Trial · NCT04930562
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | 12 Months | Analysis was performed on mITT population. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | 12 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) | 12 months | Analysis was performed on responder population. | weeks | MEDIAN |
| SECONDARY | Number of Participants With Best Response in Each Individual Organ | 12 months | Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first. The number of participants analyzed is the number of patients with abnormalities in each organ. | participants | NUMBER |
| SECONDARY | Number of Participants With Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points | Baseline and 12 months | Analysis was performed on mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Failure-free Survival (FFS) | 12 months | Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first | months | MEDIAN |
| SECONDARY | Time to Next Therapy (TTNT) | 12months | Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 12months | Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first. | months | MEDIAN |
| SECONDARY | Change From Baseline in Corticosteroids Dose | 12months | Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first. | milligrams per kilogram per day | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in Calcineurin Inhibitor (CNI) Usage. | 12months | Number of participants who took CNI at Baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in in Global Severity Rating (GSR) Score by Clinician-reported cGVHD Assessment | 12months | Analysis was performed on mITT population. | score | MEAN |
| SECONDARY | Change From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report | 12months | Analysis was performed on mITT population. | score | 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04930562/outcomes