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Trial · NCT07135973

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDrug related Grade ≥ 3 treatment emergent adverse events (TEAE)From baseline to 24 weeksDrug related Grade ≥ 3 treatment emergent adverse events (TEAE) during the treatment period (24 weeks)
SecondaryBest overall Response (BoR)Baseline to end of study i.e. 12 monthsBest overall Response (BoR), defined as the proportion of patients who achieved complete response (CR) or partial response (PR) according to the NIH Consensus Criteria.
SecondaryDuration of Response (DOR)Baseline to end of study i.e. 12 monthsDuration of Response (DOR) calculated from time of initial PR or CR until documented progression, death, or new systemic therapy.
SecondaryTime to Response (TTR)Baseline to end of study i.e. 12 months
SecondaryResponse by organ system (including GSR)Baseline to end of study i.e. 12 months
SecondaryTime taken for New Treatment (TTNT) or deathBaseline to end of study i.e. 12 months
SecondaryFailure-free survival (FFS)Baseline to end of study i.e. 12 months
SecondaryOverall survival (OS)Baseline to end of study i.e. 12 months
SecondaryChange in Corticosteroid dose.Baseline to end of study i.e. 12 months
SecondaryChange in CNI doseBaseline to end of study i.e. 12 months
SecondarySymptomatic improvement from baseline during treatment based on Lee Symptom ScaleBaseline to end of study i.e. 12 monthsdefined as a ≥7-point reduction from baseline in total symptom score on a scale of 0 to 100 which measures the symptoms of chronic GVHD, with higher scores indicating worse symptoms
SecondaryPulmonary Function Test (PFT)Baseline to end of study i.e. 12 monthsTotal lung capacity, Residual volume, Forced expiratory volume, Tidal volume
SecondaryNumber of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs)Baseline to end of study i.e. 12 months

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

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GET https://conductscience.org/api/trials/v1/NCT07135973/registered