prednisolone and Neutropenia

prednisolone has been researched along with Neutropenia in 109 studies

Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.
prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone.

Neutropenia: A decrease in the number of NEUTROPHILS found in the blood.

Research

Studies (109)

Authors

Clinical Trials (6)

Trial Overview

Trial Outcomes

Objective Response Rate (ORR)

ORR, defined as the best overall radiographic response after randomization (Period 2 Week 1) as per Investigator assessments of response for soft tissue disease per RECIST 1.1, in participants who had a measurable tumor. ORR was reported as the percentage of participants with complete response (CR) or partial response (PR). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. (NCT02288247)
Timeframe: From date of randomization up to median duration of 35 weeks

Progression Free Survival (PFS)

PFS: time from randomization (Period 2 Week 1) to earliest progression event. Progression is defined as radiographic progression, unequivocal clinical progression, or death on study. Radiographic progression is defined for bone disease by appearance of ≥ 2 new lesions on whole-body radionuclide bone scan per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria (i.e., unconfirmed progressive disease) that needs to be confirmed in the next assessment (i.e., progressive disease in the next assessment) or for soft tissue disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Unequivocal clinical progression is defined as new onset cancer pain requiring chronic administration of opiate analgesia or deterioration from prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to ≥ 3, or initiation of subsequent lines of cytotoxic chemotherapy or radiation therapy or surgical intervention due to complications of tumor progression. (NCT02288247)
Timeframe: From date of randomization to the earliest of either documented disease progression (median duration: 35 weeks)

Time to First Skeletal-related Event (SRE)

Time to first SRE, defined as the time from randomization (Period 2 Week 1) to radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. (NCT02288247)
Timeframe: From date of randomization up to median duration of 35 weeks

Time to Prostate-specific Antigen (PSA) Progression

Time to PSA progression, defined as the time from randomization (Period 2 Week 1) to the date of the first PSA value in Period 2 demonstrating progression (Period 2). The PSA progression date is defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir recorded in Period 2 is documented, which must be confirmed by a second consecutive value obtained at least 3 weeks later. (NCT02288247)
Timeframe: From date of randomization to the first PSA value (median duration: 35 weeks)

Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)

The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from 0 (worst health imaginable) to 100 (best health imaginable). (NCT02288247)
Timeframe: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)

The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from 0 (worst health imaginable) to 100 (best health imaginable). (NCT02288247)
Timeframe: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P)

FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer participants. It consists of 27 core items which assess participant function in four domains rated on 0 to 4 Likert-type scale: physical well-being (PWB) (7 items; 0 [worst] to 4 [better], score range 0-28), social/family well-being (SWB) (7 items; 0 [worst] to 4 [better], score range 0-28), emotional well-being (EWB) (6 items; 0 [worst] to 4 [better], score range 0-24), and functional well-being (FWB) (7 items; 0 [worst] to 4 [better], score range 0-28), which is further supplemented by 12 site-specific items to assess for prostate-related symptoms (Prostate Cancer Subscale [PCS] 12 items rated on Likert-type scale 0 [worst] to 4 [better], score range 0-48). The total domain scores and PCS subscale score are then combined to a global quality of life score ranging between 0 to 156; higher scores representing better quality of life. (NCT02288247)
Timeframe: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P)

FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer participants. It consists of 27 core items which assess participant function in four domains rated on 0 to 4 Likert-type scale: physical well-being (PWB) (7 items; 0 [worst] to 4 [better], score range 0-28), social/family well-being (SWB) (7 items; 0 [worst] to 4 [better], score range 0-28), emotional well-being (EWB) (6 items; 0 [worst] to 4 [better], score range 0-24), and functional well-being (FWB) (7 items; 0 [worst] to 4 [better], score range 0-28), which is further supplemented by 12 site-specific items to assess for prostate-related symptoms (Prostate Cancer Subscale [PCS] 12 items rated on Likert-type scale 0 [worst] to 4 [better], score range 0-48). The total domain scores and PCS subscale score are then combined to a global quality of life score ranging between 0 to 156; higher scores representing better quality of life. (NCT02288247)
Timeframe: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Prostate-specific Antigen (PSA) Response

PSA response, defined as a decrease in percentage change from randomization (Period 2 Week 1) of 50% or more. PSA response was derived at Week 13 and at any time after randomization in Period 2. PSA response at any time is defined as a decrease in percentage change from randomization (Period 2 Week 1) at any time after randomization of 50% or more. Percentage of participants with PSA response was reported. (NCT02288247)
Timeframe: Randomization, Week 13, any time after randomization in Period 2 (median of 35 weeks)

Area Under the Concentration-time Curve of Obinutuzumab Administered on Day 1 of Cycle 1 in Phase I of the Study

Blood samples were taken on Day 1 (pre-infusion, end of infusion, 3-6 hours post-infusion) of Cycle 1. Nonlinear mixed-effects modeling (with NONMEM software) was used to analyze the pooled samples for dose-concentration-time data of obinutuzumab. (NCT00517530)
Timeframe: Day 1 of Cycle 1

Duration of Response by Disease Type in Phase II of the Study

Duration of complete response was defined as the time from the first complete or partial response until disease progression (PD) or death, whichever occurred first. For non-Hodgkin's lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is PET-positive with histological confirmation. (NCT00517530)
Timeframe: by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)

Participants With Event-Free Survival (EFS) in Phase II of the Study

EFS is defined as the time from start of treatment to disease progression/relapse, death or, in case of early withdrawal from the treatment period, the (end) date of last dose, whatever comes first. (NCT00517530)
Timeframe: by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)

Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study

Dose-limiting toxicities were defined as obinutuzumab-related adverse events occurring within the first 28 days of each administration of obinutuzumab, with the exception of B-cell depletion and lymphopenia which are expected outcomes of treatment with obinutuzumab. (NCT00517530)
Timeframe: Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months)

Percentage of Participants With Best Overall Response in Phase II of the Study

Best overall response (BOR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) (NCT00517530)
Timeframe: by Cutoff Date: 31 March 2012 (within 3 years, 4 months)

Percentage of Participants With Partial Response (PR) in Phase II of the Study

A PR was defined as a >=50% decrease in SPD of the 6 largest nodes or nodal masses; no increase in size of other nodes, liver, or spleen; regression of splenic and hepatic nodules by >=50% in their SPD or, for single nodules, in the long axis (CLL only); and no new disease sites. (NCT00517530)
Timeframe: by Cutoff Date: 31 March 2012 (within 3 years, 4 months)

Progression-free Survival (PFS) in Phase II of the Study

PFS was defined as the time from start of treatment to disease progression (PD) or death due to any cause, whichever occurred first. For non-Hodgkin's lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is positron emission tomography (PET)-positive with histological confirmation. (NCT00517530)
Timeframe: by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)

Maximum Plasma Concentration (Cmax) of Obinutuzumab in CLL Patients

(NCT00517530)
Timeframe: at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days)

Maximum Plasma Concentration (Cmax) of Obinutuzumab in NHL Participants

Obinutuzumab serum pharmacokinetic (PK) parameters in NHL participants following ascending doses. (NCT00517530)
Timeframe: at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days)

Percentage of Participants With Complete Response (CR/CRu/CRi) in Phase II of the Study

A complete response was defined as the disappearance of all evidence of disease (NHL) and symptoms; normalization of biochemical abnormalities (NHL); regression of lymph nodes and nodal masses to normal size; decrease of nodes in the sum of the products of the greatest diameters (SPD); regression in size of the spleen and/or liver, should not be palpable, and disappearance of nodules related to lymphoma (CLL). Complete/unconfirmed (CRu) response includes NHL patients with one or more of the following: 1) a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the SPD; 2) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). Complete Response with Incomplete Bone Marrow Recovery (CRi) was measured only in patients with CLL. (NCT00517530)
Timeframe: by Cutoff Date: 31 March 2012 (within 3 years, 4 months)

Percentage of Retreated Participants With Response

Patients who might benefit from retreatment were allowed to be treated again at the request of the investigator. (NCT00517530)
Timeframe: by Cutoff Date: 25 November 2013 (within 4 years, 2 months)

Pharmacodynamics: Participants With Peripheral B-cell Recovery After Having Had Depletion at End of Treatment During Phase II of the Study

B-cell depletion was defined in two ways: definition 1 - decrease below 5% baseline level and definition 2 - decrease below 0.04 x 109/L. B-cell recovery was defined in two ways: definition 1 - return to at least 50% of baseline level and definition 2 - return to at least 0.08 x 109/L. (NCT00517530)
Timeframe: by the end of Phase II (within 3 years, 4 months)

Composite of Disease Relapse (Defined a BVAS/WG ≥ 2) and Serious Adverse Events

Number of disease relapse added with the number of SAE in each group (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Mean Number of Rituximab Infusions Per Subject

The rituximab utilization was measured in how many times a subject received Rituximab throughout the study which was then averaged for all subjects in each treatment arm, including those who did not receive any infusion. (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Number of Major Relapses Defined as a BVAS/WG ≥ 3

The Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG ) is a form with 34 predefined items grouped into 9 organ systems. The items are clinical features observed in patients with active ANCA vasculitis. Each item has a specified weight of either 3 or 1, depending on whether it reflects major or minor disease activity. The total BVAS/WG score is the weighted sum of individual manifestations that are present and believed to be due to active ANCA vasculitis. Higher scores reflect more active disease. BVAS/WG scores range from 0 to 64. (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Number of Patients Affected by Serious Adverse Events

Number of patients with serious adverse events (SAEs), including all episodes of late onset neutropenia (LON). SAE are defined in the Serious adverse event section. Serious adverse events were reported over the entire study period (5.5 years) (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Number of Patients With Hypogammaglobulinemia

Hypogammaglobulinemia defined as an IgG < 250mg/dL (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Patient Survival

number of deaths throughout the study. (NCT02749292)
Timeframe: 5.5 years

Health-related Quality of Life as Assessed by the Short Form Health Survey (SF-36) Scores

The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. (NCT02749292)
Timeframe: Assessed throughout the study period, every 6 months unless such time point was not reached or was missed by the patient. Median follow-up period is of 4.1 years (IQR, 2.5 - 5.0)

Health-related Quality of Life as Assessed by the Short Form Health Survey (SF-36) Scores

The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. (NCT02749292)
Timeframe: Assessed throughout the study period, every 6 months unless such time point was not reached or was missed by the patient. Median follow-up period is of 4.1 years (IQR, 2.5 - 5.0)

Number of Infections

Number of infections mild and severe, whether they were treated or not with antibiotics (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Number of Patients With Disease Relapse(s) as Defined by a Birmingham Vasculitis Activity Score for Wegner's Granulomatosis (BVAS/WG) ≥ 2

Relapses recording period was from 6/1/2016 to 12/31/2021. The outcome was reported as the number of participants with disease relapse who had either positive ANCA titers specific for myeloperoxidase (MPO-ANCA) or proteinase 3 (PR3-ANCA). The Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG ) is a form with 34 predefined items grouped into 9 organ systems. The items are clinical features observed in patients with active ANCA vasculitis. Each item has a specified weight of either 3 or 1, depending on whether it reflects major or minor disease activity. The total BVAS/WG score is the weighted sum of individual manifestations that are present and believed to be due to active ANCA vasculitis. Higher scores reflect more active disease. BVAS/WG scores range from 0 to 64. (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Organ Damage as Assessed by the Vasculitis Damage Index (VDI).

The Vasculitis Damage Index (VDI) is a validated formal assessment tool in ANCA-associated vasculitis clinical trials. The VDI distinguishes vasculitis-induced chronic damage from active inflammation or persistent disease. Each item represents a disease manifestation and is given a score (of 1) if present for at least 3 months. Neither the cause of damage (vasculitis vs treatment) nor an ongoing activity are taken into consideration. The VDI includes 64 items categorized into 11 groups (by organ system) and the scored items are summed to give a total score ranging from 0 to 64. A higher score means more accrued damage. (NCT02749292)
Timeframe: 3 years starting at inclusion

Health-related Quality of Life Using the SF-36 Mental Composite

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 12 months

Health-related Quality of Life Using the SF-36 Mental Composite

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 24 months

Health-related Quality of Life Using the SF-36 Mental Composite

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 36 months

Health-related Quality of Life Using the SF-36 Mental Composite

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 4 months

Health-related Quality of Life Using the SF-36 Mental Composite

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 48 months

Health-related Quality of Life Using the SF-36 Physical Composite

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 12 months

Health-related Quality of Life Using the SF-36 Physical Composite

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 24 months

Health-related Quality of Life Using the SF-36 Physical Composite

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 36 months

Health-related Quality of Life Using the SF-36 Physical Composite

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 4 months

Health-related Quality of Life Using the SF-36 Physical Composite

The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 48 months

Infection Rates

Infection (treated with intravenous or oral antibiotics) rates (NCT01697267)
Timeframe: Up to 4 years

Severe Adverse Event Rate

Severe adverse event (SAE) rate (NCT01697267)
Timeframe: Up to 48 months

Combined Damage Assessment Score (Disease Related Damage Assessment)

Cumulative accrual of damage as measured by the combined damage assessment score (CDA). Each persistent or new occurrence of damage is given a score of 1. The cumulative accrual of damage is obtained by summing across the different types of damage to get an overall score (max score = 64). (NCT01697267)
Timeframe: data in Rows represent the change from randomization (month 4) to months 12, 24, 36, and 48.

Cumulative GC Exposure

Cumulative glucocorticoid (GC) exposure during the trial. The trial had a common close out date when the final patient reached month 36 in the trial. Patients were followed until month 48 or the common close out date, whichever happened sooner. Therefore, follow up varied between 36 and 48 months. Cumulative glucocorticoid exposure is presented as a dose in mg for during the treatment period (up to month 24) and across the whole trial (until month 48 or common close out when the final patient reached month 36). (NCT01697267)
Timeframe: Up to 48 months

Number of Participants in Remission at 24 and 48 Months

Proportion of patients who maintain remission at 24 and 48 months (NCT01697267)
Timeframe: 24 and 48 months

Relapse-free Survival

The primary efficacy outcome measure of the trial is relapse-free survival, where a relapse is either major or minor. The primary analysis will be a Cox regression model adjusted for the stratification factors (ANCA type, relapse severity and prednisone induction regimen) for the difference in the distribution of relapse-free survival between the rituximab arm and the azathioprine (control) arm (two-sided at α-level of 5%). (NCT01697267)
Timeframe: Any patients who have not relapsed at up to a maximum of 4 years will be censored.

Reviews

5 reviews available for prednisolone and Neutropenia

Trials

29 trials available for prednisolone and Neutropenia

Other Studies

75 other studies available for prednisolone and Neutropenia