Trial · NCT05305989
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Response (DOR) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | Responder population included participants in the full analysis set that achieved a partial or complete response at any post-baseline response assessment. Only those participants who achieved CR or PR are reported. | months | MEDIAN |
| PRIMARY | Number of Participants With a >=7 Point Reduction (7PtR) From Baseline and >=7 Point Reduction From Baseline on 2 Consecutive Post-Baseline Assessments as Assessed by Lee Symptom Scale (LSS) | Baseline (Day 1) up to 23 months | The full analysis set included all participants enrolled in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale | Baseline (Day 1) up to 23 months | The full analysis set included all participants enrolled in the study. Only those participants with \>=7PtR from Baseline are included in the analysis. | weeks | MEAN |
| PRIMARY | Time to Next Treatment (TTNT) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | The full analysis set included all participants enrolled in the study. | months | MEDIAN |
| PRIMARY | Failure-Free Survival (FFS) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | The full analysis set included all participants enrolled in the study. | months | MEDIAN |
| PRIMARY | Overall Survival (OS) | From first dose of study drug (Day 1) to the date of death due to any cause, up to approximately 24 months | The full analysis set included all participants enrolled in the study. | months | MEDIAN |
| PRIMARY | Percentage of Participants With Complete Response (CR) and Partial Response (PR) | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | The full analysis set included all participants enrolled in the study. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Best Response by Organ System | At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months | The full analysis set included all participants enrolled in the study. Only those participants with data collected for each specified category are reported. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction | Baseline (Day 1) and Month 23 | The full analysis set included all participants enrolled in the study. Only those participants with data collected at specified timepoints are reported. | percent change | MEDIAN |
| PRIMARY | Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment | From Baseline (Day 1) up to 23 months | The full analysis set included all participants enrolled in the study. Only those categories in which at least 1 participant had data are reported. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Grade >=3 Treatment-Emergent Adverse Events and Deaths | From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months | The full analysis set included all participants enrolled in the study. | Participants | COUNT_OF_PARTICIPANTS |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05305989/outcomes