Trial · NCT02841995
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Overall Response (OR) | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on mITT population. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months) | Analysis was performed on safety population which included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Best Overall Response (BOR) | From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment | From Baseline up to end of treatment (i.e., up to 64.2 months) | Analysis was performed on mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report | From Baseline up to end of treatment (i.e., up to 64.2 months) | Analysis was performed on mITT population. Only those categories in which at least 1 participant had data were reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Failure-free Survival (FFS) | From first dose of study drug to either start of another new systemic treatment for cGVHD, relapse of the underlying disease or death or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on mITT population. | months | MEDIAN |
| SECONDARY | Change From Baseline in Corticosteroids Dose | Baseline up to end of treatment (i.e., anytime up to 64.2 months) | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | milligrams per kilogram per day | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in Calcineurin Inhibitor (CNI) Usage | Baseline up to end of treatment (i.e., anytime up to 64.2 months) | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants who had taken CNI at Baseline and with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | From the date of first response until documented disease progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on responder population which included participants who received at least 1 dose of study medication and achieved a PR or CR response at any post-baseline response assessment. | weeks | MEDIAN |
| SECONDARY | Time-to-Response (TTR) | From first dose of study drug treatment to the time of first documentation of response or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on responder population. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Best Response in Each Individual Organ | From date of randomization until disease progression or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From first dose of study drug to date of death from any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on mITT population. | months | MEDIAN |
| SECONDARY | Time to Next Therapy (TTNT) | From time of first treatment to the time of new systemic cGVHD treatment or long term follow-up assessment, whichever occurred first (maximum duration: up to 64.2 months) | Analysis was performed on mITT population. | months | MEDIAN |
| SECONDARY | Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points | Baseline, Day 1 of Cycles 2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26, 27,28,29,30,31,32,33,34,35,36,37, 38,39,40,41,42,43,44,45,46,47,48, 49, 50,51,52,53, 54,55, 56, 57,58,59,60,61,62,63,67 and EOT (i.e., anytime up to 64.2 months) | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points | Baseline, Day 1 of Cycles 2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27, 29,30,31,32,33,34,35,36,37,38, 39,40,41,43, 47,48,49,51,52,53, 54, 55,56, 57,58,60,61,62,63,67, EOT (i.e., anytime up to 64.2 months) | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. | percent predicted FEV1 | MEAN |
| SECONDARY | Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points | Baseline, Day 1 of Cycles 2, 3,4, 5,6,7,8,9,10,11,12,13, 14,15,16,17,18,19,20,21,22,23,24,25,26, 27,29,30,31,32,33,34,35,36,37,38,39,40,41,43,47, 48,49, 51,52,53,54, 55, 56,57,58,60,61, 62, 63,67, EOT (i.e., anytime up to 64.2 months) | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. | percent predicted FVC | MEAN |
| SECONDARY | Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points | Baseline, Day 1 of Cycles 2,3,4,5,6,7,8,9,10,11,12,13, 14,15,16,17,18,19,20,21,22,23,24,25,26,27, 29,31,32,33,34,35,36,37,39,40,41,43,47,49,51,53,55, 61, 62, 63, 67, EOT (i.e., anytime up to 64.2 Months) | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. | Percent Predicted HGB Corrected DLco | MEAN |
| SECONDARY | Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points | Baseline, Day 1 of Cycles 2,3, 4, 5,6,7, 8, 9, 10,11,12,13, 14, 15, 16, 17, 18, 19, 20,21, 22,23,24, 25, 26, 27,29, 30, 31,32, 33, 34, 35,36, 37, 38,39, 40,41,43,47, 48, 49,51,52,53, 54,55,56,57,58, 60,61,62, 63, 67, EOT (i.e., anytime up to 64.2 Months) | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. | Percent Predicted TLC | MEAN |
| SECONDARY | Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points | Baseline, Day 1 of Cycles 2, 3, 4,5, 6,7, 8, 9, 10, 11,12, 13, 14,15, 16,17, 18, 19,20, 21,22,23, 24, 25, 26,27, 29, 30, 31, 32, 33,34, 35,36, 37,38, 39, 40,41, 43,47, 48, 49,51,52,53, 54, 55,56,57, 58,60,61,62,63,67, EOT (i.e., anytime up to 64.2 Months) | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. | percent predicted RV | MEAN |
| SECONDARY | Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2) | Cycles 1 and 2: pre-dose (0 hour), 1, 2, 3, 4, 5, and 6 hours post-dose on Day 1 | Analysis was performed on PK population which included all participants who received at least one dose of study drug and had at least 1 post-dose PK sample drawn. Here, 'number analyzed' = participants with available data for each specified category. | nanograms per milliliter | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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