Trial | Phase | Enrollment | Study Type | Start Date | Status |
The Effect of Ticagrelor and Apixaban With or Without Acetylsalicylic Acid on Markers of Coagulation Activation at the Site of Thrombus Formation in Vivo in Healthy Male Subjects and in an ex Vivo Perfusion Chamber Model at High and Low Shear Rate [NCT02080858] | Phase 1 | 40 participants (Actual) | Interventional | 2014-05-31 | Completed |
Single-center, Open, Randomized, Single-dose, Two-cycle, Two-sequence, Crossover Bioequivalence Study to Evaluate the Effects of the Test and the Fed States [NCT05841446] | Phase 1 | 54 participants (Actual) | Interventional | 2021-03-02 | Completed |
A Randomized, Double-blind, Placebo-controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study [NCT00320255] | Phase 2 | 130 participants (Actual) | Interventional | 2006-06-30 | Completed |
Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation: a Prospective, Controlled, Randomized Pilot Study [NCT02889562] | Phase 2/Phase 3 | 56 participants (Actual) | Interventional | 2016-09-30 | Completed |
A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design, Dose Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Kn [NCT03251482] | Phase 2 | 308 participants (Actual) | Interventional | 2017-11-13 | Completed |
Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome [NCT04666454] | Phase 2 | 1,000 participants (Anticipated) | Interventional | 2020-12-14 | Recruiting |
Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism [NCT03988842] | Phase 4 | 4 participants (Actual) | Interventional | 2019-07-25 | Terminated(stopped due to COVID-19 pandemic) |
"ORBIT Versus HAS-BLED Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants." [NCT05975320] | | 100 participants (Anticipated) | Observational | 2023-08-31 | Not yet recruiting |
Treatment Patterns and Clinical Outcomes Among Venous Thromboembolism Patients Treated With Anticoagulants After the Entry of Non-vitamin K Antagonist Oral Anticoagulants in Korea [NCT05022563] | | 55,759 participants (Actual) | Observational | 2021-08-31 | Completed |
Identification of Clinical and Pharmacogenetic Factors Predictive of Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation. [NCT04297150] | | 700 participants (Anticipated) | Observational | 2020-06-18 | Active, not recruiting |
Pattern of Use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation Patients in UK General Practices [NCT03119116] | | 31,336 participants (Actual) | Observational | 2017-05-15 | Completed |
RENal Hemodialysis Patients ALlocated Apixaban Versus Warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial [NCT02942407] | Phase 4 | 154 participants (Actual) | Interventional | 2016-12-31 | Completed |
Prospective Study of the Assessment of the Dental Protocol for Tooth Extraction in Patients With Atrial Fibrillation in Continuous Use of New Oral Anticoagulants: A Pilot Study [NCT03181386] | Phase 3 | 60 participants (Actual) | Interventional | 2017-05-03 | Completed |
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation [NCT05757869] | Phase 3 | 15,500 participants (Anticipated) | Interventional | 2023-04-11 | Recruiting |
Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus: A Prospective Randomized Outcome Blinded Study on the Size Reduction or Resolution of Left Ventricular Thrombus [NCT02982590] | Phase 3 | 27 participants (Actual) | Interventional | 2016-11-30 | Completed |
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Andexanet Alfa Administered to Healthy Japanese and Caucasian Subjects [NCT03310021] | Phase 2 | 108 participants (Actual) | Interventional | 2017-08-28 | Completed |
A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembol [NCT02981472] | Phase 2 | 192 participants (Actual) | Interventional | 2017-01-19 | Completed |
A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism [NCT00633893] | Phase 3 | 2,711 participants (Actual) | Interventional | 2008-05-31 | Completed |
Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET) [NCT03196349] | Phase 4 | 44 participants (Actual) | Interventional | 2018-08-01 | Terminated(stopped due to Lack of enrollment) |
Intracerebral Hemorrhage Due to Oral Anticoagulants in the Secondary Prevention of Ischemic Stroke: Prediction of the Risk by the Detection of Leukoaraiosis and Microbleeding With Magnetic Resonance [NCT02238470] | | 1,000 participants (Actual) | Observational [Patient Registry] | 2012-04-30 | Completed |
Evaluation of Non-Vitamin K Antagonist Oral Anticoagulants Concentration Among Patients With Acute Stroke (The Direct Oral AntiCoagulant Registry in Taiwan-Emergent Department, DOACT-ED) [NCT06144866] | | 1,000 participants (Anticipated) | Observational [Patient Registry] | 2020-05-01 | Recruiting |
Safety and Effectiveness of Direct Oral Anticoagulants for Stroke Prevention in Non-valvular Atrial Fibrillation: a Multi-database Cohort Study With Meta-analysis (DOACs vs DOACs) [NCT03568916] | | 227,579 participants (Actual) | Observational | 2016-11-30 | Completed |
Prospective Study With Biological Assessment: Evolution of Coagulation Activity in Non Valvular Atrial Fibrillation Patients Under Apixaban [NCT03136510] | | 60 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial [NCT03961334] | Phase 3 | 620 participants (Anticipated) | Interventional | 2019-12-05 | Recruiting |
Effectiveness and Safety of Oral Anticoagulants Among Obese Patients With Non-Valvular Atrial Fibrillation in the Veterans Affairs Population With Medicare [NCT04681482] | | 107,383 participants (Actual) | Observational | 2020-11-02 | Completed |
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Patients With Venous Thromboembolism. [NCT03129555] | Phase 4 | 5,000 participants (Anticipated) | Interventional | 2023-04-01 | Recruiting |
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Atrial Fibrillation (DANNOAC-AF). [NCT03129490] | Phase 4 | 11,000 participants (Anticipated) | Interventional | 2023-04-01 | Recruiting |
AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study) [NCT04432220] | Phase 4 | 840 participants (Anticipated) | Interventional | 2020-07-28 | Recruiting |
Association Between Socioeconomic Factors and Use of Direct Oral Anticoagulants Versus Standard of Care (Warfarin) in Patients With Non-valvular Atrial Fibrillation in Sweden [NCT03684395] | | 68,056 participants (Actual) | Observational | 2016-06-15 | Completed |
Development of Precision Medicine Platform for Pharmacogenomics of Novel Oral Anticoagulants (NOACs) [NCT04056143] | | 500 participants (Anticipated) | Observational | 2019-01-02 | Recruiting |
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial [NCT03463317] | Phase 4 | 1,512 participants (Anticipated) | Interventional | 2018-02-28 | Recruiting |
SIFNOS STUDY: RETROSPECTIVE STUDY IN PATIENTS WITH ATRIAL FIBRILLATION (AF) EXPOSED AND UNEXPOSED TO AN ORAL ANTICOAGULANT THERAPY BETWEEN 2014-2020 IN FRANCE [NCT05838664] | | 1 participants (Anticipated) | Observational | 2023-07-07 | Active, not recruiting |
Anticoagulant Treatment Patterns and Outcomes Among Non-valvular Atrial Fibrillation Patients With High Risk of Gastrointestinal Bleeding in France: a Retrospective Cohort Analysis Using SNDS Database [NCT05038228] | | 1 participants (Actual) | Observational | 2022-08-01 | Active, not recruiting |
Evaluation of the Use of an Oral Direct Anti-Xa Anticoagulant, Apixaban, in Prevention of Venous Thromboembolic Disease in Patients Treated With IMiDs During Myeloma : a Pilot Study [NCT02066454] | Phase 3 | 105 participants (Anticipated) | Interventional | 2014-04-30 | Recruiting |
An Investigator-driven, Prospective, Parallel-group, Randomised, Open, Blinded Outcome Assessment (PROBE), Multi-centre Trial to Determine the Optimal Anticoagulation Therapy for Patients Untergoing Catheter Ablation of Atrial Fibrillation [NCT02227550] | Phase 4 | 676 participants (Actual) | Interventional | 2014-12-31 | Completed |
Early Post-marketing Study of Eliquis (Apixaban) [NCT02153424] | | 0 participants (Actual) | Observational | 2014-04-30 | Withdrawn(stopped due to Business objectives have changed.) |
The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF) [NCT04437654] | Phase 4 | 1,800 participants (Anticipated) | Interventional | 2020-07-28 | Recruiting |
Safety and Efficacy of Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk (HBR) Patients With History of Paroxysmal Atrial Fibrillation [NCT04151680] | | 100 participants (Anticipated) | Observational [Patient Registry] | 2019-12-01 | Recruiting |
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon [NCT03563937] | | 64,920 participants (Actual) | Observational | 2018-06-15 | Completed |
Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients: A Randomized Placebo-Controlled, Double-Blind Clinical Trial [NCT02048865] | Phase 2 | 575 participants (Actual) | Interventional | 2014-03-24 | Completed |
Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban and Apixaban in Patients With Compensated Liver Cirrhosis [NCT04874428] | Phase 1 | 24 participants (Anticipated) | Interventional | 2021-05-19 | Recruiting |
Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study [NCT03045406] | Phase 3 | 1,168 participants (Actual) | Interventional | 2017-04-13 | Active, not recruiting |
Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis [NCT02945280] | Phase 4 | 52 participants (Actual) | Interventional | 2017-02-22 | Terminated(stopped due to COVID-19 resource allocation) |
Apixaban for the Secondary Prevention of Thromboembolism: a Prospective Randomized Outcome Pilot Study Among Patients With the AntiphosPholipid Syndrome [NCT02295475] | Phase 4 | 48 participants (Actual) | Interventional | 2014-12-10 | Completed |
[NCT02309970] | | 90 participants (Anticipated) | Observational | 2014-12-31 | Not yet recruiting |
A Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibitors in Healthy [NCT01758432] | Phase 2 | 54 participants (Actual) | Interventional | 2012-12-31 | Completed |
Phase 2 Placebo-Controlled, Single-Site, Single-Blind Study of Apixaban Reversal by Ciraparantag as Measured by WBCT [NCT03288454] | Phase 2 | 60 participants (Actual) | Interventional | 2017-08-30 | Completed |
Effect of Apixaban on the Pharmacokinetics of Digoxin in Healthy Subjects [NCT02262520] | Phase 1 | 24 participants (Actual) | Interventional | 2006-01-31 | Completed |
Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications [NCT04662515] | | 300 participants (Anticipated) | Observational | 2016-06-01 | Recruiting |
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Second Generation Andexanet Alfa Administered to Healthy Subjects [NCT03083704] | Phase 1 | 153 participants (Actual) | Interventional | 2017-02-26 | Completed |
Randomized Trial to Test the Effect of Rivaroxaban or Apixaban on Menstrual Blood Loss in Women [NCT02829957] | Phase 2/Phase 3 | 19 participants (Actual) | Interventional | 2016-09-30 | Completed |
Impact of Apixaban on Clinical Outcome of the Patients With Large Vessel Occlusion or Stenosis Trial [NCT02818868] | | 700 participants (Actual) | Observational | 2016-07-31 | Completed |
A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE [NCT05171049] | Phase 3 | 1,655 participants (Anticipated) | Interventional | 2022-05-05 | Recruiting |
A Post-marketing Retrospective Non-interventional Study Using Nationwide Registries and Electronic Medical Records to Investigate the Real-life Effectiveness and Major Bleeding Complications of Oral Anticoagulants in Norwegian Non-valvular Atrial Fibrilla [NCT03715725] | | 70,000 participants (Actual) | Observational | 2018-10-31 | Terminated(stopped due to After feasibility assessment and due to delays in data receipt study was terminated) |
Antithrombotic Therapy After Left Atrial Appendage Occlusion: Double Antiplatelet Therapy vs Apixaban [NCT05632445] | Phase 4 | 160 participants (Actual) | Interventional | 2019-05-01 | Completed |
A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrill [NCT03398434] | Phase 2 | 0 participants (Actual) | Interventional | 2018-10-16 | Withdrawn(stopped due to Trial cancelled before First Patient First Visit (no patient enrolled)) |
Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial [NCT05208398] | Phase 3 | 50 participants (Actual) | Interventional | 2018-02-18 | Completed |
A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention Versus No Systemic Anticoagulant Prophylaxis During Induction Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Le [NCT02369653] | Phase 3 | 512 participants (Actual) | Interventional | 2015-10-22 | Completed |
Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter [NCT01195727] | Phase 1 | 13 participants (Actual) | Interventional | 2011-07-26 | Terminated |
A Phase IV, Randomized, Double Blind Study Evaluating the Safety and Efficacy of Apixaban in Subjects With Calf Vein Thrombosis [NCT03590743] | Phase 4 | 5 participants (Actual) | Interventional | 2019-02-19 | Terminated(stopped due to Lack of participant enrollment) |
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial) [NCT02744092] | | 811 participants (Actual) | Interventional | 2016-12-13 | Completed |
A Descriptive Non-interventional Study to Evaluate the Use of Direct Oral Anticoagulants in UK Clinical Practice for Patients With a First Stroke Attributable to Nonvalvular Atrial Fibrillation [NCT05262322] | | 234 participants (Actual) | Observational | 2019-02-15 | Completed |
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome [NCT04278729] | Phase 1 | 22 participants (Actual) | Interventional | 2021-04-14 | Completed |
Comparison of Efficacy and Safety Among DAbigatran, RIvaroxaban, and ApixabaN in Patients HavinG Non-Valvular Atrial Fibrillation in Taiwan (DARING-AF Study) [NCT02666157] | Phase 4 | 3,672 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
Safety and Efficacy of Rivaroxaban and Apixaban in Comparison to Warfarin in Left Ventricular Clot- a Clinical Trial [NCT05973188] | Phase 4 | 141 participants (Anticipated) | Interventional | 2023-05-01 | Recruiting |
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism [NCT00643201] | Phase 3 | 5,614 participants (Actual) | Interventional | 2008-07-31 | Completed |
Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome [NCT00831441] | Phase 3 | 7,484 participants (Actual) | Interventional | 2009-03-31 | Terminated |
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study. [NCT02611635] | | 382 participants (Actual) | Observational | 2016-02-02 | Completed |
REal-World Treatment Outcomes of Oral-Anticoagulants Among Patients With Atrial Fibrillation - Patient Survey - RETAF-PS [NCT05471830] | | 600 participants (Actual) | Observational | 2022-11-30 | Completed |
Study on the Pharmacokinetics and Point of Care Testing After a Single Dose of 150 mg Dabigatran, 20 mg Rivaroxaban, 5 mg Apixaban, and 60 mg Edoxaban in Healthy Male Subjects [NCT05491460] | Phase 1 | 24 participants (Anticipated) | Interventional | 2022-07-01 | Active, not recruiting |
OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs [NCT04262492] | | 500 participants (Anticipated) | Observational [Patient Registry] | 2020-10-21 | Recruiting |
A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery [NCT00097357] | Phase 2/Phase 3 | 1,238 participants (Actual) | Interventional | 2004-10-31 | Completed |
A Multi-center Observative Study of Apixaban After Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation [NCT04550637] | | 200 participants (Anticipated) | Observational [Patient Registry] | 2022-07-04 | Recruiting |
An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Int [NCT02415400] | Phase 4 | 4,614 participants (Actual) | Interventional | 2015-06-04 | Completed |
Eliquis Acute Stroke Safety Evaluation [NCT04435418] | | 100 participants (Actual) | Observational [Patient Registry] | 2017-03-01 | Completed |
Apixaban Versus Low-Molecular Weight Heparin For Thromboprophylaxis In Patients With Acute Spinal Cord Injury: A Pilot Study [NCT03200613] | Phase 2 | 8 participants (Actual) | Interventional | 2017-09-01 | Terminated(stopped due to study not feasible due to too slow recruitment) |
Real-World Comparisons of Bleeding Among Novel Oral Anticoagulant (NOAC)-Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage, Who Newly Initiated Novel Oral Anticoagulation Therapies or Were Treated With Warfarin [NCT03189069] | | 36,000 participants (Actual) | Observational | 2016-10-06 | Completed |
HElping Alleviate the Longer-term Consequences of COVID-19 (HEAL-COVID): a National Platform Trial [NCT04801940] | Phase 3 | 2,631 participants (Anticipated) | Interventional | 2021-05-19 | Recruiting |
Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LT3001 Drug Product and Drug-Drug Interaction in Healthy Adult Subjects [NCT04809818] | Phase 1 | 64 participants (Anticipated) | Interventional | 2021-03-21 | Recruiting |
Pharmacokinetics and Safety Profile of Apixaban in Patients With Peritoneal Dialysis [NCT05532878] | | 50 participants (Anticipated) | Observational | 2020-12-01 | Recruiting |
A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study) [NCT00452530] | Phase 3 | 3,221 participants (Actual) | Interventional | 2007-06-30 | Completed |
THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) - a Multi-centre Assessor-blind Randomised-controlled Trial [NCT05735639] | Phase 4 | 6,660 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation [NCT00412984] | Phase 3 | 20,976 participants (Actual) | Interventional | 2006-12-31 | Completed |
Randomized Trial of Apixaban vs Dose Adjusted Warfarin in Reducing Rate of Cognitive Function Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Non-valvular Atrial Fibrillation Patients With CHA2DS2-VaSc Score = 2 [NCT03839355] | Phase 3 | 34 participants (Actual) | Interventional | 2018-12-19 | Terminated(stopped due to Study terminated due to slower than anticipated enrollment.) |
Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S [NCT02769078] | | 14,201 participants (Actual) | Observational | 2014-11-30 | Completed |
Post-Discharge Treatment Patterns and Outcomes in Patients With Venous Thromboembolism [NCT05795062] | | 47,029 participants (Actual) | Observational | 2023-03-10 | Completed |
Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in Subjects With Symptomatic Peripheral Artery Disease (PAD) Undergoing Infrapopliteal Endovascular Peripheral Revascularization Procedures in Patients With Critical Limb [NCT04229264] | Phase 3 | 200 participants (Anticipated) | Interventional | 2020-01-09 | Recruiting |
Pharmacokinetics and Pharmacodynamics of Apixaban in End-stage Renal Disease Patients on Hemodialysis [NCT02672709] | Phase 4 | 7 participants (Actual) | Interventional | 2016-04-30 | Completed |
Optimal Dosing of Apixaban in Patients at Risk of Elevated Drug Levels: A Study Evaluating a Strategy of Apixaban Drug Level Measurement and Dose Reduction in Patients With Atrial Fibrillation Who Are at Risk of Elevated Drug Levels [NCT02809469] | Phase 2 | 120 participants (Anticipated) | Interventional | 2016-08-31 | Not yet recruiting |
Pharmacokinetics of Apixaban in Subjects With End-stage Renal Disease Treated With Peritoneal Dialysis: the ApiDP Study [NCT04006093] | Phase 1 | 24 participants (Actual) | Interventional | 2019-12-08 | Completed |
Effects of APIXaban on BRAIN Protection in Patients With Sinus Rhythm and Heart Failure: APIXBRAIN-HF Trial [NCT04696120] | Phase 2 | 200 participants (Anticipated) | Interventional | 2021-03-02 | Not yet recruiting |
Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial [NCT03568890] | Phase 4 | 510 participants (Anticipated) | Interventional | 2018-09-01 | Recruiting |
Clinical Application Model of Direct Oral Anticoagulants (MACACOD). Comprehensive Management of ACOD From a Specialized Center in Antithrombotic Therapy and Its Area of Influence [NCT04042155] | | 1,600 participants (Anticipated) | Observational [Patient Registry] | 2019-07-29 | Recruiting |
A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome. [NCT00313300] | Phase 2 | 1,741 participants (Actual) | Interventional | 2006-05-31 | Completed |
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization. [NCT00457002] | Phase 3 | 6,758 participants (Actual) | Interventional | 2007-06-30 | Completed |
Venous Thromboembolism Prophylaxis With Apixaban in Transplant Eligible Patients With Newly Diagnosed Multiple Myeloma Receiving Induction Therapy With an Immunomodulatory-based Regimen [NCT04106700] | Phase 2 | 60 participants (Actual) | Interventional | 2019-04-12 | Terminated(stopped due to Low recruitment) |
A Prospective, Randomized, Active (Warfarin) Controlled, Parallel-arm Clinical Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely and Effectively on Apixaban [NCT04142658] | Phase 3 | 863 participants (Actual) | Interventional | 2020-05-01 | Terminated(stopped due to Safety) |
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial [NCT03968393] | Phase 4 | 2,800 participants (Anticipated) | Interventional | 2019-06-14 | Recruiting |
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study [NCT02607371] | | 198 participants (Actual) | Observational | 2015-08-27 | Completed |
Burden of Ischemic Stroke and Adherence to Oral Anticoagulants in Atrial Fibrillation in the UK Primary Care [NCT04099238] | | 3,739 participants (Actual) | Observational | 2019-10-01 | Completed |
Pharmacokinetics of Apixaban in Nephrotic Syndrome [NCT02599532] | Phase 1 | 21 participants (Actual) | Interventional | 2017-04-30 | Completed |
Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study [NCT02581176] | Phase 4 | 300 participants (Actual) | Interventional | 2016-04-30 | Completed |
Apixaban Versus Antiplatelet Drugs or no Antithrombotic Drugs After Anticoagulation-associated Intracerebral Haemorrhage in Patients With Atrial Fibrillation: A Randomised Phase II Clinical Trial [NCT02565693] | Phase 2 | 101 participants (Actual) | Interventional | 2014-09-30 | Completed |
Venous Thromboembolism Prevention in Outpatients With Glioma [NCT05683808] | Phase 2 | 40 participants (Anticipated) | Interventional | 2023-01-16 | Not yet recruiting |
Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis [NCT02664649] | Phase 3 | 1,510 participants (Anticipated) | Interventional | 2016-08-26 | Completed |
A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Antic [NCT00423319] | Phase 3 | 5,407 participants (Actual) | Interventional | 2007-03-31 | Completed |
Targeting Investigation and Treatment in Patients With Type 2 Myocardial Infarction (TARGET-Type 2): A Pilot Randomised Controlled Trial [NCT05419583] | | 60 participants (Anticipated) | Interventional | 2022-11-14 | Recruiting |
A Phase 3 Randomized, Double-Blind Active-Controlled (Enoxaparin), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery [NCT00371683] | Phase 3 | 3,608 participants (Actual) | Interventional | 2006-11-30 | Completed |
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery [NCT03907046] | Phase 3 | 700 participants (Anticipated) | Interventional | 2020-01-28 | Recruiting |
Efficacy and Safety of Apixaban in COVID-19 Coagulopathy Patients With Respiratory Severity Under Critical [NCT05088928] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-03-01 | Not yet recruiting |
APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study [NCT02640222] | | 321,501 participants (Actual) | Observational | 2014-01-01 | Completed |
Towards Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Abdominal or Pelvic Major Cancer Surgery [NCT04479579] | Phase 4 | 53 participants (Actual) | Interventional | 2021-02-22 | Completed |
Efficacy and Safety of Apixaban, Warfarin and Aspirin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy [NCT04645550] | Phase 4 | 120 participants (Actual) | Interventional | 2020-11-22 | Completed |
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation. A Multicenter Randomized Clinical Trial. (Occlusion-AF) [NCT03642509] | | 750 participants (Anticipated) | Interventional | 2019-01-01 | Recruiting |
Safety and Effectiveness of Apixaban in Very Elderly Patients With NVAF Compared to Warfarin Using Administrative Claims Data [NCT05438888] | | 77,814 participants (Actual) | Observational | 2022-07-01 | Completed |
Bariatric Surgery and Pharmacokinetics of Apixaban: BAR-MEDS Apixaban [NCT03448783] | | 12 participants (Anticipated) | Observational | 2018-01-02 | Recruiting |
The Comparative Effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism [NCT03292666] | | 39,603 participants (Actual) | Observational | 2010-01-01 | Completed |
A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF [NCT00787150] | Phase 2 | 222 participants (Actual) | Interventional | 2008-06-30 | Completed |
Efficacy and Safety of Non-vitamin K Oral Anticoagulants and Vitamin K Oral Anticoagulants on Some Metabolic and Coagulation Parameters in Diabetic and Nondiabetic Patients With First Diagnosis of Non-valvular Atrial Fibrillation [NCT02935855] | Phase 4 | 300 participants (Actual) | Interventional | 2015-09-30 | Completed |
Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in the Treatment of Non Valvular Atrial Fibrillation in Patients Aged 80 Years and Over, Living at Home or in Nursing Home. A Prospective Cohort Study [NCT02286414] | | 159 participants (Actual) | Observational | 2015-02-28 | Completed |
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Cross Over Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Condition [NCT06043297] | Phase 1 | 30 participants (Actual) | Interventional | 2023-02-23 | Completed |
Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial [NCT00496769] | Phase 3 | 6,421 participants (Actual) | Interventional | 2007-08-31 | Completed |
Eliquis (Apixaban) Regulatory Post Marketing Surveillance in Clinical Practice for Venous Thromboembolism (VTE) Prevention [NCT01885585] | | 100 participants (Actual) | Observational | 2014-07-31 | Completed |
Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation [NCT01885598] | | 3,335 participants (Actual) | Observational | 2013-07-10 | Completed |
COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation [NCT04642430] | Phase 4 | 3,018 participants (Anticipated) | Interventional | 2021-07-06 | Recruiting |
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism [NCT03266783] | Phase 4 | 2,760 participants (Anticipated) | Interventional | 2017-12-13 | Recruiting |
Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation [NCT05679024] | Phase 3 | 1,400 participants (Anticipated) | Interventional | 2023-02-17 | Recruiting |
A Phase 2 Pilot Randomized Controlled Trial Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients [NCT04243122] | Phase 2 | 44 participants (Actual) | Interventional | 2021-02-17 | Active, not recruiting |
Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence [NCT00562289] | Phase 3 | 664 participants (Actual) | Interventional | 2007-12-31 | Completed |
Pharmacokinetics, Pharmacodynamics and Safety of Apixaban on Hemodiafiltration [NCT04952792] | Phase 2 | 11 participants (Actual) | Interventional | 2021-05-20 | Completed |
A Phase I Placebo-Controlled, Open-Label, Crossover Study to Assess the Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra in Healthy Volunteers [NCT02270918] | Phase 1 | 12 participants (Actual) | Interventional | 2014-11-30 | Completed |
Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation [NCT02007655] | | 6,372 participants (Actual) | Observational | 2013-09-01 | Completed |
Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France - Cross-sectional Study [NCT02714855] | | 2,081 participants (Actual) | Observational | 2015-10-31 | Completed |
Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation: Prospective Randomized Trial [NCT02633774] | | 200 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
Real-world Comparative Effectiveness of Apixaban Versus VKA [NCT02687854] | | 18,591 participants (Actual) | Observational | 2016-02-12 | Completed |
A Phase 2, Placebo-Controlled, Randomized, Double-Blinded, Multicenter, Study To Evaluate The Bleeding Profile Of 2.5 Mg And 5.0 Mg BID Apixaban In Combination With Standard Therapy In Patients With Recent (≤7 Days) Acute Coronary Syndrome (ACS) [NCT00852397] | Phase 2 | 151 participants (Actual) | Interventional | 2009-04-30 | Terminated(stopped due to See termination reason in detailed description.) |
The Comparative Safety of Direct Oral Anticoagulants Versus Warfarin for the Treatment of Venous Thromboembolism [NCT02833987] | | 59,525 participants (Actual) | Observational | 2015-03-31 | Completed |
Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients [NCT02792335] | | 28,000 participants (Actual) | Observational | 2012-01-31 | Completed |
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome [NCT04850378] | Phase 1/Phase 2 | 80 participants (Anticipated) | Interventional | 2021-03-25 | Recruiting |
A Randomized, Open-Label, Single Dose, Four Way Cross-Over Bioavailability Study Comparing Three Modified Release Formulations Of Apixaban Tablets To Apixaban Immediate Release Tablets In Healthy Volunteers [NCT00914641] | Phase 1 | 16 participants (Actual) | Interventional | 2009-06-30 | Completed |
Apixaban for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension [NCT05304455] | | 40 participants (Actual) | Interventional | 2022-04-01 | Completed |
Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation Using Healthcare Data for Pragmatic Research: A Randomised Controlled Trial [NCT04700826] | Phase 4 | 3,000 participants (Anticipated) | Interventional | 2021-06-01 | Recruiting |
Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19 [NCT04736901] | | 90 participants (Actual) | Observational | 2020-12-01 | Completed |
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants [NCT02912234] | Phase 1 | 20 participants (Actual) | Interventional | 2016-09-30 | Completed |
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects [NCT02074358] | Phase 1 | 43 participants (Actual) | Interventional | 2014-02-28 | Completed |
"A Pilot Study of an Oral Anticoagulant Apixaban for theTreatment of Venous Thromboembolism in Children and Adolescents" [NCT04041843] | Phase 2 | 25 participants (Actual) | Interventional | 2017-06-02 | Completed |
Randomized Controlled Trial of Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism [NCT04168203] | Phase 4 | 600 participants (Anticipated) | Interventional | 2021-03-01 | Active, not recruiting |
Direct Oral Anticoagulant Therapy With the HeartMate 3 LVAD: A Pilot Study [NCT04974684] | | 45 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
Pilot Randomized Study of the Sidlenafil Efficacy in Combination With Oral Anticoagulants in the Treatment of Patients With Intermediate-high Risk of Pulmonary Embolism [NCT02946944] | Phase 1 | 100 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
Start or STop Anticoagulants Randomised Trial (SoSTART) After Spontaneous Intracranial Haemorrhage [NCT03153150] | Phase 3 | 203 participants (Actual) | Interventional | 2018-03-28 | Completed |
Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients With Child B Liver Cirrhosis [NCT05869591] | Phase 2 | 32 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
Apixaban Discontinuation Prior to Major Surgery [NCT02935751] | | 130 participants (Anticipated) | Observational | 2016-10-31 | Completed |
Apixaban in End-stage Kidney Disease : A Pharmacokinetics Study [NCT03456648] | Phase 2 | 24 participants (Actual) | Interventional | 2016-09-25 | Completed |
A Randomized, Active-comparator-controlled, Multicenter Study to Assess the Safety and Efficacy of Different Doses of BAY1213790 for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Primary Total Knee Arthroplasty, Open-label to Tr [NCT03276143] | Phase 2 | 813 participants (Actual) | Interventional | 2017-09-21 | Completed |
Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban & Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System [NCT03026556] | | 42,534 participants (Actual) | Observational | 2016-12-29 | Completed |
A Phase II Study to Evaluate the Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT) [NCT03594045] | Phase 2 | 5 participants (Actual) | Interventional | 2018-12-18 | Terminated(stopped due to Withdrawal of funding by sponsor) |
A Phase I, Randomized, Single-Dose, Open-Label, Four-Way Crossover Study to Evaluate the Comparative Bioavailability of Apixaban for TAH3311 Oral Dissolving Film Versus ELIQUIS® Oral Tablet in Healthy Male and Female Subjects [NCT05995119] | Early Phase 1 | 12 participants (Actual) | Interventional | 2022-12-05 | Completed |
PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF) [NCT03996772] | Phase 3 | 350 participants (Anticipated) | Interventional | 2019-06-03 | Recruiting |
Study of Apixaban Oral Solution Bioavailability When Administered Through a Nasogastric Tube in Healthy Subjects [NCT02034578] | Phase 1 | 75 participants (Actual) | Interventional | 2011-07-31 | Completed |
The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study [NCT03271450] | | 416,000 participants (Anticipated) | Observational | 2017-07-01 | Enrolling by invitation |
DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis [NCT05701917] | | 300 participants (Anticipated) | Interventional | 2023-01-06 | Recruiting |
Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified? [NCT04002011] | Phase 2 | 0 participants (Actual) | Interventional | 2022-03-09 | Withdrawn(stopped due to Submission process abandoned. No patient enrolled.) |
Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Apixaban in Subjects on Hemodialysis [NCT01340586] | Phase 1 | 18 participants (Actual) | Interventional | 2011-06-30 | Completed |
An Open Label, Randomized, 2-period Crossover Study Evaluating Single Dose Food Effect On Apixaban Commercial Image Tablets In Healthy Subjects [NCT01437839] | Phase 1 | 22 participants (Actual) | Interventional | 2011-09-30 | Completed |
The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis [NCT04981327] | Phase 3 | 1,300 participants (Anticipated) | Interventional | 2022-09-01 | Not yet recruiting |
Anticoagulation Strategies for the Treatment of Acute Venous Thromboembolism in Medicare Fee For-Service Patients With End-Stage Renal Disease Using USRDS Data [NCT04818151] | | 14,914 participants (Actual) | Observational | 2021-01-01 | Completed |
A Multicenter, International, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel-group, 2-arm, Phase 3 Study to Compare the Efficacy and Safety of the Oral FXIa Inhibitor Asundexian (BAY 2433334) With Apixaban for the Preventio [NCT05643573] | Phase 3 | 14,830 participants (Actual) | Interventional | 2022-12-05 | Active, not recruiting |
Effectiveness and Safety of Rivaroxaban Compared With Apixaban in Cancer-Associated Venous Thromboembolism: A Head-to-Head (H2H) Analysis of the United States Cohort of the Observational Study in Cancer Associated Thrombosis for Rivaroxaban (H2H-OSCAR-US) [NCT05461807] | | 2,437 participants (Actual) | Observational | 2022-07-14 | Completed |
OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke: a Randomised Controlled Trial [NCT03759938] | | 3,478 participants (Anticipated) | Interventional | 2019-06-18 | Recruiting |
FREEDOM COVID Anticoagulation Strategy Randomized Trial [NCT04512079] | Phase 4 | 3,460 participants (Actual) | Interventional | 2020-09-08 | Completed |
COVID-19 Post-hospital Thrombosis Prevention Trial: An Adaptive, Multicenter, Prospective, Randomized Platform Trial Evaluating the Efficacy and Safety of Antithrombotic Strategies in Patients With COVID-19 Following Hospital Discharge [NCT04650087] | Phase 3 | 1,219 participants (Actual) | Interventional | 2021-02-15 | Completed |
The Effectiveness and Safety of Apixaban Versus Warfarin in Non-valvular Atrial Fibrillation (NVAF) Patients With the History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study [NCT04198844] | | 0 participants (Actual) | Observational | 2019-11-18 | Withdrawn(stopped due to Interaction term analysis result was not significant and thus comparative effectiveness for primary and secondary outcomes could not be considered per protocol.) |
Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms [NCT04192916] | | 442 participants (Actual) | Observational | 2019-09-01 | Completed |
A Randomized Controlled Trial to Investigate Whether a Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at the Time of Device Surgery, in Patients With Moderate to High Risk of Arterial Thrombo-embolic Events, Leads to a Reduction in the [NCT01675076] | Phase 3 | 663 participants (Actual) | Interventional | 2013-01-31 | Completed |
APB Study: Apixaban Pharmacokinetics in Bariatric Patients [NCT02406885] | Phase 4 | 33 participants (Actual) | Interventional | 2017-07-19 | Completed |
The Safety of Oral Apixaban (Eliquis) Versus Subcutaneous Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy; a Prospective Randomized Open Blinded End-point (PROBE) Design [NCT02366871] | Phase 2 | 400 participants (Actual) | Interventional | 2015-04-28 | Completed |
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS) [NCT02701062] | Phase 4 | 562 participants (Actual) | Interventional | 2016-02-29 | Completed |
APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF) [NCT03441633] | | 51,690 participants (Actual) | Observational | 2016-02-18 | Completed |
Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants [NCT02754154] | | 321,182 participants (Actual) | Observational | 2014-12-31 | Completed |
Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF: The CORRAL-AF Study [NCT04684212] | | 2,931 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interaction Between Tegoprazan and Novel Oral Anticoagulants (NOACs) After Multiple Oral Dosing in Healthy Volunteers [NCT05723510] | Phase 1 | 87 participants (Actual) | Interventional | 2023-03-06 | Completed |
Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN) [NCT01884350] | Phase 4 | 1,217 participants (Actual) | Interventional | 2013-10-15 | Completed |
Multicenter, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel Group, Dose-finding Phase 2 Study to Compare the Safety of the Oral FXIa Inhibitor BAY2433334 to Apixaban in Patients With Atrial Fibrillation [NCT04218266] | Phase 2 | 755 participants (Actual) | Interventional | 2020-01-30 | Completed |
Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition [NCT04344717] | Phase 4 | 84 participants (Anticipated) | Interventional | 2020-12-20 | Recruiting |
Apixaban for Intrahepatic Non Cirrhotic Portal Hypertension [NCT04007289] | Phase 3 | 166 participants (Anticipated) | Interventional | 2019-06-24 | Recruiting |
APIDULCIS: Extended Anticoagulation With Low-dose Apixaban After a Standard Course Anticoagulation in Patients With a First Venous Thromboembolism Who Have Positive D-dimer [NCT03678506] | Phase 4 | 800 participants (Actual) | Interventional | 2018-08-16 | Terminated(stopped due to The study was interrupted after a planned interim analysis for the high rate of primary outcomes (7.3%; 95% confidence interval [CI], 4.5-11.2)) |
Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder [NCT01707394] | Phase 1 | 49 participants (Actual) | Interventional | 2013-01-10 | Completed |
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients [NCT01727427] | | 695 participants (Actual) | Observational | 2012-11-30 | Completed |
A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy [NCT03080883] | Phase 3 | 370 participants (Actual) | Interventional | 2017-07-14 | Active, not recruiting |
Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis. [NCT04462003] | Phase 3 | 100 participants (Anticipated) | Interventional | 2019-07-03 | Recruiting |
Protocol CV185017: A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic Deep-Vein Thrombosis [NCT00252005] | Phase 2 | 520 participants | Interventional | 2005-11-30 | Completed |
A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered VMX-C001 in Healthy Subjects (Part 1) and in Combination With Selected Dire [NCT05152420] | Phase 1 | 105 participants (Actual) | Interventional | 2021-10-29 | Completed |
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism: The Pilot Study [NCT02559856] | Phase 4 | 72 participants (Actual) | Interventional | 2016-05-31 | Completed |
Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma Receiving Immunomodulatory Therapy [NCT02958969] | Phase 4 | 50 participants (Actual) | Interventional | 2018-02-28 | Completed |
A Study to Assess the Absorption of Apixaban (BMS-562247) Sprinkle Capsules Compared With Tablets in Healthy Volunteers [NCT03509883] | Phase 1 | 94 participants (Actual) | Interventional | 2018-04-26 | Completed |
A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma [NCT02749617] | Phase 2 | 2 participants (Actual) | Interventional | 2016-08-09 | Terminated(stopped due to Study was stopped due to lack of enrollment.) |
Efficacy and Safety of Vascular Boot Warming Program After Acute DVT±PE for Earlier Resolution of Venous Thromboembolism (VTE) and Prevention of Post Thrombotic Syndrome: A Pilot Study. [NCT03465735] | | 15 participants (Actual) | Interventional | 2017-01-13 | Terminated(stopped due to Due to lack of recruitment of eligible participants) |
Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data [NCT05264168] | | 41,875 participants (Actual) | Observational | 2021-05-03 | Completed |
Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data [NCT05256797] | | 529,536 participants (Actual) | Observational | 2021-05-03 | Completed |
Replication of the ARISTOTLE Anticoagulant Trial in Healthcare Claims Data [NCT04593030] | | 220,518 participants (Actual) | Observational | 2020-09-01 | Completed |
Study of Bioavailability of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects [NCT02034565] | Phase 1 | 48 participants (Actual) | Interventional | 2010-02-28 | Completed |
Early Post-Marketing Study of Eliquis (Apixaban), in Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE in Adults [NCT02345343] | | 100 participants (Anticipated) | Observational | 2015-05-04 | Completed |
Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects [NCT02262533] | Phase 1 | 15 participants (Actual) | Interventional | 2007-06-30 | Completed |
A Prospective Study in Chinese Patients With Lower Extremity Ankle Fracture of Oral Anticoagulants to Prevent Venous Thromboembolism (VTE) [NCT04128254] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2020-01-31 | Not yet recruiting |
A Randomized Controlled Trial Comparing Apixaban Versus Enoxaparin Following Microsurgical Breast Reconstruction [NCT04504318] | Phase 1/Phase 2 | 106 participants (Anticipated) | Interventional | 2020-08-12 | Recruiting |
The efficAcy and Safety of aPixaban In REal-world Practice in Korean Frail Patients With Atrial Fibrillation: a Prospective Multicenter Non-interventional, Observational Study: ASPIRE Study [NCT05773222] | | 2,500 participants (Anticipated) | Observational [Patient Registry] | 2019-08-12 | Active, not recruiting |
Avoiding Anticoagulation After IntraCerebral Haemorrhage [NCT03243175] | Phase 3 | 300 participants (Anticipated) | Interventional | 2019-01-24 | Recruiting |
Early Versus Late Initiation of Direct Oral Anticoagulants in Post-ischaemic Stroke Patients With Atrial fibrillatioN (ELAN): an International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial [NCT03148457] | | 2,013 participants (Actual) | Interventional | 2017-11-06 | Completed |
Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in High-risk Patients With Acute Non-disabling Cerebrovascular Events (ADANCE): Rationale, Objectives, and Design [NCT01924325] | Phase 2/Phase 3 | 10,000 participants (Anticipated) | Interventional | 2014-01-31 | Not yet recruiting |
Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque [NCT02090075] | Phase 4 | 66 participants (Actual) | Interventional | 2014-09-30 | Completed |
Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants [NCT02664155] | Phase 3 | 203 participants (Actual) | Interventional | 2016-10-19 | Terminated(stopped due to recruiting difficulties) |
Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation [NCT02608099] | Phase 4 | 300 participants (Actual) | Interventional | 2015-11-30 | Completed |
DIrect Oral Anticoagulant for Antithrombotic Management Of mechaNical Aortic Valve Implanted Patients for Valvular Heart Disease Study [NCT05687448] | Phase 4 | 1,044 participants (Anticipated) | Interventional | 2023-03-31 | Not yet recruiting |
The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial [NCT04284839] | Phase 3 | 6,215 participants (Anticipated) | Interventional | 2021-07-18 | Recruiting |
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices [NCT04865978] | Phase 2 | 30 participants (Actual) | Interventional | 2021-12-14 | Completed |
A Pilot Trial of Restarting Direct Oral Anticoagulants After Traumatic Intracranial Hemorrhage [NCT04891861] | Phase 3 | 100 participants (Anticipated) | Interventional | 2021-07-01 | Not yet recruiting |
Hydroxychloroquine and Apixaban: Analysis of Physiological Parameters for the Prevention of Complications in Patients With Infection With the New Coronavirus (Covid-19). A Randomized Clinical Trial [NCT04788355] | Phase 3 | 176 participants (Actual) | Interventional | 2020-07-01 | Completed |
A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism [NCT02585713] | Phase 3 | 300 participants (Actual) | Interventional | 2015-11-20 | Completed |
Monotherapy Anticoagulation To Expedite Home Treatment of Venous [NCT03404635] | | 1,300 participants (Actual) | Observational | 2017-08-04 | Completed |
A Pilot Study in Cancer Patients With Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in the Upper Extremity Treated With Low Molecular Weight Heparin (LMWH) and Apixaban (Catheter 3) [NCT03100071] | | 70 participants (Anticipated) | Observational | 2017-05-15 | Recruiting |
VICTORIE (VTE In Cancer - Treatment, Outcomes and Resource Use In Europe) [NCT04618913] | | 1 participants (Anticipated) | Observational | 2020-12-14 | Active, not recruiting |
Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19 - the Apollo Trial [NCT04746339] | Phase 4 | 411 participants (Actual) | Interventional | 2021-03-04 | Terminated(stopped due to Due to the decrease in COVID cases and in the recruitment rate, and DSMB orientation.) |
A Phase Iv Trial To Assess The Effectiveness Of Apixaban Compared With Usual Care Anticoagulation In Subjects With Non-valvular Atrial Fibrillation Undergoing Cardioversion [NCT02100228] | Phase 4 | 1,500 participants (Actual) | Interventional | 2014-07-14 | Completed |
Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis [NCT01999179] | | 27 participants (Actual) | Interventional | 2014-06-30 | Completed |
Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring [NCT01706146] | Phase 4 | 59 participants (Actual) | Interventional | 2012-10-31 | Completed |
Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation [NCT02283294] | Phase 3 | 91 participants (Actual) | Interventional | 2015-04-30 | Completed |
Medical Need of Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Head Trauma, Fracture, and Emergency Surgery Using Large Scale Claims Database (Please Note That This Study Contains no Patients Treated With Idarucizumab Although the St [NCT03254147] | | 53,969 participants (Actual) | Observational | 2017-10-15 | Completed |
Prospective, Observational, Non-interventional Open-label Multicenter Registry Regarding the Incidence of Heavy Menstrual Bleeding in Women of Reproductive Age Treated With Direct Oral Anticoagulants Because of Venous Thromboembolism [NCT04477837] | | 150 participants (Anticipated) | Observational [Patient Registry] | 2020-10-15 | Recruiting |
A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT [NCT02464969] | Phase 4 | 250 participants (Anticipated) | Interventional | 2015-11-22 | Recruiting |
Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data [NCT04736719] | | 19,002 participants (Actual) | Observational | 2020-09-22 | Completed |
THE REAL WORLD EVIDENCE ON TREATMENT PATTERNS, EFFECTIVENESS, AND SAFETY OF DRUGS FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS IN KOREA [NCT03572972] | | 64,684 participants (Actual) | Observational | 2018-01-31 | Completed |
Stroke/Systemic Embolism and Major Bleeding in Patients Newly Treated With Oral Anticoagulants: a Real World Study From Portuguese Administrative Claims Data [NCT04808934] | | 0 participants (Actual) | Observational | 2020-06-01 | Withdrawn(stopped due to Withdrawn due to COVID19 pandemic. Several delays affected this study, therefore company decided to not conduct the study. It was cancelled prior to any enrollment.) |
A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism in Patients With Advanced Upper Gastrointestinal, Hepatobiliary and Pancrea [NCT03139487] | Phase 2 | 176 participants (Anticipated) | Interventional | 2017-08-07 | Recruiting |
Safety and Effectiveness of Rivaroxaban and Apixaban Compared to Warfarin in Non-valvular Atrial Fibrillation Patients in the Routine Clinical Practice in the UK [NCT03847181] | | 45,164 participants (Actual) | Observational | 2019-02-28 | Completed |
PARADOX Trial: A Prospective, Double-Blind, Randomized Controlled Trial in Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli [NCT02378623] | Phase 2 | 0 participants (Actual) | Interventional | 2015-05-31 | Withdrawn(stopped due to Sponsor withdrew funding - May 2016) |
AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation [NCT05035277] | Phase 3 | 360 participants (Anticipated) | Interventional | 2021-12-04 | Recruiting |
Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE [NCT03965741] | | 97,765 participants (Actual) | Observational | 2019-05-30 | Completed |
Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis (SAFE-D) [NCT03987711] | Phase 2 | 151 participants (Actual) | Interventional | 2019-12-10 | Completed |
Validation Study Protocol - Additional Study on Fresh Samples STA - Apixaban Calibrator & STA - Apixaban Control [NCT03073265] | | 109 participants (Actual) | Observational | 2017-05-08 | Completed |
Apixaban for Treatment of Embolic Stroke of Undetermined Source (ATTICUS Randomized Trial) [NCT02427126] | Phase 3 | 352 participants (Actual) | Interventional | 2015-12-31 | Completed |
AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke [NCT03192215] | Phase 3 | 1,015 participants (Actual) | Interventional | 2018-01-19 | Terminated(stopped due to The DSMB halted the trial prematurely due to futility without any safety concerns.) |
An Exploratory Study of the Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy [NCT04191928] | Phase 1 | 4 participants (Actual) | Interventional | 2020-03-03 | Completed |
Pharmacokinetics of Apixaban and Tacrolimus or Cyclosporine in Kidney and Lung Transplant Recipients [NCT04023760] | Phase 4 | 14 participants (Actual) | Interventional | 2019-06-26 | Completed |
A Phase I, Open-Label, Crossover, Drug Interaction Study of Apixaban With Cyclosporine and Tacrolimus in Healthy Volunteers [NCT03083782] | Phase 1 | 12 participants (Actual) | Interventional | 2017-04-18 | Completed |
A Phase IV, Open-Label, Multi-center Study to Evaluate the Safety of Apixaban in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery [NCT01884337] | Phase 4 | 557 participants (Actual) | Interventional | 2015-03-24 | Completed |
Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation [NCT01938248] | Phase 4 | 4,012 participants (Actual) | Interventional | 2015-05-31 | Completed |
[NCT05187286] | | 0 participants | Expanded Access | | Available |
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury [NCT05484557] | | 60 participants (Anticipated) | Interventional | 2023-09-06 | Recruiting |
A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study [NCT03935451] | Early Phase 1 | 60 participants (Anticipated) | Interventional | 2021-09-01 | Recruiting |
Active-control, Multicenter, Randomized, Open-label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese [NCT01780987] | Phase 3 | 80 participants (Actual) | Interventional | 2013-01-31 | Completed |
Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty [NCT04878497] | | 1,000,000 participants (Anticipated) | Observational | 2021-03-30 | Active, not recruiting |
COVID-19 Outpatient Thrombosis Prevention Trial A Multi-center Adaptive Randomized Placebo-controlled Platform Trial Evaluating the Efficacy and Safety of Anti-thrombotic Strategies in COVID Adults Not Requiring Hospitalization at Time of Diagnosis [NCT04498273] | Phase 3 | 657 participants (Actual) | Interventional | 2020-09-07 | Terminated(stopped due to an event rate lower than anticipated) |
A Randomized Trial of the Safety of Non-vitamin K Oral Anticoagulants Compared to Warfarin Early After Cardiac Surgery: a Pilot Study [NCT05006287] | Phase 2 | 100 participants (Anticipated) | Interventional | 2021-10-01 | Not yet recruiting |
Appropriate Duration of Anti-Platelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug Eluting Stents (ADAPT AF-DES) [NCT04250116] | Phase 4 | 960 participants (Anticipated) | Interventional | 2020-04-28 | Recruiting |
Real-world Evidence for Non-valvular Atrial Fibrillation Patients Treated With Oral Anticoagulation in the Nordics [NCT04249401] | | 134,897 participants (Actual) | Observational | 2020-03-01 | Completed |
Long-term Treatment of Cancer Associated VTE: Reduced vs Full Dose of Apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis [NCT03692065] | Phase 3 | 1,767 participants (Actual) | Interventional | 2018-10-11 | Active, not recruiting |
A Safety Study Assessing Oral Anticoagulation With Apixaban Versus Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment [NCT02933697] | Phase 3 | 108 participants (Actual) | Interventional | 2017-06-20 | Completed |
International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism [NCT03778502] | | 300 participants (Anticipated) | Observational [Patient Registry] | 2019-10-01 | Recruiting |
Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With NVAF With a History of Stroke or Transient Ischemic Attack - a Nationwide Retrospective Observational Study Using Claims Data in Japan [NCT05321810] | | 10,000 participants (Actual) | Observational | 2022-04-15 | Completed |
Relative Bioavailability of Crushed Apixaban Tablets Administered With Water or Apple Sauce Compared With Intact Tablet in Healthy Subjects [NCT02101112] | Phase 1 | 69 participants (Actual) | Interventional | 2014-03-31 | Completed |
Apixaban for Prevention of Post-angioplasty Thrombosis of Hemodialysis Vascular Access [NCT04489849] | Phase 4 | 150 participants (Anticipated) | Interventional | 2020-03-14 | Recruiting |
Apixaban Versus Warfarin in Patients With Left Ventricular (LV) Thrombus [NCT03232398] | Phase 3 | 40 participants (Actual) | Interventional | 2018-01-01 | Completed |
Evaluate the Safety of Apixaban in Patients Who Undergo Cardiovascular Implantable Electronic Device (CIED) Procedure: A Randomized Pilot Study [NCT02450682] | Phase 2 | 0 participants (Actual) | Interventional | 2016-02-29 | Withdrawn |
Bioavailability of Apixaban Oral Solution Administered Through a Nasogastric Tube in the Presence of Boost® Plus and Apixaban Administered as Crushed Tablet Through a Nasogastric Tube Relative to Apixaban Oral Solution in Healthy Subjects [NCT02034591] | Phase 1 | 37 participants (Actual) | Interventional | 2011-10-31 | Completed |
Impact of Daily Prophylaxis Dose Anticoagulation With a Factor Xa Inhibitor (Apixaban) in Patients With Sickle Cell Disease [NCT02179177] | Phase 3 | 16 participants (Actual) | Interventional | 2015-01-31 | Terminated(stopped due to funding has been exhausted) |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00313300 (10) [back to overview] | Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses |
NCT00313300 (10) [back to overview] | Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B |
NCT00313300 (10) [back to overview] | Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses |
NCT00313300 (10) [back to overview] | Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B |
NCT00313300 (10) [back to overview] | Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B |
NCT00313300 (10) [back to overview] | Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses |
NCT00313300 (10) [back to overview] | Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants |
NCT00313300 (10) [back to overview] | Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B |
NCT00313300 (10) [back to overview] | Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants |
NCT00313300 (10) [back to overview] | Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B |
NCT00320255 (12) [back to overview] | Number of Participants With All-Cause Death |
NCT00320255 (12) [back to overview] | Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding |
NCT00320255 (12) [back to overview] | Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death |
NCT00320255 (12) [back to overview] | Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death |
NCT00320255 (12) [back to overview] | Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death |
NCT00320255 (12) [back to overview] | Number of Participants With Deep Vein Thrombosis |
NCT00320255 (12) [back to overview] | Number of Participants With Distal Deep Vein Thrombosis |
NCT00320255 (12) [back to overview] | Number of Participants With Nonfatal Pulmonary Embolism |
NCT00320255 (12) [back to overview] | Number of Participants With Proximal Deep Vein Thrombosis |
NCT00320255 (12) [back to overview] | Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death |
NCT00320255 (12) [back to overview] | Number of Participants With Pulmonary Embolism (Fatal or Nonfatal) |
NCT00320255 (12) [back to overview] | Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs |
NCT00371683 (24) [back to overview] | Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period |
NCT00371683 (24) [back to overview] | Mean Change From Baseline in Heart Rate During the Treatment Period |
NCT00371683 (24) [back to overview] | Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period |
NCT00371683 (24) [back to overview] | Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period |
NCT00371683 (24) [back to overview] | Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects |
NCT00371683 (24) [back to overview] | Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period |
NCT00371683 (24) [back to overview] | Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period |
NCT00371683 (24) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population |
NCT00371683 (24) [back to overview] | Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period |
NCT00371683 (24) [back to overview] | Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population |
NCT00371683 (24) [back to overview] | Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate for Participants With All-Cause Death During the Intended Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period |
NCT00371683 (24) [back to overview] | Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period |
NCT00412984 (19) [back to overview] | Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period |
NCT00412984 (19) [back to overview] | Number of Participants With Events of All-Cause Death During the Intended Treatment Period |
NCT00412984 (19) [back to overview] | Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period |
NCT00412984 (19) [back to overview] | Number of Participants With Net-Clinical Benefit During Treatment Period |
NCT00412984 (19) [back to overview] | Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period |
NCT00412984 (19) [back to overview] | Rate of Adjudicated All-Cause Death During the Intended Treatment Period |
NCT00412984 (19) [back to overview] | Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period |
NCT00412984 (19) [back to overview] | Rate of All Bleeding Events During Treatment Period |
NCT00412984 (19) [back to overview] | Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period |
NCT00412984 (19) [back to overview] | Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period |
NCT00412984 (19) [back to overview] | Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period |
NCT00412984 (19) [back to overview] | Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period |
NCT00412984 (19) [back to overview] | Rate of Net-Clinical Benefit During Treatment Period |
NCT00412984 (19) [back to overview] | Number of Participants With Adverse Events (AEs), Bleeding AEs, Serious Adverse Events (SAEs), Discontinuations Due to AEs, or Deaths During the Treatment Period |
NCT00412984 (19) [back to overview] | Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period |
NCT00412984 (19) [back to overview] | Rate of Adjudicated Bleeding Endpoints Per Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) During the Treatment Period |
NCT00412984 (19) [back to overview] | Rate of Adjudicated Bleeding Endpoints Per Thrombolysis in Myocardial Infarction (TIMI) During the Treatment Period |
NCT00412984 (19) [back to overview] | Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period |
NCT00412984 (19) [back to overview] | Number of Participants With All Bleeding Events During Treatment Period |
NCT00423319 (14) [back to overview] | Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period |
NCT00423319 (14) [back to overview] | Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued) |
NCT00423319 (14) [back to overview] | Number of Participants With a Bleeding-related Adverse Event During the Treatment Period |
NCT00423319 (14) [back to overview] | Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued) |
NCT00423319 (14) [back to overview] | Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued) |
NCT00423319 (14) [back to overview] | Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period |
NCT00423319 (14) [back to overview] | Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period |
NCT00423319 (14) [back to overview] | Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued) |
NCT00423319 (14) [back to overview] | Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period |
NCT00423319 (14) [back to overview] | Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period |
NCT00423319 (14) [back to overview] | Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period |
NCT00423319 (14) [back to overview] | Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period |
NCT00423319 (14) [back to overview] | Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period |
NCT00423319 (14) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome |
NCT00452530 (7) [back to overview] | Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements) |
NCT00452530 (7) [back to overview] | Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis) |
NCT00452530 (7) [back to overview] | Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements) |
NCT00452530 (7) [back to overview] | Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome |
NCT00452530 (7) [back to overview] | Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period |
NCT00452530 (7) [back to overview] | Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period |
NCT00452530 (7) [back to overview] | Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM |
NCT00457002 (32) [back to overview] | Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population |
NCT00457002 (32) [back to overview] | Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of All Bleeding During the Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated PE With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants |
NCT00457002 (32) [back to overview] | Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period |
NCT00457002 (32) [back to overview] | Incidence of Major Bleeding During the Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Mean Change From Baseline in Heart Rate in Treated Participants |
NCT00457002 (32) [back to overview] | Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements |
NCT00457002 (32) [back to overview] | Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period |
NCT00457002 (32) [back to overview] | Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants |
NCT00457002 (32) [back to overview] | Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period |
NCT00496769 (9) [back to overview] | Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period |
NCT00496769 (9) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome |
NCT00496769 (9) [back to overview] | Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued) |
NCT00496769 (9) [back to overview] | Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued) |
NCT00496769 (9) [back to overview] | Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality |
NCT00496769 (9) [back to overview] | Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death |
NCT00496769 (9) [back to overview] | Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period |
NCT00496769 (9) [back to overview] | Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period |
NCT00496769 (9) [back to overview] | Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period |
NCT00633893 (22) [back to overview] | Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Total Bleeding During the Treatment Period - Treated Participants |
NCT00633893 (22) [back to overview] | Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation |
NCT00633893 (22) [back to overview] | Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation |
NCT00633893 (22) [back to overview] | Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants |
NCT00633893 (22) [back to overview] | Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants |
NCT00633893 (22) [back to overview] | Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants |
NCT00633893 (22) [back to overview] | Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Major Bleeding During the Treatment Period - Treated Population |
NCT00633893 (22) [back to overview] | Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation |
NCT00633893 (22) [back to overview] | Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation |
NCT00633893 (22) [back to overview] | Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period |
NCT00643201 (21) [back to overview] | Incidence of All-Cause Death During the Intended Treatment Period |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants |
NCT00643201 (21) [back to overview] | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants |
NCT00643201 (21) [back to overview] | Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding |
NCT00643201 (21) [back to overview] | Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests |
NCT00643201 (21) [back to overview] | Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests |
NCT00643201 (21) [back to overview] | Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests |
NCT00643201 (21) [back to overview] | Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests |
NCT00643201 (21) [back to overview] | Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period |
NCT00643201 (21) [back to overview] | Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period |
NCT00787150 (14) [back to overview] | Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban |
NCT00787150 (14) [back to overview] | Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period |
NCT00787150 (14) [back to overview] | Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period |
NCT00787150 (14) [back to overview] | Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban |
NCT00787150 (14) [back to overview] | Number of Participants With Total Bleeding Events During the Treatment Period |
NCT00787150 (14) [back to overview] | Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban |
NCT00787150 (14) [back to overview] | Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period |
NCT00787150 (14) [back to overview] | Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban |
NCT00787150 (14) [back to overview] | Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban |
NCT00787150 (14) [back to overview] | Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban |
NCT00787150 (14) [back to overview] | Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period |
NCT00787150 (14) [back to overview] | Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period |
NCT00787150 (14) [back to overview] | Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period |
NCT00787150 (14) [back to overview] | Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban |
NCT00831441 (12) [back to overview] | Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants |
NCT00831441 (12) [back to overview] | Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants |
NCT00831441 (12) [back to overview] | Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants |
NCT00831441 (12) [back to overview] | Event Rate of Stroke During the Intended Treatment Period - Randomized Participants |
NCT00831441 (12) [back to overview] | Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants |
NCT00831441 (12) [back to overview] | Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants |
NCT00831441 (12) [back to overview] | Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants |
NCT00831441 (12) [back to overview] | Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants |
NCT00831441 (12) [back to overview] | Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants |
NCT00831441 (12) [back to overview] | Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants |
NCT00831441 (12) [back to overview] | Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants |
NCT00831441 (12) [back to overview] | Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants |
NCT00852397 (8) [back to overview] | Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period. |
NCT00852397 (8) [back to overview] | Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period. |
NCT00852397 (8) [back to overview] | Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy. |
NCT00852397 (8) [back to overview] | Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period. |
NCT00852397 (8) [back to overview] | Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions. |
NCT00852397 (8) [back to overview] | Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period. |
NCT00852397 (8) [back to overview] | Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period. |
NCT00852397 (8) [back to overview] | Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period. |
NCT01340586 (26) [back to overview] | Mean Renal Clearance (CLR) of BMS-730823 |
NCT01340586 (26) [back to overview] | Mean Plasma Terminal Half-life (T-Half) of BMS-730823 |
NCT01340586 (26) [back to overview] | Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823 |
NCT01340586 (26) [back to overview] | Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban |
NCT01340586 (26) [back to overview] | Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823 |
NCT01340586 (26) [back to overview] | Median Time of Maximum Observed Plasma Concentration (Tmax) of a Single 5 mg Oral Dose of Apixaban |
NCT01340586 (26) [back to overview] | Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban |
NCT01340586 (26) [back to overview] | Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823 |
NCT01340586 (26) [back to overview] | Median Time of Maximum Observed Plasma Concentration (Tmax) of Metabolite BMS-730823 |
NCT01340586 (26) [back to overview] | Percentage of Apixaban Extracted During Hemodialysis |
NCT01340586 (26) [back to overview] | Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban |
NCT01340586 (26) [back to overview] | Percentage of BMS-730823 Extracted During Hemodialysis |
NCT01340586 (26) [back to overview] | Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban |
NCT01340586 (26) [back to overview] | Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823 |
NCT01340586 (26) [back to overview] | Mean Hemodialysis Clearance (CLD) of Apixaban |
NCT01340586 (26) [back to overview] | Number of Participants Who Died or Experienced Serious Adverse Events (SAEs) or Adverse Events Leading to Discontinuation |
NCT01340586 (26) [back to overview] | Number of Participants With Laboratory Marked Abnormalities |
NCT01340586 (26) [back to overview] | Mean Hemodialysis Clearance (CLD) of BMS-730823 |
NCT01340586 (26) [back to overview] | Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban |
NCT01340586 (26) [back to overview] | Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban |
NCT01340586 (26) [back to overview] | Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban |
NCT01340586 (26) [back to overview] | Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban |
NCT01340586 (26) [back to overview] | Mean Percent Dose of Apixaban Recovered in Dialysate (%DR) |
NCT01340586 (26) [back to overview] | Mean Percent Dose of Apixaban Recovered in Urine (%UR) |
NCT01340586 (26) [back to overview] | Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban |
NCT01340586 (26) [back to overview] | Mean Renal Clearance (CLR) of Apixaban |
NCT01706146 (2) [back to overview] | Bleeding Incidence |
NCT01706146 (2) [back to overview] | Number of Days on Anticoagulation |
NCT01758432 (9) [back to overview] | Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration |
NCT01758432 (9) [back to overview] | Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf ) |
NCT01758432 (9) [back to overview] | Andexanet Apparent Terminal Elimination Half-life (t1/2) |
NCT01758432 (9) [back to overview] | Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration |
NCT01758432 (9) [back to overview] | Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration |
NCT01758432 (9) [back to overview] | Andexanet Time of Maximum Observed Plasma Concentration (Tmax) |
NCT01758432 (9) [back to overview] | Andexanet Maximum Observed Plasma Concentration (Cmax) |
NCT01758432 (9) [back to overview] | Andexanet Total Systemic Clearance (CL) |
NCT01758432 (9) [back to overview] | Andexanet Total Volume of Distribution (Vss) |
NCT01780987 (6) [back to overview] | Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods |
NCT01780987 (6) [back to overview] | Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) [Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)] or VTE-Related Death During the Intended Treatment Period |
NCT01780987 (6) [back to overview] | Number of Participants With Adjudicated Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition]During the Treatment Period |
NCT01780987 (6) [back to overview] | Number of Participants With Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition] or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period |
NCT01780987 (6) [back to overview] | Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) |
NCT01780987 (6) [back to overview] | Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE) |
NCT01884337 (2) [back to overview] | Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days |
NCT01884337 (2) [back to overview] | Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days |
NCT01884350 (6) [back to overview] | Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 Weeks |
NCT01884350 (6) [back to overview] | Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen |
NCT01884350 (6) [back to overview] | Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks Period |
NCT01884350 (6) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death |
NCT01884350 (6) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death |
NCT01884350 (6) [back to overview] | Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 12 to 24 Weeks Period Compared With During the First 12 Weeks |
NCT01999179 (5) [back to overview] | PTS Assessment Completion |
NCT01999179 (5) [back to overview] | Number of Participants With Post-thrombotic Syndrome |
NCT01999179 (5) [back to overview] | Number of Participants With Recurrent Thrombosis |
NCT01999179 (5) [back to overview] | Biomarker Sample Collection |
NCT01999179 (5) [back to overview] | Number of Participants With Major Bleeding |
NCT02034565 (5) [back to overview] | Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban |
NCT02034565 (5) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Treatment-Related Adverse Events (AEs), Deaths or Discontinuation of Study Drug Due to AEs |
NCT02034565 (5) [back to overview] | Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban |
NCT02034565 (5) [back to overview] | Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban |
NCT02034565 (5) [back to overview] | Number of Participants With Marked Laboratory Abnormalities |
NCT02034578 (8) [back to overview] | Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings |
NCT02034578 (8) [back to overview] | Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests |
NCT02034578 (8) [back to overview] | Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban |
NCT02034578 (8) [back to overview] | Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban |
NCT02034578 (8) [back to overview] | Mean Plasma Elimination Half-Life (T-HALF) of Apixaban |
NCT02034578 (8) [back to overview] | Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban |
NCT02034578 (8) [back to overview] | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death |
NCT02034578 (8) [back to overview] | Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban |
NCT02034591 (6) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs |
NCT02034591 (6) [back to overview] | Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban |
NCT02034591 (6) [back to overview] | Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban |
NCT02034591 (6) [back to overview] | Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban |
NCT02034591 (6) [back to overview] | Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban |
NCT02034591 (6) [back to overview] | Number of Participants With Marked Laboratory Abnormalities |
NCT02074358 (28) [back to overview] | Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to AEs - Treatment Population |
NCT02074358 (28) [back to overview] | Number of Participants With Marked Abnormalities (MA) in Laboratory Tests - Treated Population |
NCT02074358 (28) [back to overview] | Number of Participants With Out of Range Electrocardiogram (ECG) Intervals and Number of Participants With a Change From Baseline of Greater Than 30 Milliseconds in QT and QTcF |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in Coagulation Parameter INR From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in Coagulation Parameter International Normalized Ratio (INR) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in Coagulation Parameters Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in Coagulation Parameters PT and aPTT From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in TGA Lag Time and TGA Time to Peak From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | Mean Change From Baseline Temperature on Day 4 and Day 7 |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | Adjusted Geometric Mean AUC (0-12) of Apixaban on Day 4 |
NCT02074358 (28) [back to overview] | Adjusted Geometric Mean AUC (0-24) for Apixaban on Day 4 |
NCT02074358 (28) [back to overview] | Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours After Dose Administration [AUC(0-24)] of Apixaban on Day 4 |
NCT02074358 (28) [back to overview] | Geometric Mean Area Under the Plasma Concentration-Time Curve in One Dosing Interval [AUC(0-12)] of Apixaban on Day 4 |
NCT02074358 (28) [back to overview] | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban on Day 4 |
NCT02074358 (28) [back to overview] | Geometric Mean Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban on Day 4 |
NCT02074358 (28) [back to overview] | Geometric Mean Trough Observed Plasma Concentration at the End of One Dosing Interval (12h) [Cmin] of Apixaban on Day 4 |
NCT02074358 (28) [back to overview] | Mean Terminal Elimination Half-Life (T-HALF) of Apixaban on Day 4 |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in Plasma Anti-Xa Activity From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo |
NCT02074358 (28) [back to overview] | Mean Change From Baseline in Diastolic and Systolic Blood Pressure on Day 4 and Day 7 |
NCT02074358 (28) [back to overview] | Mean Change From Baseline in Heart Rate on Day 4 and Day 7 |
NCT02074358 (28) [back to overview] | Mean Change From Baseline in Respiration Rate on Day 4 and Day 7 |
NCT02090075 (2) [back to overview] | Coronary Plaque on CT Angiography |
NCT02090075 (2) [back to overview] | Coronary Artery Calcium (CAC) Score |
NCT02100228 (11) [back to overview] | Duration of Hospital Stay of Participants |
NCT02100228 (11) [back to overview] | Number of Participants Who Used Image Guidance Approach |
NCT02100228 (11) [back to overview] | Number of Participants With Acute Stroke Event |
NCT02100228 (11) [back to overview] | Number of Participants With All Cause Death |
NCT02100228 (11) [back to overview] | Number of Participants With Clinically Relevant Non-Major Bleeding Events |
NCT02100228 (11) [back to overview] | Number of Participants With Major Bleeding Event |
NCT02100228 (11) [back to overview] | Number of Participants With Systemic Embolism Event |
NCT02100228 (11) [back to overview] | Time to First Attempt of Cardioversion |
NCT02100228 (11) [back to overview] | Number of Cardioversion Attempt of Participants |
NCT02100228 (11) [back to overview] | Number of Participants With Their Rhythm Status |
NCT02100228 (11) [back to overview] | Number of Participants With Different Type of Cardioversion Events |
NCT02101112 (7) [back to overview] | Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban |
NCT02101112 (7) [back to overview] | Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban |
NCT02101112 (7) [back to overview] | Relative Bioavailability (Frel) of Apixaban |
NCT02101112 (7) [back to overview] | Terminal Plasma Half-life (T-HALF) of Apixaban |
NCT02101112 (7) [back to overview] | Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban |
NCT02101112 (7) [back to overview] | Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion |
NCT02101112 (7) [back to overview] | Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban |
NCT02179177 (3) [back to overview] | Number of Hospitalizations During Treatment |
NCT02179177 (3) [back to overview] | Change in Pain as Measured by Visual Analog Scale (VAS) |
NCT02179177 (3) [back to overview] | Daily Pain Scores While Hospitalized as Measured by VAS |
NCT02283294 (2) [back to overview] | Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA |
NCT02283294 (2) [back to overview] | Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT |
NCT02366871 (6) [back to overview] | Number of Participants With Incidence of Clinically Relevant Non Major Bleeding Events |
NCT02366871 (6) [back to overview] | Number of Participants With Incidence of Major Bleeding |
NCT02366871 (6) [back to overview] | Change in Quality of Life From Baseline to 28 Days Post-op |
NCT02366871 (6) [back to overview] | Number of Participants With a Patient Satisfaction Assessment |
NCT02366871 (6) [back to overview] | Number of Participants With Incidence of Venous Thromboembolism (VTEs): Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) |
NCT02366871 (6) [back to overview] | Number of Participants Who Met Medication Adherence Rates |
NCT02369653 (22) [back to overview] | The Number of Participants With Non-fatal Pulmonary Embolism (PE) |
NCT02369653 (22) [back to overview] | The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death |
NCT02369653 (22) [back to overview] | The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT) |
NCT02369653 (22) [back to overview] | The Number of Participants With Minor Bleeding Events |
NCT02369653 (22) [back to overview] | The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB) |
NCT02369653 (22) [back to overview] | The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use |
NCT02369653 (22) [back to overview] | The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB) |
NCT02369653 (22) [back to overview] | The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST) |
NCT02369653 (22) [back to overview] | The Number of Participants With an Arterial Thromboembolic Event |
NCT02369653 (22) [back to overview] | The Number of Participants With a CVAD-Related Infection |
NCT02369653 (22) [back to overview] | The Number of Participants Needing Catheter Replacements During the Study |
NCT02369653 (22) [back to overview] | The Number of Participant Deaths |
NCT02369653 (22) [back to overview] | Maximum Observed Concentration (Cmax) |
NCT02369653 (22) [back to overview] | The Number of Participants With Adjudicated Major Bleeding |
NCT02369653 (22) [back to overview] | Area Under the Concentration-Time Curve [AUC(TAU)] |
NCT02369653 (22) [back to overview] | Anti-FXa Activity |
NCT02369653 (22) [back to overview] | Anti-FXa Activity |
NCT02369653 (22) [back to overview] | Trough Observed Concentration (Cmin) |
NCT02369653 (22) [back to overview] | The Number Participants Experiencing Superficial Vein Thrombosis Events |
NCT02369653 (22) [back to overview] | The Number of Platelet Transfusions Needed During the Study |
NCT02369653 (22) [back to overview] | The Number of Participants With Venous Thromboembolism (VTE)-Related-death |
NCT02369653 (22) [back to overview] | The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT) |
NCT02406885 (3) [back to overview] | Change in Pharmacokinetics as Assessed by Cmax (Max Concentration) |
NCT02406885 (3) [back to overview] | Change in Pharmacokinetics as Assessed by Area Under the Curve (AUC) |
NCT02406885 (3) [back to overview] | Change in Pharmacodynamics as Assessed by Factor Xa Levels (Percent Activity) |
NCT02415400 (7) [back to overview] | The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA |
NCT02415400 (7) [back to overview] | Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA |
NCT02415400 (7) [back to overview] | The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period |
NCT02415400 (7) [back to overview] | The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin |
NCT02415400 (7) [back to overview] | The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA |
NCT02415400 (7) [back to overview] | The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin |
NCT02415400 (7) [back to overview] | The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period |
NCT02585713 (3) [back to overview] | 6 Month Bleeding Rate |
NCT02585713 (3) [back to overview] | Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE) |
NCT02585713 (3) [back to overview] | Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed |
NCT02608099 (16) [back to overview] | Number of Patients With Cardiovascular Death |
NCT02608099 (16) [back to overview] | Number of Patients With Thrombotic Events |
NCT02608099 (16) [back to overview] | Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events |
NCT02608099 (16) [back to overview] | Number of Patients With Cardiovascular Death |
NCT02608099 (16) [back to overview] | Number of Patients With TIAs or Non-Hemorrhagic Strokes |
NCT02608099 (16) [back to overview] | Number of Patients With TIAs or Non-Hemorrhagic Strokes |
NCT02608099 (16) [back to overview] | Number of Patients With Thrombotic Events |
NCT02608099 (16) [back to overview] | Number of Patients With Major Bleeding |
NCT02608099 (16) [back to overview] | Number of Patients With Major Bleeding |
NCT02608099 (16) [back to overview] | Number of Patients With Death |
NCT02608099 (16) [back to overview] | Number of Patients With Death |
NCT02608099 (16) [back to overview] | Number of Patients With Composite of Major Bleeding and Thrombotic Events |
NCT02608099 (16) [back to overview] | Number of Patients With Composite of Major Bleeding and Thrombotic Events |
NCT02608099 (16) [back to overview] | Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events |
NCT02608099 (16) [back to overview] | Number of Patients With Clinically-Significant Bleeding |
NCT02608099 (16) [back to overview] | Number of Patients With Clinically-Significant Bleeding |
NCT02701062 (8) [back to overview] | Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days |
NCT02701062 (8) [back to overview] | Number of Perioperative Complications Associated With AtriClip Placement |
NCT02701062 (8) [back to overview] | Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days) |
NCT02701062 (8) [back to overview] | Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days) |
NCT02701062 (8) [back to overview] | Number of Subjects With Intraoperative Successful Exclusion of LAA. |
NCT02701062 (8) [back to overview] | Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values) |
NCT02701062 (8) [back to overview] | Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values) |
NCT02701062 (8) [back to overview] | Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates) |
NCT02744092 (11) [back to overview] | Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire |
NCT02744092 (11) [back to overview] | Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire |
NCT02744092 (11) [back to overview] | Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months |
NCT02744092 (11) [back to overview] | Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months |
NCT02744092 (11) [back to overview] | Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire |
NCT02744092 (11) [back to overview] | Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire |
NCT02744092 (11) [back to overview] | Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire |
NCT02744092 (11) [back to overview] | Cumulative Non-Fatal VTE Recurrence at 6 Months (%) |
NCT02744092 (11) [back to overview] | Cumulative Rates of Major Bleeding |
NCT02744092 (11) [back to overview] | Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form) |
NCT02744092 (11) [back to overview] | Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire |
NCT02829957 (9) [back to overview] | Number of Participants With Major Hemorrhage |
NCT02829957 (9) [back to overview] | Number of Participants With Venous Thromboembolism (VTE) |
NCT02829957 (9) [back to overview] | Number of Patients That Held Drug for Menorrhagia |
NCT02829957 (9) [back to overview] | PBAC Scores |
NCT02829957 (9) [back to overview] | Number of Participants Who Crossed Over to Another Anticoagulant |
NCT02829957 (9) [back to overview] | Number of Participants Who Discontinued Planned Drug Administration |
NCT02829957 (9) [back to overview] | Hemoglobin Concentration |
NCT02829957 (9) [back to overview] | Number of Participants With Clinically Relevant Non-major Bleeding |
NCT02829957 (9) [back to overview] | Physical Component Summary of Standard From 36 |
NCT02889562 (5) [back to overview] | Total Post-operative Length of Stay |
NCT02889562 (5) [back to overview] | Units of Blood Given After Initiation of Anticoagulation Medication |
NCT02889562 (5) [back to overview] | Time in Therapeutic Range of INR, if on Warfarin |
NCT02889562 (5) [back to overview] | Number of Participants With Thromboembolytic Events |
NCT02889562 (5) [back to overview] | Number of Participants With Strokes |
NCT02942407 (10) [back to overview] | Number of Participants Experiencing Systemic Embolism |
NCT02942407 (10) [back to overview] | Number of Participants Experiencing Stroke, Systemic Embolism, Major Bleeding or All-cause Mortality |
NCT02942407 (10) [back to overview] | Number of Participants Experiencing Stroke or Systemic Embolism |
NCT02942407 (10) [back to overview] | Number of Participants Experiencing Stroke |
NCT02942407 (10) [back to overview] | Number of Participants Experiencing Mortality |
NCT02942407 (10) [back to overview] | Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding |
NCT02942407 (10) [back to overview] | Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12) |
NCT02942407 (10) [back to overview] | Apixaban Plasma Concentration, Cmin |
NCT02942407 (10) [back to overview] | Apixaban Plasma Concentration, Cmax |
NCT02942407 (10) [back to overview] | Persistence of Therapy |
NCT02958969 (4) [back to overview] | Frequency of Major and Clinically Relevant Non-major Bleeding |
NCT02958969 (4) [back to overview] | Frequency of Symptomatic Venous Thromboembolism |
NCT02958969 (4) [back to overview] | Frequency of All-cause Mortality |
NCT02958969 (4) [back to overview] | Frequency of Atherothrombotic Events |
NCT02981472 (15) [back to overview] | The Number of Participants With Adjudicated Major Bleeding |
NCT02981472 (15) [back to overview] | The Number of Participants With Adjudicated CRNM Bleeding |
NCT02981472 (15) [back to overview] | The Number of Participant Deaths in the Study |
NCT02981472 (15) [back to overview] | Maximum Observed Concentration (Cmax) |
NCT02981472 (15) [back to overview] | Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events |
NCT02981472 (15) [back to overview] | Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU)) |
NCT02981472 (15) [back to overview] | Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score |
NCT02981472 (15) [back to overview] | The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death |
NCT02981472 (15) [back to overview] | The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL) |
NCT02981472 (15) [back to overview] | Chromogenic FX Assay (Apparent FX Level) |
NCT02981472 (15) [back to overview] | Anti-FXa Activity |
NCT02981472 (15) [back to overview] | Trough Observed Concentration (Cmin) |
NCT02981472 (15) [back to overview] | Time of Maximum Observed Concentration (Tmax) |
NCT02981472 (15) [back to overview] | The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding |
NCT02981472 (15) [back to overview] | The Number of Participants With All Adjudicated Bleeding |
NCT02982590 (4) [back to overview] | Change of Left Ventricular Thrombosis (LVT) by More Than 50% |
NCT02982590 (4) [back to overview] | Clinically Definite Cardiac Embolic Ischemic Stroke |
NCT02982590 (4) [back to overview] | Life Threatening Bleeding |
NCT02982590 (4) [back to overview] | Percent Change in Left Ventricular Thrombus (LVT) Size |
NCT03026556 (13) [back to overview] | Overall Major Bleeding |
NCT03026556 (13) [back to overview] | Stroke Overall (Hemorrhagic, Ischemic, Uncertain) |
NCT03026556 (13) [back to overview] | TIA |
NCT03026556 (13) [back to overview] | Upper GI Bleeding |
NCT03026556 (13) [back to overview] | Major Intracranial Bleeding |
NCT03026556 (13) [back to overview] | Major GI Bleeding |
NCT03026556 (13) [back to overview] | Major Extracranial Bleeding |
NCT03026556 (13) [back to overview] | Lower GI Bleeding |
NCT03026556 (13) [back to overview] | Ischemic Stroke |
NCT03026556 (13) [back to overview] | Hemorrhagic Stroke |
NCT03026556 (13) [back to overview] | All-cause Mortality |
NCT03026556 (13) [back to overview] | Major Urogenital Bleeding |
NCT03026556 (13) [back to overview] | Major Other Bleeding |
NCT03080883 (3) [back to overview] | Cumulative Incidence Function of DVT/PE Treating Death or AE Resulting in End of Treatment as Competing Risk by Study Arm |
NCT03080883 (3) [back to overview] | CIF of Major or Clinically Relevant Non-major Bleeding Combined With Death as Competing Risk |
NCT03080883 (3) [back to overview] | Proportion of Patients Who Experienced at Least One Bleeding Event |
NCT03196349 (7) [back to overview] | Number of Subjects With Recurrent Venous Thromboembolism (VTE) |
NCT03196349 (7) [back to overview] | Number of Subjects With Clinically Relevant Bleeding Events |
NCT03196349 (7) [back to overview] | Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke) |
NCT03196349 (7) [back to overview] | Number of Subjects Experiencing Major Bleeding |
NCT03196349 (7) [back to overview] | Number of Subjects Experiencing Clinically Relevant Non-major Bleeding |
NCT03196349 (7) [back to overview] | Number of Subjects With Premature Termination of Study Medication |
NCT03196349 (7) [back to overview] | Number of Subjects Experiencing All-cause Mortality |
NCT03251482 (13) [back to overview] | Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Death (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Major Bleeding Event (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Minimal Bleeding Events (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Distal DVT (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Proximal and Distal DVT (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated) |
NCT03251482 (13) [back to overview] | Number of Participants With Major VTE (CEC-adjudicated) |
NCT03254147 (2) [back to overview] | The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. |
NCT03254147 (2) [back to overview] | The Number of Patients With Cardiac Tamponade and Pericardiocentesis. |
NCT03310021 (6) [back to overview] | Change in Thrombin Generation From Baseline to the End of Bolus (EOB) Nadir. |
NCT03310021 (6) [back to overview] | Percent Change in Anti-Fxa Activity From Baseline to the End of Bolus (EOB) Nadir. |
NCT03310021 (6) [back to overview] | Percent Change in Anti-Fxa Activity From Baseline to the End of Infusion (EOI) Nadir. |
NCT03310021 (6) [back to overview] | Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Bolus (EOB) Nadir. |
NCT03310021 (6) [back to overview] | Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Infusion (EOI) Nadir. |
NCT03310021 (6) [back to overview] | Change in Thrombin Generation From Baseline to the End of Infusion (EOI) Nadir. |
NCT03441633 (10) [back to overview] | Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) |
NCT03441633 (10) [back to overview] | Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) |
NCT03441633 (10) [back to overview] | International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA |
NCT03441633 (10) [back to overview] | Number of Participants by Comedications |
NCT03441633 (10) [back to overview] | Number of Participants by Comorbidity |
NCT03441633 (10) [back to overview] | Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year |
NCT03441633 (10) [back to overview] | Risk of Bleeding Events: HAS-BLED Score |
NCT03441633 (10) [back to overview] | Risk of Thromboembolic Events: CHA2DS2Vasc Score |
NCT03441633 (10) [back to overview] | Risk of Thromboembolic Events: CHADS2 Score |
NCT03441633 (10) [back to overview] | Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA |
NCT03509883 (16) [back to overview] | AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time |
NCT03509883 (16) [back to overview] | T-Half - Terminal Plasma Half Life. |
NCT03509883 (16) [back to overview] | AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration |
NCT03509883 (16) [back to overview] | Number of Participants With Out-of Range Vital Signs: Blood Pressure |
NCT03509883 (16) [back to overview] | Tmax - Time of Maximum Observed Plasma Concentration |
NCT03509883 (16) [back to overview] | Number of Participants With Out-of Range ECG Evaluations |
NCT03509883 (16) [back to overview] | Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation |
NCT03509883 (16) [back to overview] | Concentration as Measured by Maximum Observed Plasma Concentration (Cmax) |
NCT03509883 (16) [back to overview] | Number of Participants With a Given Clinical Laboratory Abnormality |
NCT03509883 (16) [back to overview] | Physical Measurement - Height |
NCT03509883 (16) [back to overview] | Frel - Relative Bioavailability |
NCT03509883 (16) [back to overview] | Physical Measurement - Weight |
NCT03509883 (16) [back to overview] | Physical Measurement - Body Mass Index (BMI) |
NCT03509883 (16) [back to overview] | Number of Participants With Out-of Range Vital Signs: Temperature |
NCT03509883 (16) [back to overview] | Number of Participants With Out-of Range Vital Signs: Respiration Rate |
NCT03509883 (16) [back to overview] | Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm) |
NCT03572972 (16) [back to overview] | Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis |
NCT03572972 (16) [back to overview] | Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis |
NCT03594045 (8) [back to overview] | Time to Platelet Recovery |
NCT03594045 (8) [back to overview] | Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban |
NCT03594045 (8) [back to overview] | Cumulative Incidence of Major Bleeding |
NCT03594045 (8) [back to overview] | Cumulative Incidence of Limb Amputation |
NCT03594045 (8) [back to overview] | Cumulative Incidence of All Cause Mortality |
NCT03594045 (8) [back to overview] | Composite Cumulative Incidence of New TEC and Major Bleeding |
NCT03594045 (8) [back to overview] | Composite Cumulative Incidence of All-cause Mortality, Limb Amputation and New TEC |
NCT03594045 (8) [back to overview] | Cumulative Incidence of New Thromboembolic Complications (TEC) |
NCT04218266 (5) [back to overview] | Number of Participants With ISTH Major Bleeding |
NCT04218266 (5) [back to overview] | Number of Participants With ISTH Minor Bleeding |
NCT04218266 (5) [back to overview] | Number of Participants of ISTH Clinically Relevant Non-major (CRNM) Bleeding |
NCT04218266 (5) [back to overview] | Number of Participants With All Bleeding |
NCT04218266 (5) [back to overview] | Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding or Clinically Relevant Non-major (CRNM) Bleeding |
NCT04498273 (1) [back to overview] | Hospitalization for Cardiovascular/Pulmonary Events |
NCT04681482 (8) [back to overview] | Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Obese Participants |
NCT04681482 (8) [back to overview] | Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Morbidly Obese Participants |
NCT04681482 (8) [back to overview] | Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Morbidly Obese Participants |
NCT04681482 (8) [back to overview] | Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants |
NCT04681482 (8) [back to overview] | Time in Therapeutic Range (TTR) During Follow-up Period |
NCT04681482 (8) [back to overview] | Charlson Comorbidity Index (CCI) |
NCT04681482 (8) [back to overview] | Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Obese Participants |
NCT04681482 (8) [back to overview] | Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Morbidly Obese Participants |
NCT05022563 (60) [back to overview] | Number of Participants Who Switched to Another Anticoagulant Therapy |
NCT05022563 (60) [back to overview] | Number of Participants Who Completely Discontinued Index Anticoagulant Treatment |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism |
NCT05022563 (60) [back to overview] | Number of Participants With Interruption in Index Anticoagulant Treatment |
NCT05022563 (60) [back to overview] | Overall Index Anticoagulant Treatment Duration |
NCT05022563 (60) [back to overview] | Time to Treatment Discontinuation |
NCT05022563 (60) [back to overview] | Time to Treatment Interruption |
NCT05022563 (60) [back to overview] | Time to Treatment Switch |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation |
NCT05022563 (60) [back to overview] | Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism |
NCT05022563 (60) [back to overview] | Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism |
NCT05022563 (60) [back to overview] | Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months |
Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B. (NCT00313300)
Timeframe: first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study
Intervention | percentage of participants (Number) |
---|
Placebo | 10.5 |
Apixaban 2.5mg BID | 20.6 |
Apixaban 10mg QD | 22.5 |
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Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B
Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group). (NCT00313300)
Timeframe: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Intervention | percentage of participants (Number) |
---|
Placebo | 0.8 |
Apixaban 2.5mg BID | 5.0 |
Apixaban 10mg QD | 5.6 |
Apixaban 10mg BID | 7.8 |
Apixaban 20 mg QD | 7.3 |
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Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups. (NCT00313300)
Timeframe: From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study
Intervention | percentage of participants (Number) |
---|
Placebo | 3.0 |
Apixaban 2.5mg BID | 5.7 |
Apixaban 10mg QD | 7.9 |
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Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure. (NCT00313300)
Timeframe: Day of randomization and ends on high dose termination date, 1-Oct-2007
Intervention | participants (Number) |
---|
Placebo | 16 |
Apixaban 2.5mg BID | 6 |
Apixaban 10mg QD | 4 |
Apixaban 10mg BID | 8 |
Apixaban 20 mg QD | 7 |
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Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). (NCT00313300)
Timeframe: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Intervention | percentage of participants (Number) |
---|
Placebo | 0.0 |
Apixaban 2.5mg BID | 0.8 |
Apixaban 10mg QD | 0.0 |
Apixaban 10mg BID | 2.9 |
Apixaban 20 mg QD | 4.1 |
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Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). (NCT00313300)
Timeframe: from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study
Intervention | percentage of participants (Number) |
---|
Placebo | 0.8 |
Apixaban 2.5mg BID | 1.6 |
Apixaban 10mg QD | 1.9 |
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Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B (NCT00313300)
Timeframe: Day of randomization to 182 days after day of randomization (183 days)
Intervention | participants (Number) |
---|
Placebo | 54 |
Apixaban 2.5mg BID | 24 |
Apixaban 10mg QD | 20 |
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Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure. (NCT00313300)
Timeframe: Day of randomization up to high dose termination, 1-Oct-2007
Intervention | participants (Number) |
---|
Placebo | 16 |
Apixaban 2.5mg BID | 6 |
Apixaban 10mg QD | 4 |
Apixaban 10mg BID | 8 |
Apixaban 20 mg QD | 7 |
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Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B. (NCT00313300)
Timeframe: Randomization to 182 days after randomization (183 days)
Intervention | participants (Number) |
---|
Placebo | 53 |
Apixaban 2.5mg BID | 24 |
Apixaban 10mg QD | 19 |
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Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group). (NCT00313300)
Timeframe: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Intervention | percentage of participants (Number) |
---|
Placebo | 6.1 |
Apixaban 2.5mg BID | 15.1 |
Apixaban 10mg QD | 17.6 |
Apixaban 10mg BID | 24.2 |
Apixaban 20 mg QD | 23.9 |
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Number of Participants With All-Cause Death
(NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug
Intervention | Participants (Number) |
---|
Cohort 1: Placebo | 0 |
Cohort 1: Apixaban, 5 mg | 0 |
Cohort 1: Apixaban, 10 mg | 0 |
Cohort 1: Apixaban, 20 mg | 0 |
Cohort 2: Placebo | 0 |
Cohort 2: Apixaban, 5 mg | 0 |
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Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding
"Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:~A decrease in hemoglobin of 20 g/L or more or~Required transfusion of 2 or more units of packed red blood cells or whole blood, or~Occurred in a critical site~Contributed to death.~CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:~Skin hematoma~Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention~Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract~Any other bleeding type that was considered to have clinical consequences." (NCT00320255)
Timeframe: From first dose to 2 days following last dose of study drug
Intervention | Participants (Number) |
---|
Cohort 1: Placebo | 1 |
Cohort 1: Apixaban, 5 mg | 1 |
Cohort 1: Apixaban, 10 mg | 1 |
Cohort 1: Apixaban, 20 mg | 4 |
Cohort 2: Placebo | 2 |
Cohort 2: Apixaban, 5 mg | 3 |
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Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death
"VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug
Intervention | Participants (Number) |
---|
Cohort 1: Placebo | 4 |
Cohort 1: Apixaban, 5 mg | 0 |
Cohort 1: Apixaban, 10 mg | 0 |
Cohort 1: Apixaban, 20 mg | 1 |
Cohort 2: Placebo | 0 |
Cohort 2: Apixaban, 5 mg | 0 |
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Number of Participants With Deep Vein Thrombosis
"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug
Intervention | Participants (Number) |
---|
Cohort 1: Placebo | 4 |
Cohort 1: Apixaban, 5 mg | 0 |
Cohort 1: Apixaban, 10 mg | 0 |
Cohort 1: Apixaban, 20 mg | 1 |
Cohort 2: Placebo | 0 |
Cohort 2: Apixaban, 5 mg | 0 |
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Number of Participants With Distal Deep Vein Thrombosis
"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug
Intervention | Participants (Number) |
---|
Cohort 1: Placebo | 1 |
Cohort 1: Apixaban, 5 mg | 0 |
Cohort 1: Apixaban, 10 mg | 0 |
Cohort 1: Apixaban, 20 mg | 0 |
Cohort 2: Placebo | 0 |
Cohort 2: Apixaban, 5 mg | 0 |
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Number of Participants With Nonfatal Pulmonary Embolism
"Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug
Intervention | Participants (Number) |
---|
Cohort 1: Placebo | 1 |
Cohort 1: Apixaban, 5 mg | 0 |
Cohort 1: Apixaban, 10 mg | 0 |
Cohort 1: Apixaban, 20 mg | 0 |
Cohort 2: Placebo | 0 |
Cohort 2: Apixaban, 5 mg | 0 |
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Number of Participants With Proximal Deep Vein Thrombosis
"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug
Intervention | Participants (Number) |
---|
Cohort 1: Placebo | 3 |
Cohort 1: Apixaban, 5 mg | 0 |
Cohort 1: Apixaban, 10 mg | 0 |
Cohort 1: Apixaban, 20 mg | 0 |
Cohort 2: Placebo | 0 |
Cohort 2: Apixaban, 5 mg | 0 |
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Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death
"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments (popliteal vein or higher) of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan (nonhigh probability) with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels." (NCT00320255)
Timeframe: First dose to 30 days following last dose of study drug
Intervention | Participants (Number) |
---|
Cohort 1: Placebo | 3 |
Cohort 1: Apixaban, 5 mg | 0 |
Cohort 1: Apixaban, 10 mg | 0 |
Cohort 1: Apixaban, 20 mg | 0 |
Cohort 2: Placebo | 0 |
Cohort 2: Apixaban, 5 mg | 0 |
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Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)
"Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels of greater than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug
Intervention | Participants (Number) |
---|
Cohort 1: Placebo | 1 |
Cohort 1: Apixaban, 5 mg | 0 |
Cohort 1: Apixaban, 10 mg | 0 |
Cohort 1: Apixaban, 20 mg | 0 |
Cohort 2: Placebo | 0 |
Cohort 2: Apixiban, 5 mg | 0 |
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Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
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. (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug
Intervention | Participants (Number) |
---|
| Deaths | SAEs | Bleeding AEs | Discontinuations due to AEs |
---|
Cohort 1: Apixaban, 10 mg | 0 | 3 | 11 | 4 |
,Cohort 1: Apixaban, 20 mg | 0 | 5 | 12 | 4 |
,Cohort 1: Apixaban, 5 mg | 1 | 6 | 15 | 4 |
,Cohort 1: Placebo | 2 | 9 | 6 | 7 |
,Cohort 2: Apixaban, 5 mg | 0 | 0 | 2 | 0 |
,Cohort 2: Placebo | 0 | 1 | 1 | 1 |
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Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period
ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Intervention | percentage of participants (Number) |
---|
Apixaban 2.5mg BID | 2.13 |
Enoxaparin 30 mg SC Injection q 12 Hours | 1.97 |
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Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period
A 60-day follow-up period started after the last dose of study drug and continued until the End of Study Visit on Day 72 (60 days ± 3 days, after the last dose of study drug). Event rate was number of participants with the endpoint divided by the number of participants analyzed (%). ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per ISTH guidelines modified for surgical patients. (NCT00371683)
Timeframe: Post last dose of study drug to Day 72 (60 days)
Intervention | percentage of participants (Number) |
---|
| MI/Stroke | MI | Stroke | Thrombocytopenia |
---|
Apixaban 2.5mg BID | 0.06 | 0.06 | 0.00 | 0.00 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 0.06 | 0.06 | 0.00 | 0.00 |
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Mean Change From Baseline in Heart Rate During the Treatment Period
Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm). (NCT00371683)
Timeframe: Baseline to last dose of study drug, plus 2 days
Intervention | bpm (Mean) |
---|
| Heart Rate Day 1 (n=240,237) | Heart Rate Day 2 (n=1575,1574) | Heart Rate Day 3 (n=1490,1498) | Heart Rate Day 4 (n=127,134) | Heart Rate Day 12 (n=1495, 1462) |
---|
Apixaban 2.5mg BID | 2.3 | 4.6 | 4.5 | 7.6 | -0.3 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 2.7 | 4.5 | 5.0 | 9.4 | -0.1 |
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Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Blood pressures (BP) were measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Systolic and diastolic pressures were measured in millimeters of mercury (mmHg). (NCT00371683)
Timeframe: Baseline to last dose of study drug, plus 2 days
Intervention | mmHg (Mean) |
---|
| Diastolic BP Day 1 (n=240, 237) | Diastolic BP Day 2 (n=1577, 1574) | Diastolic BP Day 3 (n=1489,1498) | Diastolic BP Day 4 (n=127,134) | Diastolic BP Day 12 (n=1495,1463) | Systolic BP Day 1 (n=240,237) | Systolic BP Day 2 (n=1577,1574) | Systolic BP Day 3 (n=1489,1498) | Systolic BP Day 4 (n=127,134) | Systolic BP Day 12 (n=1495,1463) |
---|
Apixaban 2.5mg BID | -0.4 | 1.7 | 2.3 | 0.6 | 7.3 | 1.5 | 5.4 | 4.7 | 2.8 | 9.1 |
,Enoxaparin 30 mg SC Injection q 12 Hours | -0.9 | 1.5 | 2.1 | 0.3 | 7.5 | -0.7 | 4.2 | 4.3 | 1.4 | 8.9 |
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Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period
Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Potassium: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Calcium: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN If pre-dose > ULN then use > 1.25*predose or < LLN. Chloride: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Sodium: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*predose or >ULN if pre-dose > ULN then use > 1.05*predose or < LLN. Bicarbonate: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN if pre-dose > ULN then use > 1.25*predose or < LLN. (NCT00371683)
Timeframe: First dose to last dose of study drug (12 days), plus 2 days
Intervention | participants (Number) |
---|
| Calcium low (n=1569,1562) | Calcium high (n=1569,1562) | Chloride low (n=1568,1562) | Chloride high (n=1568,1562) | Bicarbonate low (n=1568,1561) | Potassium low(n=1568,1559) | Potassium high(n=1568,1559) | Sodium low (n=1568,1562) | Sodium high (n=1568,1562) |
---|
Apixaban 2.5mg BID | 1 | 0 | 11 | 0 | 11 | 54 | 26 | 23 | 2 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 5 | 1 | 17 | 1 | 13 | 56 | 20 | 39 | 0 |
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Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period
Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Hematology profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 2, 3, 4, 12 (end of treatment). Upper limit of normal (ULN); lower limit of normal (LLN). Platelet Count low: < 100,000/mm^3 (or < 100*109 cells/L). Erythrocytes low: < 0.75 *pre-dose. Hemoglobin low: > 2 g/dL decrease compared to pre-dose or Value ≤ 8 g/dL. Hematocrit low: < 0.75*pre-dose . Leukocytes: < 0.75*LLN or > 1.25* ULN, or if pre-dose < LLN then use < 0.8*predose or > ULN if pre-dose > ULN then use > 1.2*predose or < LLN. Lymphocytes (absolute): < 0.750*10^3 cells/µL or > 7.50*10^3 cells/ µL. Eosinophils (absolute) high: > 0.750*10^3 cells/µL. Basophils(absolute) high: > 400/mm^3 (or > 0.4*103 cells/µL). Monocytes (absolute) high: > 2000/mm^3 (or > 2*103 cells/µL). Neutrophils(absolute) high: < 1.0*103 cells/µL. (NCT00371683)
Timeframe: First dose to last dose of study drug (12 days), plus 2 days
Intervention | participants (Number) |
---|
| Hemoglobin low (n=1561,1549) | Hematocrit low (n=1558,1547) | Platelet count low (n=1556,1543) | Erythrocytes low (n=1557,1547) | Leukocytes low(n=1583,1572) | Leukocytes high(n=1583,1572) | Basophils high (n=1577, 1564) | Eosinophils high (n=1577, 1564) | Lymphocytes low (n=1577,1564) | Lymphocytes high (n=1577,1564) | Monocytes high (n=1577,1564) | Neutrophils low (n=1577,1564) |
---|
Apixaban 2.5mg BID | 386 | 135 | 6 | 130 | 8 | 214 | 0 | 32 | 125 | 2 | 4 | 4 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 392 | 157 | 9 | 149 | 11 | 210 | 2 | 13 | 117 | 4 | 4 | 5 |
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Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period
A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Intervention | percentage of participants (Number) |
---|
Apixaban 2.5mg BID | 2.05 |
Enoxaparin 30 mg SC Injection q 12 Hours | 1.64 |
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Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period
ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). (NCT00371683)
Timeframe: From first dose to last dose, plus 2 days (12 days, plus 2)
Intervention | percentage of participants (Number) |
---|
| MI/Stroke | MI | Stroke | Thrombocytopenia |
---|
Apixaban 2.5mg BID | 0.06 | 0.06 | 0.00 | 0.00 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 0.31 | 0.25 | 0.13 | 0.13 |
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Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects
An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization. (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Intervention | percentage of participants (Number) |
---|
Apixaban 2.5mg BID | 8.99 |
Enoxaparin 30 mg SC Injection q 12 Hours | 8.85 |
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Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period
Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Bilirubin (direct) high: > 1.5*ULN. Total bilirubin: : > 2*ULN, Alanine Aminotransferase (ALT) high: > 3*ULN. Alkaline Phosphatase (ALP): > 2*ULN. Aspartate Aminotransferase (AST): > 3*ULN. Creatinine: > 1.5*ULN. (NCT00371683)
Timeframe: First dose to last dose of study drug (12 days), plus 2 days
Intervention | participants (Number) |
---|
| ALP high (n=1573,1563) | ALT high (n=1573,1562) | AST high (n=1573,1562) | Bilirubin direct high (n=1563,1553) | Bilirubin total high(n=1572,1562) | Creatinine high (n=1569,1562) |
---|
Apixaban 2.5mg BID | 42 | 33 | 29 | 63 | 2 | 17 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 55 | 45 | 40 | 54 | 8 | 28 |
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Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period
Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose < LLN then use < 0.8*predose; or > ULN if pre-dose > ULN then use > 2.0*predose or 1.1*ULN, or if pre-dose < LLN then use 0.9*predose or > ULN if pre-dose > ULN then use 1.1*predose or < LLN. Uric Acid: > 1.5*ULN, or if pre-dose > ULN then use > 2*predose. Creatine Kinase (CK): > 5*ULN. (NCT00371683)
Timeframe: First dose to last dose of study drug (12 days), plus 2 days
Intervention | participants (Number) |
---|
| Fasting Glucose low (n=611, 579) | Fasting Glucose high (n=611, 579) | Total Protein low (n=1568,1562) | CK high (n=1573,1563) | Uric Acid high (n=1567,1562) |
---|
Apixaban 2.5mg BID | 8 | 54 | 527 | 52 | 22 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 5 | 28 | 513 | 45 | 12 |
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Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population
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. (NCT00371683)
Timeframe: First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days)
Intervention | participants (Number) |
---|
| SAE | Bleeding AE | AEs leading to discontinuation | Deaths |
---|
Apixaban 2.5mg BID | 123 | 110 | 60 | 3 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 123 | 144 | 58 | 5 |
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Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period
ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72. (NCT00371683)
Timeframe: Last dose of study drug to Day 72 (60 days)
Intervention | percentage of participants (Number) |
---|
| Major Bleeding (n=1563, 1553) | CR N-M Bleeding (n=1563, 1553) | Major or CR N-M Bleeding (n=1563, 1553) | Any Bleeding (n=1563, 1553) |
---|
Apixaban 2.5mg BID | 0.13 | 0.26 | 0.38 | 0.90 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 0.13 | 0.45 | 0.58 | 1.29 |
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Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population
ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days. (NCT00371683)
Timeframe: First dose of study drug to last dose, plus 2 days post last dose
Intervention | percentage of participants (Number) |
---|
| Major Bleeding (n=1596, 1588) | CR N-M Bleeding (n=1596, 1588) | Major or CR N-M Bleeding(n=1596, 1588) | Any Bleeding (n=1596, 1588) |
---|
Apixaban 2.5mg BID | 0.69 | 2.19 | 2.88 | 5.33 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 1.39 | 2.96 | 4.28 | 6.80 |
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Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period
An ICAC adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Intervention | percentage of participants (Number) |
---|
| PE (Fatal or Non-Fatal) (n=1599, 1596) | Non-Fatal PE (n=1599, 1596) | All DVT n=1142, 1122 | Symptomatic DVT (n=1599, 1596) | Asymptomatic DVT (n=1139,1115) | Symptomatic Proximal DVT (n=1599,1596) | Symptomatic Distal DVT (n=1599,1596) |
---|
Apixaban 2.5mg BID | 1.00 | 0.88 | 7.79 | 0.19 | 7.55 | 0.13 | 0.06 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 0.44 | 0.44 | 8.20 | 0.44 | 7.62 | 0.19 | 0.38 |
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Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period
ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Intervention | percentage of participants (Number) |
---|
| Proximal DVT (n=1254, 1207) | Distal DVT (n=1146, 1133) | Asymptomatic Proximal DVT (n=1252, 1204) | Asymptomatic Distal DVT (n=1145, 1127) |
---|
Apixaban 2.5mg BID | 0.72 | 7.24 | 0.56 | 7.16 |
,Enoxaparin 30 mg SC Injection q 12 Hours | 0.91 | 8.03 | 0.66 | 7.54 |
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Event Rate for Participants With All-Cause Death During the Intended Treatment Period
Event rate was number of participants with all-cause death divided by the number of participant's analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Intervention | percentage of participants (Number) |
---|
Apixaban 2.5mg BID | 0.19 |
Enoxaparin 30 mg SC Injection q 12 Hours | 0.19 |
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Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period
ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Intervention | percentage of participants (Number) |
---|
Apixaban 2.5mg BID | 1.25 |
Enoxaparin 30 mg SC Injection q 12 Hours | 1.00 |
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Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period
ICAC adjudicated VTE, acute clinically overt bleeding events, suspected thrombocytopenia, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Intervention | percentage of participants (Number) |
---|
Apixaban 2.5mg BID | 9.90 |
Enoxaparin 30 mg SC Injection q 12 Hours | 10.60 |
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Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period
ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more, and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | participants (Number) |
---|
Apixaban | 327 |
Warfarin | 462 |
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Number of Participants With Events of All-Cause Death During the Intended Treatment Period
Death was defined as all-cause mortality. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, myocardial infarction (MI), sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death). (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."
Intervention | participants (Number) |
---|
Apixaban | 603 |
Warfarin | 669 |
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Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period
Major bleeding=bleeding that is clinically overt and that either resulted in a decrease in hemoglobin of 2 g/dL or more over a 24-hour period, led to a transfusion of 2 or more units of packed red blood cells, occurred in a critical site, or led to death. CRNM bleeding=bleeding that is clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | participants (Number) |
---|
Apixaban | 613 |
Warfarin | 877 |
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Number of Participants With Net-Clinical Benefit During Treatment Period
Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | participants (Number) |
---|
Apixaban | 459 |
Warfarin | 608 |
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Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period
For descriptions of Stroke and SE, see Outcome Measure 1. For description of Major bleeding, see Outcome Measure 3. (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."
Intervention | participants (Number) |
---|
Apixaban | 229 |
Warfarin | 285 |
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Rate of Adjudicated All-Cause Death During the Intended Treatment Period
All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, MI, sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death). (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."
Intervention | Number of events per 100 patient years (Number) |
---|
Apixaban | 3.52 |
Warfarin | 3.94 |
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Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period
Rate=number of adjudicated major (ISTH) bleed events per 100 patient years. ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | Number of events per 100 patient years (Number) |
---|
Apixaban | 2.13 |
Warfarin | 3.09 |
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Rate of All Bleeding Events During Treatment Period
"Rate=number of all bleeding events per 100 patient years. All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death." (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | number of events per 100 patient years (Number) |
---|
Apixaban | 18.08 |
Warfarin | 25.82 |
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Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period
Diagnosis for an acute or evolving MI=elevation of creatine kinase-MB isoenzyme (CK-MB) or Troponin T or I ≥ 2 × the upper limit of normal (ULN), or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1. (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."
Intervention | Number of events per 100 patient years (Number) |
---|
| Ischemic or Unspecified Stroke (n=162, 175) | Hemorrhagic Stroke (n=40, 78) | Systemic Embolism (n=15, 17) | Myocardial Infarction (n=90, 102) |
---|
Apixaban | 0.97 | 0.24 | 0.09 | 0.53 |
,Warfarin | 1.05 | 0.47 | 0.10 | 0.61 |
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Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period
Rate=Number of adjudicated stroke or SE events per 100 patient years. Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing. (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."
Intervention | Number of events per 100 patient years (Number) |
---|
Apixaban | 1.27 |
Warfarin | 1.60 |
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Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period
(NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."
Intervention | Number of events per 100 patient years (Number) |
---|
Apixaban | 3.21 |
Warfarin | 4.06 |
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Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period
Rate=number of major or CRNM bleed events per 100 patient years. Major=clinically overt and either 1) resulted in a decrease in hemoglobin of 2 g/dL or more, or 2) led to a transfusion of 2 or more units of packed red blood cells, or 3) occurred in a critical site, or 4) led to death. CRNM bleeding=clinically overt, but satisfied no additional criteria required to be adjudicated as a major bleeding event, and led to either 1) hospital admission for bleeding or 2) physician guided medical or surgical treatment for bleeding or 3) a change in antithrombotic therapy. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | number of events / 100 patient years (Number) |
---|
Apixaban | 4.07 |
Warfarin | 6.01 |
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Rate of Net-Clinical Benefit During Treatment Period
Rate=number of events of net-clinical benefit per 100 patient years. Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | Number of events per 100 patient years (Number) |
---|
Apixaban | 3.01 |
Warfarin | 4.09 |
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Number of Participants With Adverse Events (AEs), Bleeding AEs, Serious Adverse Events (SAEs), Discontinuations Due to AEs, or Deaths During the Treatment Period
AE: all SAEs or AEs with onset from first dose through 2 days (AEs) or 30 days (SAEs) after the last dose of blinded study drug (BSD). SAE: all SAEs with onset from first dose through 30 days after the last dose of BSD. Bleeding AE: all serious or non-serious bleeding-related AEs with onset from first dose through 2 days after the last dose of BSD. Discontinuations due to AE: all SAEs or AEs with onset from first dose of BSD and with action taken=drug discontinued. Deaths: all deaths occurring from first dose through 30 days after the last dose of BSD. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | participants (Number) |
---|
| AE | SAE | Bleeding AE | Discontinuations due to AE | Deaths |
---|
Apixaban | 7406 | 3182 | 2288 | 688 | 429 |
,Warfarin | 7521 | 3302 | 2961 | 758 | 468 |
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Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period
All suspected efficacy events were adjudicated by the Central Events Committee (CEC). Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing. (NCT00412984)
Timeframe: "Time to first event in Intended Treatment Period: started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding)."
Intervention | participants (Number) |
---|
| Ischemic or Unspecified Stroke | Hemorrhagic Stroke | Systemic Embolism |
---|
Apixaban | 159 | 38 | 15 |
,Warfarin | 173 | 76 | 16 |
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Rate of Adjudicated Bleeding Endpoints Per Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) During the Treatment Period
Rate=number of adjudicated GUSTO bleeding events per 100 patient years. GUSTO Bleeding Criteria: GUSTO severe (or life-threatening) bleeding: either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention. GUSTO moderate bleeding: bleeding that requires blood transfusion but does not result in hemodynamic compromise. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | Number of events per 100 patient years (Number) |
---|
| Severe (n=80, 172)) | Severe or Moderate (n=199, 328) |
---|
Apixaban | 0.52 | 1.29 |
,Warfarin | 1.13 | 2.18 |
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Rate of Adjudicated Bleeding Endpoints Per Thrombolysis in Myocardial Infarction (TIMI) During the Treatment Period
Rate=number of adjudicated TIMI bleeding events per 100 patient years. TIMI Bleeding Criteria: Major bleeding=Intracranial bleeding and/or clinically overt bleeding associated with ≥5 gm/dL fall in Hgb or 15% fall in hematocrit (Hct) from baseline, accounting for transfusions. Minor bleeding=Clinically overt bleeding associated with ≥3 gm/dL fall in Hgb or a ≥10% fall in Hct from baseline, accounting for transfusions. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | Number of events per 100 patient years (Number) |
---|
| Major (n=148, 256) | Major or Minor (n=239, 370) |
---|
Apixaban | 0.96 | 1.55 |
,Warfarin | 1.69 | 2.46 |
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Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period
Diagnosis for an acute or evolving MI=elevation of CK-MB or Troponin T or I ≥ 2 × the ULN, or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1. For description of ACD, see Outcome Measure 5. (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."
Intervention | Number of events per 100 patient years (Number) |
---|
| Stroke / SE / Major Bleeding (n=521, 666) | Stroke / SE / All-Cause Death (ACD) (n=752, 837) | Stroke / SE / Major Bleeding / ACD (n=1009, 1168) | Stroke / SE / MI / ACD (n=810, 906) | Ischemic or Unspecified Stroke / ACD (n=725, 796) | Hemorrhagic Stroke / ACD (n=622, 703) | SE / ACD (n=613, 679) | MI / ACD (n=663, 740) |
---|
Apixaban | 3.17 | 4.49 | 6.13 | 4.85 | 4.32 | 3.68 | 3.63 | 3.93 |
,Warfarin | 4.11 | 5.04 | 7.20 | 5.49 | 4.78 | 4.20 | 4.05 | 4.43 |
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Number of Participants With All Bleeding Events During Treatment Period
All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."
Intervention | participants (Number) |
---|
Apixaban | 2356 |
Warfarin | 3060 |
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Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)
preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Alanine aminotransferase (ALT) (U/L): >3 *ULN: alkaline phosphatase (ALP) (U/L): >2* ULN; aspartate aminotransferase (ASP) (U/L): >3 *ULN; bilirubin, direct (mg/dL): >2*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN; calcium (mg/dL): < 0.8*LLN or >1.2 *ULN, or if preRx ULN if preRx >ULN use > 1.25*preRx or 1.1*ULN, or if preRx ULN if preRx >ULN use >1.1* preRx or 1.25*ULN, or if preRx ULN if preRx >ULN use >1.25*preRx or 1.1*ULN, or if preRx ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx ULN if preRx >ULN use >1.05 *preRx or < LLN. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug
Intervention | Participants (Number) |
---|
| Alkaline phosphatase, high (n=2631, 2618) | Alanine aminotransferase, high (n=2629, 2616) | Aspartate aminotransferase, high (n=2629, 2616) | Bilirubin, direct, high (n=2622, 2604) | Bilirubin, total, high (n=2630, 2617) | Blood urea nitrogen (BUN), high (n=2618, 2598) | Creatinine, high (n=2618, 2598) | Calcium, total, low (n=2618, 2598) | Calcium, total, high (n=2618, 2598) | Chloride, serum, low (n=2615, 2594) | Bicarbonate, low (n=2615, 2595) | Potassium, serum, low (n=2614, 2594) | Potassium, serum, high (n=2614, 2594) | Sodium, serum, low (n=2615, 2594) | Sodium, serum, high (n=2615, 2594) |
---|
Apixaban, 2.5 mg BID Plus Placebo | 55 | 50 | 73 | 145 | 24 | 19 | 21 | 7 | 0 | 6 | 8 | 73 | 61 | 29 | 5 |
,Enoxaparin, 40 mg QD Plus Placebo | 57 | 83 | 73 | 139 | 12 | 17 | 25 | 18 | 1 | 6 | 8 | 73 | 47 | 23 | 4 |
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Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period
preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. MA criteria: Hemoglobin: >2 g/dL decrease from preRx or value ≤ 8 g/dL; hematocrit (%): <0.75*preRx; platelet count (*10^9 cells/L): <100,000/mm^3; erythrocytes (*10^6 cells/μL): <0.75*preRx level; leukocytes (*10^3 cells/μL): < 0.75*LLN or >1.25*ULN, or if preRx LLN use < 0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or 400/mm^3; eosinophils (*10^3 cells/μL): > 0.75*10^3 cells/μL; lymphocytes (*10^3 cells/μL): >0.75*10^3 cells/μL; monocytes (*10^3 cells/μL): >2000/mm^3; neutrophils (*10^3 cells/μL): <1.0; (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug
Intervention | Participants (Number) |
---|
| Hemoglobin, low (n=2605, 2587) | Hematocrit, low (n=2554, 2536) | Platelet count, low (n=2597, 2576) | Erythrocytes, low (n=2558, 2540) | Leukocytes, low (n=2632, 2617) | Leukocytes, high (n=2632, 2617) | Basophils (absolute), high (n=2629, 2613) | Eosinophils (absolute), high (n=2629, 2613) | Lymphocytes (absolute), low (n=2629, 2613) | Lymphocytes (absolute), high (n=2629, 2613) | Monocytes (absolute), high (n=2629, 2613) | Neutrophils (absolute), low (n=2629, 2613) |
---|
Apixaban, 2.5 mg BID Plus Placebo | 2189 | 1274 | 6 | 1310 | 54 | 385 | 1 | 75 | 383 | 3 | 9 | 5 |
,Enoxaparin, 40 mg QD Plus Placebo | 2218 | 1350 | 9 | 1377 | 54 | 360 | 3 | 70 | 382 | 3 | 11 | 4 |
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Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)
preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Glucose, fasting (mg/dL): <.8*LLN or >1.5*ULN, or if preRx ULN if preRx >ULN use >2*preRx or 5*ULN; uric acid (mg/dL): >.5* ULN, or if preRx >ULN use >2*preRx; 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; glucose, urine : If missing preRx use ≥2, or if value ≥4, or if preRx=0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; RBC, urine (hpf): If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx dose= 1 use ≥3, or if preRx=2 or 3 use ≥4; WBC, urine (h): If missing preRx use ≥2, or if value ≥4, or if preRx =0 or .5 use ≥2, or if preRx =1 use ≥3, or if preRx=2 or 3 use ≥4. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug
Intervention | Participants (Number) |
---|
| Glucose, fasting serum, high (n=14, 17) | Protein, total, low (n=2618, 2596) | Protein, total, high (n=2618, 2596) | Creatine kinase, high (n=2630, 2616) | Uric acid, high (n=2618, 2597) | Blood, urine, high (n=2588, 2568) | Glucose, urine, high (n=2588, 2568) | Leukocyte esterase, urine, high (n=21, 41) | Protein, urine (n=2588, 2568) | Red blood cells (RBC), urine, high (n=1310, 1230) | White blood cells (WBC),urine, high (n=1311, 1228) |
---|
Apixaban, 2.5 mg BID Plus Placebo | 0 | 747 | 3 | 615 | 2 | 275 | 68 | 0 | 169 | 216 | 217 |
,Enoxaparin, 40 mg QD Plus Placebo | 1 | 752 | 1 | 642 | 3 | 234 | 76 | 4 | 168 | 173 | 229 |
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Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period
Neurologic events were based on Medical Dictionary for Regulatory Activities search categories.For new or worsening events that were not related to the site of surgery, additional information was collected on a specific form. In addition, neurology consultation was to be obtained for these patients. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug
Intervention | Participants (Number) |
---|
| Paraesthesia | Hypoaesthesia | Burning sensation | Peroneal nerve palsy | Hypotonia | Dysarthria | Paresis | Cervicobrachial syndrome | Coordination abnormal | Hypertonia | Neuropathy peripheral | Peripheral nerve lesion | Radiculitis | Paralysis | Muscular weakness | Nerve injury | Femoral nerve injury | Sciatic nerve injury | Peroneal nerve injury | Diplopia | Gait disturbance |
---|
Apixaban, 2.5 mg BID Plus Placebo | 32 | 29 | 7 | 5 | 4 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 7 | 2 | 1 | 1 | 0 | 1 | 1 |
,Enoxaparin, 40 mg QD Plus Placebo | 19 | 35 | 5 | 6 | 4 | 1 | 1 | 1 | 0 | 1 | 2 | 1 | 0 | 1 | 11 | 1 | 0 | 0 | 1 | 0 | 0 |
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Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period
Event rate=Number of events divided by the number of patients evaluated. Major bleeding event defined as a bleeding event that was 1) Acute clinically overt bleeding accompanied by at least 1 of the following: decrease in hemoglobin of ≥ 2 g/dL over a 24-hour period, transfusion of ≥2 units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intra-spinal, intraocular, pericardial, an operated joint and requires reoperation or intervention, intramuscular with compartment syndrome, or retroperitoneal; 2) Fatal. CRNM was defined as acute clinically overt bleeding that did not satisfy the criteria for a major bleeding event and met at least 1 of the following: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, or hemoptysis. Minor bleeding was defined as an acute clinically overt bleeding event that did not meet the criteria for major bleeding or a CRNM. Fatal bleeding event was defined as bleeding that was the primary (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug
Intervention | Percentage of events/patients evaluted (Number) |
---|
| Major bleeding | CRNM | Major or CRNM | Any bleeding |
---|
Apixaban, 2.5 mg BID Plus Placebo | 0.82 | 4.08 | 4.83 | 11.71 |
,Enoxaparin, 40 mg QD Plus Placebo | 0.68 | 4.51 | 5.04 | 12.56 |
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Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period
Event rate=Number of events divided by the number of patients evaluated. All suspected events were reported by investigator. Acute MI=the presence of a clinical situation (eg, abnormal history, physical examination, new electrocardiogram changes) suggestive of an MI and at least 1 of the following: elevated creatine kinase (CK)-MB or troponin T or troponin I ≥2*upper limit of normal (ULN); if CK-MB or troponin values not available, total CK ≥2*ULN; or new significant (≥0.04 sec) Q waves in ≥2 contiguous leads. Stroke=a new focal neurologic deficit of sudden onset lasting at least 24 hours that was not due to a readily identifiable nonvascular cause. Adjudication classified each reported stroke as primary hemorrhagic, nonhemorrhagic, infarction with hemorrhagic conversion, or unknown type. Thrombocytopenia=after 3 days as drop in platelet count to <100,000/mm^3 for patients with a baseline value >150,000/mm^3 or a >50% decline, if the baseline value was ≤150,000/mm^3. (NCT00423319)
Timeframe: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Intervention | Percent of events/patients evaluated (Number) |
---|
| MI/stroke | MI | Stroke | Thrombocytopenia |
---|
Apixaban, 2.5 mg BID Plus Placebo | 0.22 | 0.19 | 0.04 | 0.07 |
,Enoxaparin, 40 mg QD Plus Placebo | 0.26 | 0.11 | 0.15 | 0.11 |
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Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome
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. All suspected bleeding events were to be reported by the investigator as either an AE or SAE and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 30 days after the last dose of study drug
Intervention | Participants (Number) |
---|
| SAEs | Bleeding AEs | Death |
---|
Apixaban, 2.5 mg BID Plus Placebo | 18 | 15 | 2 |
,Enoxaparin, 40 mg QD Plus Placebo | 18 | 21 | 0 |
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Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements)
preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): >2 decrease from preRx value or value <=8; hematocrit (%): <0.75*preRx; platelets: <100*10^9 cells/L; erythrocytes (*10^6 cells/μL): <0.75*preRx; leukocytes: <0.75*LLN or >1.25*ULN, or if preRx ULN if preRx >ULN use >1.2*preRx or 400/mm^3; abs eosinophils: > 0.750*10^3 cells/µL; abs lymphocytes: <0.750*10*3 cells/ µL or >7.50*10^3 c/ µL; abs monocytes > 2000/mm^3; abs neutrophils: <1.0*10^3 cells/μL; ALP (U/L): >2*ULN; ALT, AST (U/L): >3*ULN; U/L; bilirubin, direct (mg/dL): >1.5*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN. (NCT00452530)
Timeframe: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up
Intervention | Participants (Number) |
---|
| Hemoglobin, low (n=1424, 1442) | Hematocrit, low n=(1369, 1396) | Platelet count, low (n=1413, 1425) | Erythrocytes, low (n=1368, 1396) | Leukocytes, low (n=1457, 1471) | Leukocytes, high (n=1457, 1471) | Basophils (absolute), high (n=1448, 1465) | Eosinophils (absolute), high (n=1448, 1465) | Lymphocytes (absolute), low (n=1448, 1465) | Lymphocytes (absolute), high (n=1448, 1465) | Monocytes (absolute), high (n=1448, 1465) | Neutrophils (absolute), low (n=1448, 1465) | Alkaline phosphatase (ALP), high (n=1465, 1476) | Alanine aminotransferase (ALT), high (n=1459,1472) | Aspartate aminotransferase (AST) , high (n=1459,14 | Bilirubin, direct (high) (n=1447,1457) | Bilirubin, total (high) (n=1461,1476) | Blood urea nitrogen (BUN) (high)(n=1447,1458) | Creatinine (high) (n=1447,1458) |
---|
Apixaban, 2.5 mg BID + Placebo | 1127 | 668 | 7 | 690 | 27 | 193 | 2 | 43 | 203 | 1 | 5 | 5 | 15 | 32 | 34 | 87 | 15 | 15 | 17 |
,Enoxaparin, 40 mg QD + Placebo | 1178 | 723 | 5 | 735 | 26 | 213 | 4 | 60 | 215 | 0 | 2 | 2 | 31 | 26 | 26 | 76 | 9 | 17 | 23 |
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Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis)
preRX=pretreatment. 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; 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; 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 use ≥4; Red blood cells , 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; white blood cells, 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. (NCT00452530)
Timeframe: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up
Intervention | Participants (Number) |
---|
| Blood, urine (high) (n=1421, 1430) | Glucose, urine (high) (n=1421, 1429) | Protein, urine (high) (n=1421, 1430) | Red blood cells, urine (high) (n=441, 385) | White blood cells, urine (high)(n=441, 386) |
---|
Apixaban, 2.5 mg BID + Placebo | 169 | 160 | 60 | 133 | 101 |
,Enoxaparin, 40 mg QD + Placebo | 113 | 154 | 89 | 116 | 102 |
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Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements)
preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRxULN if preRx >ULN use >1.25*preRx or 1.1*ULN, or if preRxULN if preRx>ULN use >1.1*preRx or 1.25*ULN, or if preRx < LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or < LLN; potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRxULN if preRx>ULN use >1.1*preRx or 1.05*ULN, or if preRx ULN if preRx>ULN use >1.05*preRx or 1.1*ULN, or if preRx ULN if preRx >ULN use 1.1*preRx or 5*ULN; uric acid (mg/dL): >1.5*ULN, or if preRx >ULN use >2*preRx; glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRx ULN. (NCT00452530)
Timeframe: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up
Intervention | Participants (Number) |
---|
| Calcium, total (low) (n=1447, 1457) | Chloride, serum (low)(n=1442, 1454) | Bicarbonate (low) (n=1435, 1447) | Potassium, serum (low) (n=1438, 1453) | Potassium, serum (high)(n=1438, 1453) | Sodium, serum (low) (n=1442, 1454) | Sodium, serum (high) (n=1442, 1454) | Glucose, fasting serum (low) (n=715, 713) | Glucose, fasting serum (high) (n=715, 713) | Protein, total (low) (n=1447, 1457 | Creatine kinase (CK) (high) (n=1463, 1476) | Uric acid (high) (n=1446, 1458) |
---|
Apixaban, 2.5 mg BID + Placebo | 5 | 1 | 0 | 38 | 34 | 5 | 1 | 8 | 46 | 223 | 66 | 1 |
,Enoxaparin, 40 mg QD + Placebo | 9 | 0 | 3 | 41 | 40 | 10 | 0 | 1 | 25 | 243 | 65 | 2 |
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Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome
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. Bleeding AEs=all serious or nonserious bleeding-related AEs. (NCT00452530)
Timeframe: Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug
Intervention | Participants (Number) |
---|
| SAE | Bleeding AE | Discontinuations due to AEs | Deaths |
---|
Apixaban, 2.5 mg BID + Placebo | 72 | 90 | 40 | 2 |
,Enoxaparin, 40 mg QD + Placebo | 88 | 112 | 44 | 0 |
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Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM
Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment. (NCT00452530)
Timeframe: Days 1 to 12
Intervention | Percentage of events/patients evaluated (Number) |
---|
| Major bleeding (n=9, 14) | CRNM (n=44, 58) | Major bleeding or CRNM (n=53, 72) | Any bleeding |
---|
Apixaban, 2.5 mg BID + Placebo | 0.60 | 2.93 | 3.53 | 6.93 |
,Enoxaparin, 40 mg QD + Placebo | 0.93 | 3.85 | 4.77 | 8.36 |
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Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days
Intervention | Event Rate (%): (Number) |
---|
Apixaban 2.5 mg | 2.26 |
Enoxaparin 40 mg | 1.90 |
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Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 7.16 |
Enoxaparin 40 mg | 6.83 |
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Incidence of All Bleeding During the Treatment Period in Treated Participants
Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of drug to last dose of drug plus 2 days
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 7.73 |
Enoxaparin 40 mg | 6.81 |
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Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 6.44 |
Enoxaparin 40 mg | 6.63 |
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Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period
A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 2.36 |
Enoxaparin 40 mg | 2.12 |
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Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 0.22 |
Enoxaparin 40 mg | 0.24 |
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Incidence of Adjudicated PE With Onset During the Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 0.22 |
Enoxaparin 40 mg | 0.24 |
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Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 2.40 |
Enoxaparin 40 mg | 2.50 |
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Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 6.44 |
Enoxaparin 40 mg | 6.50 |
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Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period
Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 0.00 |
Enoxaparin 40 mg | 0.15 |
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Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 0.15 |
Enoxaparin 40 mg | 0.49 |
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Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants
Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | participants (Number) |
---|
| Glucose Fasting <0.9*LLN (N=284,287) | Glucose Fasting > 1.5*ULN (N=284,287) | Total Protein < 0.9 *LLN (N=2864, 2890) | Total Protein > 1.1*ULN (N=2864, 2890) | Creatine kinase >5*ULN U/L(N=2856, 2888) | Uric acid > 1.5* ULN (N=2862, 2889) |
---|
Apixaban 2.5 mg | 5 | 39 | 78 | 16 | 8 | 47 |
,Enoxaparin 40 mg | 3 | 30 | 51 | 8 | 10 | 44 |
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Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 3.11 |
Enoxaparin 40 mg | 3.46 |
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Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 0.15 |
Enoxaparin 40 mg | 0.37 |
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Incidence of Major Bleeding During the Treatment Period in Treated Participants
Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 0.47 |
Enoxaparin 40 mg | 0.19 |
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Mean Change From Baseline in Heart Rate in Treated Participants
Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | bpm (Mean) |
---|
| Hospital Discharge (N=1606,1622) | Day 30 of treatment (N=2225,2299) |
---|
Apixaban 2.5 mg | -5.4 | -4.0 |
,Enoxaparin 40 mg | -5.1 | -4.3 |
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Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days
Intervention | Event Rate (%) (Number) |
---|
Apixaban 2.5 mg | 2.67 |
Enoxaparin 40 mg | 2.08 |
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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants
Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths. (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)
Intervention | participants (Number) |
---|
| AEs | SAEs | Bleeding AEs | Discontinuations Due to AE | Deaths |
---|
Apixaban 2.5 mg | 1871 | 611 | 244 | 290 | 131 |
,Enoxaparin 40 mg | 1910 | 601 | 221 | 262 | 133 |
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Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements
Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)
Intervention | participants (Number) |
---|
| Neurologic AEs | Neurologic SAEs | Liver-related AEs | Liver-related SAEs |
---|
Apixaban 2.5 mg | 45 | 5 | 127 | 9 |
,Enoxaparin 40 mg | 42 | 1 | 142 | 12 |
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Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants
Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | participants (Number) |
---|
| Calcium < 0.8*LLN (N=2861, 2893) | Calcium > 1.2*ULN (N=2861, 2893) | Chloride < 0.9*LLN (N=2861, 2886) | Chloride > 1.1*ULN (N=2861, 2886) | Bicarbonate < 0.75*LLN (N=2831, 2855) | Bicarbonate > 1.25*ULN (N=2831, 2855) | Potassium < 0.9*LLN (N=2851, 2878) | Potassium > 1.1*ULN (N=2851, 2878) | Sodium < 0.95*LLN (N=2862, 2888) | Sodium > 1.05*ULN (N=2862, 2888) |
---|
Apixaban 2.5 mg | 6 | 3 | 25 | 5 | 5 | 6 | 61 | 140 | 23 | 9 |
,Enoxaparin 40 mg | 8 | 3 | 25 | 1 | 6 | 4 | 58 | 137 | 25 | 6 |
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Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants
Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | Event Rate (%) (Number) |
---|
| MI or stoke (N=3183, 3216) | MI (N=3184, 3217) | Stroke (N=3183, 3216) | Thrombocytopenia (N=3184, 3217) |
---|
Apixaban 2.5 mg | 0.38 | 0.22 | 0.16 | 0.19 |
,Enoxaparin 40 mg | 0.37 | 0.12 | 0.25 | 0.09 |
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Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period
Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | mmHg (Mean) |
---|
| Day of Discharge from Hospital (N=1607, 1625) | Day 30 of Treatment + 2 (N=2227,2301) |
---|
Apixaban 2.5 mg | -1.0 | 0.0 |
,Enoxaparin 40 mg | -0.4 | -0.5 |
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Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants
Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | participants (Number) |
---|
| Hemoglobin >2 g/dL decrease (N=2835, 2871) | Hematocrit <0.75*PreRx (N=2688, 2722) | Platelet Count < 100*10^9 c/L (N=2761, 2799) | Erythrocytes <0.75*PreRx c/µL (N=2697, 2730) | Leukocytes <0.75*LLN (N= 2835, 2869) | Leukocytes > 1.25*ULN (N=2835, 2869) | Abs Eosinophils > 0.75*10^3 c/µL (N=20, 24) | Abs Lymphocytes < 0.750*10*3 c/ µL (N=20, 24) | Abs Monocytes > 2000/MM^3 (N= 19, 25) |
---|
Apixaban 2.5 mg | 133 | 23 | 9 | 28 | 64 | 331 | 1 | 4 | 1 |
,Enoxaparin 40 mg | 98 | 17 | 7 | 16 | 55 | 283 | 1 | 2 | 0 |
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Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants
Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | participants (Number) |
---|
| Alkaline phosphatase U/L > 2*ULN(N=2866, 2895) | ALT U/L > 3*ULN (N=2827, 2861) | AST U/L > 3*ULN (N=2831, 2863) | Bilirubin Direct mg/dL > 1.5*ULN (N=2782, 2821) | Bilirubin Total mg/dL > 2*ULN (N=2853, 2884) | BUN mg/dL > 1.5*ULN (N=2864, 2891) | Creatinine mg/dL > 1.5*ULN (N=2862, 2892) |
---|
Apixaban 2.5 mg | 35 | 23 | 24 | 123 | 17 | 194 | 150 |
,Enoxaparin 40 mg | 47 | 33 | 29 | 106 | 15 | 188 | 156 |
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Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period
Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | mmHg (Mean) |
---|
| Discharge from Hospital (N=1607, 1625) | Day 30 of Treatment + 2 (N=2227, 2301) |
---|
Apixaban 2.5 mg | -3.0 | -2.3 |
,Enoxaparin 40 mg | -2.4 | -2.9 |
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Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period
Event rate=percent of participants with an event divided by the total participants in the arm. (NCT00496769)
Timeframe: First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010
Intervention | Percentage of events per year (Number) |
---|
| Major bleeding | Major or CRNM bleeding | All bleeding |
---|
Acetylsalicylic Acid, 81-324 mg Once Daily | 0.92 | 3.24 | 8.32 |
,Apixaban, 2.5 or 5 mg Twice Daily | 1.41 | 4.46 | 10.85 |
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Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome
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. (NCT00496769)
Timeframe: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Intervention | Participants (Number) |
---|
| AEs | SAEs | Bleeding AEs | Discontinuations due to AE | Deaths |
---|
Acetylsalicylic Acid, 81-324 mg Once Daily | 1925 | 804 | 259 | 362 | 115 |
,Apixaban, 2.5 or 5 mg Twice Daily | 1833 | 657 | 281 | 266 | 91 |
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Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)
ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BLULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BLULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BLULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2. (NCT00496769)
Timeframe: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Intervention | Participants (Number) |
---|
| Creatine kinase, low (n=2780, 2758) | Creatine kinase, high (n=2780, 2758) | Protein (total), low (n=103, 109) | Protein (total), high (n=103, 109) | Uric acid, low (n=386, 390) | Uric acid, high (n=386, 390) | Glucose (urine), low (n=2, 3) | Glucose (urine), high (n=2, 3) | Protein (urine), low (n=3, 5) | Protein (urine), high (n=3, 5) | Blood (urine), low (n=3, 5) | Blood (urine), high (n=3, 5) | Leukocyte esterase (urine), low (n=3,5) | Leukocyte esterase (urine), high (n=3,5) | Red blood cells (RBC) (urine), low (n=2,2) | RBC (urine), high (n=2,2) | White blood cells (urine), low (n=2,2) | WBC (urine), high (n=2,2) |
---|
Acetylsalicylic Acid, 81-324 mg Once Daily | 0 | 25 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Apixaban, 2.5 or 5 mg Twice Daily | 0 | 13 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
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Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BLULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BLULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BLULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BLULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BLULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN (NCT00496769)
Timeframe: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Intervention | Participants (Number) |
---|
| Sodium (serum), low (n=1768, 1740) | Sodium (serum), high (n=1768, 1740) | Potassium (serum), low (n=1763, 1737) | Potassium (serum), high (n=1763, 1737) | Chloride (serum), low (n=1768, 1740) | Chloride (serum), high (n=1768, 1740) | Calcium (total), low (n=106, 109) | Calcium (total), high (n=106, 109) | Bicarbonate, low (n=1664, 1619) | Bicarbonate, high (n=1664, 1619) |
---|
Acetylsalicylic Acid, 81-324 mg Once Daily | 6 | 2 | 8 | 28 | 3 | 1 | 0 | 0 | 0 | 0 |
,Apixaban, 2.5 or 5 mg Twice Daily | 2 | 1 | 6 | 20 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality
BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BLULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN. (NCT00496769)
Timeframe: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Intervention | Participants (Number) |
---|
| Hemoglobin, low (n=1956, 1893) | Hemoglobin, high (n=1956, 1893) | Hematocrit, low (n=1728, 1687) | Hematocrit, high (n=1728, 1687) | Erythrocytes, low (n=1728, 1687) | Erythrocytes, high (n=1728, 1687) | Platelet count, low (n=2148, 2098) | Platelet count, high (n=2148, 2098) | Leukocytes, low (n=1738, 1698) | Leukocytes, high (n=1738, 1698) | Neutrophils (absolute), low (n=2170, 2138) | Neutrophils (absolute), high (n=2170, 2138) | Eosinophils (absolute), low (n=2170, 2138) | Eosinophils (absolute), high (n=2170, 2138) | Basophils (absolute), low (n=2170, 2138) | Basophils (absolute), high (n=2170, 2138) | Monocytes (absolute), low (n=2170, 2138) | Monocytes (absolute), high (n=2170, 2138) | Lymphocytes (absolute), low (n=2170, 2138) | Lymphocytes (absolute), high (n=2170, 2138) | Alkaline phosphatase (ALP), low (n=2781, 2758) | ALP, high (n=2781, 2758) | Aspartate phosphatase (AST), low (n=2779, 2753) | AST, high (n=2779, 2753) | Alanine aminotransferase (ALT), low (n=2779, 2753) | ALT, high (n=2779, 2753) | Bilirubin (total), low (n=2781, 2758) | Bilirubin (total), high (n=2781, 2758) | Bilirubin (direct), low (n=2773, 2750) | Bilirubin (direct), high (n=2773, 2750) | Blood urea nitrogen (BUN), low (n=2201, 2172) | BUN, high (n=2201, 2172) | Creatinine, low (n=2209, 2178) | Creatinine, high (n=2209, 2178) |
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Acetylsalicylic Acid, 81-324 mg Once Daily | 120 | 0 | 9 | 0 | 12 | 0 | 10 | 0 | 14 | 18 | 1 | 0 | 0 | 68 | 0 | 0 | 0 | 2 | 62 | 5 | 0 | 27 | 0 | 33 | 0 | 31 | 0 | 43 | 0 | 248 | 0 | 50 | 0 | 71 |
,Apixaban, 2.5 or 5 mg Twice Daily | 131 | 0 | 13 | 0 | 12 | 0 | 7 | 0 | 12 | 14 | 2 | 0 | 0 | 48 | 0 | 0 | 0 | 0 | 52 | 4 | 0 | 34 | 0 | 28 | 0 | 23 | 0 | 30 | 0 | 241 | 0 | 42 | 0 | 67 |
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Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death
Event rate=percent of participants with an event divided by the total participants in the arm. (NCT00496769)
Timeframe: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Intervention | Percentage of events per year (Number) |
---|
| All-cause death (n=111, 140) | Net clinical benefit (n=163, 220) | Vascular death (n=84, 96) |
---|
Acetylsalicylic Acid, 81-324 mg Once Daily | 4.42 | 7.13 | 3.03 |
,Apixaban, 2.5 or 5 mg Twice Daily | 3.51 | 5.23 | 2.65 |
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Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period
Event rate=percent of participants with an event divided by the total participants in the arm. (NCT00496769)
Timeframe: Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Intervention | Percentage of events per year (Number) |
---|
Apixaban, 2.5 or 5 mg Twice Daily | 10.85 |
Acetylsalicylic Acid, 81-324 mg Once Daily | 8.32 |
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Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.) (NCT00496769)
Timeframe: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Intervention | Percentage of events (Number) |
---|
Apixaban, 2.5 or 5 mg Twice Daily | 1.62 |
Acetylsalicylic Acid, 81-324 mg Once Daily | 3.63 |
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Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period
Event rate=percent of participants with an event divided by the total participants in the arm. (NCT00496769)
Timeframe: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Intervention | Percentage of events per year (Number) |
---|
Apixaban, 2.5 or 5 mg Twice Daily | 4.21 |
Acetylsalicylic Acid, 81-324 mg Once Daily | 6.35 |
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Adjudicated Total Bleeding During the Treatment Period - Treated Participants
All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug. (NCT00633893)
Timeframe: Day 1 up to 12 months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.1119 |
Apixaban 5 mg | 0.1492 |
Placebo | 0.0896 |
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Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation
PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted. (NCT00633893)
Timeframe: Day 1 up to 12 Months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0095 |
Apixaban 5 mg | 0.0049 |
Placebo | 0.0181 |
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Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation
PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits. (NCT00633893)
Timeframe: Day 1 up to 12 Months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0274 |
Apixaban 5 mg | 0.0308 |
Placebo | 0.0446 |
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Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits. (NCT00633893)
Timeframe: Day 1 up to 12 Months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0262 |
Apixaban 5 mg | 0.0308 |
Placebo | 0.0398 |
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Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted. (NCT00633893)
Timeframe: Day 1 up to 12 Months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0083 |
Apixaban 5 mg | 0.0049 |
Placebo | 0.0169 |
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Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation
DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. (NCT00633893)
Timeframe: Day 1 up to 12 Months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0226 |
Apixaban 5 mg | 0.0344 |
Placebo | 0.0869 |
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Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants
All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug. (NCT00633893)
Timeframe: Day 1 up to 12 months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0893 |
Apixaban 5 mg | 0.1208 |
Placebo | 0.0702 |
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Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. (NCT00633893)
Timeframe: Day 1 up to 12 months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0298 |
Apixaban 5 mg | 0.0419 |
Placebo | 0.0230 |
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Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug. (NCT00633893)
Timeframe: Day 1 up to 12 Months
Intervention | proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0321 |
Apixaban 5 mg | 0.0432 |
Placebo | 0.0266 |
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Adjudicated Major Bleeding During the Treatment Period - Treated Population
Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug. (NCT00633893)
Timeframe: Day 1 up to 12 Months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0024 |
Apixaban 5 mg | 0.0012 |
Placebo | 0.0048 |
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Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event. (NCT00633893)
Timeframe: Day 1 up to 12 Months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0381 |
Apixaban 5 mg | 0.0418 |
Placebo | 0.1158 |
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Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation
All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. (NCT00633893)
Timeframe: Day 1 up to 12 Months
Intervention | participants (Number) |
---|
| First event: Participants with nonfatal DVT | First event: Participants with nonfatal PE | First event: All-Cause Death | CV-related Death (included in all-cause total) | VTE-related Death (included in all-cause total) | Participants with event: nonfatal DVT | Participants with event: nonfatal PE | Participants with event: All cause death |
---|
Apixaban 2.5 mg | 6 | 7 | 6 | 0 | 2 | 6 | 8 | 7 |
,Apixaban 5 mg | 7 | 4 | 3 | 0 | 3 | 8 | 4 | 4 |
,Placebo | 53 | 13 | 11 | 3 | 7 | 53 | 15 | 14 |
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Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation
DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted. (NCT00633893)
Timeframe: Day 1 up to 12 Months
Intervention | proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0071 |
Apixaban 5 mg | 0.0098 |
Placebo | 0.0639 |
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Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. (NCT00633893)
Timeframe: Day 1 up to 12 months
Intervention | Proportion of participants (Number) |
---|
Apixaban 2.5 mg | 0.0226 |
Apixaban 5 mg | 0.0172 |
Placebo | 0.0929 |
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Incidence of All-Cause Death During the Intended Treatment Period
Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information). (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | proportion of participants (Number) |
---|
Apixaban | 0.0157 |
Enoxaparin + Warfarin | 0.0198 |
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Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | proportion of participants (Number) |
---|
Apixaban | 0.0385 |
Enoxaparin + Warfarin | 0.0800 |
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Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants
Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | proportion of participants (Number) |
---|
Apixaban | 0.1502 |
Enoxaparin + Warfarin | 0.2514 |
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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants
Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. 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. (NCT00643201)
Timeframe: First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued
Intervention | participants (Number) |
---|
| AE | SAE | Bleeding AE or SAE | Discontinued Due to AE or SAE | Death |
---|
Apixaban | 1795 | 417 | 415 | 162 | 37 |
,Enoxaparin + Warfarin | 1923 | 410 | 695 | 199 | 44 |
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Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests
All tests in urine: Glucose: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Protein: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Blood: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Leukocyte esterase: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4;Red blood cells (RBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; White blood cells (WBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | participants (Number) |
---|
| Blood in Urine High (N=2289, 2273) | Glucose in Urine High (N=2289, 2273) | Leukocyte Esterase in Urine High (N=2289, 2273) | Protein in Urine High (N=2289, 2273) | RBC + WBC in Urine High (N=1685, 1719) | RBC in Urine High (N=1293, 1389) | WBC in Urine High (N=1354, 1361) |
---|
Apixaban | 85 | 46 | 105 | 41 | 359 | 111 | 274 |
,Enoxaparin + Warfarin | 127 | 31 | 102 | 50 | 361 | 140 | 263 |
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Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests
Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | participants (Number) |
---|
| BUN High (N=517, 523) | Creatinine High (N=2601, 2596) | ALT High (N=2601, 2598) | ALP High (N=2601, 2598) | AST High (N=2601, 2598) | Direct Bilirubin High (N=2601, 2593) | Total Bilirubin High (N=2601, 2597) |
---|
Apixaban | 2 | 47 | 52 | 35 | 40 | 28 | 8 |
,Enoxaparin + Warfarin | 7 | 37 | 145 | 27 | 40 | 21 | 7 |
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Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests
Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | participants (Number) |
---|
| Erthrocytes Low (N=2599, 2593) | Hematocrit Low (N=2588, 2587) | Hemoglobin Low (N=2599, 2593) | Platelet Count Low (N=2594, 2589) | Leukocytes Low (N=2528, 2519) | Leukocytes High (N=2528, 2519) | Absolute Basophils High (N=2594,2589) | Absolute Eosinophils High (N=2594,2589) | Absolute Lyphocytes Low (N=2594,2589) | Absolute Lyphocytes High (N=2594,2589) | Absolute Monocytes High (N=2594,2589) | Absolute Neutrophils Low (N=2594,2589) |
---|
Apixaban | 23 | 26 | 96 | 23 | 41 | 26 | 1 | 84 | 94 | 4 | 1 | 9 |
,Enoxaparin + Warfarin | 17 | 20 | 101 | 13 | 41 | 15 | 2 | 79 | 76 | 3 | 2 | 20 |
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Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests
Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | participants (Number) |
---|
| Bicarbonate Low (N=2600,2593) | Bicarbonate High (N=2600,2593) | Total Calcium Low (N=2601,2596) | Total Calcium High (N=2601,2596) | Chloride Low Total Calcium Low (N=2601,2596) | Chloride Low Total Calcium High (N=2601,2596) | Potassium Low (N=2601,2596) | Potassium High (N=2601,2596) | Sodium Low (N=2601,2596) |
---|
Apixaban | 44 | 17 | 3 | 12 | 5 | 0 | 26 | 19 | 10 | 4 |
,Enoxaparin + Warfarin | 31 | 11 | 10 | 11 | 3 | 1 | 22 | 22 | 6 | 4 |
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Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests
Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | participants (Number) |
---|
| Creatine Kinase High (N=2601, 2596) | Uric Acid High (N=2601, 2596) | Total Protein Low (N=2601, 2596) | Total Protein High (N=2601, 2596) |
---|
Apixaban | 20 | 6 | 15 | 0 |
,Enoxaparin + Warfarin | 24 | 3 | 16 | 0 |
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Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death
VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded. (NCT00643201)
Timeframe: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Intervention | proportion of participants (Number) |
---|
Apixaban | 0.0322 |
Enoxaparin + Warfarin | 0.0395 |
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Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants
All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | proportion of participants (Number) |
---|
Apixaban | 0.0056 |
Enoxaparin + Warfarin | 0.0182 |
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Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants
Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug). (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | proportion of participants (Number) |
---|
Apixaban | 0.0430 |
Enoxaparin + Warfarin | 0.0971 |
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Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants
Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Intervention | proportion of participants (Number) |
---|
Apixaban | 0.1170 |
Enoxaparin + Warfarin | 0.1878 |
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Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period
DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). (NCT00643201)
Timeframe: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Intervention | proportion of participants (Number) |
---|
Apixaban | 0.0084 |
Enoxaparin + Warfarin | 0.0133 |
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Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period
PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). (NCT00643201)
Timeframe: Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)
Intervention | proportion of participants (Number) |
---|
Apixaban | 0.0104 |
Enoxaparin + Warfarin | 0.0095 |
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Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists. (NCT00787150)
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Intervention | International normalized ratio (Mean) |
---|
| Week 0 (n=72, 71) | 0 hour post dose at Week 1 (n=67, 70) | 2 hours post dose at Week 1 (n=68, 70) | 4 hours post dose at Week 1 (n=38, 35) | 0 hour post dose at Week 8 (n=67, 66) | 2 hours post dose at Week 8 (n=67, 66) | 4 hours post dose at Week 8 (n=35, 29) |
---|
Apixaban 2.5mg BID | 1.76 | 1.30 | 1.33 | 1.30 | 1.27 | 1.37 | 1.34 |
,Apixaban 5.0 mg BID | 1.72 | 1.34 | 1.48 | 1.51 | 1.38 | 1.61 | 1.59 |
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Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period
Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event. (NCT00787150)
Timeframe: Baseline to Week 12
Intervention | participants (Number) |
---|
Warfarin | 1 |
Apixaban 2.5mg BID | 0 |
Apixaban 5.0 mg BID | 0 |
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Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period
Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. (NCT00787150)
Timeframe: Baseline to Week 12
Intervention | participants (Number) |
---|
Warfarin | 3 |
Apixaban 2.5mg BID | 1 |
Apixaban 5.0 mg BID | 1 |
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Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban
Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated. (NCT00787150)
Timeframe: Week 0, Week 1, Week 8
Intervention | pmol/L (Mean) |
---|
| Week 0 (n=75, 72, 71) | Week 1 (n=75, 68, 70) | Week 8 (n=68, 67, 66) |
---|
Apixaban 2.5mg BID | 0 | 133.8 | 152.9 |
,Apixaban 5.0 mg BID | 91.4 | 137.0 | 121.1 |
,Warfarin | 144.0 | 100.4 | 0 |
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Number of Participants With Total Bleeding Events During the Treatment Period
Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding. (NCT00787150)
Timeframe: Baseline to Week 12
Intervention | participants (Number) |
---|
Warfarin | 13 |
Apixaban 2.5mg BID | 9 |
Apixaban 5.0 mg BID | 17 |
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Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
Sample at 4 hours postdose was to be taken if possible. (NCT00787150)
Timeframe: 0, 2, 4 hours postdose at Week 1 and Week 8
Intervention | ng/mL (Mean) |
---|
| 0 hour post dose at Week 1 (n=68, 70) | 2 hours post dose at Week 1 (n=68, 70) | 4 hours post dose at Week 1 (n=38, 35) | 0 hour post dose at Week 8 (n=67, 66) | 2 hours post dose at Week 8 (n=67, 66) | 4 hours post dose at Week 8 (n=35, 29) |
---|
Apixaban 2.5mg BID | 53.31 | 99.43 | 104.09 | 62.83 | 120.16 | 110.58 |
,Apixaban 5.0 mg BID | 119.34 | 201.80 | 224.40 | 137.79 | 250.53 | 244.55 |
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Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period
"The definition of the Intended Treatment Period was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day." (NCT00787150)
Timeframe: Baseline to Week 12
Intervention | participants (Number) |
---|
Warfarin | 3 |
Apixaban 2.5mg BID | 0 |
Apixaban 5.0 mg BID | 0 |
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Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban
Below the limit of quantification (BLQ) was assigned the value 0 for calculation. (NCT00787150)
Timeframe: Week 0, Week 1, Week 8
Intervention | ng/mL (Mean) |
---|
| Week 0 (n=75, 72, 71) | Week 1 (n=75, 68, 70) | Week 8 (n=68, 67, 66) |
---|
Apixaban 2.5mg BID | 297.8 | 209.9 | 227.0 |
,Apixaban 5.0 mg BID | 196.4 | 237.0 | 203.5 |
,Warfarin | 240.4 | 245.2 | 209.9 |
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Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated. (NCT00787150)
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Intervention | ng/mL (Mean) |
---|
| Week 0 (n=72, 71) | 0 hour post dose at Week 1 (n=68, 69) | 2 hours post dose at Week 1 (n=68, 70) | 4 hours post dose at Week 1 (n=38, 35) | 0 hour post dose at Week 8 (n=67, 65) | 2 hours post dose at Week 8 (n=67, 66) | 4 hours post dose at Week 8 (n=35, 29) |
---|
Apixaban 2.5mg BID | 0 | 45.29 | 94.90 | 99.07 | 56.81 | 114.97 | 103.61 |
,Apixaban 5.0 mg BID | 0 | 111.19 | 187.58 | 213.24 | 130.12 | 236.36 | 237.78 |
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Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. (NCT00787150)
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Intervention | Second (Mean) |
---|
| Week 0 (n=72, 71) | 0 hour post dose at Week 1 (n=67, 70) | 2 hours post dose at Week 1 (n=68, 70) | 4 hours oist dose at Week 1 (n=38, 35) | 0 hour post dose at Week 8 (n=67, 66) | 2 hours post dose at Week 8 (n=67, 66) | 4 hours post dose at Week 8 (n=35, 29) |
---|
Apixaban 2.5mg BID | 34.51 | 33.26 | 33.04 | 32.00 | 33.83 | 34.67 | 32.75 |
,Apixaban 5.0 mg BID | 32.98 | 33.24 | 35.19 | 35.36 | 35.65 | 37.92 | 36.46 |
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Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period
"The definition of the Intended Treatment Period was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day." (NCT00787150)
Timeframe: Baseline to Week 12
Intervention | participants (Number) |
---|
Warfarin | 3 |
Apixaban 2.5mg BID | 0 |
Apixaban 5.0 mg BID | 0 |
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Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period
"The definition of the Intended Treatment Period was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day." (NCT00787150)
Timeframe: Baseline to Week 12
Intervention | participants (Number) |
---|
Warfarin | 0 |
Apixaban 2.5mg BID | 0 |
Apixaban 5.0 mg BID | 0 |
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Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period
Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. (NCT00787150)
Timeframe: Baseline to Week 12
Intervention | participants (Number) |
---|
Warfarin | 4 |
Apixaban 2.5mg BID | 1 |
Apixaban 5.0 mg BID | 1 |
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Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
Sample at 4 hours postdose was to be taken if possible. (NCT00787150)
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Intervention | second (Mean) |
---|
| Week 0 (n=72, 71) | 0 hour post dose at Week 1 (n=67, 70) | 2 hours post dose at Week 1 (n=68, 70) | 4 hours post dose at Week 1 (n=38, 35) | 0 hour post dose at Week 8 (n=67, 66) | 2 hours post dose at Week 8 (n=67, 66) | 4 hours post dose at Week 8 (n=35, 29) |
---|
Apixaban 2.5mg BID | 14.54 | 12.22 | 12.46 | 12.36 | 12.09 | 12.68 | 12.47 |
,Apixaban 5.0 mg BID | 14.41 | 12.54 | 13.28 | 13.48 | 12.74 | 13.83 | 13.85 |
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Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
Event rate was percent of participants with an event of cardiovascular (CV) death, myocardial infarction (MI), or ischemic stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Study was terminated early and last patient, last visit was in Year 2. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes (eg, cardiogenic shock, heart failure, arrhythmia/sudden death, cardiac rupture, ischemic stroke, pulmonary embolism, venous/arterial thrombotic events) and other sudden deaths for which an alternative cause was not identified. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010). (NCT00831441)
Timeframe: Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 13.96 |
Apixaban 5 mg BID | 13.20 |
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Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants
Bleeding events were adjudicated by the Adjudication Committee and classified according to Thrombolysis in Myocardial Infarction (TIMI) major, minor, minimal, and International Society on Thrombosis and Hemostasis (ISTH) major and clinically relevant non-major bleeding (CRNM) criteria. The adjudicated results based on TIMI and ISTH classifications, and programmatically identified events (not adjudicated) according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification were used in the analyses of bleeding endpoints. GUSTO Bleed Criteria included Severe or life-threatening: Intracranial hemorrhage, or bleeding that causes hemodynamic compromise requiring intervention; Moderate: Bleeding that requires a blood transfusion, but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either severe or moderate bleeding. Treatment Period=events with onset from first dose to last dose plus 2 days. (NCT00831441)
Timeframe: From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 16.33 |
Apixaban 5 mg BID | 39.98 |
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Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants
Unstable Angina (UA) defined as worsening or recurrent severe or repetitive angina symptoms at rest lasting at least 10 minutes with at least 2 of the following: New and dynamic electrocardiogram (ECG) changes; angina symptoms leading to inpatient hospitalization; angina symptoms leading to an unplanned or urgent cardiac catheterization, with or without revascularization, that showed evidence of hemodynamically and clinically significant stenosis. Event rate was percent of participants with an event of unstable angina (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010). (NCT00831441)
Timeframe: Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 4.21 |
Apixaban 5 mg BID | 3.95 |
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Event Rate of Stroke During the Intended Treatment Period - Randomized Participants
Event rate was percent of participants with an event of stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause (ie, brain tumor). All strokes were classified as hemorrhagic (documentation on imaging (eg computed tomography scan or magnetic resonance imaging) of hemorrhage in the cerebral parenchyma, or a subdural or subarachnoid hemorrhage), non-hemorrhagic/ischemic stroke, ischemic stroke with hemorrhagic conversion, or type unknown. Intended Treatment Period: the period that started on the day of randomization (Day 1) and ended at the efficacy cut-off date (notification of study termination). (NCT00831441)
Timeframe: Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 1.85 |
Apixaban 5 mg BID | 1.65 |
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Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants
Stent thrombosis: Definite stent thrombosis considered to have occurred by either angiographic or pathological confirmation; Probable stent thrombosis considered to have occurred in the following cases: any unexplained death within the first 30 days after stent implantation; irrespective of the time after the procedure, any MI that was related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause; Possible stent thrombosis considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of study (in Year 2). Event rate was percent of participants with an event of stent thrombosis (number with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice of study termination. (NCT00831441)
Timeframe: Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 2.21 |
Apixaban 5 mg BID | 1.61 |
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Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants
MI took into account whether the participant had a recent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Selected key criteria: Elevation of cardiac biomarkers (eg, Creatine Kinase MB fraction (CKMB), Troponin T, Troponin I) above the upper reference limit (URL) plus ischemic symptoms, ECG changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; Death of CV etiology with new ST-segment elevation or left bundle branch block (LBBB) or fresh intracoronary thrombus by angiography or at autopsy occurring before biomarkers could be obtained or before their appearance in the blood; Following a PCI, elevation of cardiac biomarkers more than 3*URL; Following CABG surgery, elevation of cardiac biomarkers more than 5*URL; New, significant (≥0.04 s) Q waves in ≥2 contiguous leads; Pathologic findings of acute MI. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice. (NCT00831441)
Timeframe: Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 9.20 |
Apixaban 5 mg BID | 8.59 |
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Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants
TIMI Major Bleed Criteria: Fatal bleeding, intracranial hemorrhage, and clinically overt bleeding with a hemoglobin (Hgb) drop of ≥ 5 grams per deciliter (g/dL), or ≥15% absolute decrease in hematocrit. To account for transfusions, Hgb measurements were adjusted for transfusions. A transfusion of 1 unit of blood was assumed to result in an increase by 1 g/dL in Hgb or 3% in hematocrit. Event rate was percent of participants with an event of Major Bleed as per TIMI (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Treatment Period=events with onset from first dose to last dose plus 2 days. (NCT00831441)
Timeframe: From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 0.91 |
Apixaban 5 mg BID | 2.40 |
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Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants
ISTH Criteria: Acute clinically overt bleeding defined as new onset, visible bleeding or signs or symptoms suggestive of bleeding confirmed by imaging techniques, which can detect the presence of blood (eg, ultrasound, CT, MRI). Major bleeding: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed red blood cells (RBCs); Bleeding that occurs in at least one of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. Bleeding events were adjudicated by the Adjudication Committee. Event rate was percent of participants with an event (number with event/number randomized) per 100-pt years. Treatment Period=events with onset from first dose to last dose plus 2 days. (NCT00831441)
Timeframe: From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 2.04 |
Apixaban 5 mg BID | 5.13 |
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Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants
ISTH Major bleed: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed RBCs; Bleeding that occurs in at least one of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. CRNM: acute clinically overt bleeding that did not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least one of the following: Hospital admission for bleeding; Physician guided medical or surgical treatment for bleeding; Change in anti-thrombotic treatment (anticoagulant or antiplatelet) therapy. Bleeding events were adjudicated by the Adjudication Committee. Treatment Period=events with onset from first dose to last dose plus 2 days. (NCT00831441)
Timeframe: From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 2.29 |
Apixaban 5 mg BID | 6.15 |
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Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
Event rate was percent of participants with an event of CV death, MI, unstable angina (UA), or ischemic stroke (number of participants with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Each type of event was counted once per participant, but participants could have been counted in multiple categories. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination). (NCT00831441)
Timeframe: Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 17.95 |
Apixaban 5 mg BID | 16.92 |
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Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
Event rate was percent of participants with an event of CV death, fatal bleed, MI, or stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes; Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause; Fatal bleeding defined as bleeding that Adjudication Committee determined was the primary cause of death or contributed directly to death; MI took into account whether the participant had a recent PCI or CABG surgery. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination). (NCT00831441)
Timeframe: Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 14.27 |
Apixaban 5 mg BID | 13.97 |
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Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
"Cause of death was determined by the principal condition that caused the death, not the immediate mode of death.~CV death: included deaths due to CV causes. Non-CV death: included non-CV deaths caused primarily by a malignancy, infection, bleeding, trauma, non-CV system organ failure, or non-CV surgery. Unknown: included deaths that were not attributable to one of the above categories of CV death or to a non-CV cause. MI accounted whether the participant had a recent PCI or CABG surgery. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause. Only events confirmed by the adjudication committee were included in analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination)." (NCT00831441)
Timeframe: Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years
Intervention | percentage of participants/100-pt years (Number) |
---|
Placebo | 15.65 |
Apixaban 5 mg BID | 15.48 |
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Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.
TIMI major bleeding event was difined as an intracranial bleeding or clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 5 gm/dL fall in hemoglobin or a 15% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit). (NCT00852397)
Timeframe: Week 0 to Week 24
Intervention | Percentage of Participants (Number) |
---|
Placebo | 0 |
Apixaban 2.5 mg BID | 2.0 |
Apixaban 5.0 mg BID | 2.0 |
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Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period.
"ISTH-defined CRNM bleeding was defined as an acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.~ISTH defined minor bleeding event was defined as all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM bleeding were classified as minor bleeding." (NCT00852397)
Timeframe: Week 0 to Week 24
Intervention | Percentage of Participants (Number) |
---|
| ISTH defined CRNM | ISTH defined minor bleeding |
---|
Apixaban 2.5 mg BID | 2.0 | 36.7 |
,Apixaban 5.0 mg BID | 0 | 40.8 |
,Placebo | 2.0 | 31.4 |
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Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy.
(NCT00852397)
Timeframe: For 30 days after Week 24 or the discontinuation of study drug
Intervention | Percentage of Participants (Number) |
---|
Placebo | 0 |
Apixaban 2.5 mg BID | 0 |
Apixaban 5.0 mg BID | 2 |
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Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period.
Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. CRNM bleeding was acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. (NCT00852397)
Timeframe: Week 0 to Week 24
Intervention | Percentage of Participants (Number) |
---|
Placebo | 2.0 |
Apixaban 2.5 mg BID | 4.1 |
Apixaban 5.0 mg BID | 4.1 |
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Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.
Major bleeding event was defined as an acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occured in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. (NCT00852397)
Timeframe: Week 0 to Week 24
Intervention | Percentage of Participants (Number) |
---|
Placebo | 0 |
Apixaban 2.5 mg BID | 2.0 |
Apixaban 5.0 mg BID | 4.1 |
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Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.
All bleeding included major bleeding (including fatal bleeding), clinically-relevant non-major (CRNM) bleeding, and minor bleeding per international society on thrombosis and haemostasis (ISTH) definitions. (NCT00852397)
Timeframe: Week 0 to Week 24
Intervention | Percentage of Participants (Number) |
---|
Placebo | 33.3 |
Apixaban 2.5 mg BID | 38.8 |
Apixaban 5.0 mg BID | 44.9 |
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Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period.
"TIMI minor bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 3 gm/dL fall in hemoglobin or a 9% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).~TIMI minimal bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) not meeting criteria for TIMI minor bleeding." (NCT00852397)
Timeframe: Week 0 to Week 24
Intervention | Percentage of Participants (Number) |
---|
| TIMI defined minor bleeding | TIMI defined minimal bleeding |
---|
Apixaban 2.5 mg BID | 2.0 | 38.8 |
,Apixaban 5.0 mg BID | 2.0 | 40.8 |
,Placebo | 0 | 33.3 |
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Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period.
Intended treatment period for efficacy endpoints was defined as a period starting on the day of randomization and ending at the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]). (NCT00852397)
Timeframe: From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time])
Intervention | Percentage of Participants (Number) |
---|
Placebo | 1.9 |
Apixaban 2.5 mg BID | 0 |
Apixaban 5.0 mg BID | 2.0 |
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Mean Renal Clearance (CLR) of BMS-730823
Renal clearance (CLR) was calculated by dividing the cumulative amount of BMS-730823 excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min). (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose
Intervention | mL/min (Geometric Mean) |
---|
Normal Renal Function | 6.36 |
ESRD Dose Before Hemodialysis | NA |
ESRD Dose After Hemodialysis | NA |
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Mean Plasma Terminal Half-life (T-Half) of BMS-730823
Mean plasma terminal half-life (T-Half) for BMS-730823 was derived from plasma concentrations versus time data. (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose
Intervention | hours (Mean) |
---|
ESRD Maintained With Hemodialysis | NA |
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Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823
The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL). (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose
Intervention | ng*h/mL (Mean) |
---|
Normal Renal Function | NA |
ESRD Dose Before Hemodialysis | NA |
ESRD Dose After Hemodialysis | NA |
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Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban
The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL). (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose
Intervention | ng*hr/mL (Geometric Mean) |
---|
Normal Renal Function | 1265 |
ESRD Dose Before Hemodialysis | 1474 |
ESRD Dose After Hemodialysis | 1717 |
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Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL). (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose
Intervention | ng*hr/mL (Geometric Mean) |
---|
Normal Renal Function | 1205 |
ESRD Dose Before Hemodialysis | 1430 |
ESRD Dose After Hemodialysis | 1673 |
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Percentage of Apixaban Extracted During Hemodialysis
The percentage of apixaban extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6) exiting - AUC(2-6) entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage. (NCT01340586)
Timeframe: 2 to 6 hours post-dose
Intervention | percentage of apixaban extracted (Mean) |
---|
ESRD Maintained With Hemodialysis | -1.1 |
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Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban
Maximum observed plasma concentration (Cmax) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanograms per milliliter (ng/mL). (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose
Intervention | ng/mL (Geometric Mean) |
---|
Normal Renal Function | 125.6 |
ESRD Dose Before Hemodialysis | 98.9 |
ESRD Dose After Hemodialysis | 113.6 |
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Percentage of BMS-730823 Extracted During Hemodialysis
The percentage of BMS-730823 extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6)exiting - AUC(2-6)entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage. (NCT01340586)
Timeframe: 2 to 6 hours post-dose
Intervention | percentage of BMS-730823 extracted (Mean) |
---|
ESRD Maintained With Hemodialysis | -19.9 |
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Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban
Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for Apixaban was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer. (NCT01340586)
Timeframe: 2 to 6 hours post-dose
Intervention | ng*hr/mL (Geometric Mean) |
---|
| Blood entering dialyzer | Blood exiting dialyzer |
---|
ESRD Maintained With Hemodialysis | 309 | 312 |
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Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823
Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for BMS-730823 was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer. (NCT01340586)
Timeframe: 2 to 6 hours post-dose
Intervention | ng*hr/mL (Geometric Mean) |
---|
| Blood entering dialyzer | Blood exiting dialyzer |
---|
ESRD Maintained With Hemodialysis | 15.0 | 17.7 |
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Mean Hemodialysis Clearance (CLD) of Apixaban
Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of apixaban excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min). (NCT01340586)
Timeframe: 2 to 6 hours post-dose
Intervention | mL/min (Geometric Mean) |
---|
ESRD Maintained With Hemodialysis | 17.7 |
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Number of Participants Who Died or Experienced Serious Adverse Events (SAEs) or Adverse Events Leading to Discontinuation
"The number of participants who died or experienced SAEs or AEs leading to discontinuation was reported for each arm.~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. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling." (NCT01340586)
Timeframe: From Day 1 to 30 days post study discontinuation
Intervention | participants (Number) |
---|
| Deaths | SAEs | AEs leading to discontinuation |
---|
ESRD Maintained With Hemodialysis | 0 | 0 | 0 |
,Normal Renal Function | 0 | 0 | 0 |
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Number of Participants With Laboratory Marked Abnormalities
"ULN=Upper Limit of Normal, LLN=Lower Limit of Normal, Pre-Rx= Baseline value. BUN=Blood Urea Nitrogen (mmol/L=millimoles per Liter): High if BUN > 1.1*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx).~Platelet count (*10^9 cell/L): Low if Platelet Count < 0.85*LLN (if Pre-Rx 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).~Calcium, Total (mmol/L): High if Calcium > 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).~Potassium, serum (mmol/L): High if Potassium > 1.1*ULN (if Pre-Rx>ULN: >1.1*Pre-Rx; if Pre-RxULN).~Phosphorus, Inorganic (mmol/L): Low if Phosphate < 0.85*LLN (if Pre-Rx>ULN: 1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)." (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose
Intervention | participants (Number) |
---|
| BUN | Platelet count | Creatine | Potassium | Phosphorus | Lactate dehydrogenase |
---|
ESRD Maintained With Hemodialysis | 4 | 1 | 1 | 1 | 1 | 1 |
,Normal Renal Function | 0 | 0 | 0 | 0 | 0 | 0 |
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Mean Hemodialysis Clearance (CLD) of BMS-730823
Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of BMS-730823 excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min). (NCT01340586)
Timeframe: 2 to 6 hours post-dose
Intervention | mL/min (Mean) |
---|
ESRD Maintained With Hemodialysis | NA |
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Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban
The mean maximum percent change in Activated Partial Thromboplastin Time (aPTT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing. (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose
Intervention | maximum percent change from baseline (Mean) |
---|
Normal Renal Function | 19.9 |
ESRD Dose Before Hemodialysis | 7.0 |
ESRD Dose After Hemodialysis | 23.0 |
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Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban
The mean maximum percent change in baseline for INR was reported for each arm. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing. (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose
Intervention | maximum percent change from baseline (Mean) |
---|
Normal Renal Function | 31.5 |
ESRD Dose Before Hemodialysis | 16.6 |
ESRD Dose After Hemodialysis | 16.8 |
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Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban
The mean maximum percent change in Prothrombin Time (PT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing. (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose
Intervention | maximum percent change from baseline (Mean) |
---|
Normal Renal Function | 32.4 |
ESRD Dose Before Hemodialysis | 16.9 |
ESRD Dose After Hemodialysis | 17.4 |
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Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban
Anti-FXa activity was assessed from an activity-time profile for doses both before and after hemodialysis. Maximal means were reported in International Units per milliliter (IU/mL). (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose
Intervention | IU/mL (Mean) |
---|
Normal Renal Function | 1.47 |
ESRD Dose Before Hemodialysis | 1.03 |
ESRD Dose After Hemodialysis | 1.29 |
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Mean Percent Dose of Apixaban Recovered in Dialysate (%DR)
Percent dose of Apixaban recovered in dialysate (%DR) was calculated by dividing the cumulative amount of apixaban excreted in each dialysate collection over 2-6 hours (DR(2-6)) by the apixaban dose. %DR was recorded only in period 1. (NCT01340586)
Timeframe: 2 to 6 hours post-dose
Intervention | percent of dose recovered in dialysate (Mean) |
---|
ESRD Maintained With Hemodialysis | 6.68 |
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Mean Percent Dose of Apixaban Recovered in Urine (%UR)
The percent dose recovered in urine was calculated by dividing the cumulative amount of unchanged apixaban excreted in urine from the time of dose up to 72 hours post-dose by the apixaban dose administered. (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose
Intervention | percent of dose recovered in urine (Mean) |
---|
Normal Renal Function | 18.397 |
ESRD Dose Before Hemodialysis | 0.145 |
ESRD Dose After Hemodialysis | 0.181 |
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Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban
Plasma terminal half-life (T-Half) for apixaban was derived from plasma concentrations versus time data. Means were reported in hours. (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose
Intervention | hours (Mean) |
---|
Normal Renal Function | 20.0 |
ESRD Dose Before Hemodialysis | 12.5 |
ESRD Dose After Hemodialysis | 12.7 |
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Mean Renal Clearance (CLR) of Apixaban
Renal clearance (CLR) was calculated by dividing the cumulative amount of apixaban excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min). (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose
Intervention | mL/min (Geometric Mean) |
---|
Normal Renal Function | 11.263 |
ESRD Dose Before Hemodialysis | 0.020 |
ESRD Dose After Hemodialysis | 0.020 |
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Bleeding Incidence
To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation. (NCT01706146)
Timeframe: up to 12 months
Intervention | participants (Number) |
---|
Non-Coumadin Oral Anticoagulant | 3 |
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Number of Days on Anticoagulation
Assess subject anticoagulant utilization and number of days on anticoagulation (NCT01706146)
Timeframe: up to 12 months
Intervention | days (Mean) |
---|
Non-Coumadin Oral Anticoagulant | 24.9 |
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Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration
Unbound apixaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for apixaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay. (NCT01758432)
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administration
Intervention | % change in unbound apixaban concentrat. (Mean) |
---|
Module 1 Placebo | -5 |
Module 1 ( 90 mg) | -51 |
Module 1 (210 mg) | -54 |
Module 1 (420 mg) | -72 |
Module 1 (420 mg Bolus + 180 mg Infusion) | -79 |
Module 1 (420 mg Bolus + 180 mg Bolus) | -89 |
Module 1 (420 mg Bolus + 480 mg Infusion) | -84 |
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Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )
Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Intervention | ng*hr/mL (Mean) |
---|
Module 1 Placebo | NA |
Module 1 ( 90 mg) | 23400 |
Module 1 (210 mg) | 49200 |
Module 1 (420 mg) | 93500 |
Module 1 (420 mg Bolus + 180 mg Infusion) | 131000 |
Module 1 (420 mg Bolus + 180 mg Bolus) | 155000 |
Module 1 (420 mg Bolus + 480 mg Infusion) | 213000 |
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Andexanet Apparent Terminal Elimination Half-life (t1/2)
Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electro chemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve. (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Intervention | hr (Mean) |
---|
Module 1 Placebo | NA |
Module 1 ( 90 mg) | 5.51 |
Module 1 (210 mg) | 5.12 |
Module 1 (420 mg) | 5.02 |
Module 1 (420 mg Bolus + 180 mg Infusion) | 4.35 |
Module 1 (420 mg Bolus + 180 mg Bolus) | 5.79 |
Module 1 (420 mg Bolus + 480 mg Infusion) | 6.45 |
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Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration
Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay. (NCT01758432)
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administration
Intervention | Percent change in thrombin generation (Mean) |
---|
Module 1 Placebo | 28.11 |
Module 1 ( 90 mg) | 76.58 |
Module 1 (210 mg) | 137.50 |
Module 1 (420 mg) | 120.95 |
Module 1 (420 mg Bolus + 180 mg Infusion) | 222.56 |
Module 1 (420 mg Bolus + 180 mg Bolus) | 196.29 |
Module 1 (420 mg Bolus + 480 mg Infusion) | 191.77 |
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Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration
Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma) (NCT01758432)
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administration
Intervention | Percent change in anti-fXa activity (Mean) |
---|
Module 1 Placebo | -7.06 |
Module 1 ( 90 mg) | -67.79 |
Module 1 (210 mg) | -78.51 |
Module 1 (420 mg) | -95.04 |
Module 1 (420 mg Bolus + 180 mg Infusion) | -94.03 |
Module 1 (420 mg Bolus + 180 mg Bolus) | -93.07 |
Module 1 (420 mg Bolus + 480 mg Infusion) | -92.82 |
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Andexanet Time of Maximum Observed Plasma Concentration (Tmax)
Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data. (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Intervention | hr (Median) |
---|
Module 1 Placebo | NA |
Module 1 ( 90 mg) | 0.07 |
Module 1 (210 mg) | 0.15 |
Module 1 (420 mg) | 0.27 |
Module 1 (420 mg Bolus + 180 mg Infusion) | 0.43 |
Module 1 (420 mg Bolus + 180 mg Bolus) | 0.27 |
Module 1 (420 mg Bolus + 480 mg Infusion) | 0.28 |
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Andexanet Maximum Observed Plasma Concentration (Cmax)
Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Cmax was taken directly from the raw data. (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Intervention | ng/mL (Mean) |
---|
Module 1 Placebo | NA |
Module 1 ( 90 mg) | 21200 |
Module 1 (210 mg) | 42800 |
Module 1 (420 mg) | 81400 |
Module 1 (420 mg Bolus + 180 mg Infusion) | 93300 |
Module 1 (420 mg Bolus + 180 mg Bolus) | 88000 |
Module 1 (420 mg Bolus + 480 mg Infusion) | 90800 |
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Andexanet Total Systemic Clearance (CL)
Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach, calculated as Dose/AUC0-inf (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Intervention | L (Mean) |
---|
Module 1 Placebo | NA |
Module 1 ( 90 mg) | 3.93 |
Module 1 (210 mg) | 4.29 |
Module 1 (420 mg) | 4.60 |
Module 1 (420 mg Bolus + 180 mg Infusion) | 4.70 |
Module 1 (420 mg Bolus + 180 mg Bolus) | NA |
Module 1 (420 mg Bolus + 480 mg Infusion) | 4.30 |
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Andexanet Total Volume of Distribution (Vss)
Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach. (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.
Intervention | L (Mean) |
---|
Module 1 Placebo | NA |
Module 1 ( 90 mg) | 6.97 |
Module 1 (210 mg) | 6.18 |
Module 1 (420 mg) | 6.26 |
Module 1 (420 mg Bolus + 180 mg Infusion) | 5.11 |
Module 1 (420 mg Bolus + 180 mg Bolus) | NA |
Module 1 (420 mg Bolus + 480 mg Infusion) | 4.01 |
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Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods
All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis [ISTH] Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding. (NCT01780987)
Timeframe: Baseline to Week 24
Intervention | participants (Number) |
---|
Apixaban | 7 |
Unfractionated Heparin (UFH)/Warfarin | 17 |
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Number of Participants With Adjudicated Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition]During the Treatment Period
Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. (NCT01780987)
Timeframe: Baseline to Week 24
Intervention | participants (Number) |
---|
Apixaban | 0 |
Unfractionated Heparin (UFH)/Warfarin | 2 |
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Number of Participants With Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition] or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period
Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. (NCT01780987)
Timeframe: Baseline to Week 24
Intervention | participants (Number) |
---|
Apixaban | 3 |
Unfractionated Heparin (UFH)/Warfarin | 11 |
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Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24. (NCT01780987)
Timeframe: Baseline to Week 24
Intervention | participants (Number) |
---|
| CUS - Week 2 (n=22, n=22) | CTV - Week 12 (n=20, n=21) | CUS - Week 12 (n=21, n=22) | CUS - Week 24 (n=20, n=22) |
---|
Apixaban | 1 | 0 | 0 | 0 |
,Unfractionated Heparin (UFH)/Warfarin | 2 | 0 | 0 | 1 |
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Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24. (NCT01780987)
Timeframe: Baseline to Week 24
Intervention | participants (Number) |
---|
| CTPA - Week 2 (n=18, n=17) | CTPA - Week 12 (n=18, n=16) | CTPA - Week 24 (n=16, n=15) |
---|
Apixaban | 0 | 0 | 0 |
,Unfractionated Heparin (UFH)/Warfarin | 0 | 0 | 1 |
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Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days
VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism. (NCT01884337)
Timeframe: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR
Intervention | Participants (Count of Participants) |
---|
Total Knee Replacement (TKR) | 1 |
Total Hip Replacement (THR) | 1 |
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Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days
"TKR = Total knee replacement; THR = Total hip replacement. ISTH major bleeding is 1) Fatal or 2) Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or 3) Bleeding that results in a fall of hemoglobin of 2 g/dL or more or transfusion of 2 units or more of packed red cells or whole blood within 24 hours. CRNM bleeding is bleeding that~1) Is clinically acute and overt 2) Does not satisfy criteria as a major bleed but requires medical intervention, such as a visit to a physician's office, emergency room, or urgent care center for epistaxis" (NCT01884337)
Timeframe: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR
Intervention | Participants (Count of Participants) |
---|
| Major Bleeding | Clinically Relevant Non-Major Bleeding | Major or Clinically Relevant Non-Major Bleeding | Any Bleeding |
---|
Total Hip Replacement (THR) | 0 | 1 | 1 | 1 |
,Total Knee Replacement (TKR) | 0 | 0 | 0 | 0 |
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Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 Weeks
Logit analyses were conducted on the Primary Efficacy Set to identify non-adherence predictors of 20% or more (vs. at least 80% adherence) at 24 weeks. In the Primary SOC group, alcohol use, Mini-Mental State Evaluation (MMSE) score, UK standard occupational classification, and type of atrial fibrillation were retained in the model (p-value <= 0.2). In the Additional Educational Program group, alcohol use, type of atrial fibrillation, age and Vitamin K Antagonists (VKA) status were retained in the model (p-value <= 0.2). Odds ratios are presented for predictors of non-adherence. (NCT01884350)
Timeframe: Week 24
Intervention | Odds ratio (Number) |
---|
| <=2 Alcoholic Drink/Day Average vs None | >=3 Alcoholic Drink/Day Average vs None | Mini-mental state examination score | Higher mgmt., adm. and professional jobs vs UKSOC1 | Higher professional occupations vs UKSOC1 | Intermediate occupations vs UKSOC1 | Large employers and mgmt. and adm. jobs vs UKSOC1 | Lower mgmt., adm. and professional jobs vs UKSOC1 | Lower supervisory and tech. occupations vs UKSOC1 | Never worked and long-term unemployed vs UKSOC1 | Routine occupations vs UKSOC1 | Semi-routine occupations vs UKSOC1 | Paroxysmal vs Persistant Atrial Fibrillation | Permanent vs Persistant Atrial Fibrillation | VKA Naïve vs Non-Naïve |
---|
Apixaban (Additional Educational Program) | 0.994 | 3.782 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 1.911 | 1.846 | 1.686 |
,Apixaban (Primary SOC Information) | 1.251 | 4.268 | 0.808 | 0.827 | 0.898 | 1.230 | 2.823 | 0.948 | 3.587 | 1.289 | 0.508 | 0.450 | 1.626 | 2.560 | NA |
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Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen
The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence *100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence up to 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 24 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days. (NCT01884350)
Timeframe: Day 1 up to week 24
Intervention | percentage of days (Mean) |
---|
Apixaban (Primary SOC Information) | 91.64 |
Apixaban (Additional Educational Program) | 91.88 |
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Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks Period
The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence *100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence over 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 48 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days. (NCT01884350)
Timeframe: Week 24 to Week 48
Intervention | percentage (Mean) |
---|
Apixaban (Primary SOC Information) | 87.59 |
Apixaban (Additional Educational Program) | 88.41 |
Apixaban (Secondary SOC) | 87.51 |
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Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 12 to 24 Weeks Period Compared With During the First 12 Weeks
The mean adherence to apixaban treatment during the first 24 weeks was measured between the standard of care (SOC) information and Additional Education Program (AEP) arms and expressed as a percentage. Adherence to Apixaban = number of units of adherence *100 / total number of eligible days for the time period. (NCT01884350)
Timeframe: Day 1 to Week 12, Week 12 to Week 24
Intervention | percentage (Mean) |
---|
| Day 1 to Week 12 | Week 12 to Week 24 |
---|
Apixaban (Additional Educational Program) | 93.0 | 90.9 |
,Apixaban (Primary SOC Information) | 93.7 | 90.3 |
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PTS Assessment Completion
Percentage of participants who completed post-thrombotic syndrome assessments (NCT01999179)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Low-molecular-weight Heparin or Direct Oral Anticoagulant | 17 |
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Number of Participants With Post-thrombotic Syndrome
The number of participants with post-thrombotic syndrome 6 months after catheter removal in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal
Intervention | Participants (Count of Participants) |
---|
Low-molecular-weight Heparin or Direct Oral Anticoagulant | 0 |
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Number of Participants With Recurrent Thrombosis
Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal
Intervention | Participants (Count of Participants) |
---|
Low-molecular-weight Heparin or Direct Oral Anticoagulant | 0 |
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Biomarker Sample Collection
Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis (NCT01999179)
Timeframe: 1 year
Intervention | participants (Number) |
---|
Low-molecular-weight Heparin or Direct Oral Anticoagulant | 7 |
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Number of Participants With Major Bleeding
Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal
Intervention | Participants (Count of Participants) |
---|
Low-molecular-weight Heparin or Direct Oral Anticoagulant | 1 |
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Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban
Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL) (NCT02034565)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A: Apixaban Tablet | 2668.310 |
Treatment B: Apixaban Oral Solution | 2784.366 |
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Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban
Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL) (NCT02034565)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A: Apixaban Tablet | 2712.477 |
Treatment B: Apixaban Oral Solution | 2848.968 |
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Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban
Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL) (NCT02034565)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention
Intervention | ng/mL (Geometric Mean) |
---|
Treatment A: Apixaban Tablet | 293.994 |
Treatment B: Apixaban Oral Solution | 287.164 |
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Number of Participants With Marked Laboratory Abnormalities
Clinical laboratory tests were performed pre-study and at selected times throughout the study. Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes < 0.9* lower limits of normal (LLN), absolute neutrophils + bands <= 1.500 10*3 cells/microliter, white blood cells (WBC) urine value >= 2+. These laboratory abnormalities were not considered clinically significant and therefore not adverse events. (NCT02034565)
Timeframe: Pre-study screen (Day -1) to Day 8 or day of study discharge
Intervention | participants (Number) |
---|
| Leukocytes, Low | Absolute Neutrophils + Bands, Low | WBC, Urine, High |
---|
Arm A: Apixaban Tablet | 1 | 1 | 0 |
,Arm B: Apixaban Oral Solution | 1 | 1 | 1 |
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Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings
12-lead electrocardiograms (ECGs) and Vital Signs were performed at Screening, and Day 1 of Periods 1, 2 and 3 (pre-dose and prior to NGT placement, if done). Vital signs and ECGs were also performed on Day 4 of Period 3, prior to discharge from the study. Vital signs included body temperature, respiratory rate, seated blood pressure and heart rate. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. Participants had physical examinations on Period 1, Day 1 (pre-dose) and Day 4 of Period 3, prior to study discharge. (NCT02034578)
Timeframe: Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3
Intervention | participants (Number) |
---|
| ECG | Vital Signs | Physical Examination |
---|
5 mg Apixaban Via NGT Followed by Infant Formula (C) | 0 | 0 | 0 |
,5mg Apixaban Via NGT Followed by D5W (B) | 0 | 0 | 0 |
,5mg Apixaban Via Oral Syringe (A) | 0 | 0 | 0 |
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Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests
Participants were required to fast for at least 10 hours prior to the collection of specimens for clinical laboratory tests. Tests were performed at Screening, Day -1, and Day 4 of each period 1 - 3. Leukocyte criteria: Lower limits of normal (LLN), upper limits of normal (ULN), pre-treatment (preRX). Low Leukocytes: if value < 0.9*LLN, or if preRX < LLN then use < 0.85* preRX. High lymphocytes: if value > 7.500 10^3 cells/ µL. Low neutrophils plus bands: if value <= 1.500 10^3 cells/µL. High creatine kinase: if value > 1.5* ULN. Blood in urine: if value >= 2 plus, or if preRX >= 1 plus then use >= 2*preRX. (NCT02034578)
Timeframe: Screening, Day -1, Day 4 of Periods, 1, 2, and 3
Intervention | participants (Number) |
---|
| Low Leukocytes | High Lymphocytes | Low Neutrophils plus bands | High Creatine Kinase | Blood in Urine |
---|
5mg Apixaban | 1 | 1 | 5 | 1 | 1 |
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Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban
Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-T) was measured in nanograms*hours per milliliter (ng*h/mL). (NCT02034578)
Timeframe: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
Intervention | ng*h/mL (Geometric Mean) |
---|
5mg Apixaban Via Oral Syringe (A) | 1269.784 |
5mg Apixaban Via NGT Followed by D5W (B) | 1226.339 |
5 mg Apixaban Via NGT Followed by Infant Formula (C) | 1166.572 |
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Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban
Samples of plasma from participants were obtained at the following times: 0 hour (h) and post dose at 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h. Apixaban was assayed using a validated Liquid chromatography tandem mass spectrometry (LC-MS/MS) method during the period of known analyte stability. Maximum observed plasma concentration (Cmax) was measured in nanograms per milliliter (ng/mL). (NCT02034578)
Timeframe: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
Intervention | ng/mL (Geometric Mean) |
---|
5mg Apixaban Via Oral Syringe (A) | 190.873 |
5mg Apixaban Via NGT Followed by D5W (B) | 181.862 |
5 mg Apixaban Via NGT Followed by Infant Formula (C) | 153.693 |
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Mean Plasma Elimination Half-Life (T-HALF) of Apixaban
Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. T-HALF was measured in hours (h). (NCT02034578)
Timeframe: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
Intervention | h (Mean) |
---|
5mg Apixaban Via Oral Syringe (A) | 10.5 |
5mg Apixaban Via NGT Followed by D5W (B) | 10.4 |
5 mg Apixaban Via NGT Followed by Infant Formula (C) | 10.6 |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death
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. (NCT02034578)
Timeframe: Day 1 to Day 12
Intervention | participants (Number) |
---|
| Discontinuation Due to AE | SAE | Death | Adverse Events |
---|
5 mg Apixaban Via NGT Followed by Infant Formula (C) | 0 | 0 | 0 | 3 |
,5mg Apixaban Via NGT Followed by D5W (B) | 0 | 0 | 0 | 4 |
,5mg Apixaban Via Oral Syringe (A) | 0 | 0 | 0 | 2 |
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Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban
Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-INF) was measured in ng*h/mL. (NCT02034578)
Timeframe: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
Intervention | ng*h/mL (Geometric Mean) |
---|
5mg Apixaban Via Oral Syringe (A) | 1292.775 |
5mg Apixaban Via NGT Followed by D5W (B) | 1250.913 |
5 mg Apixaban Via NGT Followed by Infant Formula (C) | 1192.387 |
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Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban
AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL) (NCT02034591)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A | 1397.666 |
Treatment B | 1136.380 |
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Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban
AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL) (NCT02034591)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A | 1397.666 |
Treatment C | 1327.248 |
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Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban
AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL) (NCT02034591)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A | 1372.836 |
Treatment B | 1112.493 |
,Treatment A | 1372.836 |
Treatment C | 1300.728 |
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Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban
Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL) (NCT02034591)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention
Intervention | ng/mL (Geometric Mean) |
---|
Treatment A | 179.116 |
Treatment B | 122.145 |
,Treatment A | 179.116 |
Treatment C | 158.371 |
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Number of Participants With Marked Laboratory Abnormalities
Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes >1.2* upper limits of normal (ULN) , Basophils >3%, Eosinophils >1.5*ULN, Blood Urine >=2, Red Blood Cell (RBC) Urine >=2, White Blood Cell (WBC) Urine >=2 (NCT02034591)
Timeframe: Day 1 to 30 days after last dose of study drug
Intervention | participants (Number) |
---|
| Leukocytes | Basophils | Eosinophils | Blood, Urine | RBC, Urine | WBC, Urine |
---|
Treatment A | 0 | 1 | 0 | 1 | 0 | 0 |
,Treatment B | 1 | 0 | 1 | 1 | 2 | 2 |
,Treatment C | 0 | 0 | 0 | 0 | 1 | 1 |
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Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to AEs - Treatment Population
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. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Medical Dictionary for Regulatory Activities (MedDRA) version 17.0 was used. (NCT02074358)
Timeframe: Day 1 to 30 days Post Last Dose
Intervention | participants (Number) |
---|
| Adverse Events | SAEs | Discontinuation due to AEs | Death |
---|
Treatment A: Apixaban + Placebo | 1 | 0 | 0 | 0 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | 5 | 0 | 0 | 0 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 2 | 0 | 0 | 0 |
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Number of Participants With Marked Abnormalities (MA) in Laboratory Tests - Treated Population
Blood, urine samples obtained at screening, Days -1, 4, and 7 of each treatment period, and study discharge (Day 11 of Treatment Period 3). MA: Leukocyte White Blood Cells (WBC) *10^3 cells per microliter (c/µL); High (H): > 1.2*upper limits normal (ULN) if lower limits normal (LLN) <= pre-therapy (PreRx) <= ULN; > 1.2*ULN if PreRx = Missing; > 1.5*PreRx if PreRx > ULN; > ULN if PreRx < LLN. Alanine Aminotransferase (ALT) units per liter (U/L); H: > 1.25*PreRx if PreRx > ULN; > 1.25*ULN if PreRx <= ULN; > 1.25*ULN if PreRx = Missing. Total and Direct Bilirubin in milligrams/deciliter (mg/dL) H: > 1.1*ULN if PreRx <= ULN;> 1.1*ULN if PreRx = Missing; > 1.25*PreRx if PreRx > ULN. Blood in Urine H: >= 2*PreRx if PreRx >= 1; >= 2 if PreRx < 1; >= 2 if PreRx = Missing. Urine Red Blood Cells (RBC) and Urine WBC/ high powered field (hpf) H: >= 2 if PreRx = Missing; >= 2 if PreRx < 2; >= 4 if PreRx >= 2. Crossover study: same participant with MA could be reported in multiple arms. (NCT02074358)
Timeframe: Day 1 (first dose) to Day of Study Discharge (Day 11 of Treatment Period 3)
Intervention | participants (Number) |
---|
| Leukocytes High (n=15,15,15) | ALT High (n=15,15,15) | Bilirubin Direct High (n=4,4,4) | Bilirubin Total High (n=15,15,15) | Blood in Urine (n=15,15,15) | Red Blood Cells in Urine (n=5,7,6) | White Blood Cells in Urine (n=5,7,6) |
---|
Treatment A: Apixaban + Placebo | 0 | 1 | 2 | 2 | 1 | 1 | 0 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | 1 | 1 | 2 | 1 | 1 | 0 | 2 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 0 | 0 | 2 | 2 | 2 | 0 | 0 |
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Number of Participants With Out of Range Electrocardiogram (ECG) Intervals and Number of Participants With a Change From Baseline of Greater Than 30 Milliseconds in QT and QTcF
Single 12-lead ECGs were obtained at screening, Day -1 of Period 1, and Days 4 and 7 of each treatment period after the participant had been supine for at least 5 minutes. Pulse Rate (PR), Complex of Q, R, S waves (QRS), and contraction of ventricle between the beginning of the Q wave and end of the T wave (QT) were measured in milliseconds (msec). QT was corrected by the Fridericia method (QTcF) and measured in msec. Baseline was Day -1 of first treatment period. Crossover study: same participant with out of range ECG intervals could be reported in multiple arms. (NCT02074358)
Timeframe: Day -1 first treatment period, Days 4 and 7 each treatment period
Intervention | participants (Number) |
---|
| PR >200 msec (n=15,15,15) | QRS > 120 msec (n=15,15,15) | QT > 500 msec (n=15,15,15) | QTcF > 450 msec (n=15,15,15) | Change from Baseline >30 msec in QT (n=15,15,15) | Change from Baseline >30 msec in QTcF (n=15,15,15) |
---|
Treatment A: Apixaban + Placebo | 0 | 0 | 0 | 0 | 3 | 0 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | 0 | 0 | 0 | 0 | 2 | 0 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 0 | 0 | 0 | 0 | 3 | 0 |
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PD Parameter: Adjusted Mean Change in Coagulation Parameter INR From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction (NCT02074358)
Timeframe: Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.
Intervention | fraction (Mean) |
---|
| INR (Neoplastin CI+) (n=15,14,15) | INR (Recombiplastin 2G) (n=15,14,15) |
---|
Treatment A: Apixaban + Placebo | 0.290 | 0.460 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | 0.103 | 0.216 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 0.130 | 0.281 |
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PD Parameter: Adjusted Mean Change in Coagulation Parameter International Normalized Ratio (INR) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction. (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.
Intervention | fraction (Mean) |
---|
| INR (Neoplastin CI+) (n=15, 14, 15) | INR (Recombiplastin 2G) (n=15, 14, 15) |
---|
Treatment A: Apixaban + Placebo | -0.015 | 0.032 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | -0.213 | -0.207 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -0.185 | -0.144 |
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PD Parameter: Adjusted Mean Change in Coagulation Parameters Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. PT (Neoplastin CT+), PT (Recombiplastin 2G) and activated partial thromboplastin time (aPTT) parameters were measured in seconds. (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.
Intervention | seconds (Mean) |
---|
| PT (Neoplastin CI+) (n=15, 14, 15) | PT (Recombiplastin 2G) (n=15, 14, 15) | aPTT (n=15, 14, 15) |
---|
Treatment A: Apixaban + Placebo | -0.21 | 0.35 | 1.13 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | -1.85 | -2.24 | 9.60 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -1.68 | -1.54 | 3.43 |
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PD Parameter: Adjusted Mean Change in Coagulation Parameters PT and aPTT From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, pre-apixaban dose. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. (NCT02074358)
Timeframe: Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.
Intervention | seconds (Mean) |
---|
| PT (Neoplastin CI+) (n=15,14,15) | PT (Recombiplastin 2G) (n=15,14,15) | aPTT (n=15, 14, 15) |
---|
Treatment A: Apixaban + Placebo | 2.74 | 4.94 | 7.49 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | 1.17 | 2.30 | 15.87 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 1.31 | 3.01 | 9.68 |
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PD Parameter: Adjusted Mean Change in TGA Lag Time and TGA Time to Peak From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes. (NCT02074358)
Timeframe: Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.
Intervention | minutes (Mean) |
---|
| TGA Lag Time (n=15,14,15) | TGA Time to Peak (n=15,14,15) |
---|
Treatment A: Apixaban + Placebo | 3.56 | 6.42 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | 3.36 | 7.90 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 3.40 | 10.81 |
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Mean Change From Baseline Temperature on Day 4 and Day 7
Temperature was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period and was measured in degrees centigrade (C). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose. (NCT02074358)
Timeframe: Screening, Day -1 first treatment period, Days 4 and 7 post treatment
Intervention | C (Mean) |
---|
| Temperature Day 4 (n=15,15,15) | Temperature Day 7 (n=15,15,15) |
---|
Treatment A: Apixaban + Placebo | -0.15 | -0.20 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | -0.14 | -0.08 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -0.22 | -0.17 |
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PD Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
"ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. A dedicated software program (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting thrombogram curve. Pre-dose Apixaban baseline was Day 1 pre-dose (0 hour). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period." (NCT02074358)
Timeframe: Day 1 pre-dose apixaban (pre-apixaban Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)
Intervention | nM*minute (Mean) |
---|
Treatment A: Apixaban + Placebo | -708.0 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | -276.3 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -607.7 |
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Adjusted Geometric Mean AUC (0-12) of Apixaban on Day 4
Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. (NCT02074358)
Timeframe: Day 4
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A: Apixaban + Placebo | 1972 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 2049 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 2014 |
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Adjusted Geometric Mean AUC (0-24) for Apixaban on Day 4
Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. (NCT02074358)
Timeframe: Day 4
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A: Apixaban + Placebo | 2546 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 2594 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 2592 |
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Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours After Dose Administration [AUC(0-24)] of Apixaban on Day 4
Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-24) was measured in ng*h/mL. (NCT02074358)
Timeframe: Day 4
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A: Apixaban + Placebo | 2537 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 2583 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 2585 |
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Geometric Mean Area Under the Plasma Concentration-Time Curve in One Dosing Interval [AUC(0-12)] of Apixaban on Day 4
Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-12) was measured in ng*hours/mL (ng*h/mL) (NCT02074358)
Timeframe: Day 4
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A: Apixaban + Placebo | 1965 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 2046 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 2010 |
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Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban on Day 4
Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) assay within the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL). (NCT02074358)
Timeframe: Day 4
Intervention | ng/mL (Geometric Mean) |
---|
Treatment A: Apixaban + Placebo | 291 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 310 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 290 |
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Geometric Mean Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban on Day 4
Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Tmax was measured in hours. (NCT02074358)
Timeframe: Day 4
Intervention | hours (Median) |
---|
Treatment A: Apixaban + Placebo | 2.00 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 2.00 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 2.00 |
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Geometric Mean Trough Observed Plasma Concentration at the End of One Dosing Interval (12h) [Cmin] of Apixaban on Day 4
Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Cmin was measured in nanograms per milliliter (ng/mL). (NCT02074358)
Timeframe: Day 4
Intervention | ng/mL (Geometric Mean) |
---|
Treatment A: Apixaban + Placebo | 86.0 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 93.7 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 95.5 |
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Mean Terminal Elimination Half-Life (T-HALF) of Apixaban on Day 4
Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. T-HALF was measured in hours (NCT02074358)
Timeframe: Day 4
Intervention | hours (Mean) |
---|
Treatment A: Apixaban + Placebo | 10.9 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 10.8 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 11.0 |
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PD Parameter: Adjusted Mean Change in Plasma Anti-Xa Activity From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
Anti-FXa activity was measured using a validated method at Esoterix Coagulation Laboratory (Englewood, CO) using the Diagnostica Stago Rotachrom (Registered) Heparin assay on a STA-Compact (Registered) analyzer. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. The results of this chromogenic assay were reported in low molecular weight heparin (LMWH) activity units per milliliter (U/mL), which are equivalent to international units per milliliter (IU/mL) with assay reportable range: 0.1 to 18.4 IU/mL. (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.
Intervention | U/mL (Mean) |
---|
Treatment A: Apixaban + Placebo | -0.368 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | -0.607 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -0.538 |
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PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes. (NCT02074358)
Timeframe: Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.
Intervention | nM (Mean) |
---|
Treatment A: Apixaban + Placebo | -196.1 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | -174.9 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -202.7 |
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PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Peak height parameter was measured in nanomolar (nM). (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.
Intervention | nM (Mean) |
---|
Treatment A: Apixaban + Placebo | 11.1 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 32.1 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 4.7 |
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PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour (pre-dose apixaban). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA velocity index was measured in nM/min. (NCT02074358)
Timeframe: Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.
Intervention | nM/min (Mean) |
---|
Treatment A: Apixaban + Placebo | -63.7 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | -63.6 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -71.5 |
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PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Lag Time and Time to Peak parameters were measured in minutes. (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.
Intervention | minutes (Mean) |
---|
| TGA Lag Time (n=15, 14, 15) | TGA Time to Peak (n=15, 14, 15) |
---|
Treatment A: Apixaban + Placebo | -0.16 | -1.29 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | -0.38 | 0.06 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -0.32 | 3.32 |
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PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Velocity Index parameter was measured in nM per minute (nM/min). (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.
Intervention | nM/min (Mean) |
---|
Treatment A: Apixaban + Placebo | 3.4 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 3.4 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -3.2 |
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Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
"ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. Dedicated software (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting thrombogram curve. Pre-infusion baseline= sample on Day 4, 3 hours post apixaban dose (just prior to IV infusion of PCC or placebo). Samples on Day 4 were obtained at 0 (pre-dose), 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. ETP was measured as nanomolar*minute (nM*min)." (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)
Intervention | nM*min (Mean) |
---|
Treatment A: Apixaban + Placebo | 95.8 |
Treatment B: Apixaban + Cofact (4-Factor PCC) | 521.0 |
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 186.3 |
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Mean Change From Baseline in Diastolic and Systolic Blood Pressure on Day 4 and Day 7
Blood pressures were recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Blood pressure was measured after the participant had been seated quietly for at least 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose. (NCT02074358)
Timeframe: Screening, Day -1 first treatment period, Days 4 and 7 post treatment
Intervention | mmHg (Mean) |
---|
| Systolic BP Day 4 (n=15,15,15) | Systolic BP Day 7 (n=15,15,15) | Diastolic BP Day 4 (n=15,15,15) | Diastolic BP Day 7 (n=15,15,15) |
---|
Treatment A: Apixaban + Placebo | 0.9 | 2.1 | -2.1 | -0.1 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | -2.1 | 3.7 | -3.3 | 0.0 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -2.9 | 1.3 | -3.1 | -0.1 |
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Mean Change From Baseline in Heart Rate on Day 4 and Day 7
Heart Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Heart Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in beats per minute (bpm). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose. (NCT02074358)
Timeframe: Screening, Day -1 first treatment period, Days 4 and 7 post treatment
Intervention | bpm (Mean) |
---|
| Heart Rate Day 4 (n=15,15,15) | Heart Rate Day 7 (n=15,15,15) |
---|
Treatment A: Apixaban + Placebo | -4.3 | -1.8 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | -4.9 | 0.4 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -5.5 | -2.1 |
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Mean Change From Baseline in Respiration Rate on Day 4 and Day 7
Respiration Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Respiration Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in respirations (breaths) per minute. Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose. (NCT02074358)
Timeframe: Screening, Day -1 first treatment period, Days 4 and 7 post treatment
Intervention | breaths per minute (Mean) |
---|
| Respirate Rate Day 4 (n=15,15,15) | Respirate Rate Day 7 (n=15,15,15) |
---|
Treatment A: Apixaban + Placebo | -0.7 | -0.4 |
,Treatment B: Apixaban + Cofact (4-Factor PCC) | -1.3 | -0.3 |
,Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | -1.4 | -0.5 |
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Coronary Plaque on CT Angiography
To evaluate if treatment with apixaban therapy, as compared to warfarin therapy, will modify the progression, regression and stabilization of coronary atherosclerosis. Modifications will include differences in plaque volume, composition and arterial remodeling; as well as new atherosclerosis formation. The scale is based upon volume of plaque in the coronary arteries, with zero being no plaque and a higher number being more plaque. There is no scale or maximum measure, this is a linear measure of atherosclerosis volume in the coronary arteries and more is worse. None is best, any plaque is considered worse, and a higher plaque volume represents more atherosclerosis. An individual of average health will have a score of 50. (NCT02090075)
Timeframe: 1 year
Intervention | units on a scale (Mean) |
---|
Apixaban | 47 |
Warfarin | 54 |
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Coronary Artery Calcium (CAC) Score
amount of calcification measured by Agatston Score. The range of values for the Agatston score is 0-10000. Higher score is worse outcome. (NCT02090075)
Timeframe: 1 year
Intervention | units on a scale (Mean) |
---|
Apixaban | 66 |
Warfarin | 31 |
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Duration of Hospital Stay of Participants
Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Intervention | hours (Median) |
---|
Apixaban | 45.36 |
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 49.47 |
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Number of Participants Who Used Image Guidance Approach
An image-guided approach helped cardioversion earlier than the conventional minimum of 3 weeks of anticoagulation that would normally be required prior to cardioversion. Transesophageal echocardiography (TEE or TOE) and computed tomography (CT) were 2 image-guided approaches that were used in this study. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Intervention | participants (Number) |
---|
Apixaban | 383 |
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 399 |
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Number of Participants With Acute Stroke Event
An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma). (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Intervention | participants (Number) |
---|
Apixaban | 0 |
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 6 |
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Number of Participants With All Cause Death
(NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Intervention | participants (Number) |
---|
Apixaban | 2 |
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 1 |
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Number of Participants With Clinically Relevant Non-Major Bleeding Events
Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life. (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Intervention | participants (Number) |
---|
Apixaban | 11 |
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 13 |
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Number of Participants With Major Bleeding Event
Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal. (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Intervention | participants (Number) |
---|
Apixaban | 3 |
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 6 |
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Number of Participants With Systemic Embolism Event
Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing. (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Intervention | participants (Number) |
---|
Apixaban | 0 |
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 0 |
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Time to First Attempt of Cardioversion
Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Intervention | days (Median) |
---|
Apixaban | 2.0 |
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 2.0 |
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Number of Cardioversion Attempt of Participants
Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Intervention | participants (Number) |
---|
| No Cardioversion Attempt | 1 Cardioversion Attempt | More than 2 Cardioversion Attempts |
---|
Apixaban | 234 | 488 | 31 |
,Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 224 | 496 | 27 |
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Number of Participants With Their Rhythm Status
Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute). (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Intervention | participants (Number) |
---|
| Normal Sinus | Atrial Fibrillation | Atrial Flutter |
---|
Apixaban | 1 | 715 | 3 |
,Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 2 | 704 | 6 |
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Number of Participants With Different Type of Cardioversion Events
Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Intervention | participants (Number) |
---|
| Electrical | Pharmacologic |
---|
Apixaban | 461 | 35 |
,Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 464 | 30 |
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Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban
Area Under the Plasma Concentration-time Curve (AUC) From Time of Zero Extrapolated to Infinite Time (INF) [AUC (INF)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL) (NCT02101112)
Timeframe: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose
Intervention | ng*h/mL (Geometric Mean) |
---|
Apixaban, 10 mg (Whole Tablets) | 2461 |
Apixaban, 10 mg (Crushed and Suspended in Water) | 2528 |
Apixaban, 10 mg (Crushed and Mixed With Applesauce) | 2055 |
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Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Concentration [AUC (0-T)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL) (NCT02101112)
Timeframe: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose
Intervention | ng*h/mL (Geometric Mean) |
---|
Apixaban, 10 mg (Whole Tablets) | 2423 |
Apixaban, 10 mg (Crushed and Suspended in Water) | 2488 |
Apixaban, 10 mg (Crushed and Mixed With Applesauce) | 2015 |
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Relative Bioavailability (Frel) of Apixaban
Frel is calculated using the treatment ratio of AUC(INF) where the denominator is the AUC(INF) of the reference therapy, 10mg of Apixaban (whole tablet). (NCT02101112)
Timeframe: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose
Intervention | ratio (Geometric Mean) |
---|
Apixaban, 10 mg (Crushed and Suspended in Water) | 1.03 |
Apixaban, 10 mg (Crushed and Mixed With Applesauce) | 0.836 |
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Terminal Plasma Half-life (T-HALF) of Apixaban
Terminal plasma half-life (T-HALF) was derived from plasma concentration versus time data. T-HALF was the time required for one half of the total amount of administered drug to be eliminated from the body. (NCT02101112)
Timeframe: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose
Intervention | hours (Mean) |
---|
Apixaban, 10 mg (Whole Tablets) | 12.4 |
Apixaban, 10 mg (Crushed and Suspended in Water) | 12.2 |
Apixaban, 10 mg (Crushed and Mixed With Applesauce) | 12.5 |
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Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban
Time of maximum observed plasma concentration (Tmax) measured in hours (h) (NCT02101112)
Timeframe: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose
Intervention | hours (Median) |
---|
Apixaban, 10 mg (Whole Tablets) | 2.00 |
Apixaban, 10 mg (Crushed and Suspended in Water) | 2.00 |
Apixaban, 10 mg (Crushed and Mixed With Applesauce) | 2.00 |
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Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion
Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious Adverse Event (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. (NCT02101112)
Timeframe: Randomization to May 2014; approximately 6 weeks
Intervention | participants (Number) |
---|
| Deaths | SAEs | Drug-related AEs | Discontinuation due to AE |
---|
Apixaban, 10 mg (Crushed and Mixed With Applesauce) | 0 | 0 | 0 | 0 |
,Apixaban, 10 mg (Crushed and Suspended in Water) | 0 | 0 | 1 | 1 |
,Apixaban, 10 mg (Whole Tablets) | 0 | 0 | 0 | 0 |
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Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban
Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL) (NCT02101112)
Timeframe: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dose
Intervention | ng/mL (Geometric Mean) |
---|
Apixaban, 10 mg (Whole Tablets) | 236 |
Apixaban, 10 mg (Crushed and Suspended in Water) | 249 |
Apixaban, 10 mg (Crushed and Mixed With Applesauce) | 186 |
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Number of Hospitalizations During Treatment
(NCT02179177)
Timeframe: up to 8 months
Intervention | hospitalizations (Mean) |
---|
Apixaban | 3 |
Placebo | 1.5 |
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Change in Pain as Measured by Visual Analog Scale (VAS)
"The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with 0 corresponding to no pain at one end and 10 indicating the worst pain at the other." (NCT02179177)
Timeframe: Month 1 to Month 8
Intervention | score on a scale (Mean) |
---|
Apixaban | -1 |
Placebo | 0 |
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Daily Pain Scores While Hospitalized as Measured by VAS
"The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with 0 corresponding to no pain at one end and 10 indicating the worst pain at the other. Secondary analysis will be performed to evaluate differences when patients are hospitalized and on study drug versus placebo." (NCT02179177)
Timeframe: up to 8 months
Intervention | score on a scale (Mean) |
---|
Apixaban | 6.4 |
Placebo | 6.6 |
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Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA
(NCT02283294)
Timeframe: 180 days
Intervention | Participants (Count of Participants) |
---|
Apixaban | 7 |
Warfarin | 12 |
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Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT
(NCT02283294)
Timeframe: 180 days
Intervention | Participants (Count of Participants) |
---|
Apixaban | 5 |
Warfarin | 6 |
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Number of Participants With Incidence of Clinically Relevant Non Major Bleeding Events
Participants were monitored for up to 90 days. This is the number of participants with bleeding events that did not meet the ISTH criteria but still required intervention. This is the number of participants who had at least one non-major bleeding event during the time of observation. (NCT02366871)
Timeframe: Day 1 post-op/standard of care first dose of medication to day 90 (+/- 14 days) post-op/standard of care
Intervention | Participants (Count of Participants) |
---|
Oral Apixaban | 12 |
Subcutaneous Enoxaparin | 19 |
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Number of Participants With Incidence of Major Bleeding
The International Society on Thrombosis and Hemostasis criteria (ISTH) will be used to assess incidence of major bleeding. Participants were monitored for up to 90 days. This is the number of participants who have had at least one major bleeding incidence during the time of observation. (NCT02366871)
Timeframe: Day 1 post-op/standard of care first medication dose to day 90 (+/-14 days) post-op/standard of care
Intervention | Participants (Count of Participants) |
---|
Oral Apixaban | 1 |
Subcutaneous Enoxaparin | 1 |
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Change in Quality of Life From Baseline to 28 Days Post-op
This was measured through a validated health survey (SF-8™) provided by a healthcare company (Optum®), which measured overall physical and mental well-being, with responses ranging from none to very, not at all to extremely, etc. Change was calculated as the difference at baseline versus 28 days post op. The score was 0-100 and a higher score was considered a better outcome. (NCT02366871)
Timeframe: At baseline, and visit 4, which is 28 days (+/- 4 days) post-op/standard of care
Intervention | score on a scale (Median) |
---|
| physical score-baseline | physical score-visit 4 | Physical change | mental score-baseline | mental score-visit 4 | Mental change |
---|
Oral Apixaban | 50.7 | 39.2 | -5.9 | 50.7 | 50.7 | 0.8 |
,Subcutaneous Enoxaparin | 49.7 | 38.5 | -6.2 | 49.7 | 49.3 | 0.0 |
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Number of Participants With a Patient Satisfaction Assessment
Participants were monitored at the 28 (+/- 4) day post-op visit. This was measured through administering a participant satisfaction questionnaire ranging from strongly agree to strongly disagree.This is the number of participants that completed the questionnaire in response to agreeing it was difficult to remember to take the medication, agreeing that there was pain associated with the medication, and agreeing that the medication was easy to use. (NCT02366871)
Timeframe: On visit 4, which is 28 days (+/- 4 days) post-op/standard of care
Intervention | Participants (Count of Participants) |
---|
| Difficult remembering to take medication72102815 | Difficult remembering to take medication72102814 | Pain associated with taking the medication72102814 | Pain associated with taking the medication72102815 | Was medication easy to take72102814 | Was medication easy to take72102815 |
---|
| Agree | Neutral | Disagree |
---|
Oral Apixaban | 23 |
Subcutaneous Enoxaparin | 23 |
Oral Apixaban | 16 |
Subcutaneous Enoxaparin | 15 |
Oral Apixaban | 149 |
Subcutaneous Enoxaparin | 149 |
Oral Apixaban | 4 |
Subcutaneous Enoxaparin | 92 |
Oral Apixaban | 10 |
Subcutaneous Enoxaparin | 25 |
Oral Apixaban | 173 |
Subcutaneous Enoxaparin | 70 |
Oral Apixaban | 186 |
Subcutaneous Enoxaparin | 110 |
Oral Apixaban | 2 |
Subcutaneous Enoxaparin | 21 |
Oral Apixaban | 0 |
Subcutaneous Enoxaparin | 56 |
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Number of Participants With Incidence of Venous Thromboembolism (VTEs): Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Participants were monitored for up to 90 days. Both DVTs and PEs will be measured using the Wells criteria, ultrasound, and/or CT. This is the number of participants who had at least one DVT or PE during the time of observation. (NCT02366871)
Timeframe: Day 1 post-op/standard of care to day first dose of medication 90 (+/- 14 days) post-op/standard of care
Intervention | Participants (Count of Participants) |
---|
Oral Apixaban | 2 |
Subcutaneous Enoxaparin | 3 |
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Number of Participants Who Met Medication Adherence Rates
Participants were monitored for up to 28 days. This was measured through self-report, patient diaries, and the return of all medication bottles/syringes. This was the number of participants that did not miss more than 2 days of study medication over 28 days (less than 4 pills or 2 injections missed). (NCT02366871)
Timeframe: Day 1 post-op/standard of care first dose of medication to Day 28 (+/- 4 days) post-op/standard of care
Intervention | Participants (Count of Participants) |
---|
Oral Apixaban | 173 |
Subcutaneous Enoxaparin | 164 |
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The Number of Participants With Non-fatal Pulmonary Embolism (PE)
The number of participants with non-fatal pulmonary embolism (PE) adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 0 |
Standard of Care | 0 |
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The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT)
The number of participants with non-fatal asymptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose up to approximately 40 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 27 |
Standard of Care | 38 |
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The Number of Participants With Minor Bleeding Events
"The number of participants with minor bleeding events adjudicated by a blinded, independent adjudication committee.~Minor bleeding defined as any overt or macroscopic evidence of bleeding that does not fulfill the criteria for either major bleeding or CRNMB" (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 37 |
Standard of Care | 20 |
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The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB)
"The number of participants with major and clinically relevant non-major bleeding (CRNMB) adjudicated by a blinded, independent adjudication committee~CRNM bleeding is defined as bleeding that satisfies one or both of the following:~overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition and~bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room" (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 13 |
Standard of Care | 5 |
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The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use
The number of participants with central venous access device (CVAD) patency restoration events after thrombolytic therapy use (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 0 |
Standard of Care | 0 |
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The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB)
"The number of participants with clinically relevant non-major bleeding events (CRNMB) adjudicated by a blinded, independent adjudication committee.~CRNM bleeding is defined as bleeding that satisfies one or both of the following:~overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition and~bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room" (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 11 |
Standard of Care | 3 |
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The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST)
The number of participants with cerebral venous sinus thrombosis (CVST) adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 0 |
Standard of Care | 1 |
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The Number of Participants With an Arterial Thromboembolic Event
The number of participants with an arterial thromboembolic event including paradoxical embolism and stroke adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 0 |
Standard of Care | 0 |
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The Number of Participants Needing Catheter Replacements During the Study
The number of participants needing catheter replacements during the study (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 3 |
Standard of Care | 2 |
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The Number of Participant Deaths
The number of participant deaths adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose date until the end of the treatment period + 30 days (Up to approximately 59 days)
Intervention | Participants (Count of Participants) |
---|
Apixaban | 1 |
Standard of Care | 3 |
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Maximum Observed Concentration (Cmax)
The maximum observed concentration (Cmax) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. (NCT02369653)
Timeframe: pre-dose, 1-4 hours post dose
Intervention | ng/mL (Geometric Mean) |
---|
Participants Weight Range ≥ 35 kg | 56.5 |
Participants Weight Range 25 to < 35 kg | 63.6 |
Participants Weight Range 18 to < 25 kg | 61.4 |
Participants Weight Range 10.5 to < 18 kg | 54.2 |
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The Number of Participants With Adjudicated Major Bleeding
"The number of participants with major bleeding adjudicated by a blinded, independent adjudication committee. Adjudicated major bleeding is defined as bleeding that satisfies one or more of the following criteria:~fatal bleeding~clinically overt bleeding associated with a decrease in hemoglobin of at least 20g/L (ie, 2g/dL) in a 24-hour period~bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS; and/or~bleeding that requires surgical intervention in an operating suite, including interventional radiology." (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 2 |
Standard of Care | 2 |
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Area Under the Concentration-Time Curve [AUC(TAU)]
The area under the concentration-time curve [AUC(TAU)] was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. (NCT02369653)
Timeframe: pre-dose, 1-4 hours post dose
Intervention | ng•h/mL (Geometric Mean) |
---|
Participants Weight Range ≥ 35 kg | 470 |
Participants Weight Range 25 to < 35 kg | 510 |
Participants Weight Range 18 to < 25 kg | 453 |
Participants Weight Range 10.5 to < 18 kg | 416 |
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Anti-FXa Activity
Anti-FXa Activity was measured to characterize the relationship between apixaban plasma concentration and anti-FXa activity in pediatric subjects receiving induction chemotherapy (NCT02369653)
Timeframe: pre-dose and 2.5 hours after dosing on day 7. Day 8 and day 15.
Intervention | Anti-FXa activity (ng/mL) (Mean) |
---|
| Day 7 (Predose) | Day 7 (2.5 hours) | Day 8 | Day 15 |
---|
Participants Weight Range ≥ 35 kg | 55.3 | 78.7 | 55.2 | 70.2 |
,Participants Weight Range 10.5 to < 18 kg | 44.2 | 87.5 | 48 | 64.8 |
,Participants Weight Range 18 to < 25 kg | 52.8 | 77.5 | 47.5 | 63.9 |
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Anti-FXa Activity
Anti-FXa Activity was measured to characterize the relationship between apixaban plasma concentration and anti-FXa activity in pediatric subjects receiving induction chemotherapy (NCT02369653)
Timeframe: pre-dose and 2.5 hours after dosing on day 7. Day 8 and day 15.
Intervention | Anti-FXa activity (ng/mL) (Mean) |
---|
| Day 7 (Predose) | Day 7 (2.5 hours) | Day 15 |
---|
Participants Weight Range 25 to < 35 kg | 62.2 | 72.1 | 75.3 |
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Trough Observed Concentration (Cmin)
The trough observed concentration (Cmin) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. (NCT02369653)
Timeframe: pre-dose, 1-4 hours post dose
Intervention | ng/mL (Geometric Mean) |
---|
Participants Weight Range ≥ 35 kg | 18.8 |
Participants Weight Range 25 to < 35 kg | 18.1 |
Participants Weight Range 18 to < 25 kg | 12 |
Participants Weight Range 10.5 to < 18 kg | 12.9 |
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The Number Participants Experiencing Superficial Vein Thrombosis Events
"The number participants experiencing superficial vein thrombosis events.~Clots that occur in a superficial vein ie, cephalic vein, basilic vein (upper extremity) or saphenous vein (lower extremity) confirmed by radiographic imaging." (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 4 |
Standard of Care | 2 |
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The Number of Platelet Transfusions Needed During the Study
"The number of platelet transfusions needed during the study.~The events are not adjudicated. A subject could have more than one platelet transfusion." (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Platelet Transfusions (Number) |
---|
Apixaban | 266 |
Standard of Care | 248 |
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The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT)
The number of participants with non-fatal symptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose
Intervention | Participants (Count of Participants) |
---|
Apixaban | 4 |
Standard of Care | 6 |
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Change in Pharmacokinetics as Assessed by Cmax (Max Concentration)
To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures. Change in Cmax (ng/ml) between 12 months and baseline. (NCT02406885)
Timeframe: Baseline and 12 months
Intervention | ng/ml (Mean) |
---|
APB Study: Apixaban Pharmacokinetics in VSG | 5.3 |
APB Study: Apixaban Pharmacokinetics in RYGB | -6.7 |
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Change in Pharmacokinetics as Assessed by Area Under the Curve (AUC)
To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures. Change in AUC (ng*h/ml) between 12 months and baseline. (NCT02406885)
Timeframe: Baseline to 12 months
Intervention | ng*h/ml (Mean) |
---|
APB Study: Apixaban Pharmacokinetics in VSG | -168.25 |
APB Study: Apixaban Pharmacokinetics in RYGB | -166.34 |
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Change in Pharmacodynamics as Assessed by Factor Xa Levels (Percent Activity)
"To determine the durability or change in pharmacodynamics of apixaban in patients with obesity following one of two bariatric surgical procedures. Reported data is the difference between 12 months and baseline. Factor Xa levels is measured in percent activity." (NCT02406885)
Timeframe: Baseline and 12 months
Intervention | Percent Activity (Mean) |
---|
APB Study: Apixaban Pharmacokinetics in VSG | -7.3 |
APB Study: Apixaban Pharmacokinetics in RYGB | -15.7 |
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The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA
"Time to first occurrence during the 6-month treatment period with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment.~Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months
Intervention | Percentage per year (Number) |
---|
Apixaban | 15.85 |
Vitamin K Antagonist | 17.17 |
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Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA
"Time to first occurrence during the time the participants were treated with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months
Intervention | Percentage per year (Number) |
---|
Apixaban | 24.66 |
Vitamin K Antagonist | 35.79 |
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The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period
"Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo.~N is the number of participants with aspirin or placebo.~n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months
Intervention | Percentage per year (Number) |
---|
Acetylsalicylic Acid Film Coated Tablet | 40.51 |
Placebo Matching Acetylsalicylic Acid Film Coated Tablet | 21.03 |
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The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin
"Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo.~N is the number of participants treated with aspirin or placebo.~n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period.~Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months
Intervention | Percentage per year (Number) |
---|
Acetylsalicylic Acid Film Coated Tablet | 15.28 |
Placebo Matching Acetylsalicylic Acid Film Coated Tablet | 17.73 |
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The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA
"Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months
Intervention | Percentage per year (Number) |
---|
Apixaban | 57.24 |
Vitamin K Antagonist | 69.19 |
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The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin
"Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo.~N is the number of participants treated with aspirin or placebo.~n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months
Intervention | Percentage per year (Number) |
---|
Acetylsalicylic Acid Film Coated Tablet | 65.72 |
Placebo Matching Acetylsalicylic Acid Film Coated Tablet | 60.56 |
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The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period
"Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months
Intervention | Percentage per year (Number) |
---|
Apixaban | 24.66 |
Vitamin K Antagonist | 35.79 |
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6 Month Bleeding Rate
The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk. (NCT02585713)
Timeframe: Up to 6 months
Intervention | percentage of patients (Number) |
---|
Arm A (Apixaban) | 0 |
Arm B (Dalteparin) | 2.1 |
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Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
Analyzed using the same methods described above for the primary endpoint.Time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) is defined as the time from randomization to the date the patient experienced the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE). (NCT02585713)
Timeframe: Up to 3 months post-treatment
Intervention | months (Median) |
---|
Arm A (Apixaban) | NA |
Arm B (Dalteparin) | NA |
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Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed
A similar analysis as described for the primary safety analysis will be used. The rate (percentage) of patients experiencing major bleeding or a clinically relevant non-major bleed at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk. (NCT02585713)
Timeframe: Up to 6 months
Intervention | percentage of patients (Number) |
---|
Arm A (Apixaban) | 7.0 |
Arm B (Dalteparin) | 8.1 |
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Number of Patients With Cardiovascular Death
Cardiovascular death is included in this measurement. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 0 |
Uninterrupted Apixaban | 0 |
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Number of Patients With Thrombotic Events
Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 0 |
Uninterrupted Apixaban | 0 |
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Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events
"Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.~Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher." (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 14 |
Uninterrupted Apixaban | 17 |
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Number of Patients With Cardiovascular Death
Cardiovascular death is included in this measurement. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 0 |
Uninterrupted Apixaban | 0 |
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Number of Patients With TIAs or Non-Hemorrhagic Strokes
This measurement includes TIAs or non-hemorrhagic strokes. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 1 |
Uninterrupted Apixaban | 1 |
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Number of Patients With TIAs or Non-Hemorrhagic Strokes
Number of Patients who had TIAs or non-hemorrhagic strokes. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 1 |
Uninterrupted Apixaban | 1 |
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Number of Patients With Thrombotic Events
Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 0 |
Uninterrupted Apixaban | 0 |
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Number of Patients With Major Bleeding
Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 3 |
Uninterrupted Apixaban | 2 |
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Number of Patients With Major Bleeding
Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 3 |
Uninterrupted Apixaban | 2 |
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Number of Patients With Death
Death is included in this measurement. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 0 |
Uninterrupted Apixaban | 0 |
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Number of Patients With Death
Death is included in this measurement. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 0 |
Uninterrupted Apixaban | 0 |
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Number of Patients With Composite of Major Bleeding and Thrombotic Events
Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 3 |
Uninterrupted Apixaban | 2 |
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Number of Patients With Composite of Major Bleeding and Thrombotic Events
"Thrombotic events are defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.~Major bleeding is defined as bleeding meeting BARC criteria type 3 or higher." (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 3 |
Uninterrupted Apixaban | 2 |
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Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events
"Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.~Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher." (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 14 |
Uninterrupted Apixaban | 17 |
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Number of Patients With Clinically-Significant Bleeding
Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 14 |
Uninterrupted Apixaban | 17 |
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Number of Patients With Clinically-Significant Bleeding
Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation
Intervention | Participants (Count of Participants) |
---|
Interrupted Apixaban | 17 |
Uninterrupted Apixaban | 17 |
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Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days
Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 365 Days Post-Procedure
Intervention | percent of participants (Number) |
---|
AtriClip With OAC | 15.8 |
AtriClip Without OAC | 6.7 |
Combined AtriClip | 8.5 |
Standard of Care With OAC | 14.8 |
Standard of Care Without OAC | 7.5 |
Combined Standard of Care | 8.6 |
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Number of Perioperative Complications Associated With AtriClip Placement
Defined as: stroke, major bleeding that requires re-operation and/or transfusion of > 2 U packed red blood cells (PRBC), myocardial infarction (MI), or death. (NCT02701062)
Timeframe: Within any 24 hour period during the first 2 days post-index procedure
Intervention | perioperative complications reported (Number) |
---|
AtriClip® | 0 |
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Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)
Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 365 days post index procedure
Intervention | percent of participants (Number) |
---|
AtriClip With OAC | 19.6 |
AtriClip Without OAC | 8.2 |
Standard of Care With OAC | 16.0 |
Standard of Care Without OAC | 6.5 |
Combined Standard of Care | 9.9 |
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Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)
Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 30 days Post-Procedure
Intervention | percent of participants (Number) |
---|
AtriClip With OAC | 5.0 |
AtriClip Without OAC | 5.1 |
Standard of Care With OAC | 0.0 |
Standard of Care Without OAC | 8.0 |
Combined Standard of Care | 7.8 |
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Number of Subjects With Intraoperative Successful Exclusion of LAA.
Successful exclusion of LAA is defined as no (0 mm) flow between LAA and LA and < 5 mm LAA remnant by intraoperative TEE with Doppler. (NCT02701062)
Timeframe: Intraoperative period
Intervention | percentage of participants (Number) |
---|
| Total Patients, No Flow and No Stump | Total Patients, No Flow with Stump <= 5mm | Total Patients, No Flow with Stump <= 10mm |
---|
AtriClip® | 82.2 | 95.4 | 98.9 |
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Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits). (NCT02744092)
Timeframe: 6-months
Intervention | score on a scale (Mean) |
---|
Randomized Arm 1 (DOACs) | 11.6 |
Randomized Arm 2 (LMWH) | 11.3 |
Preference Cohort 1 (DOACs) | 11.5 |
Preference Cohort 2 (LMWH) | 10.1 |
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Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden). (NCT02744092)
Timeframe: 3 months
Intervention | score on a scale (Mean) |
---|
Randomized Arm 1 (DOACs) | 56.7 |
Randomized Arm 2 (LMWH) | 53.3 |
Preference Cohort 1 (DOACs) | 55.8 |
Preference Cohort 2 (LMWH) | 54.9 |
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Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden). (NCT02744092)
Timeframe: 6 months
Intervention | score on a scale (Mean) |
---|
Randomized Arm 1 (DOACs) | 56.5 |
Randomized Arm 2 (LMWH) | 54.1 |
Preference Cohort 1 (DOACs) | 54.9 |
Preference Cohort 2 (LMWH) | 53.1 |
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Cumulative Non-Fatal VTE Recurrence at 6 Months (%)
To compare the effectiveness of anticoagulation with a DOAC (intervention) with LMWH/warfarin (comparator) for preventing VTE recurrence in patients with cancer based on cumulative VTE recurrence reported by patients or clinicians at 6 months. Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE. (NCT02744092)
Timeframe: 6 months
Intervention | percentage of patients (Number) |
---|
Randomized Arm 1 (DOACs) | 6.1 |
Randomized Arm 2 (LMWH) | 8.8 |
Preference Cohort 1 (DOACs) | 7.5 |
Preference Cohort 2 (LMWH) | 4.1 |
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Cumulative Rates of Major Bleeding
To compare the harms of DOAC vs. LMWH/warfarin therapy for cancer patients with VTE based on the cumulative rate of major bleeding at 6 months. d. Major bleeding was defined as Grade >=3 on the Common Terminology Criteria for Adverse Events from the National Cancer Institute (NCI CTCAE) criteria version 5.0 (i.e., severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living). (NCT02744092)
Timeframe: 6 months
Intervention | percentage of patients (Number) |
---|
Randomized Arm 1 (DOACs) | 5.2 |
Randomized Arm 2 (LMWH) | 5.6 |
Preference Cohort 1 (DOACs) | 11.5 |
Preference Cohort 2 (LMWH) | 7.6 |
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Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits). (NCT02744092)
Timeframe: 3-months
Intervention | score on a scale (Mean) |
---|
Randomized Arm 1 (DOACs) | 11.2 |
Randomized Arm 2 (LMWH) | 10.7 |
Preference Cohort 1 (DOACs) | 10.3 |
Preference Cohort 2 (LMWH) | 10.5 |
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Number of Participants With Major Hemorrhage
(NCT02829957)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
Rivaroxaban | 0 |
Apixaban | 0 |
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Number of Participants With Venous Thromboembolism (VTE)
(NCT02829957)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
Rivaroxaban | 0 |
Apixaban | 0 |
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Number of Patients That Held Drug for Menorrhagia
(NCT02829957)
Timeframe: 1, 2, and 3 months
Intervention | Participants (Count of Participants) |
---|
Rivaroxaban | 0 |
Apixaban | 0 |
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PBAC Scores
"Measure Description: A PBAC Score of < 100 indicates a normal menstrual cycle. The lowest possible score would be zero. Higher values indicate worse outcomes. The higher theoretical range value cannot be calculated. The scoring mechanism is as follows;~Towels~1 point for each lightly stained towel~5 points or each moderately soiled towel~20 points if the towel is completely saturated with blood~Tampons~1 point for each lightly stained tampon~5 points for each moderately soiled tampon~10 points if the tampon is completely saturated with blood~Clots~1 point for small clots~5 points for large clots" (NCT02829957)
Timeframe: 3 months
Intervention | score on a scale (Median) |
---|
Rivaroxaban | 292 |
Apixaban | 146 |
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Number of Participants Who Crossed Over to Another Anticoagulant
(NCT02829957)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
Rivaroxaban | 3 |
Apixaban | 1 |
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Number of Participants Who Discontinued Planned Drug Administration
(NCT02829957)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
Rivaroxaban | 4 |
Apixaban | 2 |
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Hemoglobin Concentration
Measure Description: Normal hemoglobin range for adult women - 12 - 16 g/dL. Lower levels indicate worse outcomes. (NCT02829957)
Timeframe: 3 months
Intervention | g/dl (Median) |
---|
Rivaroxaban | 12.8 |
Apixaban | 13.25 |
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Number of Participants With Clinically Relevant Non-major Bleeding
(NCT02829957)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
Rivaroxaban | 3 |
Apixaban | 0 |
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Physical Component Summary of Standard From 36
The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. (NCT02829957)
Timeframe: 3 months
Intervention | Score (Median) |
---|
Rivaroxaban | 55.5 |
Apixaban | 45.6 |
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Total Post-operative Length of Stay
This will be measured from the date/time of the end of the subject's surgery until the date/time of the patient's discharge from the hospital. This will be measured in hours, to the nearest tenth of an hour. (NCT02889562)
Timeframe: 30 days
Intervention | hours (Mean) |
---|
Apixaban | 167.5 |
Warfarin | 143.1 |
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Units of Blood Given After Initiation of Anticoagulation Medication
Units of blood or blood products given after the first dose of anticoagulation. (NCT02889562)
Timeframe: 30 days
Intervention | total units of blood (Number) |
---|
Apixaban | 6 |
Warfarin | 2 |
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Time in Therapeutic Range of INR, if on Warfarin
Time in therapeutic range of INR, if on warfarin, (eg. 2-3), measured as a percentage and defined for each patient using the Rosendaal equation (NCT02889562)
Timeframe: 30 days
Intervention | percentage (Mean) |
---|
Warfarin | 56.8 |
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Number of Participants With Thromboembolytic Events
Efficacy will be measured by the freedom from thromboembolytic events during the study period. Events relating to thromboembolytic events will be adjudicated using pre-determined definitions by independent committee members that remain blinded to the patient's treatment arm. (NCT02889562)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|
Apixaban | 0 |
Warfarin | 0 |
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Number of Participants With Strokes
Efficacy will be measured by the freedom from stroke during the study period. Events relating to stroke will be adjudicated using pre-determined definitions by independent committee members that remain blinded to the patient's treatment arm. (NCT02889562)
Timeframe: 30 days
Intervention | participants (Number) |
---|
Apixaban | 0 |
Warfarin | 0 |
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Number of Participants Experiencing Systemic Embolism
"Adjudicated diagnosis of systemic arterial embolism (Non-pulmonary, non-cranial events) will require a positive clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which is supported by evidence of embolism/thrombosis from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.~Clinical presentation would include:~Abrupt development of pain, absent pulses, pallor, and/or paresis in an extremity (at least an entire digit) without previous severe claudication or findings of severe peripheral vascular disease.~Renal embolism will be diagnosed when sudden flank pain or a change in renal laboratory findings occurred.~Abdominal vascular/visceral embolism was considered definite if acute abdominal symptoms or referred symptoms developed along with a change in abdominal examination or appropriate laboratory values." (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit
Intervention | Participants (Count of Participants) |
---|
Apixaban | 0 |
Warfarin | 0 |
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Number of Participants Experiencing Stroke, Systemic Embolism, Major Bleeding or All-cause Mortality
"Evaluate those experiencing stroke, systemic embolism, ISTH major bleeding, or all-cause mortality for those randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis~Definitions of stroke and systemic embolism are provided under the measurement description of the secondary outcomes for each individual event. Definition of major bleed is provided in outcome measurement description of the primary outcome measure." (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit
Intervention | Participants (Count of Participants) |
---|
Apixaban | 27 |
Warfarin | 29 |
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Number of Participants Experiencing Stroke or Systemic Embolism
Number of participants experiencing adjudicated stroke or systemic embolism. (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit
Intervention | Participants (Count of Participants) |
---|
Apixaban | 2 |
Warfarin | 2 |
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Number of Participants Experiencing Stroke
"Adjudcated stroke defined as a new, non-traumatic episode of focal or global neurological dysfunction of sudden onset caused by central nervous system (CNS) vascular injury as a result of hemorrhage or infarction and not due to a readily identifiable non-vascular cause (i.e. brain tumor). CNS includes brain, spinal cord and retina. The required duration of the deficit is ≥ 24 hours.~Events with neurologic deficit lasting for < 24 hours and an imaging modality showing evidence of an acute stroke will be counted as stroke as well.~A retinal ischemic event (embolism, infarction) will be considered a stroke" (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit
Intervention | Participants (Count of Participants) |
---|
Apixaban | 2 |
Warfarin | 2 |
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Number of Participants Experiencing Mortality
Evaluate mortality rates for those participants randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit
Intervention | Participants (Count of Participants) |
---|
Apixaban | 21 |
Warfarin | 13 |
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Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding
"Assess the safety of apixaban versus warfarin regarding ISTH major bleeding or clinically relevant non-major bleeding events in patients with NVAF (nonvalvular atrial fibrillation) and ESRD (end-stage renal disease) on hemodialysis.~Major bleeding event is defined as:Acute clinically overt bleeding (including access site related bleeding) accompanied by 1 or more of the following: Decrease in Hgb of 2g/dL or more with overt bleeding; Transfusion of 2 or more units of packed RBCs in the setting of an overt bleeding event; Bleeding within a critical site. Hemorrhagic stroke (primary or infarction with hemorrhagic conversion) were classified as major bleeds.~Non-major bleeding event is defined as: Acute or sub-acute clinically overt bleeding (including access site related bleeding) that does not meet criteria for major bleeding & results in Hospital admission for bleeding, physician guided medical or surgical treatment for bleeding, or change in antithrombotic therapy" (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit
Intervention | Participants (Count of Participants) |
---|
Apixaban | 21 |
Warfarin | 16 |
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Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12)
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0 to 12 hours after dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose
Intervention | ng*h/mL (Geometric Mean) |
---|
Apixaban 2.5 mg | 507 |
Apixaban 5mg | 868 |
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Apixaban Plasma Concentration, Cmin
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose
Intervention | ng/mL (Geometric Mean) |
---|
Apixaban 2.5 mg | 28.2 |
Apixaban 5mg | 49.7 |
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Apixaban Plasma Concentration, Cmax
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose
Intervention | ng/mL (Geometric Mean) |
---|
Apixaban 2.5 mg | 59.7 |
Apixaban 5 mg | 97.9 |
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Persistence of Therapy
Evaluate days between time from initiation to discontinuation of randomized therapy. (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit
Intervention | Days (Mean) |
---|
Apixaban | 304.4 |
Warfarin | 279.6 |
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Frequency of Major and Clinically Relevant Non-major Bleeding
"Major and clinically relevant non-major bleeding. Using the ISTH classification, bleeding is defined as major if it is overt and associated with a decrease in the hemoglobin level of 2 g/dL or more, requires the transfusion of 2 or more units of blood, occurs into a critical site, or contributes to death (12).~Using the ISTH classification, clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, surgical intervention, or interruption of the study drug." (NCT02958969)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Apixaban | 3 |
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Frequency of Symptomatic Venous Thromboembolism
Symptomatic deep vein thrombosis or pulmonary embolism (NCT02958969)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Apixaban | 0 |
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Frequency of All-cause Mortality
All-cause mortality at 6 months will be recorded. Cause of death will be classified as related to cancer, myocardial infarction, PE, other cardiovascular or other disease state. Death will be attributed to PE if there is evidence to support an association with PE. (NCT02958969)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Apixaban | 0 |
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Frequency of Atherothrombotic Events
6-month rates of myocardial infarction and stroke will be calculated. (NCT02958969)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Apixaban | 0 |
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The Number of Participants With Adjudicated Major Bleeding
"The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).~Major bleeding is defined as bleeding that satisfies one or more of the following criteria:~fatal bleeding~clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period~bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS~bleeding that requires surgical intervention in an operating suite, including interventional radiology" (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
Intervention | Participants (Count of Participants) |
---|
Apixaban | 1 |
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 1 |
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The Number of Participants With Adjudicated CRNM Bleeding
"The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).~CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:~overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition~bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room" (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
Intervention | Participants (Count of Participants) |
---|
Apixaban | 1 |
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 2 |
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The Number of Participant Deaths in the Study
The number of participant deaths in the study. (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
Intervention | Participants (Count of Participants) |
---|
Apixaban | 0 |
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 0 |
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Maximum Observed Concentration (Cmax)
(NCT02981472)
Timeframe: From first dose up to 6 months after first dose
Intervention | ng/mL (Geometric Mean) |
---|
Participants Weight Range 6 to < 9 kg | 185 |
Participants Weight Range 9 to < 12 kg | 218 |
Participants Weight Range 12 to < 18 kg | 222 |
Participants Weight Range 18 to < 25 kg | 244 |
Participants Weight Range 25 to < 35 kg | 249 |
Participants Weight Range ≥ 35 kg | 203 |
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Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
"The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC).~Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology.~CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room." (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
Intervention | Participants (Count of Participants) |
---|
Apixaban | 1 |
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 3 |
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Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
(NCT02981472)
Timeframe: From first dose up to 6 months after first dose
Intervention | ng • h/mL (Geometric Mean) |
---|
Participants Weight Range 6 to < 9 kg | 1460 |
Participants Weight Range 9 to < 12 kg | 1840 |
Participants Weight Range 12 to < 18 kg | 1610 |
Participants Weight Range 18 to < 25 kg | 1760 |
Participants Weight Range 25 to < 35 kg | 1840 |
Participants Weight Range ≥ 35 kg | 1630 |
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The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
"Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.~PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot).~Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems." (NCT02981472)
Timeframe: from randomization up to 12 months after randomization
Intervention | Score on a scale (Mean) |
---|
| GENERAL-SPECIFIC MODULE ASSESSED BY CHILD - BASELINE | GENERAL-SPECIFIC MODULE ASSESSED BY CHILD - MONTH 12 | GENERAL-SPECIFIC MODULE ASSESSED BY PARENT - BASELINE | GENERAL-SPECIFIC MODULE ASSESSED BY PARENT - MONTH 12 | HEART PROBLEMS AND TREATMENT ASSESSED BY CHILD - BASELINE | HEART PROBLEMS AND TREATMENT ASSESSED BY CHILD - MONTH 12 | TREATMENT II ASSESSED BY CHILD - BASELINE | TREATMENT II ASSESSED BY CHILD - MONTH 12 | PERCEIVED PHYSICAL APPEARANCE ASSESSED BY CHILD - BASELINE | PERCEIVED PHYSICAL APPEARANCE ASSESSED BY CHILD - MONTH 12 | TREATMENT ANXIETY ASSESSED BY CHILD - BASELINE | TREATMENT ANXIETY ASSESSED BY CHILD - MONTH 12 | COGNITIVE PROBLEMS ASSESSED BY CHILD - BASELINE | COGNITIVE PROBLEMS ASSESSED BY CHILD - MONTH 12 | COMMUNICATION ASSESSED BY CHILD - BASELINE | COMMUNICATION ASSESSED BY CHILD - MONTH 12 | HEART PROBLEMS AND TREATMENT ASSESSED BY PARENT - BASELINE | HEART PROBLEMS AND TREATMENT ASSESSED BY PARENT - MONTH 12 | TREATMENT II ASSESSED BY PARENT - BASELINE | TREATMENT II ASSESSED BY PARENT - MONTH 12 | PERCEIVED PHYSICAL APPEARANCE ASSESSED BY PARENT - BASELINE | PERCEIVED PHYSICAL APPEARANCE ASSESSED BY PARENT - MONTH 12 | TREATMENT ANXIETY ASSESSED BY PARENT - BASELINE | TREATMENT ANXIETY ASSESSED BY PARENT - MONTH 12 | COGNITIVE PROBLEMS ASSESSED BY PARENT - BASELINE | COGNITIVE PROBLEMS ASSESSED BY PARENT - MONTH 12 | COMMUNICATION ASSESSED BY PARENT - BASELINE | COMMUNICATION ASSESSED BY PARENT - MONTH 12 |
---|
Apixaban | 69.64 | 73.37 | 65.61 | 70.00 | 65.34 | 69.46 | 87.39 | 91.77 | 75.51 | 80.56 | 80.52 | 80.71 | 69.85 | 68.24 | 66.15 | 70.31 | 63.68 | 66.37 | 91.41 | 90.30 | 79.16 | 79.38 | 61.44 | 64.03 | 60.29 | 58.69 | 65.57 | 68.20 |
,Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 60.71 | 64.81 | 65.42 | 70.32 | 64.70 | 63.44 | 85.68 | 86.27 | 78.44 | 81.37 | 60.31 | 60.31 | 53.24 | 53.53 | 63.55 | 57.28 | 67.71 | 69.00 | 85.27 | 83.80 | 79.66 | 74.33 | 56.27 | 57.77 | 61.60 | 58.53 | 67.33 | 66.17 |
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Chromogenic FX Assay (Apparent FX Level)
"Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban.~125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below." (NCT02981472)
Timeframe: From first dose up to 6 months after first dose
Intervention | Percent (Mean) |
---|
| Day 1 (PREDOSE) | Day 1 (4 HRS POSTDOSE) | Week 2 (PREDOSE) | Week 2 (2 HRS POSTDOSE) | Month 3 (2 HRS POSTDOSE) | Month 6 (PREDOSE) |
---|
Apixaban | 58.87 | 18.90 | 35.88 | 21.26 | 18.25 | 36.57 |
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Anti-FXa Activity
"Anti-FXa Activity was measured to assess participant plasma apixaban levels.~125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below." (NCT02981472)
Timeframe: From first dose up to 6 months after first dose
Intervention | ng/mL (Mean) |
---|
| Day 1 (4 HRS POSTDOSE) | Week 2 (PREDOSE) | Week 2 (2 HRS POSTDOSE) | Month 3 (2 HRS POSTDOSE) | Month 6 (PREDOSE) |
---|
Apixaban | 147.69 | 86.24 | 242.34 | 228.88 | 66.93 |
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Trough Observed Concentration (Cmin)
(NCT02981472)
Timeframe: From first dose up to 6 months after first dose
Intervention | ng/mL (Geometric Mean) |
---|
Participants Weight Range 6 to < 9 kg | 57.9 |
Participants Weight Range 9 to < 12 kg | 82.7 |
Participants Weight Range 12 to < 18 kg | 64.3 |
Participants Weight Range 18 to < 25 kg | 67.4 |
Participants Weight Range 25 to < 35 kg | 73.1 |
Participants Weight Range ≥ 35 kg | 72.7 |
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Time of Maximum Observed Concentration (Tmax)
(NCT02981472)
Timeframe: From first dose up to 6 months after first dose
Intervention | hours (Median) |
---|
Participants Weight Range 6 to < 9 kg | 2.24 |
Participants Weight Range 9 to < 12 kg | 2.47 |
Participants Weight Range 12 to < 18 kg | 1.72 |
Participants Weight Range 18 to < 25 kg | 1.74 |
Participants Weight Range 25 to < 35 kg | 1.65 |
Participants Weight Range ≥ 35 kg | 1.85 |
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The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding. (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
Intervention | Participants (Count of Participants) |
---|
Apixaban | 7 |
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 1 |
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The Number of Participants With All Adjudicated Bleeding
The number of participants with all adjudicated bleeding events (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
Intervention | Participants (Count of Participants) |
---|
Apixaban | 47 |
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 23 |
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Change of Left Ventricular Thrombosis (LVT) by More Than 50%
Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms. (NCT02982590)
Timeframe: 3 months
Intervention | percentage of participants (Number) |
---|
Warfarin Sodium | 77.7 |
Apixaban | 61.5 |
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Clinically Definite Cardiac Embolic Ischemic Stroke
Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan (NCT02982590)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
Warfarin Sodium | 0 |
Apixaban | 1 |
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Life Threatening Bleeding
Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation. (NCT02982590)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
Warfarin Sodium | 1 |
Apixaban | 0 |
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Percent Change in Left Ventricular Thrombus (LVT) Size
Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment (NCT02982590)
Timeframe: 3 months
Intervention | percentage of change (Mean) |
---|
Warfarin Sodium | -61.45 |
Apixaban | -65.08 |
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Overall Major Bleeding
"The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 1.82 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 2.24 |
Dabigatran (Dabigatran vs Apixaban) | 1.69 |
Apixaban (Dabigatran vs Apixaban) | 1.24 |
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Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
"The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:~The day of discontinuation of the index NOAC exposure;~The day before a switch to an anticoagulant different from the index exposure;~The day before a change in dose for the index NOAC;~The end of continuous eligibility of a patient in the health plan (disenrollment);~The end of the study observation period; or~The date of death of the patient." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 0.52 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 0.69 |
Dabigatran (Dabigatran vs Apixaban) | 0.46 |
Apixaban (Dabigatran vs Apixaban) | 0.36 |
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TIA
"The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 0.26 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 0.20 |
Dabigatran (Dabigatran vs Apixaban) | 0.28 |
Apixaban (Dabigatran vs Apixaban) | 0.17 |
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Upper GI Bleeding
"The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 0.41 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 0.55 |
Dabigatran (Dabigatran vs Apixaban) | 0.37 |
Apixaban (Dabigatran vs Apixaban) | 0.34 |
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Major Intracranial Bleeding
"The event rate of major intracranial bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 0.27 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 0.41 |
Dabigatran (Dabigatran vs Apixaban) | 0.24 |
Apixaban (Dabigatran vs Apixaban) | 0.21 |
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Major GI Bleeding
"The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 1.45 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 1.66 |
Dabigatran (Dabigatran vs Apixaban) | 1.36 |
Apixaban (Dabigatran vs Apixaban) | 0.92 |
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Major Extracranial Bleeding
"The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 1.55 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 1.83 |
Dabigatran (Dabigatran vs Apixaban) | 1.44 |
Apixaban (Dabigatran vs Apixaban) | 1.03 |
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Lower GI Bleeding
"The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 1.08 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 1.17 |
Dabigatran (Dabigatran vs Apixaban) | 0.98 |
Apixaban (Dabigatran vs Apixaban) | 0.58 |
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Ischemic Stroke
"The event rate of ischemic stroke in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 0.5 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 0.54 |
Dabigatran (Dabigatran vs Apixaban) | 0.39 |
Apixaban (Dabigatran vs Apixaban) | 0.36 |
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Hemorrhagic Stroke
"The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 0.03 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 0.16 |
Dabigatran (Dabigatran vs Apixaban) | 0.07 |
Apixaban (Dabigatran vs Apixaban) | NA |
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All-cause Mortality
"The event rate of all-cause mortality in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 1.54 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 1.37 |
Dabigatran (Dabigatran vs Apixaban) | 1.46 |
Apixaban (Dabigatran vs Apixaban) | 1.25 |
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Major Urogenital Bleeding
"The event rate of major urogenital bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | NA |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 0.01 |
Dabigatran (Dabigatran vs Apixaban) | NA |
Apixaban (Dabigatran vs Apixaban) | NA |
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Major Other Bleeding
"The event rate of major other bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Intervention | Event Rate in 100 person-years (Number) |
---|
Dabigatran (Dabigatran vs Rivaroxaban) | 0.13 |
Rivaroxaban (Dabigatran vs Rivaroxaban) | 0.18 |
Dabigatran (Dabigatran vs Apixaban) | 0.11 |
Apixaban (Dabigatran vs Apixaban) | 0.13 |
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Cumulative Incidence Function of DVT/PE Treating Death or AE Resulting in End of Treatment as Competing Risk by Study Arm
For the secondary outcome analysis, the time from starting treatment to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) outcome will be analyzed using the same method described in the section for primary outcome plan. For this outcome, death without DVT/PE and adverse events leading to termination of treatment will be treated as the competing risks. (NCT03080883)
Timeframe: 12 months
Intervention | proportion of participants (Number) |
---|
Group I (2.5mg Dose Apixaban) | 5.8 |
Group II (5mg Dose Apixaban) | 7.1 |
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CIF of Major or Clinically Relevant Non-major Bleeding Combined With Death as Competing Risk
Incidence of major bleeding and clinically relevant non-major bleeding will be estimated using the cumulative incidence function (CIF) with death without major bleeding or clinically relevant non-major bleeding and with adverse events that results in termination of treatment (including vascular events) as competing risks. The time to event is defined as the time from randomization to the first occurrence of a major bleeding, a clinically relevant non-major bleeding, death without major bleeding or clinically relevant non-major bleeding, or an adverse event that results in termination of treatment. Patients who were lost to follow-up, who withdrew informed consent before the end of the predefined study duration will be censored at the last day the patient had a complete assessment for study outcomes within the intended study period. The difference in the incidences of the combined endpoint at 12 months between treatment arms will be estimated along with a 95% confidence interval (NCT03080883)
Timeframe: 12 months
Intervention | proportion of participants (Number) |
---|
Group I (2.5mg Dose Apixaban) | 9.6 |
Group II (5mg Dose Apixaban) | 13.5 |
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Proportion of Patients Who Experienced at Least One Bleeding Event
Incidence of major bleeding and clinically relevant non-major bleeding will be estimated using the cumulative incidence function (CIF) with death without major bleeding or clinically relevant non-major bleeding and with adverse events that results in termination of treatment (including vascular events) as competing risks. The time to event is defined as the time from randomization to the first occurrence of a major bleeding, a clinically relevant non-major bleeding, death without major bleeding or clinically relevant non-major bleeding, or an adverse event that results in termination of treatment. Patients who were lost to follow-up, who withdrew informed consent before the end of the predefined study duration will be censored at the last day the patient had a complete assessment for study outcomes within the intended study period. The difference in the incidences of the combined endpoint at 6 months between treatment arms will be estimated along with a 95% confidence interval. (NCT03080883)
Timeframe: 6 months
Intervention | proportion of participants (Number) |
---|
Group I (2.5mg Dose Apixaban) | 4.9 |
Group II (5mg Dose Apixaban) | 5.8 |
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Number of Subjects With Recurrent Venous Thromboembolism (VTE)
Primary efficacy outcome of recurrent VTE (NCT03196349)
Timeframe: Randomization to 12 months
Intervention | Participants (Count of Participants) |
---|
Warfarin | 0 |
Apixaban | 1 |
Rivaroxaban | 0 |
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Number of Subjects With Clinically Relevant Bleeding Events
Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB)) (NCT03196349)
Timeframe: Randomization to 12 months
Intervention | Participants (Count of Participants) |
---|
Warfarin | 0 |
Apixaban | 0 |
Rivaroxaban | 0 |
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Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke)
MI, ischemic stroke, peripheral arterial embolism (NCT03196349)
Timeframe: Randomization to 12 months
Intervention | Participants (Count of Participants) |
---|
Warfarin | 1 |
Apixaban | 0 |
Rivaroxaban | 0 |
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Number of Subjects Experiencing Major Bleeding
Major bleeding (NCT03196349)
Timeframe: Randomization to 12 months
Intervention | Participants (Count of Participants) |
---|
Warfarin | 0 |
Apixaban | 0 |
Rivaroxaban | 0 |
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Number of Subjects Experiencing Clinically Relevant Non-major Bleeding
Clinically relevant non-major bleeding (NCT03196349)
Timeframe: Randomization to 12 months
Intervention | Participants (Count of Participants) |
---|
Warfarin | 0 |
Apixaban | 0 |
Rivaroxaban | 0 |
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Number of Subjects With Premature Termination of Study Medication
Premature termination of study medication (NCT03196349)
Timeframe: Randomization to 12 months
Intervention | Participants (Count of Participants) |
---|
Warfarin | 0 |
Apixaban | 0 |
Rivaroxaban | 0 |
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Number of Subjects Experiencing All-cause Mortality
All cause mortality (NCT03196349)
Timeframe: Randomization to 12 months
Intervention | Participants (Count of Participants) |
---|
Warfarin | 0 |
Apixaban | 0 |
Rivaroxaban | 0 |
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Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)
Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 1 |
JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 2 |
JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 1 |
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 0 |
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Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)
Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 1 |
JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 2 |
JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 1 |
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 0 |
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Number of Participants With Death (CEC-adjudicated)
Number of participants with death (adjudicated by CEC) were reported. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 0 |
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 0 |
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Number of Participants With Major Bleeding Event (CEC-adjudicated)
Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 0 |
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 0 |
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Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)
Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. (NCT03251482)
Timeframe: Up to Day 10 and 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 1 |
JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 2 |
JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 1 |
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 0 |
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Number of Participants With Minimal Bleeding Events (CEC-adjudicated)
Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 2 |
JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 4 |
JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 0 |
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 4 |
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Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
Number of participants with nonfatal PE (adjudicated by CEC) were reported. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 0 |
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 0 |
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Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)
Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 10 |
JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 9 |
JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 9 |
JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 31 |
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 6 |
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Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)
Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 2 |
JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 0 |
JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 5 |
JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 1 |
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 4 |
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Number of Participants With Distal DVT (CEC-adjudicated)
Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
| Asymptomatic | Symptomatic |
---|
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 6 | 1 |
,JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 8 | 0 |
,JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 7 | 0 |
,JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 8 | 0 |
,JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 24 | 1 |
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Number of Participants With Proximal and Distal DVT (CEC-adjudicated)
Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
| Asymptomatic | Symptomatic |
---|
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 0 | 0 |
,JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 1 | 0 |
,JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 0 | 0 |
,JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 1 | 0 |
,JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 4 | 0 |
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Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)
Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
| Asymptomatic | Symptomatic |
---|
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 0 | 0 |
,JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 1 | 0 |
,JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 2 | 0 |
,JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 0 | 0 |
,JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 3 | 2 |
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Number of Participants With Major VTE (CEC-adjudicated)
Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)
Intervention | Participants (Count of Participants) |
---|
JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 2 |
JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 2 |
JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 1 |
JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 7 |
Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 0 |
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The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma. (NCT03254147)
Timeframe: One year
Intervention | Number of Patients (Number) |
---|
| Age <=64 | Age 65-74 | Age >=75 |
---|
Patients Prescribed With Non-warfarin Oral Anti Coagulants | 14 | 35 | 84 |
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The Number of Patients With Cardiac Tamponade and Pericardiocentesis.
The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI. (NCT03254147)
Timeframe: One year
Intervention | Number of Patients (Number) |
---|
Patients Prescribed With Non-warfarin Oral Anti Coagulants | 1 |
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Change in Thrombin Generation From Baseline to the End of Bolus (EOB) Nadir.
The change in thrombin generation from baseline to its EOB peak. (NCT03310021)
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours
Intervention | nM.min (Median) |
---|
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet | 1145.03 |
Cohort 1 Apixaban 5 mg BID/Placebo | 179.94 |
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet | 1337.28 |
Cohort 2 Rivaroxaban 15 mg BID/Placebo | 209.99 |
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet | 758.92 |
Cohort 3 Edooxaban 60 mg QD/Placebo | 215.71 |
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet | 815.07 |
Cohort 4 Edooxaban 60 mg QD/Placebo | 48.59 |
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet | 1244.30 |
Cohort 5 Apixaban 5 mg BID/Placebo | 103.13 |
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet | 1177.47 |
Cohort 6 Apixaban 10 mg BID/Placebo | 0.16 |
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet | 781.42 |
Cohort 7 Edoxaban 30 mg QD/Placebo | 67.97 |
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet | 1184.62 |
Cohort 8 Apixaban 10 mg BID/Placebo | 2.69 |
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet | 1306.23 |
Cohort 9 Rivaroxaban 15 mg BID/Placebo | 117.50 |
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet | 902.17 |
Cohort 10 Edoxaban 60 mg QD/Placebo | -92.82 |
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Percent Change in Anti-Fxa Activity From Baseline to the End of Bolus (EOB) Nadir.
The percent change from baseline in anti-FXa activity at its end of bolus (EOB) nadir. (NCT03310021)
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours
Intervention | percent change (Median) |
---|
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet | -94.50 |
Cohort 1 Apixaban 5 mg BID/Placebo | -14.00 |
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet | -97.50 |
Cohort 2 Rivaroxaban 15 mg BID/Placebo | -18.00 |
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet | -65.50 |
Cohort 3 Edooxaban 60 mg QD/Placebo | -16.00 |
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet | -22.50 |
Cohort 4 Edooxaban 60 mg QD/Placebo | -15.00 |
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet | -94.00 |
Cohort 5 Apixaban 5 mg BID/Placebo | -10.00 |
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet | -96.00 |
Cohort 6 Apixaban 10 mg BID/Placebo | -18.00 |
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet | -58.00 |
Cohort 7 Edoxaban 30 mg QD/Placebo | -8.00 |
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet | -94.50 |
Cohort 8 Apixaban 10 mg BID/Placebo | -5.00 |
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet | -95.00 |
Cohort 9 Rivaroxaban 15 mg BID/Placebo | -11.00 |
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet | -73.00 |
Cohort 10 Edoxaban 60 mg QD/Placebo | -4.00 |
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Percent Change in Anti-Fxa Activity From Baseline to the End of Infusion (EOI) Nadir.
The primary efficacy endpoint is the percent change in the anti-FXa activity from baseline to the end of infusion (EOI) nadir. (NCT03310021)
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours
Intervention | percent change (Median) |
---|
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet | -94.50 |
Cohort 1 Apixaban 5 mg BID/Placebo | -29.00 |
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet | -98.00 |
Cohort 2 Rivaroxaban 15 mg BID/Placebo | -37.00 |
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet | -81.00 |
Cohort 3 Edooxaban 60 mg QD/Placebo | -47.50 |
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet | -75.50 |
Cohort 4 Edooxaban 60 mg QD/Placebo | -37.00 |
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet | -93.00 |
Cohort 5 Apixaban 5 mg BID/Placebo | -34.00 |
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet | -97.00 |
Cohort 6 Apixaban 10 mg BID/Placebo | -31.00 |
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet | -52.50 |
Cohort 7 Edoxaban 30 mg QD/Placebo | -37.00 |
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet | -92.00 |
Cohort 8 Apixaban 10 mg BID/Placebo | -24.00 |
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet | -93.50 |
Cohort 9 Rivaroxaban 15 mg BID/Placebo | -37.00 |
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet | -63.50 |
Cohort 10 Edoxaban 60 mg QD/Placebo | -27.00 |
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Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Bolus (EOB) Nadir.
The percent change from baseline in free FXa inhibitors concentration (ng/mL) at its EOB nadir. (NCT03310021)
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours
Intervention | percent change (Median) |
---|
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet | -93.00 |
Cohort 1 Apixaban 5 mg BID/Placebo | -11.94 |
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet | -97.72 |
Cohort 2 Rivaroxaban 15 mg BID/Placebo | -28.57 |
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet | -78.20 |
Cohort 3 Edooxaban 60 mg QD/Placebo | -17.60 |
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet | -56.05 |
Cohort 4 Edooxaban 60 mg QD/Placebo | -2.49 |
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet | -94.45 |
Cohort 5 Apixaban 5 mg BID/Placebo | 5.80 |
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet | -93.57 |
Cohort 6 Apixaban 10 mg BID/Placebo | -12.94 |
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet | -70.88 |
Cohort 7 Edoxaban 30 mg QD/Placebo | -5.48 |
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet | -91.61 |
Cohort 8 Apixaban 10 mg BID/Placebo | -0.32 |
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet | -95.51 |
Cohort 9 Rivaroxaban 15 mg BID/Placebo | -14.02 |
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet | -75.80 |
Cohort 10 Edoxaban 60 mg QD/Placebo | -17.91 |
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Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Infusion (EOI) Nadir.
The percent change from baseline in free FXa inhibitors concentration (ng/mL) at its EOI nadir. (NCT03310021)
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours
Intervention | percent change (Median) |
---|
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet | -92.940 |
Cohort 1 Apixaban 5 mg BID/Placebo | -33.550 |
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet | -98.650 |
Cohort 2 Rivaroxaban 15 mg BID/Placebo | -39.390 |
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet | -85.005 |
Cohort 3 Edooxaban 60 mg QD/Placebo | -48.710 |
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet | -81.040 |
Cohort 4 Edooxaban 60 mg QD/Placebo | -42.755 |
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet | -93.495 |
Cohort 5 Apixaban 5 mg BID/Placebo | -31.830 |
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet | -96.65 |
Cohort 6 Apixaban 10 mg BID/Placebo | -29.02 |
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet | -62.72 |
Cohort 7 Edoxaban 30 mg QD/Placebo | -24.34 |
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet | -90.63 |
Cohort 8 Apixaban 10 mg BID/Placebo | -31.45 |
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet | -94.89 |
Cohort 9 Rivaroxaban 15 mg BID/Placebo | -37.82 |
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet | -67.10 |
Cohort 10 Edoxaban 60 mg QD/Placebo | -34.25 |
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Change in Thrombin Generation From Baseline to the End of Infusion (EOI) Nadir.
The change in thrombin generation from baseline to its EOI peak. (NCT03310021)
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours
Intervention | nM.min (Median) |
---|
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet | 1000.630 |
Cohort 1 Apixaban 5 mg BID/Placebo | 171.220 |
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet | 1329.580 |
Cohort 2 Rivaroxaban 15 mg BID/Placebo | 207.590 |
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet | 804.405 |
Cohort 3 Edooxaban 60 mg QD/Placebo | 347.535 |
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet | 910.935 |
Cohort 4 Edooxaban 60 mg QD/Placebo | 236.610 |
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet | 1130.575 |
Cohort 5 Apixaban 5 mg BID/Placebo | 118.130 |
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet | 1119.41 |
Cohort 6 Apixaban 10 mg BID/Placebo | 108.67 |
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet | 833.46 |
Cohort 7 Edoxaban 30 mg QD/Placebo | 175.72 |
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet | 1058.09 |
Cohort 8 Apixaban 10 mg BID/Placebo | 138.14 |
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet | 1173.38 |
Cohort 9 Rivaroxaban 15 mg BID/Placebo | 293.15 |
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet | 793.44 |
Cohort 10 Edoxaban 60 mg QD/Placebo | -72.69 |
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Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2). (NCT03441633)
Timeframe: Day 1
Intervention | Participants (Count of Participants) |
---|
| Missing | 18.5 - 25 kg per m^2 (Normal) | Less than (<) 18.5 kg per m^2 (Underweight) | 25 - 30 kg per m^2 (Overweight) | Greater than (>) 30 kg per m^2 (Obese) |
---|
Acenocoumarol: Naive | 6898 | 4471 | 141 | 10074 | 10628 |
,Acenocoumarol: Non-Naive | 34 | 30 | 0 | 68 | 60 |
,Apixaban: Naive | 1424 | 423 | 12 | 1229 | 1624 |
,Apixaban: Non Naive | 261 | 253 | 6 | 493 | 410 |
,Dabigatran: Naive | 960 | 272 | 10 | 735 | 878 |
,Dabigatran: Non-Naive | 178 | 144 | 8 | 306 | 317 |
,Rivaroxaban: Naive | 1746 | 464 | 16 | 1289 | 1617 |
,Rivaroxaban: Non-Naive | 311 | 271 | 0 | 482 | 498 |
,Warfarin: Naive | 509 | 295 | 6 | 712 | 764 |
,Warfarin: Non-Naive | 87 | 78 | 2 | 119 | 77 |
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Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)
NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription
Intervention | milligrams per day (Median) |
---|
Apixaban: Naive | 15.0 |
Apixaban: Non Naive | 30.0 |
Acenocoumarol: Naive | 16.0 |
Acenocoumarol: Non-Naive | 16.0 |
Warfarin: Naive | 53.0 |
Warfarin: Non-Naive | 16.0 |
Dabigatran: Naive | 22.0 |
Dabigatran: Non-Naive | 22.0 |
Rivaroxaban: Naive | 21.0 |
Rivaroxaban: Non-Naive | 28.0 |
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International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (23). (NCT03441633)
Timeframe: Up to 12 months after date of first prescription
Intervention | ratio (Mean) |
---|
Acenocoumarol: Naive | 2.5 |
Acenocoumarol: Non-Naive | 2.5 |
Warfarin: Naive | 2.5 |
Warfarin: Non-Naive | 2.6 |
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Number of Participants by Comedications
Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine. (NCT03441633)
Timeframe: Up to 30 days after date of first prescription
Intervention | Participants (Count of Participants) |
---|
Apixaban: Naive | 4712 |
Apixaban: Non Naive | 1406 |
Acenocoumarol: Naive | 32212 |
Acenocoumarol: Non-Naive | 188 |
Warfarin: Naive | 2286 |
Warfarin: Non-Naive | 352 |
Dabigatran: Naive | 2855 |
Dabigatran: Non-Naive | 947 |
Rivaroxaban: Naive | 5132 |
Rivaroxaban: Non-Naive | 1532 |
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Number of Participants by Comorbidity
Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription
Intervention | Participants (Count of Participants) |
---|
Apixaban: Naive | 3695 |
Apixaban: Non Naive | 1316 |
Acenocoumarol: Naive | 26450 |
Acenocoumarol: Non-Naive | 173 |
Warfarin: Naive | 1819 |
Warfarin: Non-Naive | 318 |
Dabigatran: Naive | 2030 |
Dabigatran: Non-Naive | 870 |
Rivaroxaban: Naive | 3731 |
Rivaroxaban: Non-Naive | 1417 |
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Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year
Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription
Intervention | Participants (Count of Participants) |
---|
Apixaban: Naive | 881 |
Apixaban: Non Naive | 236 |
Acenocoumarol: Naive | 11326 |
Acenocoumarol: Non-Naive | 85 |
Warfarin: Naive | 1009 |
Warfarin: Non-Naive | 127 |
Dabigatran: Naive | 1002 |
Dabigatran: Non-Naive | 248 |
Rivaroxaban: Naive | 1191 |
Rivaroxaban: Non-Naive | 322 |
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Risk of Bleeding Events: HAS-BLED Score
Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and >3 = high risk of bleed per 100 participants-year. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment
Intervention | bleed per 100 participants-year (Mean) |
---|
Apixaban: Naive | 1.7 |
Apixaban: Non Naive | 2.7 |
Acenocoumarol: Naive | 2.2 |
Acenocoumarol: Non-Naive | 2.5 |
Warfarin: Naive | 1.9 |
Warfarin: Non-Naive | 2.4 |
Dabigatran: Naive | 1.5 |
Dabigatran: Non-Naive | 2.6 |
Rivaroxaban: Naive | 1.6 |
Rivaroxaban: Non-Naive | 2.6 |
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Risk of Thromboembolic Events: CHA2DS2Vasc Score
Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, >=65 and <75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age >=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment
Intervention | stroke risk per year (Mean) |
---|
Apixaban: Naive | 3.0 |
Apixaban: Non Naive | 4.4 |
Acenocoumarol: Naive | 3.2 |
Acenocoumarol: Non-Naive | 3.7 |
Warfarin: Naive | 2.9 |
Warfarin: Non-Naive | 3.9 |
Dabigatran: Naive | 2.7 |
Dabigatran: Non-Naive | 4.0 |
Rivaroxaban: Naive | 2.7 |
Rivaroxaban: Non-Naive | 4.1 |
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Risk of Thromboembolic Events: CHADS2 Score
Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age >=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment
Intervention | stroke risk per year (Mean) |
---|
Apixaban: Naive | 1.7 |
Apixaban: Non Naive | 2.8 |
Acenocoumarol: Naive | 1.9 |
Acenocoumarol: Non-Naive | 2.3 |
Warfarin: Naive | 1.8 |
Warfarin: Non-Naive | 2.5 |
Dabigatran: Naive | 1.5 |
Dabigatran: Non-Naive | 2.6 |
Rivaroxaban: Naive | 1.5 |
Rivaroxaban: Non-Naive | 2.6 |
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Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (23). (NCT03441633)
Timeframe: Up to 12 months after date of first prescription
Intervention | days (Median) |
---|
Acenocoumarol: Naive | 60.2 |
Acenocoumarol: Non-Naive | 59.6 |
Warfarin: Naive | 66.2 |
Warfarin: Non-Naive | 58.9 |
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AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A | 714.7 |
Treatment B | 787.9 |
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T-Half - Terminal Plasma Half Life.
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of time required to reach to half of plasma concentration (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | h (hours) (Geometric Mean) |
---|
Treatment A | 8.81 |
Treatment B | 7.91 |
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AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A | 695.9 |
Treatment B | 769.2 |
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Number of Participants With Out-of Range Vital Signs: Blood Pressure
"Number of participants with Out-of Range Blood Pressure changes as follows:~Systolic Blood Pressure (SBP) mmHg < 90 and change from baseline < -20 > 140 and change from baseline > 20~Diastolic Blood Pressure (DBP) mmHg < 55 and change from baseline < -10 > 90 and change from baseline > 10" (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | participants (Number) |
---|
| SBP < 90 and change from baseline < -20 | SBP >140 and change from baseline >20 | DBP < 55 and change from baseline < -10 | DBP >90 and change from baseline >10 |
---|
Treatment A | 0 | 0 | 0 | 0 |
,Treatment B | 0 | 0 | 1 | 0 |
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Tmax - Time of Maximum Observed Plasma Concentration
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms time of maximum concentration (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | h (hours) (Geometric Mean) |
---|
Treatment A | 2.30 |
Treatment B | 0.98 |
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Number of Participants With Out-of Range ECG Evaluations
Number of participants with out-of-range ECG changes. ECG intervals are measured in milliseconds (msec) (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | participants (Number) |
---|
| PR Interval Baseline ≤ 200 | PR Interval Baseline >200 | PR Interval Maximum on Treatment ≤ 200 | PR Interval Maximum on Treatment >200 | QRS Interval Baseline ≤ 120 | QRS Interval Baseline >200 | QRS Interval Maximum on Treatment ≤ 120 | QRS Interval Maximum on Treatment > 120 | QT Interval Baseline ≤ 500 | QT Interval Baseline >500 | QT Interval Maximum on Treatment ≤ 500 | QT Interval Maximum on Treatment > 500 | QT Interval Increase from Baseline ≤ 30 | QT Interval Increase from Baseline > 30 | QTcF Interval Baseline ≤ 450 | QTcF Interval Baseline >450 | QTcF Interval Maximum on Treatment ≤ 450 | QTcF Interval Maximum on Treatment > 450 | QTcF Interval Increase from Baseline ≤ 30 | QTcF Interval Increase from Baseline > 30 |
---|
Treatment A | 30 | 0 | 29 | 1 | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 29 | 1 | 30 | 0 | 30 | 0 | 30 | 0 |
,Treatment B | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 29 | 1 | 30 | 0 | 30 | 0 | 30 | 0 |
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Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation
Adverse events regardless of causality, Serious Adverse Events & Adverse events leading to discontinuation (NCT03509883)
Timeframe: Day 1 to Day 38
Intervention | Participants (Number) |
---|
| Adverse Events | Serious Adverse Events | Adverse Events leading to Discontinuation |
---|
Treatment A | 7 | 0 | 0 |
,Treatment B | 3 | 0 | 0 |
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Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | ng/mL (Geometric Mean) |
---|
Treatment A | 77.4 |
Treatment B | 99.3 |
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Number of Participants With a Given Clinical Laboratory Abnormality
Assessment of clinical laboratory abnormalities (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | participants (Number) |
---|
| hemoglobin abnormal low | Hematocrit abnormal low | Platelet count abnormal low | platelet count abnormal high | Leukocytes abnormal low | Leukocytes Abnormal high | Neutrophils (Absolute) Abnormal low | Lymphocytes abnormal low | Lymphocytes Abnormal high | Monocytes (Absolute) Abnormal High | Basophils (absolute) Abnormal High | Eosinophils (absolute) Abnormal High | Prothrombin Time (PT) Abnormal High | International Normalized Ratio (INR) Abnormal High | Alkaline Phosphate (ALP) Abnormal High | Aspartate Aminotransferase (AST) Abnormal High | Alanine Aminotransferase (ALT) Abnormal High | Bilirubin, Total Abnormal High | Blood Urea Nitrogen (BUN) Abnormal High | Creatinine Abnormal High | Sodium Abnormal Low | Sodium, Serum Abnormal High | Potassium Abnormal Low | Potassium, Serum Abnormal High | Chloride, Serum Abnormal Low | Chloride, Serum Abnormal High | Calcium, Serum Abnormal Low | Calcium, Serum Abnormal High | Phosphorus, Inorganic Abnormal Low | Phosphorus, Inorganic Abnormal High | Glucose, Fasting Serum Abnormal Low | Glucose, Fasting Serum Abnormal High | Protein, Total Abnormal Low | Protein, Total Abnormal High | Albumin Abnormal Low | Lactate Dehydrogenase (LDH) Abnormal High | Protein, Urine Abnormal High | Glucose, Urine Abnormal High | Blood, Urine Abnormal High | WBC, Urine Abnormal High | RBC, Urine Abnormal High |
---|
Treatment A | 0 | 0 | 0 | 0 | 0 | 0 | 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 | 2 | 2 | 1 |
,Treatment B | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 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 | 2 | 2 | 0 |
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Physical Measurement - Height
Average height of all participants treated (NCT03509883)
Timeframe: Pre-treatment Screening
Intervention | centimeter (cm) (Mean) |
---|
Treatment A | 173.23 |
Treatment B | 165.86 |
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Frel - Relative Bioavailability
The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | Percentage (Geometric Mean) |
---|
Treatment B | 110.24 |
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Physical Measurement - Weight
Average weight of all participants treated (NCT03509883)
Timeframe: Pre-treatment screening to Day 8
Intervention | kilograms (kg) (Mean) |
---|
| Pre-treatment | Day 1 | Day 8 |
---|
Treatment A | 78.09 | 77.83 | 76.15 |
,Treatment B | 165.86 | 71.47 | 70.64 |
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Physical Measurement - Body Mass Index (BMI)
Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Body mass index = weight (kg)/[height(m)]2. (NCT03509883)
Timeframe: Pre-treatment Screening to Day 8
Intervention | kilograms / Meters² (kg/m²) (Mean) |
---|
| Pre-treatment | Day 1 | Day 8 |
---|
Treatment A | 22.96 | 25.87 | 25.31 |
,Treatment B | 25.85 | 25.84 | 25.55 |
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Number of Participants With Out-of Range Vital Signs: Temperature
"Number of participants with Out-of Range temperature changes as follows:~Temperature is measured in Degrees centigrade (°C)~>38.3°C Change from baseline > 1.6°C >38.3°C or change from baseline > 1.6°C" (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | participants (Number) |
---|
| >38.3°C | change from baseline > 1.6°C | >38.3°C or change from baseline > 1.6°C |
---|
Treatment A | 0 | 0 | 0 |
,Treatment B | 0 | 0 | 0 |
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Number of Participants With Out-of Range Vital Signs: Respiration Rate
"Number of participants with Out-of Range respiration rate changes as follows:~Respiration Rate is measured by number of respiration per min (rpm) > 16 rpm Change from baseline >10 rpm > 16 rpm or change from baseline > 10 rpm" (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | participants (Number) |
---|
| >16 rpm | change from baseline > 10 rpm | >16 or change from baseline >10 rpm |
---|
Treatment A | 1 | 0 | 1 |
,Treatment B | 1 | 0 | 1 |
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Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)
"Number of participants with Out-of Range Heart Rate changes as follows:~< 55 and change from baseline < -16 >100 and change from baseline > 10" (NCT03509883)
Timeframe: Day 1 to Day 8
Intervention | participants (Number) |
---|
| <55 and change from baseline < -16 | >100 and change from baseline > 10 |
---|
Treatment A | 0 | 0 |
,Treatment B | 0 | 0 |
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Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
Event rate was defined as number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938-939, M250, R233, R040-042, R048-049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Dabigatran (Apixaban) | 7.70 |
Apixaban vs Dabigatran (Dabigatran) | 8.65 |
Apixaban vs Rivaroxaban (Apixaban) | 7.77 |
Apixaban vs Rivaroxaban (Rivaroxaban) | 9.86 |
Dabigatran vs Rivaroxaban (Dabigatran) | 8.18 |
Dabigatran vs Rivaroxaban (Rivaroxaban) | 9.36 |
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Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
Event rate: number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62,H448,H3572,H356,H313,H210,H113,H052,H470,H431,I312,N020-N029,N421,N831,N857,N920,N923,N930,N938-939,M250,R233,R040-042,R048-049,T792,T810,N950,R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date= first prescription date of study drugs during intake duration. Participants were identified as NOAC user/Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Warfarin (Apixaban) | 7.97 |
Apixaban vs Warfarin (Warfarin) | 14.73 |
Dabigatran vs Warfarin (Dabigatran) | 8.57 |
Dabigatran vs Warfarin (Warfarin) | 13.77 |
Rivaroxaban vs Warfarin (Rivaroxaban) | 9.55 |
Rivaroxaban vs Warfarin (Warfarin) | 14.23 |
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Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Dabigatran (Apixaban) | 3.67 |
Apixaban vs Dabigatran (Dabigatran) | 4.06 |
Apixaban vs Rivaroxaban (Apixaban) | 3.73 |
Apixaban vs Rivaroxaban (Rivaroxaban) | 4.54 |
Dabigatran vs Rivaroxaban (Dabigatran) | 3.83 |
Dabigatran vs Rivaroxaban (Rivaroxaban) | 4.35 |
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Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Warfarin (Apixaban) | 3.75 |
Apixaban vs Warfarin (Warfarin) | 6.93 |
Dabigatran vs Warfarin (Dabigatran) | 3.86 |
Dabigatran vs Warfarin (Warfarin) | 6.61 |
Rivaroxaban vs Warfarin (Rivaroxaban) | 4.42 |
Rivaroxaban vs Warfarin (Warfarin) | 6.85 |
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Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Dabigatran (Apixaban) | 7.75 |
Apixaban vs Dabigatran (Dabigatran) | 7.47 |
Apixaban vs Rivaroxaban (Apixaban) | 7.35 |
Apixaban vs Rivaroxaban (Rivaroxaban) | 7.48 |
Dabigatran vs Rivaroxaban (Dabigatran) | 7.01 |
Dabigatran vs Rivaroxaban (Rivaroxaban) | 7.31 |
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Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Warfarin (Apixaban) | 7.66 |
Apixaban vs Warfarin (Warfarin) | 13.52 |
Dabigatran vs Warfarin (Dabigatran) | 7.2 |
Dabigatran vs Warfarin (Warfarin) | 13.53 |
Rivaroxaban vs Warfarin (Rivaroxaban) | 7.18 |
Rivaroxaban vs Warfarin (Warfarin) | 12.89 |
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Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date= the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Dabigatran (Apixaban) | 0.20 |
Apixaban vs Dabigatran (Dabigatran) | 0.25 |
Apixaban vs Rivaroxaban (Apixaban) | 0.20 |
Apixaban vs Rivaroxaban (Rivaroxaban) | 0.28 |
Dabigatran vs Rivaroxaban (Dabigatran) | 0.24 |
Dabigatran vs Rivaroxaban (Rivaroxaban) | 0.26 |
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Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Dabigatran (Apixaban) | 1.11 |
Apixaban vs Dabigatran (Dabigatran) | 0.74 |
Apixaban vs Rivaroxaban (Apixaban) | 1.05 |
Apixaban vs Rivaroxaban (Rivaroxaban) | 1.15 |
Dabigatran vs Rivaroxaban (Dabigatran) | 0.71 |
Dabigatran vs Rivaroxaban (Rivaroxaban) | 1.14 |
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Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Dabigatran (Apixaban) | 3.23 |
Apixaban vs Dabigatran (Dabigatran) | 4.18 |
Apixaban vs Rivaroxaban (Apixaban) | 3.28 |
Apixaban vs Rivaroxaban (Rivaroxaban) | 4.59 |
Dabigatran vs Rivaroxaban (Dabigatran) | 3.97 |
Dabigatran vs Rivaroxaban (Rivaroxaban) | 4.25 |
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Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Warfarin (Apixaban) | 3.44 |
Apixaban vs Warfarin (Warfarin) | 6.2 |
Dabigatran vs Warfarin (Dabigatran) | 4.17 |
Dabigatran vs Warfarin (Warfarin) | 5.56 |
Rivaroxaban vs Warfarin (Rivaroxaban) | 4.32 |
Rivaroxaban vs Warfarin (Warfarin) | 5.78 |
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Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Dabigatran (Apixaban) | 1.39 |
Apixaban vs Dabigatran (Dabigatran) | 1.12 |
Apixaban vs Rivaroxaban (Apixaban) | 1.35 |
Apixaban vs Rivaroxaban (Rivaroxaban) | 1.43 |
Dabigatran vs Rivaroxaban (Dabigatran) | 1.08 |
Dabigatran vs Rivaroxaban (Rivaroxaban) | 1.41 |
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Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
Event rate was number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Warfarin (Apixaban) | 1.1 |
Apixaban vs Warfarin (Warfarin) | 1.73 |
Dabigatran vs Warfarin (Dabigatran) | 0.78 |
Dabigatran vs Warfarin (Warfarin) | 1.71 |
Rivaroxaban vs Warfarin (Rivaroxaban) | 1.18 |
Rivaroxaban vs Warfarin (Warfarin) | 1.72 |
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Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Warfarin (Apixaban) | 1.37 |
Apixaban vs Warfarin (Warfarin) | 2.38 |
Dabigatran vs Warfarin (Dabigatran) | 1.17 |
Dabigatran vs Warfarin (Warfarin) | 2.31 |
Rivaroxaban vs Warfarin (Rivaroxaban) | 1.47 |
Rivaroxaban vs Warfarin (Warfarin) | 2.37 |
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Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Dabigatran (Apixaban) | 6.99 |
Apixaban vs Dabigatran (Dabigatran) | 6.84 |
Apixaban vs Rivaroxaban (Apixaban) | 6.60 |
Apixaban vs Rivaroxaban (Rivaroxaban) | 6.58 |
Dabigatran vs Rivaroxaban (Dabigatran) | 6.37 |
Dabigatran vs Rivaroxaban (Rivaroxaban) | 6.43 |
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Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Warfarin (Apixaban) | 0.18 |
Apixaban vs Warfarin (Warfarin) | 0.78 |
Dabigatran vs Warfarin (Dabigatran) | 0.24 |
Dabigatran vs Warfarin (Warfarin) | 0.75 |
Rivaroxaban vs Warfarin (Rivaroxaban) | 0.27 |
Rivaroxaban vs Warfarin (Warfarin) | 0.74 |
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Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Intervention | events per 100 participants-years (Number) |
---|
Apixaban vs Warfarin (Apixaban) | 6.9 |
Apixaban vs Warfarin (Warfarin) | 11.8 |
Dabigatran vs Warfarin (Dabigatran) | 6.53 |
Dabigatran vs Warfarin (Warfarin) | 11.92 |
Rivaroxaban vs Warfarin (Rivaroxaban) | 6.29 |
Rivaroxaban vs Warfarin (Warfarin) | 11.19 |
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Time to Platelet Recovery
The time to platelet recovery serves as a surrogate index of the activity of apixaban. (NCT03594045)
Timeframe: From the start of treatment until time of platelet recovery, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT
Intervention | Days (Median) |
---|
Apixaban for HITT | 2 |
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Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban
New TEC (NCT03594045)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|
Apixaban for HITT | 0 |
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Cumulative Incidence of Major Bleeding
Major Bleeding (NCT03594045)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT
Intervention | Participants (Count of Participants) |
---|
Apixaban for HITT | 0 |
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Cumulative Incidence of Limb Amputation
(NCT03594045)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT
Intervention | Participants (Count of Participants) |
---|
Apixaban for HITT | 0 |
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Cumulative Incidence of All Cause Mortality
Death due to any cause during treatment or the follow-up period following treatment. (NCT03594045)
Timeframe: From the start of treatment until the time of death or until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT
Intervention | Participants (Count of Participants) |
---|
Apixaban for HITT | 0 |
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Composite Cumulative Incidence of New TEC and Major Bleeding
Composite cumulative incidence (NCT03594045)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT
Intervention | Participants (Count of Participants) |
---|
Apixaban for HITT | 0 |
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Composite Cumulative Incidence of All-cause Mortality, Limb Amputation and New TEC
Composite cumulative incidence (NCT03594045)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT
Intervention | Participants (Count of Participants) |
---|
Apixaban for HITT | 0 |
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Cumulative Incidence of New Thromboembolic Complications (TEC)
New TEC during the study. (NCT03594045)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT
Intervention | Participants (Count of Participants) |
---|
Apixaban for HITT | 0 |
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Number of Participants With ISTH Major Bleeding
ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. (NCT04218266)
Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)
Intervention | Participants (Count of Participants) |
---|
Asundexian 20 mg | 0 |
Asundexian 50 mg | 0 |
Apixaban | 0 |
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Number of Participants With ISTH Minor Bleeding
All other overt bleeding episodes not meeting ISTH Major Bleeding criteria or clinically relevant non major bleeding were classified as minor bleeding. (NCT04218266)
Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)
Intervention | Participants (Count of Participants) |
---|
Asundexian 20 mg | 10 |
Asundexian 50 mg | 9 |
Asundexian Pooled | 19 |
Apixaban | 20 |
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Number of Participants of ISTH Clinically Relevant Non-major (CRNM) Bleeding
ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation. (NCT04218266)
Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)
Intervention | Participants (Count of Participants) |
---|
Asundexian 20 mg | 3 |
Asundexian 50 mg | 1 |
Asundexian Pooled | 4 |
Apixaban | 6 |
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Number of Participants With All Bleeding
Adjudication of all bleeding events was performed by members of the Clinical events committee (CEC) who reviewed events in a blinded fashion and adjudicated and classified the following events in a consistent and unbiased manner according to the following classifications: ISTH (major, clinically relevant non-major and minor); Thrombolysis in myocardial infarction (TIMI major, minor, requiring medical attention, minimal); Bleeding Academic Research Consortium (BARC type 1, 2, 3, 5). (NCT04218266)
Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)
Intervention | Participants (Count of Participants) |
---|
Asundexian 20 mg | 12 |
Asundexian 50 mg | 10 |
Asundexian Pooled | 22 |
Apixaban | 26 |
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Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding or Clinically Relevant Non-major (CRNM) Bleeding
"ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood.~ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation." (NCT04218266)
Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)
Intervention | Participants (Count of Participants) |
---|
Asundexian 20 mg | 3 |
Asundexian 50 mg | 1 |
Asundexian Pooled | 4 |
Apixaban | 6 |
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Hospitalization for Cardiovascular/Pulmonary Events
The primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment. (NCT04498273)
Timeframe: 45 days
Intervention | participants (Number) |
---|
Apixaban 2.5mg | 1 |
Apixaban 5mg | 1 |
Asprin | 0 |
Placebo | 0 |
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Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Obese Participants
Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Intervention | Event Rate Per 100 Participant-Years (Number) |
---|
Warfarin | 8.44 |
Apixaban | 5.12 |
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Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Morbidly Obese Participants
Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in morbidly obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Intervention | Event Rate Per 100 Participant-Years (Number) |
---|
Warfarin | 6.48 |
Apixaban | 4.52 |
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Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Morbidly Obese Participants
Event rate per 100 participant-years for first occurrence of MB event after index date in morbidly obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of GI, ICH, and other sites. MB was equal to 1 if bleeding event was >=1. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Intervention | Events Per 100 Participant-Years (Number) |
---|
Warfarin | 5.52 |
Apixaban | 3.94 |
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Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants
Event rate per 100 participant-years for first occurrence of major bleeding (MB) event after index date in obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017 [3.5 years]). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of gastrointestinal (GI), intracranial hemorrhage (ICH), and other sites. MB was equal to 1 if bleeding event was greater than equal to (>=) 1. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Intervention | Events Per 100 Participant-Years (Number) |
---|
Warfarin | 7.27 |
Apixaban | 4.06 |
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Time in Therapeutic Range (TTR) During Follow-up Period
TTR was computed using INR values among warfarin participants during the follow-up. TTR was calculated based on the percentage of time a participant remained in therapeutic range evaluated during the entire follow-up period. TTR >=65 percent (%) was observed as good and TTR less than (<) 65% was observed as poor. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Intervention | Percentage of time (Median) |
---|
Warfarin | 14 |
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Charlson Comorbidity Index (CCI)
"CCI based on various comorbid conditions such as myocardial infarction, CHF, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. CCI score range was from 0 to 14, where 0= low comorbid condition and 14= high comorbid condition, higher scores indicated more comorbidity." (NCT04681482)
Timeframe: Baseline (6 months prior to index date)
Intervention | Units on a scale (Mean) |
---|
Warfarin | 3.13 |
Apixaban | 2.55 |
Dabigatran | 2.21 |
Rivaroxaban | 2.49 |
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Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Obese Participants
Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Intervention | Events Per 100 Participant-Years (Number) |
---|
Warfarin | 2.09 |
Apixaban | 1.51 |
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Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Morbidly Obese Participants
Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in morbidly obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Intervention | Events Per 100 Participant-Years (Number) |
---|
Warfarin | 1.51 |
Apixaban | 0.92 |
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Number of Participants Who Switched to Another Anticoagulant Therapy
Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Without Active Cancer | With Active Cancer |
---|
NOAC-Based Therapy | 1273 | 173 |
,NOAC-Based Therapy: Apixaban | 319 | 33 |
,NOAC-Based Therapy: Dabigatran | 276 | 30 |
,NOAC-Based Therapy: Edoxaban | 204 | 26 |
,NOAC-Based Therapy: Rivaroxaban | 1777 | 208 |
,PAC Only | 535 | 208 |
,Warfarin-Based Therapy | 1541 | 144 |
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Number of Participants Who Completely Discontinued Index Anticoagulant Treatment
Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Without Active Cancer | With Active Cancer |
---|
NOAC-Based Therapy | 19826 | 2570 |
,NOAC-Based Therapy: Apixaban | 2828 | 279 |
,NOAC-Based Therapy: Dabigatran | 1028 | 115 |
,NOAC-Based Therapy: Edoxaban | 1164 | 147 |
,NOAC-Based Therapy: Rivaroxaban | 14170 | 1968 |
,PAC Only | 4534 | 1449 |
,Warfarin-Based Therapy | 4707 | 444 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Apixaban | 3 | 0 | 0 | 2 | 6 | 1 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Dabigatran | 4 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Edoxaban | 1 | 0 | 1 | 2 | 6 | 0 | 0 | 0 | 0 | 1 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer |
---|
NOAC-Based Therapy: Rivaroxaban | 28 | 10 | 13 | 4 | 20 | 2 | 0 | 2 | 0 | 1 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer |
---|
NOAC-Based Therapy | 13 | 5 | 2 | 4 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to NOAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to NOAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
PAC Only | 5 | 4 | 1 | 0 | 1 | 2 | 1 | 2 | 1 | 0 | 1 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to NOAC: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to NOAC: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
Warfarin-Based Therapy | 22 | 6 | 3 | 1 | 1 | 17 | 2 | 0 | 1 | 0 | 0 | 1 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Apixaban | 1 | 3 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Dabigatran | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Edoxaban | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer |
---|
NOAC-Based Therapy: Rivaroxaban | 12 | 2 | 10 | 1 | 1 | 2 | 3 | 0 | 0 | 1 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer |
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NOAC-Based Therapy | 12 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to NOAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to NOAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
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PAC Only | 1 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Dabigatran | 3 | 0 | 1 | 1 | 6 | 0 | 0 | 0 | 0 | 3 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to NOAC: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to NOAC: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
Warfarin-Based Therapy | 108 | 5 | 8 | 9 | 7 | 85 | 12 | 7 | 1 | 3 | 0 | 8 |
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Number of Participants With Interruption in Index Anticoagulant Treatment
Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Without Active Cancer | With Active Cancer |
---|
NOAC-Based Therapy | 8169 | 961 |
,NOAC-Based Therapy: Apixaban | 965 | 115 |
,NOAC-Based Therapy: Dabigatran | 492 | 51 |
,NOAC-Based Therapy: Edoxaban | 439 | 38 |
,NOAC-Based Therapy: Rivaroxaban | 5973 | 728 |
,PAC Only | 1226 | 401 |
,Warfarin-Based Therapy | 3429 | 172 |
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Overall Index Anticoagulant Treatment Duration
Overall anticoagulant treatment duration was defined as the time period from the index date to the earliest of treatment interruption, switch, or discontinuation. Treatment interruption: when a participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after this period of 30 days. Treatment switching: a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Treatment discontinuation: when a participant who ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to the earliest of treatment interruption, switch, or discontinuation; during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Days (Median) |
---|
| Without Active Cancer | With Active Cancer |
---|
NOAC Based Therapy: Apixaban | 96 | 104 |
,NOAC Based Therapy: Dabigatran | 137 | 105 |
,NOAC Based Therapy: Edoxaban | 164 | 123 |
,NOAC-Based Therapy | 140 | 111 |
,NOAC-Based Therapy: Rivaroxaban | 128 | 102 |
,PAC Only | 3 | 34 |
,Warfarin-Based Therapy | 139 | 80 |
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Time to Treatment Discontinuation
Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The time to treatment discontinuation was defined as the period from the index date to the date of treatment discontinuation. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Days (Median) |
---|
| Without Active Cancer | With Active Cancer |
---|
NOAC-Based Therapy | 119 | 101 |
,NOAC-Based Therapy: Apixaban | 84 | 99 |
,NOAC-Based Therapy: Dabigatran | 134 | 118 |
,NOAC-Based Therapy: Edoxaban | 154 | 112 |
,NOAC-Based Therapy: Rivaroxaban | 119 | 97 |
,PAC Only | 2 | 25 |
,Warfarin-Based Therapy | 129 | 75 |
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Time to Treatment Interruption
Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The time to treatment interruption was defined as the period from the index date to the date of treatment interruption. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Days (Median) |
---|
| Without Active Cancer | With Active Cancer |
---|
NOAC-Based Therapy | 129 | 137 |
,NOAC-Based Therapy: Apixaban | 86 | 123 |
,NOAC-Based Therapy: Dabigatran | 137 | 119 |
,NOAC-Based Therapy: Edoxaban | 130 | 159 |
,NOAC-Based Therapy: Rivaroxaban | 128 | 134 |
,PAC Only | 3 | 61 |
,Warfarin-Based Therapy | 163 | 129 |
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Time to Treatment Switch
Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The time to treatment switch was defined as the period from the index date to the date of treatment switch. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Days (Median) |
---|
| Without Active Cancer | With Active Cancer |
---|
NOAC-Based Therapy | 179 | 76 |
,NOAC-Based Therapy: Apixaban | 66 | 44 |
,NOAC-Based Therapy: Dabigatran | 105 | 60 |
,NOAC-Based Therapy: Edoxaban | 87 | 98 |
,NOAC-Based Therapy: Rivaroxaban | 99 | 53 |
,PAC Only | 27 | 49 |
,Warfarin-Based Therapy | 57 | 36 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer |
---|
NOAC-Based Therapy | 13 | 6 | 2 | 3 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Edoxaban | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Dabigatran | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Apixaban | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to NOAC: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to NOAC: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
Warfarin-Based Therapy | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment interruption. Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. (NCT05022563)
Timeframe: Within 30 days before treatment interruption during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Major Bleeding: Without Active Cancer | Complications of VTE: Without Active Cancer | Thromboembolism: Without Active Cancer | Major Surgery: Without Active Cancer | Cancer-related Event: Without Active Cancer | Kidney Function Changes: Without Active Cancer | Liver Function Change: Without Active Cancer | Major Bleeding: With Active Cancer | Complications of VTE: With Active Cancer | Thromboembolism: With Active Cancer | Major Surgery: With Active Cancer | Kidney Function Changes: With Active Cancer | Liver Function Change: With Active Cancer |
---|
NOAC-Based Therapy | 53 | 13 | 328 | 566 | 126 | 87 | 158 | 8 | 1 | 21 | 33 | 8 | 9 |
,NOAC-Based Therapy: Apixaban | 5 | 0 | 50 | 126 | 14 | 10 | 12 | 3 | 0 | 3 | 1 | 1 | 3 |
,NOAC-Based Therapy: Dabigatran | 2 | 3 | 19 | 9 | 5 | 8 | 7 | 0 | 0 | 1 | 2 | 0 | 1 |
,NOAC-Based Therapy: Edoxaban | 2 | 0 | 18 | 17 | 4 | 7 | 6 | 0 | 0 | 0 | 1 | 0 | 0 |
,NOAC-Based Therapy: Rivaroxaban | 42 | 10 | 233 | 407 | 99 | 55 | 129 | 4 | 0 | 17 | 27 | 7 | 5 |
,PAC Only | 4 | 5 | 209 | 171 | 100 | 44 | 72 | 2 | 0 | 9 | 55 | 10 | 9 |
,Warfarin-Based Therapy | 27 | 6 | 158 | 92 | 62 | 45 | 79 | 1 | 1 | 12 | 15 | 1 | 2 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to NOAC: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to NOAC: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
Warfarin-Based Therapy | 63 | 7 | 3 | 6 | 3 | 51 | 1 | 3 | 0 | 0 | 1 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer |
---|
NOAC-Based Therapy: Rivaroxaban | 11 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to NOAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to NOAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
PAC Only | 10 | 29 | 5 | 4 | 5 | 16 | 1 | 7 | 1 | 0 | 0 | 6 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer |
---|
NOAC-Based Therapy | 36 | 11 | 3 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer |
---|
NOAC-Based Therapy: Rivaroxaban | 4 | 1 | 9 | 2 | 3 | 1 | 1 | 1 | 0 | 2 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Apixaban | 6 | 1 | 1 | 9 | 14 | 1 | 0 | 0 | 1 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
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NOAC-Based Therapy: Edoxaban | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Dabigatran | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Apixaban | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to NOAC: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to NOAC: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
Warfarin-Based Therapy | 17 | 0 | 2 | 3 | 0 | 12 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to NOAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to NOAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
PAC Only | 5 | 11 | 1 | 1 | 2 | 7 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer |
---|
NOAC-Based Therapy | 5 | 1 | 1 | 1 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer |
---|
NOAC-Based Therapy: Rivaroxaban | 10 | 5 | 11 | 5 | 8 | 2 | 2 | 1 | 1 | 3 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Edoxaban | 1 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Dabigatran | 2 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 1 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Apixaban | 0 | 0 | 0 | 4 | 2 | 0 | 1 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to NOAC: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to NOAC: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
Warfarin-Based Therapy | 26 | 3 | 1 | 4 | 3 | 18 | 3 | 1 | 0 | 0 | 1 | 2 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to NOAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to NOAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
PAC Only | 14 | 65 | 11 | 5 | 10 | 36 | 2 | 18 | 2 | 5 | 2 | 9 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer |
---|
NOAC-Based Therapy: Rivaroxaban | 48 | 13 | 30 | 15 | 25 | 8 | 8 | 4 | 1 | 1 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
NOAC-Based Therapy: Edoxaban | 2 | 1 | 4 | 3 | 9 | 0 | 1 | 0 | 0 | 0 |
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Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation
Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment discontinuation. Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. (NCT05022563)
Timeframe: Within 30 days before treatment discontinuation during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Major Bleeding: Without Active Cancer | Complications of VTE: Without Active Cancer | Thromboembolism: Without Active Cancer | Major Surgery: Without Active Cancer | Cancer-related Event: Without Active Cancer | Kidney Function Changes: Without Active Cancer | Liver Function Change: Without Active Cancer | Major Bleeding: With Active Cancer | Complications of VTE: With Active Cancer | Thromboembolism: With Active Cancer | Major Surgery: With Active Cancer | Kidney Function Changes: With Active Cancer | Liver Function Change: With Active Cancer |
---|
NOAC-Based Therapy | 118 | 25 | 777 | 1691 | 307 | 240 | 452 | 36 | 2 | 122 | 66 | 64 | 50 |
,NOAC-Based Therapy: Apixaban | 13 | 4 | 123 | 508 | 40 | 39 | 65 | 4 | 0 | 14 | 7 | 7 | 3 |
,NOAC-Based Therapy: Dabigatran | 7 | 2 | 48 | 18 | 14 | 13 | 34 | 2 | 0 | 9 | 1 | 1 | 2 |
,NOAC-Based Therapy: Edoxaban | 5 | 3 | 53 | 25 | 20 | 11 | 28 | 0 | 0 | 11 | 5 | 5 | 3 |
,NOAC-Based Therapy: Rivaroxaban | 90 | 15 | 537 | 1138 | 232 | 172 | 321 | 29 | 2 | 87 | 52 | 51 | 42 |
,PAC Only | 20 | 18 | 734 | 625 | 291 | 383 | 441 | 14 | 0 | 89 | 190 | 48 | 34 |
,Warfarin-Based Therapy | 42 | 10 | 258 | 78 | 133 | 104 | 158 | 7 | 1 | 17 | 11 | 14 | 16 |
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Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months
Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: Within 6 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Without Active Cancer | With Active Cancer |
---|
NOAC-Based Therapy | 10557 | 1089 |
,NOAC-Based Therapy: Apixaban | 1213 | 125 |
,NOAC-Based Therapy: Dabigatran | 606 | 46 |
,NOAC-Based Therapy: Edoxaban | 817 | 91 |
,NOAC-Based Therapy: Rivaroxaban | 7209 | 773 |
,PAC Only | 75 | 221 |
,Warfarin-Based Therapy | 4393 | 217 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to NOAC: Without Active Cancer | Switched to Apixaban: Without Active Cancer | Switched to Dabigatran: Without Active Cancer | Switched to Edoxaban: Without Active Cancer | Switched to Rivaroxaban: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to NOAC: With Active Cancer | Switched to Apixaban: With Active Cancer | Switched to Dabigatran: With Active Cancer | Switched to Edoxaban: With Active Cancer | Switched to Rivaroxaban: With Active Cancer |
---|
PAC Only | 12 | 51 | 6 | 3 | 6 | 36 | 4 | 8 | 1 | 1 | 1 | 5 |
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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Switched to Warfarin: Without Active Cancer | Switched to PAC: Without Active Cancer | Switched to Warfarin: With Active Cancer | Switched to PAC: With Active Cancer |
---|
NOAC-Based Therapy | 59 | 15 | 9 | 9 |
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Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months
Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: Within 3 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)
Intervention | Participants (Count of Participants) |
---|
| Without Active Cancer | With Active Cancer |
---|
NOAC Based Therapy: Apixaban | 2390 | 290 |
,NOAC Based Therapy: Dabigatran | 1225 | 120 |
,NOAC Based Therapy: Edoxaban | 1395 | 148 |
,NOAC-Based Therapy | 19848 | 2405 |
,NOAC-Based Therapy: Rivaroxaban | 14037 | 1770 |
,PAC Only | 222 | 673 |
,Warfarin-Based Therapy | 6313 | 388 |
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