1.0*10^9 cells/L. CRi for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; partial recovery of peripheral blood counts not meeting criteria for CR. For LL participants, ORR was defined as percentage of participants who had CR or PR during or after treatment administration but prior to start of subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant(HSCT). CR for LL: disappearance of all evidence of disease from all sites. PR for LL: decrease of >=50% in sum of products of diameter of lesions of up to 6 of largest dominant nodes or nodal masses with no new lesions. (NCT03384654)
Timeframe: Up to 4 years 4 months
Intervention | Percentage of participants (Number) |
---|
Cohort 1: B-cell ALL (1-17 Years) | 14.3 |
Cohort 2: T-Cell ALL (1-17 Years) | 83.3 |
Cohort 2: T-Cell ALL (18-30 Years) | 80.0 |
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 50.0 |
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Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. (NCT03384654)
Timeframe: Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15
Intervention | mcg/mL (Mean) |
---|
| Cycle 1 Day 1 predose | Cycle 2 Day 1 predose |
---|
Cohort 1: B-cell ALL (1-17 Years) | NA | 0.573 |
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Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. (NCT03384654)
Timeframe: Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15
Intervention | mcg/mL (Mean) |
---|
| Cycle 1 Day 1 predose | Cycle 1 Day 15 predose | Cycle 2 Day 2 predose | Cycle 2 Day 15 predose |
---|
Cohort 2: T-Cell ALL (1-17 Years) | NA | 0.907 | 0.915 | 0.934 |
,Cohort 2: T-Cell ALL (18-30 Years) | NA | 0.319 | 0.296 | 0.163 |
,Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | NA | 0.456 | 1.23 | 1.06 |
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Minimum Observed Serum Concentration (Cmin) of Daratumumab
Cmin was defined as minimum observed serum concentration of daratumumab. (NCT03384654)
Timeframe: Cohort 1: B-cell ALL: Predose on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): Predose on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): Predose on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): Predose on Day 22 of Cycle 2
Intervention | mcg/mL (Mean) |
---|
Cohort 1: B-cell ALL (1-17 Years) | 172 |
Cohort 2: T-Cell ALL (1-17 Years) | 369 |
Cohort 2: T-Cell ALL (18-30 Years) | 172 |
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 365 |
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Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL
Complete response based on the modified NCCN criteria was defined as: less than 5% blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets >100*10^9 cells/L and ANC >1.0*10^9 cells/L. This outcome measure was planned to be analyzed for specified arms only. (NCT03384654)
Timeframe: End of Cycle 1 (that is, up to 28 days)
Intervention | Percentage of participants (Number) |
---|
Cohort 2: T-Cell ALL (1-17 Years) | 41.7 |
Cohort 2: T-Cell ALL (18-30 Years) | 60.0 |
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 30.0 |
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Event-free Survival (EFS)
EFS was defined as the time (in months) from the date of first treatment to the first documented treatment failure (that is [ie], disease progression) or date of relapse from CR or death due to any cause, whichever occurred first. Per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or >5% blasts in the bone marrow; reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in the absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for the analysis. (NCT03384654)
Timeframe: Up to 4 years 4 months
Intervention | Months (Median) |
---|
Cohort 1: B-cell ALL (1-17 Years) | 1.1 |
Cohort 2: T-Cell ALL (1-17 Years) | 8.9 |
Cohort 2: T-Cell ALL (18-30 Years) | 10.3 |
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 2.9 |
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Maximum Observed Serum Concentration (Cmax) of Daratumumab
Cmax was defined as maximum observed serum concentration of daratumumab. (NCT03384654)
Timeframe: Cohort 1: B-cell ALL: End of infusion (EOI) on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): EOI on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): EOI on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): EOI on Day 22 of Cycle 2
Intervention | Micrograms per milliliter (mcg/mL) (Mean) |
---|
Cohort 1: B-cell ALL (1-17 Years) | 494 |
Cohort 2: T-Cell ALL (1-17 Years) | 763 |
Cohort 2: T-Cell ALL (18-30 Years) | 501 |
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 758 |
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Minimal Residual Disease (MRD) Negative Rate
MRD negative rate was defined as the percentage of participants who were considered MRD negative after MRD testing by bone marrow aspirate at any timepoint after first study treatment administration and before disease progression or starting subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant (HSCT). MRD negative was defined as less than (<) 0.01% abnormal population counts to nucleated mononuclear cells when measured by flow cytometry. (NCT03384654)
Timeframe: Up to 4 years 4 months
Intervention | Percentage of participants (Number) |
---|
Cohort 1: B-cell ALL (1-17 Years) | 0 |
Cohort 2: T-Cell ALL (1-17 Years) | 45.8 |
Cohort 2: T-Cell ALL (18-30 Years) | 20.0 |
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 50.0 |
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Overall Survival (OS)
OS was defined as the time (in months) from the date of first study drug administration to the date of death due to any cause. Kaplan-Meier method was used for the analysis. Participants who died after consent withdrawal were considered as having an OS event. (NCT03384654)
Timeframe: Up to 4 years 4 months
Intervention | Months (Median) |
---|
Cohort 1: B-cell ALL (1-17 Years) | 3.2 |
Cohort 2: T-Cell ALL (1-17 Years) | 10.9 |
Cohort 2: T-Cell ALL (18-30 Years) | 12.0 |
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 4.2 |
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Number of Participants With Anti-daratumumab Antibodies
Number of participants with anti-daratumumab antibodies was reported. (NCT03384654)
Timeframe: Up to 4 years 4 months
Intervention | Participants (Count of Participants) |
---|
Cohort 1: B-cell ALL (1-17 Years) | 0 |
Cohort 2: T-Cell ALL (1-17 Years) | 0 |
Cohort 2: T-Cell ALL (18-30 Years) | 0 |
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 0 |
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Relapse-free Survival (RFS)
RFS was defined as the time (in months) from CR to relapse from CR, or disease progression or death due to any cause, whichever occurred first. For ALL, as per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or >5% blasts in the bone marrow, or reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for analysis. (NCT03384654)
Timeframe: Up to 4 years 4 months
Intervention | Months (Median) |
---|
Cohort 2: T-Cell ALL (1-17 Years) | 19.4 |
Cohort 2: T-Cell ALL (18-30 Years) | 9.4 |
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | NA |
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Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Percentage of participants who received an allogeneic HSCT after treatment with daratumumab were reported. (NCT03384654)
Timeframe: Up to 4 years 4 months
Intervention | Percentage of participants (Number) |
---|
Cohort 1: B-cell ALL (1-17 Years) | 14.3 |
Cohort 2: T-Cell ALL (1-17 Years) | 75.0 |
Cohort 2: T-Cell ALL (18-30 Years) | 60.0 |
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 30.0 |
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Donor-specific HLA Antibodies, Re-transplantation, or Death
The Outcome Measure is a composite primary endpoint of the development of donor-specific HLA antibodies, re-transplantation, or death. Testing for donor-specifc HLA antibodies was performed at study-specified time points using the single antigen bead assay at the study core lab. Donor-specific HLA antibodies were defined as reactivity with a mean fluorescence intensity (MFI) ≥ 2,000. (NCT03388008)
Timeframe: 365 days
Intervention | participants (Number) |
---|
| Death | Donor-specific HLA antibodies | Re-transplantation |
---|
Belatacept-based Immunosuppression | 5 | 3 | 0 |
,Standard of Care | 0 | 3 | 0 |
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Maximum Observed Serum Concentration (Cmax) of Daratumumab
Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days. (NCT03412565)
Timeframe: D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8
Intervention | micrograms per milliliter (mcg/mL) (Mean) |
---|
| Cycle 1 Day 4 | Cycle 3 Day 4 |
---|
Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 108 | 648 |
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Maximum Observed Serum Concentration (Cmax) of Daratumumab
Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days. (NCT03412565)
Timeframe: D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8
Intervention | micrograms per milliliter (mcg/mL) (Mean) |
---|
| Cycle 1 Day 4 | Cycle 2 Day 4 | Post-treatment Phase Week 8 |
---|
D + Bortezomib + Melphalan + Prednisone (D-VMP) | 98.6 | 612 | 162 |
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Maximum Observed Serum Concentration (Cmax) of Daratumumab
Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days. (NCT03412565)
Timeframe: D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8
Intervention | micrograms per milliliter (mcg/mL) (Mean) |
---|
| Cycle 1 Day 4 | Cycle 3 Day 4 | Post-treatment Phase Week 8 |
---|
Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 137 | 869 | 49.3 |
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Maximum Observed Serum Concentration (Cmax) of Daratumumab
Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days. (NCT03412565)
Timeframe: D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8
Intervention | micrograms per milliliter (mcg/mL) (Mean) |
---|
| Cycle 1 Day 4 | Cycle 4 Day 4 | Post-treatment Phase Week 8 |
---|
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | 100 | 746 | 263 |
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D-VRd Cohort: Overall Response Rate (ORR)
ORR was defined as the percentage of participants who achieved a PR or better, IMWG criteria, during the study or during follow up. IMWG criteria for PR >= 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required. (NCT03412565)
Timeframe: Up to 2 years and 3 months
Intervention | percentage of participants (Number) |
---|
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | 97.0 |
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D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response
VGPR or better rate was defined as the percentage of participants who achieved VGPR or CR (including sCR) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry. (NCT03412565)
Timeframe: From baseline up to 2 years 7 months
Intervention | percentage of participants (Number) |
---|
D + Bortezomib + Melphalan + Prednisone (D-VMP) | 77.6 |
Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 80.0 |
Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 77.3 |
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D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate
MRD negativity rate was defined as the percentage of participants who were considered MRD negative after MRD testing at any timepoint after the first dose by bone marrow aspirate. MRD negativity rate was assessed by next-generation sequencing at a threshold of <10^5. (NCT03412565)
Timeframe: Up to 2 years and 3 months
Intervention | percentage of participants (Number) |
---|
D + Bortezomib + Melphalan + Prednisone (D-VMP) | 25.4 |
Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 21.5 |
Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 27.3 |
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D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR)
ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligrams (mg) per 24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required. (NCT03412565)
Timeframe: Up to 2 years 3 months
Intervention | percentage of participants (Number) |
---|
D + Bortezomib + Melphalan + Prednisone (D-VMP) | 88.1 |
Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 90.8 |
Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 84.8 |
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D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR)
DOR was defined as the time from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death due to PD. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. (NCT03412565)
Timeframe: From baseline up to 2 years 7 months
Intervention | months (Median) |
---|
D + Bortezomib + Melphalan + Prednisone (D-VMP) | NA |
Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | NA |
Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | NA |
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D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response
VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response [sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry. (NCT03412565)
Timeframe: Up to 2 years and 3 months
Intervention | percentage of participants (Number) |
---|
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | 71.6 |
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Percentage of Participants With CR or Better Response
CR or better rate was defined as the percentage of participants with a CR or better response (that is, CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal FLC ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. (NCT03412565)
Timeframe: For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months
Intervention | percentage of participants (Number) |
---|
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | 16.4 |
D + Bortezomib + Melphalan + Prednisone (D-VMP) | 55.2 |
Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 50.8 |
Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 42.4 |
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Percentage of Participants With Anti-rHuPH20 Antibodies
Percentage of participants with antibodies to rHuPH20 were reported. (NCT03412565)
Timeframe: For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months
Intervention | percentage of participants (Number) |
---|
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | 6.1 |
D + Bortezomib + Melphalan + Prednisone (D-VMP) | 3.1 |
Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 4.8 |
Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 4.7 |
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Percentage of Participants With Anti-Daratumumab Antibodies
Percentage of participants with antibodies to daratumumab were reported. (NCT03412565)
Timeframe: For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months
Intervention | percentage of participants (Number) |
---|
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | 0 |
D + Bortezomib + Melphalan + Prednisone (D-VMP) | 0 |
Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | 0 |
Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | 0 |
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Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose
AUC(0-168 hours) was defined as area under the plasma concentration-time curve from time zero to 168 hours of Niraparib administered with AA After a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Intervention | Nanograms*hour per milliliter (ng*h/mL) (Mean) |
---|
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | 14672 |
Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | 11862 |
Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | 13321 |
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Combination 1: Part 2: Objective Response Rate (ORR)
ORR of soft tissue (visceral or nodal disease) was defined as percentage of participants with measurable disease who achieved a best response of either complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with no evidence of bone progression according to prostate cancer working group 3 (PCWG3) criteria. (NCT03431350)
Timeframe: Up to 37 months
Intervention | Percentage of participants (Number) |
---|
Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | 23.8 |
Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | 9.1 |
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Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the NCI-CTCAE as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death). (NCT03431350)
Timeframe: Up to 31 months
Intervention | Participants (Count of Participants) |
---|
Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | 6 |
Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | 7 |
Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | 4 |
Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | 1 |
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Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death). (NCT03431350)
Timeframe: Up to 37 months
Intervention | Participants (Count of Participants) |
---|
Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | 14 |
Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | 8 |
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Combination 1: Part 2: Number of Participants With Adverse Events (AEs)
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. (NCT03431350)
Timeframe: Up to 37 months
Intervention | Participants (Count of Participants) |
---|
Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | 21 |
Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | 11 |
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Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose
Cmax is defined as maximum observed plasma concentration of niraparib and abiraterone acetate (AA) after a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Intervention | Nanograms per milliliter (ng/mL) (Mean) |
---|
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | 428 |
Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | 398 |
Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | 417 |
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Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose
Cmax/dose of niraparib was defined as maximum observed plasma concentration of niraparib Cmax normalized by the dose of niraparib administered with AA after a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Intervention | nanograms per milliliter per milligram (Mean) |
---|
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | 2.14 |
Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | 1.99 |
Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | 2.09 |
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Combination 2: Composite Response Rate (RR)
Composite response rate was defined as the percentage of participants who had a composite response which is defined as one of the following PCWG3 criteria: Objective response (percentage of participants with measurable disease who achieved a best response of either CR or PR as assessed by RECIST 1.1 with no evidence of bone progression according to PCWG3 criteria) (confirmed per RECIST 1.1), or; circulating tumor cells (CTC) response: defined as CTC=0 per 7.5 milliliters (mL) of blood at 8 weeks for participants who had CTC greater than or equal to (>=) 1 at baseline or CTC less than (<) 5 per 7.5 mL with CTC >=5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later, or prostate-specific antigen (PSA) declined of >=50 percentage (%), measured twice 3 to 4 weeks apart. This outcome measure was analyzed for specified arms only as pre-planned in the protocol. (NCT03431350)
Timeframe: Up to 31 months
Intervention | Percentage of participants (Number) |
---|
Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | 75.0 |
Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | 55.6 |
Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | 33.3 |
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Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose
AUC0(168 hours)/dose was defined as area under the plasma concentration-time curve for niraparib from time 0 to 168 hours of niraparib administered with AA after a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Intervention | nanogram*hour/milliliter/milligram (Mean) |
---|
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | 73.36 |
Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | 59.31 |
Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | 66.61 |
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Combination 2: Number of Participants With Adverse Events (AEs)
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. (NCT03431350)
Timeframe: Up to 31 months
Intervention | Participants (Count of Participants) |
---|
Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | 8 |
Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | 9 |
Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | 5 |
Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | 1 |
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Combination 1: Part 1: Number of Participants With Specified Toxicity
Number of participants with specified toxicity during Cycle 1 was reported. Only toxicities that occurred during safety evaluation period(defined as first 28 days of treatment-Cycle 1 of Part 1) was used for analysis of specified toxicities and for dose reduction decisions. Toxicities were graded for severity as per NCI-CTCAE, version 4.03. Safety evaluation criteria were: Any Grade(G) >=3 non-hematological toxicity without anorexia, or constipation, fatigue improved to G<=2 in <7 days, vomiting and diarrhea resolved in <=3 days, laboratory abnormalities with hospitalization, tumor flare improved to G<=2 in <=7 days, elevation in AST/ALT for <=7 days and G3 hypertension controlled by medical therapy; any treatment-related(TR)G4 or G>=3 thrombocytopenia required platelet transfusion; Any TR G4 neutropenia >=7 days or G3 or 4 neutropenia with infection/fever >38.5 degrees Celsius; Any TR SAE or intolerable toxicity. (NCT03431350)
Timeframe: Cycle 1 (28 days)
Intervention | Participants (Count of Participants) |
---|
Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | 0 |
Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | 0 |
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Efficacy Measured by Time to Stand Test (TTSTAND) Velocity in Rises/Second Change From Baseline
Vamorolone at 6.0mg/kg/day vs. placebo group in change from baseline to the Week 24 assessment (NCT03439670)
Timeframe: 24 weeks
Intervention | Rises/Seconds (Mean) |
---|
Treatment Group 1 | -.007 |
Treatment Group 2 | 0.054 |
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Number of Participants With Minimal Residual Disease (MRD) Negativity
MRD levels continuously assessed during induction and consolidation therapy by 6-color multiparameter flow. MRD negativity defined by a value of at least 10-4 and confirmed on a second bone marrow aspiration/biopsy performed after a subsequent cycle. (NCT03488225)
Timeframe: Start of treatment up to 2 years
Intervention | Participants (Count of Participants) |
---|
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 4 |
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Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT03488225)
Timeframe: Start of treatment up to 2 years
Intervention | Months (Median) |
---|
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 24 |
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Event-Free Survival
Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse. (NCT03488225)
Timeframe: Start of treatment up to 2 years
Intervention | Months (Median) |
---|
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 24 |
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Participants to Achieve Complete Remission (CR):
Complete Remission (CR) is defined as - Normalization of the peripheral blood and bone marrow blasts = 5% in normocellular or hypercellular marrow, granulocyte count of 1x10^9/L or above and platelets >/= 100X10^9/L and complete resolution of all sites of extramedullary disease. (NCT03488225)
Timeframe: Start of treatment up to 2 years
Intervention | Participants (Count of Participants) |
---|
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 4 |
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Number of Participants With Adverse Events
For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting. (NCT03488225)
Timeframe: Start of treatment up to 30 days after last dose received.
Intervention | Participants (Count of Participants) |
---|
| Neutropenic Fever | Peripheral Sensory Neuropathy | Allergic Reaction | Muscle Weakness |
---|
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 2 | 1 | 1 | 1 |
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Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase
MRD-negative CR was achieved when a participant met the criteria for both MRD negativity and CR. MRD-negativity: ≤0.01 % breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (cDNA) with ≥ 10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system [CNS] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) > 1000 per microliter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). (NCT03589326)
Timeframe: From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days)
Intervention | Participants (Count of Participants) |
---|
Cohort A: Ponatinib 30 mg | 53 |
Cohort B: Imatinib 600 mg | 13 |
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Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population
Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 24 were reported. (NCT03600805)
Timeframe: From Week 12 through Week 24
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 21 |
Placebo+26 Week Taper | 7 |
Sarilumab 150mg q2w+26 Week Taper | 10 |
Sarilumab 200mg q2w+26 Week Taper | 15 |
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Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52
Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. (NCT03600805)
Timeframe: Baseline, Weeks 2, 12, 24, and 52
Intervention | nanograms per Liter (Mean) |
---|
| Baseline | Week 2 | Week 12 | Week 24 | Week 52 |
---|
Placebo+26 Week Taper | 8.74 | 3.47 | 5.56 | 5.57 | 2.82 |
,Placebo+52 Week Taper | 10.91 | 2.90 | -0.88 | -1.03 | 0.43 |
,Sarilumab 150mg q2w+26 Week Taper | 11.03 | 31.74 | 52.38 | 53.60 | 42.14 |
,Sarilumab 200mg q2w+26 Week Taper | 7.71 | 117.33 | 81.82 | 69.20 | 33.28 |
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Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab
Ctrough was pre dose concentration of drug. Data for this outcome measure was not planned to be collected and analyzed for placebo arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol. (NCT03600805)
Timeframe: Pre-dose on Week 0 (Baseline), Weeks 2, 4, 12, 16, 24 and 52
Intervention | nanograms per milliliter (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 12 | Week 16 | Week 24 | Week 52 |
---|
Sarilumab 150mg q2w+26 Week Taper | 0.00 | 2099.29 | 4644.71 | 8371.33 | 8111.08 | 12926.67 | 19780.00 |
,Sarilumab 200mg q2w+26 Week Taper | 0.00 | 5400.82 | 11640.98 | 27586.00 | 28911.88 | 35451.74 | 46766.67 |
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Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52
Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6. (NCT03600805)
Timeframe: Baseline, Weeks 2, 12, 24, and 52
Intervention | nanograms per milliliter (Mean) |
---|
| Baseline | Week 2 | Week 12 | Week 24 | Week 52 |
---|
Sarilumab 150mg q2w+26 Week Taper | 50.05 | 212.19 | 336.30 | 311.88 | 377.23 |
,Sarilumab 200mg q2w+26 Week Taper | 61.37 | 224.87 | 427.40 | 456.09 | 471.16 |
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Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52
Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6. (NCT03600805)
Timeframe: Baseline, Weeks 2, 12, 24, and 52
Intervention | nanograms per milliliter (Mean) |
---|
| Baseline | Week 12 | Week 24 | Week 52 |
---|
Placebo+52 Week Taper | 136.63 | 17.67 | -12.72 | -131.47 |
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Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52
Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6. (NCT03600805)
Timeframe: Baseline, Weeks 2, 12, 24, and 52
Intervention | nanograms per milliliter (Mean) |
---|
| Baseline | Week 52 |
---|
Placebo+26 Week Taper | 54.80 | -9.69 |
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Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
ESR is a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeters per hour. (NCT03600805)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
Intervention | millimeters per hour (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 32 | Week 40 | Week 52 |
---|
Placebo+26 Week Taper | 21.9 | 0.7 | 5.2 | 10.2 | 9.8 | 9.8 | 8.8 | 13.9 | 6.6 | 4.0 | -1.4 |
,Placebo+52 Week Taper | 29.3 | -1.1 | -4.2 | -2.0 | -1.5 | -4.1 | -6.6 | -4.2 | -7.0 | -1.5 | -1.0 |
,Sarilumab 150mg q2w+26 Week Taper | 24.9 | -10.4 | -13.3 | -11.9 | -14.7 | -13.5 | -18.2 | -16.4 | -9.4 | -10.1 | -15.2 |
,Sarilumab 200mg q2w+26 Week Taper | 18.2 | -8.8 | -9.4 | -8.7 | -11.0 | -10.4 | -10.9 | -9.3 | -7.9 | -7.9 | -7.0 |
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Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
CRP is a protein made by the liver. CRP levels increase in blood when inflammation occurs in the body. (NCT03600805)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
Intervention | milligrams per liter (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 32 | Week 40 | Week 52 |
---|
Placebo+26 Week Taper | 9.7 | -1.0 | -2.2 | -0.9 | 4.4 | 5.0 | 0.6 | 0.3 | 1.1 | -9.2 | -13.8 |
,Placebo+52 Week Taper | 10.9 | 0.4 | -3.6 | -4.0 | -4.4 | -4.5 | -4.5 | -4.1 | -5.2 | -1.9 | 8.2 |
,Sarilumab 150mg q2w+26 Week Taper | 10.1 | -3.5 | -2.6 | -3.5 | -3.3 | -5.0 | -4.9 | -3.1 | -5.8 | -2.2 | -4.5 |
,Sarilumab 200mg q2w+26 Week Taper | 3.7 | -2.0 | -1.9 | -1.7 | -1.1 | -1.8 | -1.6 | -1.0 | -0.4 | -2.8 | -4.6 |
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Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response
ADA response categories: 1) Treatment-boosted ADA positive participant: Participant with a positive ADA assay response at Baseline and with at least a 4-fold increase in titer compared to Baseline during TEAE period. 2) Treatment-emergent ADA positive participant: Participant with non-positive assay (meaning negative or missing) response at Baseline but with a positive assay response during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Titer values were categorized as low (titer <1,000); moderate (1,000<= titer <=10,000) and high (titer >10,000). (NCT03600805)
Timeframe: From Day 1 (Baseline) up to last dose date of study drug + 60 days (i.e., up to Week 60)
Intervention | percentage of participants (Number) |
---|
| Treatment-boosted ADA positive participants | Treatment-emergent ADA positive participants |
---|
Placebo+26 Week Taper | 0 | 0 |
,Placebo+52 Week Taper | 0 | 3.8 |
,Sarilumab 150mg q2w+26 Week Taper | 0 | 7.1 |
,Sarilumab 200mg q2w+26 Week Taper | 0 | 0 |
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) to the last dose of the SC IMP +60 days). (NCT03600805)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose (i.e., up to Week 60)
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Any treatment emergent SAE |
---|
Placebo+26 Week Taper | 14 | 3 |
,Placebo+52 Week Taper | 24 | 2 |
,Sarilumab 150mg q2w+26 Week Taper | 13 | 2 |
,Sarilumab 200mg q2w+26 Week Taper | 22 | 7 |
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Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52
GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity. (NCT03600805)
Timeframe: At Week 52
Intervention | units on a scale (Mean) |
---|
| Cumulative worsening score | Aggregate improvement score |
---|
Placebo+26 Week Taper | 84.7 | 31.2 |
,Placebo+52 Week Taper | 73.0 | -19.5 |
,Sarilumab 150mg q2w+26 Week Taper | 77.2 | 23.7 |
,Sarilumab 200mg q2w+26 Week Taper | 52.8 | -0.5 |
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Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population
GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 24 are reported in this outcome measure (OM). CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity. (NCT03600805)
Timeframe: At Week 24
Intervention | units on a scale (Mean) |
---|
| Cumulative worsening score | Aggregate improvement score |
---|
Placebo+26 Week Taper | 30.7 | -13.4 |
,Placebo+52 Week Taper | 29.2 | -21.6 |
,Sarilumab 150mg q2w+26 Week Taper | 55.1 | 14.2 |
,Sarilumab 200mg q2w+26 Week Taper | 31.0 | -3.3 |
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Total Cumulative Corticosteroid (Including Prednisone) Dose
Cumulative dose of CS used for GCA disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, CS used in rescue therapy and the use of commercial prednisone (an excess of <=100 mg of prednisone during the study treatment period employed to manage AE not related to GCA). The total cumulative CS dose was based on the total number of days with complete or partial intake, no imputation was done on missed tablets. (NCT03600805)
Timeframe: Up to Week 52
Intervention | milligrams (Mean) |
---|
Placebo+52 Week Taper | 2577.3 |
Placebo+26 Week Taper | 2270.7 |
Sarilumab 150mg q2w+26 Week Taper | 2177.1 |
Sarilumab 200mg q2w+26 Week Taper | 1643.1 |
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Time to First Giant Cell Arteritis Disease Flare
Time to first GCA flare was defined as the duration (in days) from randomization to first GCA flare after clinical remission (defined as resolution of signs and symptoms and normalization of CRP [<10 mg/L]) and up to 52 weeks. Disease flare was defined as either the recurrence of signs or symptoms attributable to active plus an increase in CS dose due to GCA or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Kaplan-Meier method was used for the analysis. Participants who never achieved remission were censored at randomization day; and those who achieved clinical remission and never flared were censored at the end of treatment assessment date up to Week 52. (NCT03600805)
Timeframe: Up to Week 52
Intervention | days (Median) |
---|
Placebo+52 Week Taper | NA |
Placebo+26 Week Taper | 170.00 |
Sarilumab 150mg q2w+26 Week Taper | NA |
Sarilumab 200mg q2w+26 Week Taper | NA |
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Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24
Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay. (NCT03600805)
Timeframe: post-dose at Week 24
Intervention | nanograms per milliliter (Mean) |
---|
Sarilumab 150mg q2w+26 Week Taper | 25255.45 |
Sarilumab 200mg q2w+26 Week Taper | 44551.54 |
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Percentage of Participants Who Achieved Sustained Disease Remission at Week 52
Disease remission was defined as resolution of signs and symptoms of giant cell arteries (GCA), and normalization of C-reactive protein (CRP) (<10 mg/L). Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in corticosteroid [CS] dose due to GCA or elevation of erythrocyte sedimentation rate [ESR] attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 52, normalization of CRP (to <10 mg/L, with absence of successive elevations to >=10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52. (NCT03600805)
Timeframe: At Week 52
Intervention | percentage of participants (Number) |
---|
Placebo+52 Week Taper | 30.0 |
Placebo+26 Week Taper | 0 |
Sarilumab 150mg q2w+26 Week Taper | 42.9 |
Sarilumab 200mg q2w+26 Week Taper | 46.2 |
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Percentage of Participants Who Achieved Sustained Disease Remission at Week 24
Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP <10 mg/L. Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 24, normalization of CRP (to <10 mg/L, with an absence of successive elevations to >=10 mg/L) from Week 12 through Week 24, and successful adherence to the prednisone taper from Week 12 through Week 24. (NCT03600805)
Timeframe: At Week 24
Intervention | percentage of participants (Number) |
---|
Placebo+52 Week Taper | 39.3 |
Placebo+26 Week Taper | 7.1 |
Sarilumab 150mg q2w+26 Week Taper | 42.9 |
Sarilumab 200mg q2w+26 Week Taper | 48.1 |
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Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set
Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as participants who did not take rescue therapy from Week 12 through Week 52 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to GCA. (NCT03600805)
Timeframe: From Week 12 through Week 52
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 6 |
Placebo+26 Week Taper | 2 |
Sarilumab 150mg q2w+26 Week Taper | 3 |
Sarilumab 200mg q2w+26 Week Taper | 6 |
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Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population
Successful adherence to the prednisone taper from Week 12 through Week 24 was defined as participants who did not take rescue therapy from Week 12 through Week 24 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage AE not related to GCA. (NCT03600805)
Timeframe: From Week 12 through Week 24
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 18 |
Placebo+26 Week Taper | 5 |
Sarilumab 150mg q2w+26 Week Taper | 7 |
Sarilumab 200mg q2w+26 Week Taper | 13 |
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Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set
Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP. (NCT03600805)
Timeframe: From Week 12 through Week 52
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 6 |
Placebo+26 Week Taper | 3 |
Sarilumab 150mg q2w+26 Week Taper | 5 |
Sarilumab 200mg q2w+26 Week Taper | 8 |
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Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population
Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP. (NCT03600805)
Timeframe: From Week 12 through Week 24
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 20 |
Placebo+26 Week Taper | 4 |
Sarilumab 150mg q2w+26 Week Taper | 11 |
Sarilumab 200mg q2w+26 Week Taper | 17 |
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Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set
Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue corticosteroid (CS) due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. (NCT03600805)
Timeframe: Up to Week 12
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 7 |
Placebo+26 Week Taper | 3 |
Sarilumab 150mg q2w+26 Week Taper | 4 |
Sarilumab 200mg q2w+26 Week Taper | 7 |
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Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population
Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue CS due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. (NCT03600805)
Timeframe: Up to Week 12
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 16 |
Placebo+26 Week Taper | 6 |
Sarilumab 150mg q2w+26 Week Taper | 9 |
Sarilumab 200mg q2w+26 Week Taper | 15 |
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Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set
Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 52 were reported. (NCT03600805)
Timeframe: From Week 12 through Week 52
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 7 |
Placebo+26 Week Taper | 3 |
Sarilumab 150mg q2w+26 Week Taper | 4 |
Sarilumab 200mg q2w+26 Week Taper | 7 |
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Number of Participants With Absence of Disease Flare From Week 12 Through Week 52
Disease flare was defined as either recurrence of signs and symptoms attributable to active PMR plus an increase in CS dose due to PMR, or elevation of ESR attributable to active PMR plus an increase in CS dose due to PMR. (NCT03600818)
Timeframe: From Week 12 Through Week 52
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 19 |
Sarilumab 200mg q2w+14 Week Taper | 33 |
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Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period
"Criteria for potentially clinically significant vital sign abnormalities:~Systolic Blood Pressure (SBP): <= 95 mmHg and decrease from baseline (DFB) more than or equal to (>=) 20 mmHg; >= 160 mmHg and increase from baseline (IFB) >= 20 mmHg~Diastolic blood pressure (DBP): <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg.~Heart Rate (HR): <= 50 beats per min (bpm) and DFB >=20 bpm; >=120 bpm and IFB >= 20 bpm~Weight: >=5% DFB; >=5% IFB.~TEAE period was defined as the time from the first dose of the IMP to the last dose of the IMP + 60 days." (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)
Intervention | Participants (Count of Participants) |
---|
| SBP <=95 mmHg and DFB >=20 mmHg | SBP >=160 mmHg and IFB >=20 mmHg | DBP <=45 mmHg and DFB >=10 mmHg | DBP >=110 mmHg and IFB >=10 mmHg | HR <=50 bpm and DFB >= 20 bpm | HR >=120 bpm and IFB >=20 bpm | Weight >=5% DFB | Weight >=5% IFB |
---|
Placebo+52 Week Taper | 0 | 4 | 1 | 1 | 1 | 1 | 2 | 9 |
,Sarilumab 200mg q2w+14 Week Taper | 2 | 5 | 0 | 1 | 0 | 0 | 5 | 12 |
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) to the last dose of the IMP +60 days). (NCT03600818)
Timeframe: From first dose (i.e. Day 1) up to 60 days after last dose date of study drug (i.e. up to Week 60)
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | TESAE |
---|
Placebo+52 Week Taper | 49 | 12 |
,Sarilumab 200mg q2w+14 Week Taper | 56 | 8 |
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Number of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response
ADA response categories: 1) Treatment-boosted ADA positive participant: Participant with a positive ADA assay response at Baseline and with at least a 4-fold increase in titer compared to Baseline during TEAE period. 2) Treatment-emergent ADA positive participant: Participant with non-positive assay (meaning negative or missing) response at Baseline but with a positive assay response during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the IMP +60 days). (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)
Intervention | Participants (Count of Participants) |
---|
| Treatment-boosted ADA | Treatment-emergent ADA |
---|
Placebo+52 Week Taper | 0 | 1 |
,Sarilumab 200mg q2w+14 Week Taper | 0 | 2 |
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Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function
"Criteria for potentially clinically significant abnormalities:~Albumin: <= 25 g/L.~Alanine Aminotransferase (ALT): >3 ULN; >5 ULN; >10 ULN.~Aspartate Aminotransferase (AST): >3 ULN; >5 ULN; >10 ULN; >20 ULN.~Alkaline Phosphatase: >1.5 ULN.~Bilirubin: >1.5 ULN; >2 ULN.~ALT and Total Bilirubin: ALT > 3 ULN and Bilirubin > 2 ULN" (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)
Intervention | Participants (Count of Participants) |
---|
| Albumin: <= 25 g/L | ALT: >3 ULN | ALT: >5 ULN | ALT: >10 ULN | AST: >3 ULN | AST: >5 ULN | AST: >10 ULN | AST: >20 ULN | Alkaline Phosphatase: >1.5 ULN | Bilirubin: >1.5 ULN | Bilirubin: >2 ULN | ALT > 3 ULN and Bilirubin > 2 ULN |
---|
Placebo+52 Week Taper | 0 | 2 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 0 |
,Sarilumab 200mg q2w+14 Week Taper | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
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Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter
"Criteria for potentially clinically significant laboratory abnormalities included:~Hemoglobin (Hb): <= 115 grams per liter (g/L) (Male [M]), <= 95 g/L (Female [F]); >= 185 g/L (M), >= 165 g/L (F); DFB >= 20 g/L .~Hematocrit: <= 0.37 volume/volume (v/v) (M); <= 0.32 v/v (F); >= 0.55 v/v (M); >= 0.5 v/v (F).~Erythrocytes: >=6 Tera/ liter (L).~Platelets: < 100 Giga/L, >= 700 Giga/L.~Leukocytes: < 3.0 Giga/L (Non-Black [NB]); < 2.0 Giga/L (Black [B]), >= 16.0 Giga/L.~Neutrophils: < 1.5 Giga/L (NB); < 1.0 Giga/L (B).~Lymphocytes: > 4.0 Giga/L.~Monocytes: > 0.7 Giga/L.~Basophils: > 0.1 Giga/L.~Eosinophils: > 0.5 Giga/L or > upper limit of normal (ULN) (if ULN >= 0.5 Giga/L)." (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)
Intervention | Participants (Count of Participants) |
---|
| Hb: <= 115 g/L (M), <= 95 g/L (F) | Hb: >=185 g/L(M), >=165 g/L(F) | Hb: DFB >=20 g/L | Hematocrit: <= 0.37 v/v(M); <=0.32 v/v(F) | Hematocrit: >=0.55 v/v(M); >=0.5 v/v(F) | Erythrocytes: >=6 Tera/L | Platelets: < 100 Giga/L | Platelets: >= 700 Giga/L | Leukocytes:<3.0Giga/L(NB);<2.0Giga/L(B) | Leukocytes: >= 16.0 Giga/L. | Neutrophils: < 1.5 Giga/L (NB); < 1.0 Giga/L (B). | Lymphocytes: > 4.0 Giga/L | Monocytes: > 0.7 Giga/L | Basophils: > 0.1 Giga/L. | Eosinophils:>0.5 Giga/L; >ULN (if ULN>=0.5Giga/L) |
---|
Placebo+52 Week Taper | 1 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 4 | 12 | 16 | 2 |
,Sarilumab 200mg q2w+14 Week Taper | 1 | 1 | 2 | 1 | 0 | 0 | 2 | 0 | 11 | 1 | 18 | 2 | 8 | 13 | 2 |
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Total Cumulative Corticosteroid Dose
Cumulative dose of CS used for PMR disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, add-on prednisone, CS used in rescue therapy and the use of commercial prednisone (an excess of <=100 mg of prednisone during the study treatment period). The total cumulative CS dose was based on the total number of days with complete or partial intake, no imputation was done on missed tablets. (NCT03600818)
Timeframe: Up to Week 52
Intervention | milligrams (Mean) |
---|
Placebo+52 Week Taper | 2235.8 |
Sarilumab 200mg q2w+14 Week Taper | 1039.5 |
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Number of Participants Who Achieved Disease Remission up to Week 12
Disease remission was defined as resolution of signs and symptoms of PMR, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue CS due to active PMR prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. During the initial 12 weeks of prednisone taper, treatment for one flare before Week 12 was permitted if it was successfully treated with a low dose (<=5 mg/day) prednisone add-on taper regimen (completed prior to Week 12) and provided that all other sustained remission parameters were met. (NCT03600818)
Timeframe: Up to Week 12
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 22 |
Sarilumab 200mg q2w+14 Week Taper | 28 |
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Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab
Ctrough was pre dose concentration of drug. Data for this outcome measure was not planned to be collected and analyzed for placebo arm (Placebo+52 Week Taper) as pre-specified in the protocol. (NCT03600818)
Timeframe: Pre-dose on Week 0 (Baseline), Week 2, 4, 12, 16, 24, and 52
Intervention | nanograms per milliliter (ng/mL) (Mean) |
---|
| Baseline | Week 2 | Week 4 | Week 12 | Week 16 | Week 24 | Week 52 |
---|
Sarilumab 200mg q2w+14 Week Taper | 0.00 | 5209.02 | 9259.25 | 17494.20 | 23082.86 | 27289.75 | 27604.95 |
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Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52
Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as participants who did not take rescue therapy from Week 12 through Week 52 and any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to PMR. (NCT03600818)
Timeframe: From Week 12 through Week 52
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 14 |
Sarilumab 200mg q2w+14 Week Taper | 30 |
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Number of Participants With Sustained Reduction of CRP From Week 12 Through Week 52
Normalization (sustained reduction) of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP. (NCT03600818)
Timeframe: From Week 12 through Week 52
Intervention | Participants (Count of Participants) |
---|
Placebo+52 Week Taper | 26 |
Sarilumab 200mg q2w+14 Week Taper | 40 |
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Percentage of Participants Achieving Sustained Remission at Week 52
Sustained remission was defined as meeting all of the following parameters: achievement of disease remission (defined as resolution of signs and symptoms of polymyalgia rheumatica [PMR], and normalization of C-reactive protein [CRP] {less than [<]10 milligrams per liter [mg/L]}) not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active PMR plus an increase in corticosteroid [CS] dose due to PMR or elevation of erythrocyte sedimentation rate [ESR] attributable to active PMR plus an increase in CS dose due to PMR) from Week 12 through Week 52, sustained reduction of CRP (to <10 mg/L, with absence of successive elevations to greater than or equal to [>=]10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52. (NCT03600818)
Timeframe: At Week 52
Intervention | percentage of participants (Number) |
---|
Placebo+52 Week Taper | 10.3 |
Sarilumab 200mg q2w+14 Week Taper | 28.3 |
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Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24
Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay. (NCT03600818)
Timeframe: Post-dose at Week 24
Intervention | ng/mL (Mean) |
---|
Sarilumab 200mg q2w+14 Week Taper | 35757.69 |
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Time to First Polymyalgia Rheumatica Flare After Clinical Remission up to Week 52
Time to first PMR flare was defined as the duration (in days) from randomization to first PMR flare after clinical remission (defined as resolution of signs and symptoms and normalization of CRP [<10 mg/L]) and up to 52 weeks. Disease flare was defined as either the recurrence of signs or symptoms attributable to active plus an increase in CS dose due to PMR or elevation of ESR attributable to active PMR plus an increase in CS dose due to PMR. Kaplan-Meier method was used for the analysis. Participants who never achieved remission were censored at randomization day; and those who achieved clinical remission and never flared were censored at the end of treatment assessment date up to Week 52. (NCT03600818)
Timeframe: Up to Week 52
Intervention | days (Median) |
---|
Placebo+52 Week Taper | 99.00 |
Sarilumab 200mg q2w+14 Week Taper | NA |
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Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 52
GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: C-GTI and Specific List. C-GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. C-GTI score was sum of 9 domain-specific scores at each visit and Cumulative GTI score was sum of C-GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this outcome measure. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. Negative scores reflect improvement in CS toxicities present from Baseline. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, minimum score implies least toxicity and maximum score implies most toxicity. (NCT03600818)
Timeframe: At Week 52
Intervention | units on a scale (Least Squares Mean) |
---|
| CWS | AIS |
---|
Placebo+52 Week Taper | 57.22 | 2.57 |
,Sarilumab 200mg q2w+14 Week Taper | 52.32 | -4.02 |
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Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function
"Criteria for potentially clinically significant abnormalities:~Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline.~Creatinine clearance: >=60 to <90 milliliters per minute (mL/min); >=30 to <60 mL/min ; >=15 to <30 mL/min; <15 mL/min.~Blood urea nitrogen: >=17 mmol/L.~Urate: <120 micromol/L; >408 micromol/L." (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)
Intervention | Participants (Count of Participants) |
---|
| Creatinine: >=150 micromol/L (adults) | Creatinine: >=30% change from baseline | Creatinine: >=100% change from baseline | Creatinine clearance: >=60 to <90 mL/min | Creatinine clearance: >=30 to <60 mL/min | Creatinine clearance: >=15 to <30 mL/min | Creatinine clearance: <15 mL/min | Blood urea nitrogen: >=17 mmol/L | Urate: <120 micromol/L | Urate: >408 micromol/L |
---|
Placebo+52 Week Taper | 2 | 3 | 0 | 30 | 13 | 0 | 0 | 0 | 0 | 16 |
,Sarilumab 200mg q2w+14 Week Taper | 2 | 14 | 1 | 29 | 17 | 1 | 0 | 0 | 0 | 16 |
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Rate of Undetectable Prostate Specific Antigen (PSA) (< 0.2)
The number of patients with undetectable PSA at 6-months will be summarized by each arm and all combined. (NCT03649841)
Timeframe: At 6 months after start of abiraterone acetate
Intervention | Participants (Count of Participants) |
---|
Arm I (ADT, Abiraterone, Prednisone) | 1 |
Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy) | 1 |
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Incidence of Adverse Events
Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety and tolerability as evaluated by the incidence, severity, duration, causality, seriousness of adverse events. Toxicities will be summarized as the number of patients with grade 3 or higher toxicities per CTCAE v4.0, in addition to total number of toxicities (allowing for multiple toxicities within a patient) among all patients, and per treatment arm. (NCT03649841)
Timeframe: Up to 6 months
Intervention | Participants (Count of Participants) |
---|
Arm I (ADT, Abiraterone, Prednisone) | 2 |
Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy) | 0 |
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Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug. (NCT03721965)
Timeframe: up to 45 days
Intervention | Participants (Count of Participants) |
---|
Cohort 1 : Itacitinib + Corticosteroids | 2 |
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Adverse Events
Number and percentage of participants with at least one adverse event by week 52 (NCT03726749)
Timeframe: 52 weeks
Intervention | Participants (Count of Participants) |
---|
Tocilizumab Plus Prednisone Treatment | 30 |
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Cumulative Prednisone Dose
Cumulative prednisone dose (mg) by week 52 (NCT03726749)
Timeframe: 52 Weeks
Intervention | mg (Mean) |
---|
Tocilizumab and Prednisone | 1187 |
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Disease Flares
Total number of disease flares by week 52. Flare was defined as the re-appearance of clinical manifestations of GCA with or without elevation of the inflammatory makers erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) (NCT03726749)
Timeframe: 52 Weeks
Intervention | Total number of flares (Number) |
---|
Tocilizumab and Prednisone | 9 |
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Serious Adverse Events
Number and percentage of participants with at least one serious adverse event by week 52 (NCT03726749)
Timeframe: 52 weeks
Intervention | Participants (Count of Participants) |
---|
Tocilizumab and Prednisone | 4 |
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Sustained Remission
Number and percentage of patients in sustained remission by week 52. Sustained remission was defined as the absence of disease flare between baseline and week 52. Flare was defined as the re-appearance of clinical manifestations of GCA with or without elevation of the inflammatory makers erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) (NCT03726749)
Timeframe: 52 weeks
Intervention | Participants (Count of Participants) |
---|
Tocilizumab and Prednisone | 23 |
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Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurs first. Radiographic progression was determined by: 1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; 2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >= 2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later. (NCT03748641)
Timeframe: Up to 32 months
Intervention | Months (Median) |
---|
Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 16.46 |
Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 13.70 |
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Number of Participants With 50% Reduction in Corticosteroid Requirement
50% reduction in corticosteroid requirement by week 16, without significant decline in their pulmonary function-defined as a >15% decline in forced vital capacity (FVC), forced expiratory volume at 1 second (FEV1), or diffusing capacity of lung for carbon monoxide (DLCO) relative to the baseline value (NCT03793439)
Timeframe: 16 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label | 3 |
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Duration of Overall Survival After Receiving Nivolumab, Tacrolimus, and Prednisone
The time from the participant's first dose of nivolumab to the date of death from any cause. (NCT03816332)
Timeframe: Up to 3 years
Intervention | months (Median) |
---|
Nivolumab, Tacrolimus, and Prednisone | 9.1 |
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Duration of Progression-free Survival After Receiving Nivolumab, Tacrolimus, and Prednisone
From the first dose of nivolumab to the date of the first documented tumor progression or death due to any cause, whichever occurs first. (NCT03816332)
Timeframe: Up to 4 months
Intervention | days (Mean) |
---|
Nivolumab, Tacrolimus, and Prednisone | 59 |
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Rate of Allograft Loss After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone
Number of patients who experienced allograft loss after receiving nivolumab, ipilimumab, tacrolimus, and prednisone. (NCT03816332)
Timeframe: Up to 3 years
Intervention | Participants (Count of Participants) |
---|
| Experienced allograft loss | Did not experience allograft loss |
---|
Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | 3 | 3 |
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Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone
Percentage of kidney transplant recipients who experienced complete response (CR), partial response (PR) or stable disease (SD) without allograft loss. (NCT03816332)
Timeframe: At 16 weeks
Intervention | Participants (Count of Participants) |
---|
| Complete response (CR), partial response (PR) or stable disease (SD) without allograft loss | Progressive Disease (PD) without allograft loss |
---|
Nivolumab, Tacrolimus, and Prednisone | 0 | 8 |
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Objective Response Rate (ORR) at the End of Induction (EOI) Therapy
ORR at EOI therapy was defined as the percentage of particpants with either a CR, CR unconfirmed or PR at the EOI visit, as determined by the investigator and according to the guidelines used at the site. (NCT03817853)
Timeframe: Baseline up to end of induction therapy (up to approximately 6 months)
Intervention | Percentage of Participants (Number) |
---|
| Complete Response | Partial Response |
---|
All Participants | 72.1 | 19.1 |
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Duration (In Minutes) of Obinutuzumab Administration by Cycle
The duration of obinutuzumab administration (in minutes) by cycle was defined as the difference between the end time and the start time of obinutuzumab administration. (NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)
Intervention | Minutes (Mean) |
---|
| Cycle(C) 1 Day(D) 1 | C1D8 | C1D15 | C2 | C3 | C4 | C5 | C6 | C7 | C8 | Maintenance Week 1 | Maintenance Week 9 | Maintenance Week 17 | Maintenance Week 25 | Maintenance Week 33 | Maintenance Week 41 |
---|
All Participants | 295.96 | 215.97 | 207.52 | 101.48 | 102.97 | 98.33 | 98.26 | 99.49 | 99.56 | 94.54 | 101.48 | 97.21 | 97.64 | 93.83 | 92.50 | 90.00 |
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Time to IRR From Infusion to Onset of the IRR During Cycle 2
Time to IRR (of any grade) in Cycle 2 was defined as the time from the start of infusion (i.e., start date/time of infusion of the first component of study treatment) in Cycle 2 to the onset of the IRR (of any grade) during Cycle 2. (NCT03817853)
Timeframe: From infusion to onset of IRR during Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected)
Intervention | Hours (Mean) |
---|
All Participants | 11.800 |
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Percentage of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study, recurrence of an intermittent medical condition, deterioration in a laboratory value or other clinical test or were related to a protocol-mandated intervention were also considered AEs. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. (NCT03817853)
Timeframe: Baseline up to clinical cut off date (up to approximately 1.5 years)
Intervention | Percentage of Participants (Number) |
---|
All Participants | 99.1 |
Maintenance: Obinutuzumab | 41.1 |
Follow-up | 35.3 |
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Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
The duration, in minutes, of IRRs during all cycles, where obinutuzumab was administered as an SDI. (NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)
Intervention | Minutes (Mean) |
---|
All Participants | 165.0 |
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Percentage of IRRs Regardless of Grade by Cycle
IRRs were defined as all adverse events (AEs) that occurred during or within 24 hours from the end of study treatment infusion and were judged as related to infusion of study treatment components by the investigator. (NCT03817853)
Timeframe: Within 24 hours from the end of study treatment infusion in all cycles, including maintenance ((1 cycle: 21 or 28 days depending on the chemotherapy selected); up to approximately 2.5 years)
Intervention | Percentage of Participants (Number) |
---|
| Cycle 1 Day 1 | Cycle 1 Day 2 | Cycle 1 Day 8 | Cycle 1 Day 15 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | Cycle 6 | Cycle 7 |
---|
All Participants | 49.6 | 7.8 | 4.5 | 4.5 | 11.8 | 8.3 | 4.9 | 6.2 | 3.6 | 4.4 |
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Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
(NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)
Intervention | Percentage of Participants (Number) |
---|
| Cycle (C) 5- Hypertension | C5 - Renal failure | C5 - Weight increased |
---|
All Participants | 33.3 | 33.3 | 33.3 |
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Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26
Kaplan-Meier method used to estimate the survival functions for each treatment arm. (NCT03827018)
Timeframe: Week 26
Intervention | weeks (Median) |
---|
Mavrilimumab | NA |
Placebo | 25.1 |
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Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26
Elevated ESR is defined as first occurrence of ESR value ≥ 30 mm/hr. Participants with elevated ESR within 3 days of first dose are excluded from the analysis. Kaplan-Meier method used to estimate the survival functions for each treatment arm. (NCT03827018)
Timeframe: Week 26
Intervention | weeks (Median) |
---|
Mavrilimumab | 26.1 |
Placebo | 12.1 |
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Time to Elevated C-Reactive Protein (CRP) by Week 26
Elevated CRP is defined as first occurrence of CRP value ≥ 1.0 mg/dL. Participants with elevated CRP within 3 days of first dose are excluded from the analysis. Kaplan-Meier method used to estimate the survival functions for each treatment arm. (NCT03827018)
Timeframe: Week 26
Intervention | weeks (Median) |
---|
Mavrilimumab | NA |
Placebo | 12.3 |
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Cumulative Corticosteroid Dose at the End of the Washout Safety Follow-up Period
(NCT03827018)
Timeframe: Final Safety Follow-up visit (Week 38)
Intervention | mg (Mean) |
---|
Mavrilimumab | 2464.93 |
Placebo | 2845.45 |
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Cumulative Corticosteroid Dose at Week 26
(NCT03827018)
Timeframe: Week 26
Intervention | mg (Mean) |
---|
Mavrilimumab | 2074.15 |
Placebo | 2402.98 |
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Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal CRP Level
Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses < 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals. (NCT03827018)
Timeframe: Week 26
Intervention | percentage of participants (Number) |
---|
Mavrilimumab | 23.8 |
Placebo | 14.3 |
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Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal ESR
Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses < 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals. (NCT03827018)
Timeframe: Week 26
Intervention | percentage of participants (Number) |
---|
Mavrilimumab | 45.2 |
Placebo | 14.3 |
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Percentage of Participants Who Completed the 26-week Corticosteroid Taper and Who Had No Signs or Symptoms of GCA Nor New or Worsening Vasculitis by Imaging by Week 26
Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses < 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals. (NCT03827018)
Timeframe: Week 26
Intervention | percentage of participants (Number) |
---|
Mavrilimumab | 71.4 |
Placebo | 32.1 |
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Sustained Remission Rate at Week 26
The sustained remission rate at Week 26 is defined as the percentage of participants with sustained remission, as assessed by independent adjudication, at Week 26, derived from the time to flare curve. Kaplan-Meier Survival Estimates with standard error and 95% CI for each arm. Participants who completed the treatment period without a flare by Week 26 were considered to have sustained remission. (NCT03827018)
Timeframe: Week 26
Intervention | percentage of participants (Number) |
---|
Mavrilimumab | 83.2 |
Placebo | 49.9 |
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Time to Flare by Week 26
"Time to flare by Week 26 was defined as time from randomization to the date of first flare occurring within the 26-week period, as assessed by independent adjudication. Kaplan-Meier method used to estimate the survival functions for each treatment arm.~Flare/relapse was defined as a C-reactive protein (CRP) of 1 mg/dL or greater and/or erythrocyte sedimentation rate (ESR) of 30 mm/h or greater AND at least one of the following signs or symptoms attributed to GCA: Cranial symptoms (new-onset localized headache; scalp or temporal artery tenderness; ischemic-related vision loss; unexplained mouth or jaw pain upon mastication; transient ischemic attack or stroke related to GCA); Extracranial symptoms (claudication of the extremities; symptoms of polymyalgia rheumatica); New or worsening angiographic abnormalities detected via MRI, CT/CTA, or PET-CT of the aorta or other great vessels or via ultrasound of the temporal arteries." (NCT03827018)
Timeframe: Week 26
Intervention | weeks (Median) |
---|
Mavrilimumab | NA |
Placebo | 25.1 |
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Prostate Specific Antigen Progression Free Survival (PSA-PFS)
Prostate Specific Antigen (PSA) will be measured every three months while on study. PSA Progression Free Survival (PSA-PSF) will be reported as the number of participants who have not demonstrated PSA progression by the end of the follow-up period. PSA progression is defined by meeting the following criteria: 1) an increase in PSA of greater than or equal to 25% from baseline or nadir, AND 2) an increase in PSA of at least 2 ng/dL, AND 3) the increase is confirmed at least 3 weeks later. This analysis was planned for up to 18 months following study enrollment, but the only participant enrolled on the study was only followed for 3 months. (NCT03827473)
Timeframe: Planned up to 18 months, but actual was 3 months
Intervention | Participants (Count of Participants) |
---|
Arm A (ADT, Docetaxel) | 1 |
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Prostate-specific Antigen (PSA) Response
PSA evaluations will occur every 3 months while on study. PSA response is defined as a reduction in PSA value of greater than or equal to 90% from baseline, reported as a count of participants who had a PSA response on the study. (NCT03827473)
Timeframe: Planned for up to 18 months, but actual was 3 months
Intervention | Participants (Count of Participants) |
---|
Arm A (ADT, Docetaxel) | 1 |
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Change in Quality of Life - FACT-P
The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead. (NCT03827473)
Timeframe: Planned for up to one year, but actual was 3 months
Intervention | score on a scale (Number) |
---|
| Baseline Score | Month 3 Score |
---|
Arm A (ADT, Docetaxel) | 139.83 | 127 |
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Change in Quality of Life - FACT/GOG-NTX
Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) (FACT/GOG-NTX) scale (version 4). FACT/GOG-NTX total score ranges from 0 to 152, with higher scores indicating a higher quality of life. (NCT03827473)
Timeframe: Planned for up to 18 months, but actual was 3 months
Intervention | score on a scale (Number) |
---|
| Baseline Score | Month 3 Score |
---|
Arm A (ADT, Docetaxel) | 131.83 | 126 |
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Change in Quality of Life - PROMIS Fatigue
Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale. Total raw scores range from 7 to 35, with higher scores indicating a higher level of fatigue. (NCT03827473)
Timeframe: Planned for up to 18 months, but actual was 3 months
Intervention | score on a scale (Number) |
---|
| Baseline Score | Month 3 Score |
---|
Arm A (ADT, Docetaxel) | 10 | 16 |
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Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment. (NCT03834506)
Timeframe: Up to 36.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 12.4 |
Placebo + Docetaxel | 11.2 |
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Time to Prostate-specific Antigen (PSA) Progression
"The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of:~≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR~≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline~Time to PSA progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment." (NCT03834506)
Timeframe: Up to 36.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 6.9 |
Placebo + Docetaxel | 7.0 |
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Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit (Kaplan-Meier) method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received. (NCT03834506)
Timeframe: Up to approximately 28 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 10.7 |
Placebo + Docetaxel | 10.4 |
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Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented. (NCT03834506)
Timeframe: Up to approximately 27 months
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab + Docetaxel | 150 |
Placebo + Docetaxel | 115 |
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Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for ≥6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment. (NCT03834506)
Timeframe: Up to 36.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 6.3 |
Placebo + Docetaxel | 6.2 |
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"Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (Worst Pain in 24 Hours) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score"
"TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF and by the AQA score. Pain progression was defined as:~For participants asymptomatic at baseline: a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain~For participants symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids:, a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.~TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had > 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment." (NCT03834506)
Timeframe: Up to 36.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 21.1 |
Placebo + Docetaxel | NA |
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Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment. (NCT03834506)
Timeframe: Up to approximately 28 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 8.6 |
Placebo + Docetaxel | 8.3 |
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Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. (NCT03834506)
Timeframe: Up to 36.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 19.6 |
Placebo + Docetaxel | 19.0 |
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Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
ORR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG). (NCT03834506)
Timeframe: Up to 36.5 months
Intervention | Percentage of participants (Number) |
---|
Pembrolizumab + Docetaxel | 33.5 |
Placebo + Docetaxel | 35.3 |
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Number of Participants Who Experienced an Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented. (NCT03834506)
Timeframe: Up to approximately 30 months
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab + Docetaxel | 508 |
Placebo + Docetaxel | 505 |
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Prostate-specific Antigen (PSA) Response Rate
The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements. (NCT03834506)
Timeframe: Up to 36.5 months
Intervention | Percentage of participants (Number) |
---|
Pembrolizumab + Docetaxel | 44.5 |
Placebo + Docetaxel | 45.7 |
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Radiographic Progression-Free Survival (rPFS)
rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves. (NCT03834519)
Timeframe: Up to ~31 months
Intervention | Months (Median) |
---|
Pembrolizumab + Olaparib | 4.4 |
Next-generation Hormonal Agent Monotherapy (NHA) | 4.2 |
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Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves. (NCT03834519)
Timeframe: Up to ~31 months
Intervention | Months (Median) |
---|
Pembrolizumab + Olaparib | 15.8 |
Next-generation Hormonal Agent Monotherapy (NHA) | 14.6 |
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IFX-1 Blocking Activity 10 nM
Pharmacodynamics endpoint: IFX-1 blocking activity 10 nM (NCT03895801)
Timeframe: Week 16
Intervention | percentage of IFX-1 blocking activity (Mean) |
---|
IFX-1 + Placebo-GC | 100.571 |
IFX-1 + Reduced Dose GC | 100.508 |
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Vasculitis Damage Index (VDI)
Efficacy endpoint: Absolute values of VDI; The VDI total score ranges from 0 to 64 with higher scores indicating more organ damage since the onset of vasculitis. The total score is the number of present damage items. (NCT03895801)
Timeframe: Week 16
Intervention | score on a scale (Mean) |
---|
IFX-1 + Placebo-GC | 1.0 |
Placebo-IFX-1 + Standard Dose GC | 1.5 |
IFX-1 + Reduced Dose GC | 1.9 |
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Change From Baseline in BVASv3 Total Score
Efficacy endpoint: Absolute Change from baseline (= screening assessment) in Birmingham Vasculitis Activity Score version 3 (BVASv3) total score; The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity. The total score is derived by summing up item scores according to the scoring manual for the BVASv3. (NCT03895801)
Timeframe: Baseline, Week 16
Intervention | score on a scale (Mean) |
---|
IFX-1 + Placebo-GC | -13.8 |
Placebo-IFX-1 + Standard Dose GC | -14.7 |
IFX-1 + Reduced Dose GC | -16.6 |
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Plasma Concentrations of C5a
Pharmacodynamics endpoint: Plasma concentrations of C5a (NCT03895801)
Timeframe: Week 16
Intervention | ng/mL (Mean) |
---|
IFX-1 + Placebo-GC | 10.6816 |
Placebo-IFX-1 + Standard Dose GC | 39.2822 |
IFX-1 + Reduced Dose GC | 13.6320 |
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Physician Global Assessment (PGA)
Efficacy endpoint: Absolute values in PGA; Physician global assessment scale: 0 = Remission to 10 = Maximum activity; (NCT03895801)
Timeframe: Week 16
Intervention | score on a scale (Mean) |
---|
IFX-1 + Placebo-GC | 0.4 |
Placebo-IFX-1 + Standard Dose GC | 0.1 |
IFX-1 + Reduced Dose GC | 0.7 |
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IFX-1 Plasma Concentrations (Pre-dose)
Pharmacokinetics endpoint: IFX-1 plasma concentrations assessed prior to study drug administration at corresponding visit. (NCT03895801)
Timeframe: Week 16 (pre-dose)
Intervention | ng/mL (Geometric Mean) |
---|
IFX-1 + Placebo-GC | 67077.19 |
Placebo-IFX-1 + Standard Dose GC | 47.80 |
IFX-1 + Reduced Dose GC | 52597.85 |
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IFX-1 Blocking Activity 2.5 nM
Pharmacodynamics endpoint: IFX-1 blocking activity 2.5 nM (NCT03895801)
Timeframe: Week 16
Intervention | percentage of IFX-1 blocking activity (Mean) |
---|
IFX-1 + Placebo-GC | 98.260 |
IFX-1 + Reduced Dose GC | 121.881 |
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Glucocorticoid Toxicity Index (GTI)
"Safety endpoint: The GTI total score ranges from -35 to 410 (because the bone domain is excluded in this study) with higher score indicating greater Glucocorticoid toxicity. Scoring was performed in the electronic case report form according to the corresponding scoring manual in Development of a Glucocorticoid Toxicity Index (GTI) using multicriteria decision analysis. by Miloslavsky EM, Naden RP, Bijlsma JW, Brogan PA, Brown ES, Brunetta P, et al." (NCT03895801)
Timeframe: Week 16
Intervention | score on a scale (Mean) |
---|
IFX-1 + Placebo-GC | 0.8 |
Placebo-IFX-1 + Standard Dose GC | 44.9 |
IFX-1 + Reduced Dose GC | 26.1 |
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Percentage of Subjects With Clinical Remission
Efficacy endpoint: Percentage of subjects with clinical remission, defined as having a BVASv3 = 0. Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity. (NCT03895801)
Timeframe: Week 16
Intervention | Participants (Count of Participants) |
---|
IFX-1 + Placebo-GC | 14 |
Placebo-IFX-1 + Standard Dose GC | 20 |
IFX-1 + Reduced Dose GC | 10 |
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Percentage of Subjects Achieving Clinical Response
Efficacy Endpoint: Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score version 3 [BVASv3] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity. (NCT03895801)
Timeframe: Baseline, Week 16
Intervention | Participants (Count of Participants) |
---|
IFX-1 + Placebo-GC | 16 |
Placebo-IFX-1 + Standard Dose GC | 22 |
IFX-1 + Reduced Dose GC | 10 |
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Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE)
Safety endpoint: Number and percentage of subjects who had a treatment-emergent adverse event (TEAE) (NCT03895801)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
IFX-1 + Placebo-GC | 16 |
Placebo-IFX-1 + Standard Dose GC | 24 |
IFX-1 + Reduced Dose GC | 15 |
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Estimated Glomerular Filtration Rate
"Efficacy endpoint: Absolute values of estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²; The eGFR was calculated by the central laboratory according to the Modified Diet in Renal Disease equation:~eGFR = 175 x (serum creatinine, mg/dL)-1.154 x (age, years)-0.203 x (0.742 if female) x (1.212 if black)" (NCT03895801)
Timeframe: Week 16
Intervention | mL/min/1.73 m² (Mean) |
---|
IFX-1 + Placebo-GC | 50.2 |
Placebo-IFX-1 + Standard Dose GC | 57.0 |
IFX-1 + Reduced Dose GC | 51.2 |
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Fasting Glucose
mg/dL, 0-unlimited, higher score indicates worse outcome (NCT04054375)
Timeframe: Baseline and 6 months (Final Visit)
Intervention | mg/dL (Mean) |
---|
| Baseline | End |
---|
Weekly Steroid | 93 | 102 |
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Fasting Lipid Profile
cholesterol levels - mg/dL, higher levels indicate worse outcomes (NCT04054375)
Timeframe: Baseline and 6 months (Final Visit)
Intervention | mg/dL (Mean) |
---|
| Baseline | End |
---|
Weekly Steroid | 182 | 185 |
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Muscle Strength Test
Manual motor testing of the right knee flexion muscle group. (NCT04054375)
Timeframe: baseline, 6 months
Intervention | Units on scale (Mean) |
---|
| Baseline | 6 months |
---|
Weekly Steroid | 3 | 3 |
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Functional Assessments - Upper Limb Strength
"Grip strength of the total force (Newtons) in both hands.~Participants attempted 3 trials in the right hand that was then averaged to create a right-hand average force score.~Then, the participants attempted 3 trials in the left hand that was then averaged to create a left-hand average force score.~The right-hand average force score was added to the left-hand average force score to create a total grip strength score." (NCT04054375)
Timeframe: Baseline and 6 months
Intervention | Force (Newtons) (Mean) |
---|
| Baseline | 6 months |
---|
Weekly Steroid | 39 | 41 |
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Respiratory Changes
Force Vital Capacity (% of predicted value), decrease in FVC indicates declining respiratory function. (NCT04054375)
Timeframe: Baseline, 6 months
Intervention | % Expected (Mean) |
---|
| Baseline | End |
---|
Weekly Steroid | 80 | 79 |
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Creatine Kinase
units/L, 0-unlimited, higher scores indicate worse outcome (NCT04054375)
Timeframe: Baseline and 6 months (Final Visit)
Intervention | U/L (Mean) |
---|
| Baseline | End |
---|
Weekly Steroid | 1574 | 1047 |
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Brooke Scale Score
upper extremity assessment, scoring between 1- 6, lower score indicates more upper extremity function (NCT04054375)
Timeframe: Baseline, Month 6
Intervention | scores on a scale (Mean) |
---|
| baseline | 6 months |
---|
Weekly Steroid | 3 | 3 |
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Bone Density
"whole dexa body scan to assess bone density with Z scores (more negative z score indicates increased risk for fractures).~Z-score of 0 represents the population mean, and is the average bone density. Positive scores indicate greater bone density and negative scores indicate decreased bone density, which could be clinically correlated with osteoporosis." (NCT04054375)
Timeframe: Baseline, 6 months
Intervention | z-score (Mean) |
---|
| baseline | 6 months |
---|
Weekly Steroid | -1.64 | -1.65 |
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Vignos Scale Score
Lower extremity assessment, score from 1-10, lower score indicates more function. (NCT04054375)
Timeframe: Baseline, Month 6
Intervention | scores on a scale (Mean) |
---|
| baseline | 6 months |
---|
Steroid Treatment Group | 5 | 5 |
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HbgA1c
% , 0-100, higher score indicates worse outcome (NCT04054375)
Timeframe: Baseline and 6 months (Final Visit)
Intervention | % A1c (Mean) |
---|
| Baseline | End |
---|
Weekly Steroid | 5.2 | 5.3 |
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6 Minute Walk Test
number of meters walked in 6 minute period. Higher values indicate more motor function. (NCT04054375)
Timeframe: Baseline, Month 6
Intervention | meters (Mean) |
---|
| Baseline | 6 months |
---|
Steroid Group | 386 | 410 |
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10 Meter Run Timed
time in seconds to walk/run 10 meters , less time to run indicates greater motor function (NCT04054375)
Timeframe: Baseline, Month 6
Intervention | seconds (Mean) |
---|
| Baseline | 6 months |
---|
Steroid Treatment | 7.32 | 6.67 |
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Muscle Imaging
MRI of leg muscles to measure changes in muscle fat percentage. The data point was collected by taking fat percentage at 6 months minus fat percentage at baseline with the following equation: (([final fat percentage - initial fat percentage]/initial fat percentage) * 100%)). All participants were included, both ambulatory and nonambulatory, with all genetic subtypes included. Five participants didn't have an MRI scan at 6 months and therefore were not included. Muscles imaged were analyzed for muscle fat changes from baseline to 6 months. Data is limited in interpretation due to various muscle groups in both ambulatory and non-ambulatory patients. (NCT04054375)
Timeframe: Baseline, 6 months
Intervention | percent of change from baseline (Mean) |
---|
Weekly Steroid | -14 |
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Lean Mass %
whole body dexa scans to assess lean mass % (0- 100 %). Increase lean mass % is the desired outcome. (NCT04054375)
Timeframe: Baseline, 6 months
Intervention | percentage (Mean) |
---|
| baseline | 6 months |
---|
Weekly Steroid | 37.5 | 38.1 |
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Functional Assessments - NSAD Change
"Northstar Assessment for Dysferlinopathy~- score out of 58, range from 0 to 58, higher score indicates greater functional ability." (NCT04054375)
Timeframe: Baseline, Month 6
Intervention | score on a scale (Mean) |
---|
| baseline | 6 months |
---|
Weekly Steroid | 18.4 | 18.6 |
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Number of Participants With AKI (Acute Kidney Injury)
"Increase in creatinine of 50% above baseline over a period of 7 days~Increase in creatinine of 0.3 mg/dl within a period of 48 hrs~Onset of renal failure requiring dialysis" (NCT04072822)
Timeframe: 7, 30, and 90 days
Intervention | Participants (Number) |
---|
| Day 7 | Day 30 | Day 90 |
---|
Anakinra and Zinc | 17 | 20 | 5 |
,Prednisone | 4 | 6 | 5 |
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Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation.
"The SOFA score will be calculated at the following website https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-score~Scores can be from 0 - >14 (favorable to less favorable)" (NCT04072822)
Timeframe: 180 days
Intervention | Participants (Number) |
---|
| Increase in SOFA > 2 points | Need for hemodynamic support | Renal replacement therapy |
---|
Anakinra and Zinc | 3 | 11 | 10 |
,Prednisone | 3 | 9 | 7 |
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Number of Participants Requiring Transfer to ICU for Care, Intubation for Airway Control, Need for Ventilator Support or RRT.
(NCT04072822)
Timeframe: 180 days
Intervention | Participant counts (Number) |
---|
Prednisone | 6 |
Anakinra and Zinc | 15 |
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Number of Participants With Infections
(NCT04072822)
Timeframe: 180 days
Intervention | participants (Number) |
---|
Prednisone | 20 |
Anakinra and Zinc | 23 |
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Percentage of Participants With Renal Dysfunction
Defined by a creatinine > 2 mg/dl (NCT04072822)
Timeframe: 180 days
Intervention | Percentage of Participants (Number) |
---|
Prednisone | 21.9 |
Anakinra and Zinc | 47.3 |
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Survival at 90 Days
The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone. (NCT04072822)
Timeframe: 90 days
Intervention | percentage of participants (Number) |
---|
Prednisone | 90 |
Anakinra and Zinc | 70 |
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To Measure the Changes in Lille Score
"Change in Lille score is represented as the percentage of participants who achieved a Lille score < 0.45 on day 7.~The Lille score will be calculated using the following website: https://www.mdcalc.com/lille-model-alcoholic-hepatitis Lille score = (exp(-R))/(1 + exp(-R)) where the variables are as follows: R = 3.19 - 0.101*(age, years) + 0.147*(albumin day 0, g/L) + 0.0165* (evolution in bilirubin level, µmol/L) - 0.206*(renal insufficiency) - 0.0065*(bilirubin day 0, µmol/L) - 0.0096*(prothrombin time, sec) Renal insufficiency = 1 (if creatinine >1.3 mg/dL (115 µmol/L)) or 0 (if ≤1.3 mg/dL (115 µmol/L)) The Lille score was developed to provide early recognition of patients with severe alcoholic hepatitis not responding to corticosteroids. Lower scores indicate more improvement in response to corticosteroids. A Lille score > 0.45 predicts worse 6-month survival. A Lille score < 0.45 predicts better 6-month survival." (NCT04072822)
Timeframe: Day 7
Intervention | percentage of participants (Number) |
---|
Prednisone | 67.8 |
Anakinra and Zinc | 65.6 |
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Transplant Free Survival Rate
(NCT04072822)
Timeframe: 90 Days
Intervention | Percentage of Participants (Number) |
---|
Prednisone | 88 |
Anakinra and Zinc | 64 |
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Changes in Liver Function
"Changes in liver function were evaluated by changes in the Child Pugh Score at days 7, 30, and 90. The Child Pugh Score is a scoring system used to assess the severity of chronic liver disease. Scores range from 5 to 15, with higher scores indicating more severe disease. Points are assigned as follows:~Hepatic encephalopathy: None = 1 point, Grade 1 and 2 = 2 points, Grade 3 and 4 = 3 points Ascites: None = 1 point, mild = 2 points, moderate to severe = 3 points Total Bilirubin: under 2 mg/dl = 1 point, 2 to 3 mg/dl = 2 points, over 3 mg/dl = 3 points Albumin: greater than 3.5g/dl = 1 point, 2.8 to 3.5g/dl = 2 points, less than 2.8g/dl = 3 points International normalised ratio (INR): under 1.7 = 1 point, 1.7 to 2.3 = 2 points, above 2.3 = 3 points~Assigned points for each category are summed to calculate the Child Pugh Score." (NCT04072822)
Timeframe: 7, 30, and 90 days
Intervention | score on a scale (Mean) |
---|
| Day 0 | Day 7 | Day 30 | Day 90 |
---|
Anakinra and Zinc | 10.1 | 9.7 | 9.2 | 8.0 |
,Prednisone | 10.3 | 9.4 | 8.5 | 7.2 |
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Number of Participants With Progression of Sepsis
"Life-threatening organ dysfunction caused by a dysregulated host response to infection~An increase in SOFA score of 2 points of more~Note: most participants with severe AH have 4 points based on bilirubin only" (NCT04072822)
Timeframe: 180 days
Intervention | Participants (Number) |
---|
| Sepsis | Sepsis shock |
---|
Anakinra and Zinc | 0 | 5 |
,Prednisone | 3 | 2 |
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Number of Transfers to ICU
Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation (NCT04072822)
Timeframe: 7, 30, and 90 days
Intervention | Transfers (Number) |
---|
| Day 7 | Day 30 | Day 90 |
---|
Anakinra and Zinc | 5 | 9 | 0 |
,Prednisone | 2 | 2 | 2 |
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Survival
(NCT04072822)
Timeframe: 30 days and 180 days
Intervention | Percentage of Participants (Number) |
---|
| Day 30 | Day 180 |
---|
Anakinra and Zinc | 85 | 68 |
,Prednisone | 97 | 81 |
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Changes in MELD Score
The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months. (NCT04072822)
Timeframe: 7, 30, and 90 days
Intervention | scores on a scale (Mean) |
---|
| Day 7 | Day 30 | Day 90 |
---|
Anakinra and Zinc | 0.2 | -1.6 | -8.1 |
,Prednisone | -2.8 | -6.9 | -10.3 |
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Development of Multi-organ Failure
Defined as failure ≥2 organs (NCT04072822)
Timeframe: 7, 30, and 90 days
Intervention | Number of Subjects (Number) |
---|
| Day 7 | Day 30 | Day 90 |
---|
Anakinra and Zinc | 2 | 4 | 1 |
,Prednisone | 3 | 1 | 1 |
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Development of SIRS (Systemic Inflammatory Response Syndrome)
Defined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 points (NCT04072822)
Timeframe: 7, 30, and 90 days
Intervention | Events (Number) |
---|
| Day 7 | Day 30 | Day 90 |
---|
Anakinra and Zinc | 2 | 0 | 0 |
,Prednisone | 0 | 2 | 1 |
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Incidence of Acute Rejection
Biopsy-proven according to Banff 2017 criteria (NCT04177095)
Timeframe: Enrollment through 12 months
Intervention | Participants (Count of Participants) |
---|
Belatacept Treated Patients | 0 |
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Incidence of Acute Rejection
Biopsy-proven according to Banff 2017 criteria (NCT04177095)
Timeframe: Through study completion, 1 year
Intervention | Participants (Count of Participants) |
---|
Belatacept Treated Patients | 0 |
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Incidence of de Novo Donor Specific Antibodies
Screened for using Luminex platform (NCT04177095)
Timeframe: At 12 months
Intervention | Participants (Count of Participants) |
---|
Belatacept Treated Patients | 0 |
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Increase in eGFR
Calculated using CKD-EPI formula (NCT04177095)
Timeframe: From baseline to 12 months
Intervention | Participants (Count of Participants) |
---|
Belatacept Treated Patients | 6 |
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Survival
Overall and death-censored graft survival (NCT04177095)
Timeframe: At 12 months
Intervention | Participants (Count of Participants) |
---|
Belatacept Treated Patients | 12 |
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Rate of New-onset Proteinuria
Defined as g/g creatinine, measured on random urine sample (NCT04177095)
Timeframe: At 12 months
Intervention | Participants (Count of Participants) |
---|
Belatacept Treated Patients | 1 |
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Percent Change From Baseline Mean in Autoantibody Levels
Autoantibodies that may be positive include: Thyroglobulin Antibody [TgAb], Thyroid peroxidase antibody [TPO], Thyroid Stimulating Ig antibody [TSI], and/or Thyrotropin Receptor antibody [TRAb]. Any that were positive pre-op will be measured at each time point. Baseline level will be 1. (NCT04542278)
Timeframe: baseline measure day of surgery (up to 4 weeks), up to 6 weeks (2 weeks post-op), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)
Intervention | percent change from baseline mean (Mean) |
---|
| surgery to 2 weeks post op | surgery to 6 weeks post-op | surgery to 6 months post-op |
---|
No Steroids | 0.78 | 0.54 | 0.24 |
,Steroids | 0.81 | 0.43 | 0.12 |
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Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score
The ThyPRO survey is a quality of life measure designed to evaluate how thyroid disease has affected the participant's life. It is a 39-item survey that was scored from 0-4, higher scores indicate worse quality of life. (NCT04542278)
Timeframe: baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)
Intervention | score on a scale (Mean) |
---|
| Baseline | 6 weeks post-op | 6 months post-op |
---|
No Steroids | 1.95 | 1.05 | 0.99 |
,Steroids | 2.03 | 1.47 | 1.29 |
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Thyroid Difficulty Scale Score
"The surgeon will fill out the Thyroid Difficulty Scale at the conclusion of the operation. This is a 4-item survey to rate the vascularity, friability, mobility, and glandular size of the thyroid. The total possible range of scores from 4-20, higher scores indicate increased difficulty in thyroid surgery" (NCT04542278)
Timeframe: surgery occurs up to 4 weeks, data collected a conclusion of operation
Intervention | score on a scale (Mean) |
---|
Steroids | 9.8 |
No Steroids | 9.75 |
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Surgical Complications: Parathyroid Hormone (PTH) Level
PTH is measured right after surgery to determine whether the nearby parathyroid glands were injured during surgery. Low PTH levels immediately after surgery are concerning for symptomatic low calcium levels, either temporarily or permanent, after thyroidectomy. Normal PTH is typically between 20-70. (NCT04542278)
Timeframe: immediately after surgery (baseline for all participants)
Intervention | pg/mL (Mean) |
---|
Steroids | 52 |
No Steroids | 38 |
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Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury
(NCT04542278)
Timeframe: up to 4 weeks (Post Operative Day 1)
Intervention | Participants (Count of Participants) |
---|
Steroids | 2 |
No Steroids | 2 |
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Observed SC and IV Rituximab Area Under the Curve (AUCsc and AUCiv)
The area under the curve (AUC) for serum rituximab concentration versus time after dosage was measured for SC and IV administrations during Cycle 7. Geometric mean ratio and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline and are reported in the statistical analysis. (NCT04660799)
Timeframe: During Cycle 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks
Intervention | day*mcg/mL (Geometric Mean) |
---|
Rituximab IV+CHOP | 3050.7 |
Rituximab SC+CHOP | 3806.7 |
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Subcutaneous Serum Rituximab Trough Concentration (Ctrough SC) and Intravenous Serum Rituximab Trough Concentration (Ctrough IV)
For this pharmacokinetics (PK) primary outcome measure the serum rituximab Ctrough for SC and IV administrations were measured at Cycle 7, 21 days after study treatment administration for Cycle 7 (pre-dose of Cycle 8). Geometric mean ratio and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline and are reported in the statistical analysis. (NCT04660799)
Timeframe: At Cycle 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks
Intervention | micrograms/milliliter (mcg/mL) (Geometric Mean) |
---|
Rituximab IV+CHOP | 90.7 |
Rituximab SC+CHOP | 137.4 |
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Area Under the Curve (AUC) of Rituximab
AUC is the area under the serum concentration curve over the dosing interval of 21 days during Cycle 2 and Cycle 7. (NCT04660799)
Timeframe: During Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks
Intervention | day*mcg/mL (Geometric Mean) |
---|
| Cycle 2 | Cycle 7 |
---|
Rituximab IV+CHOP | 1730 | 3050 |
,Rituximab SC+CHOP | 2130 | 3810 |
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Maximum Observed Serum Concentration (Cmax) of Rituximab
(NCT04660799)
Timeframe: At Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks
Intervention | micrograms per milliliter (mcg/mL) (Geometric Mean) |
---|
| Cycle 2 | Cycle 7 |
---|
Rituximab IV+CHOP | 200 | 255 |
,Rituximab SC+CHOP | 144 | 228 |
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Number of Participants Positive for Anti-drug Antibodies (ADAs) to Rituximab
Reported here is the number of participants who had a positive ADA assay result at baseline or post-baseline. The post-baseline results are divided in treatment-enhanced ADAs and treatment-induced ADAs. Treatment-enhanced ADAs are participants with a positive ADA result at baseline who had one or more post-baseline titer results that was at least 0.60 titer unit greater than the baseline titer result. Treatment-induced ADAs include participants with negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. (NCT04660799)
Timeframe: From baseline up to 6 months after the last dose of study treatment (up to approximately 1 year)
Intervention | Participants (Count of Participants) |
---|
| Baseline | Post-baseline: Treatment-enhanced | Post-baseline: Treatment-induced |
---|
Rituximab IV+CHOP | 2 | 1 | 1 |
,Rituximab SC+CHOP | 1 | 0 | 1 |
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Number of Participants Positive for Anti-rHuPH20 Antibodies
Reported here is the number of participants who had a positive anti-rHuPH20 antibody assay result at baseline or post-baseline. The post-baseline results are divided in treatment-enhanced anti-rHuPH20 antibodies and treatment-induced anti-rHuPH20 antibodies. Treatment-enhanced anti-rHuPH20 antibodies are participants with a positive anti-rHuPH20 antibody result at baseline who had one or more post-baseline titer results that was at least 0.60 titer unit greater than the baseline titer result. Treatment-induced anti-rHuPH20 antibodies include participants with negative or missing baseline anti-rHuPH20 antibody result(s) and at least one positive post-baseline anti-rHuPH20 antibody result. (NCT04660799)
Timeframe: From baseline up to 6 months after the last dose of study treatment (up to approximately 1 year)
Intervention | Participants (Count of Participants) |
---|
| Baseline | Post-baseline: Treatment-enhanced | Post-baseline: Treatment-induced |
---|
Rituximab SC+CHOP | 2 | 1 | 1 |
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. New disease, exacerbation of existing disease, recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test associated with symptoms or leading to a change in study/concomitant treatment or discontinuation from study drug as well as events related to protocol-mandated interventions are considered AEs. SAEs: any event that met any of these criteria: fatal, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, medically significant or required intervention to prevent any of the outcomes listed here. (NCT04660799)
Timeframe: AEs were reported up to 28 days after the last dose (up to approximately 7 months), and SAEs were reported up to 6 months after the last dose of study treatment (up to approximately 1 year)
Intervention | Participants (Count of Participants) |
---|
| AEs | SAEs |
---|
Rituximab IV+CHOP | 24 | 11 |
,Rituximab SC+CHOP | 26 | 8 |
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Objective Response Rate (ORR), Complete Response (CR) or Partial Response (PR), as Determined by Investigator and IRC Using Lugano Response Criteria (LRC) for Malignant Lymphoma
ORR=CR+PR. Per LRC: CR by PET-CT: complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions, no FDG-avid disease in bone marrow; CR by CT: complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi, no extralymphatic disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow; PR by PET-CT: partial MR in lymph nodes and extralymphatic sites with a score of 4 or 5 with reduced uptake compared with baseline + residual masses of any size; no new lesions, residual uptake higher than in normal bone marrow but reduced compared with baseline; PR by CT: ≥ 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target nodes and extranodal sites; non-measured lesion absent/normal, regressed, but no increase; spleen regressed by >50 % in length beyond normal; no new lesions. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)
Intervention | percentage of participants (Number) |
---|
| Investigator | IRC |
---|
Rituximab IV+CHOP | 70.8 | 66.7 |
,Rituximab SC+CHOP | 88.5 | 80.8 |
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Time to Cmax (Tmax) of Rituximab
(NCT04660799)
Timeframe: At Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks
Intervention | day (Median) |
---|
| Cycle 2 | Cycle 7 |
---|
Rituximab IV+CHOP | 0.14 | 0.16 |
,Rituximab SC+CHOP | 5.42 | 1.99 |
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Trough Serum Concentration (Ctrough) of Rituximab
Ctrough was measured at Cycle 2 and Cycle 7, 21 days after study treatment administration for each cycle (pre-dose of Cycle 3 and Cycle 8, respectively). (NCT04660799)
Timeframe: At Cycles 2 and 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks
Intervention | mcg/mL (Geometric Mean) |
---|
| Cycle 2 | Cycle 7 |
---|
Rituximab IV+CHOP | 43.2 | 90.7 |
,Rituximab SC+CHOP | 63.5 | 137 |
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Complete Response Rate (CRR) as Determined by the Independent Review Committee (IRC) Using Lugano Response Criteria (LRC) for Malignant Lymphoma
Per LRC, CR based on positron emission tomography- computed tomography (PET-CT) was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)
Intervention | percentage of participants (Number) |
---|
Rituximab IV+CHOP | 62.5 |
Rituximab SC+CHOP | 80.8 |
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CRR, as Determined by IRC Using International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) 1999 Guidelines
CRR was assessed according to the IWG Response Criteria for NHL 1999 guidelines and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)
Intervention | percentage of participants (Number) |
---|
Rituximab IV+CHOP | 58.3 |
Rituximab SC+CHOP | 65.4 |
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CRR, as Determined by the Investigator Using Lugano Response Criteria for Malignant Lymphoma
Per LRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)
Intervention | percentage of participants (Number) |
---|
Rituximab IV+CHOP | 58.3 |
Rituximab SC+CHOP | 76.9 |
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Number of SAEs (Zandelisib When Combined With Rituximab)
Measured by the number of SAEs (NCT04745832)
Timeframe: 1 year 7 months
Intervention | Participants (Count of Participants) |
---|
Rituximab Plus Zandelisib | 12 |
Rituximab Plus Chemotherapy | 8 |
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Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)
Measured by the number of Treatment Emergent AEs (NCT04745832)
Timeframe: 1 year 7 months
Intervention | Participants (Count of Participants) |
---|
Rituximab Plus Zandelisib | 38 |
Rituximab Plus Chemotherapy | 37 |
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Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm
The Nebraska Interprofessional Education Attitude Scale (NIPEAS) was developed to measure the attitudes of pre-clinical learners to practicing health professionals. The NIPEAS is a 19-item questionnaire assessing attitudes related to interprofessional collaboration. Responses were given using a 5-point Likert scale where 1 = Strongly Disagree to 5 = Strongly Agree. The total score is the average of the average scores for each item and ranges from 1 to 5. A higher total score indicates increased positive perceptions toward interprofessional collaboration. (NCT04766996)
Timeframe: Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)
Intervention | score on a scale (Mean) |
---|
| Baseline |
---|
Professional Staff | 4.35 |
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Total Post-operative Opioid Requirements With Non-opioid Drug Regimen
Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication. (NCT04766996)
Timeframe: Up to 5 weeks
Intervention | milligrams (Mean) |
---|
Prospective Cases Undergoing Non-opioid Drug Regimen | 400 |
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Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit (Kaplan-Meier) method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received. The TFST results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 9.4 |
Placebo + Docetaxel | 8.3 |
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Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment. The rPFS results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 6.4 |
Placebo + Docetaxel | 11.2 |
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Prostate-specific Antigen (PSA) Response Rate
The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements. The PSA response rate results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months
Intervention | Percentage of participants (Number) |
---|
Pembrolizumab + Docetaxel | 24.4 |
Placebo + Docetaxel | 22.5 |
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Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
ORR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG). The ORR results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months
Intervention | Percentage of participants (Number) |
---|
Pembrolizumab + Docetaxel | 17.6 |
Placebo + Docetaxel | 13.3 |
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Number of Participants Who Experienced an Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented. (NCT04907227)
Timeframe: Up to 17 months
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab + Docetaxel | 37 |
Placebo + Docetaxel | 34 |
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Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented. (NCT04907227)
Timeframe: Up to 14 months
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab + Docetaxel | 3 |
Placebo + Docetaxel | 6 |
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"Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (Worst Pain in 24 Hours) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score"
TTPP=the time from randomization to pain progression determined by BPI-SF Item 3 and the AQA score. Pain progression was defined as: 1. For participants asymptomatic at baseline: a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain 2. For participants symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids:, a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of ≥2) OR any increase in opioid use at 2 consecutive follow-up visits. TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had >2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment. The TTPP results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | NA |
Placebo + Docetaxel | NA |
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Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The OS results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 16.3 |
Placebo + Docetaxel | 13.9 |
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Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment. The time to radiographic soft tissue progression results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | NA |
Placebo + Docetaxel | 11.2 |
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Time to Prostate-specific Antigen (PSA) Progression
The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of: 1. ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR 2. ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline Time to PSA progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment. The time to PSA progression results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | 5.0 |
Placebo + Docetaxel | 3.7 |
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Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for ≥6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment. The DOR results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months
Intervention | Months (Median) |
---|
Pembrolizumab + Docetaxel | NA |
Placebo + Docetaxel | NA |
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