Trial · NCT01002742
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | GVHD-free Survival | Day 56 | Success is defined as alive and free of GVHD at day 56 after randomization, all others are considered to be a study failure. |
| Secondary | Percentage of Surviving Participants With Complete Response (CR) | Days 14, 28, and 56 | CR is defined as a score of 0 for the GVHD grading in all evaluable organs. |
| Secondary | Incidence of GVHD Flares Requiring Increased Therapy | Day 90 | Flares are defined as any progression of acute GVHD after an initial response (i.e., earlier CR or PR) that requires re-escalation of steroid dosing, or initiation of additional topical or systemic therapy. |
| Secondary | Incidence of Discontinuation of Immune Suppression Without Flare | Day 56, Day 180 and Day 360 post-treatment | |
| Secondary | Cumulative Steroid Dose | Days 28 and 56 | The cumulative steroid dose for each patient will be calculated by adding the doses (end of each week's dose) for each of the first four weeks of treatment, divided by the number of days of survival during this interval. The cumulative steroid dose was calculated for all patients per treatment arm and compared. |
| Secondary | Incidence of Topical/Non-absorbable Therapy | Day 56 | |
| Secondary | Overall GVHD-free Survival Post-randomization | Months 6 and 12 | |
| Secondary | Incidence of Chronic GVHD | 12 months post-randomization | |
| Secondary | Incidence of Systemic Infections | 6 Months | Number of participants that experienced at least one infection. |
| Secondary | Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma | 12 months | |
| Secondary | Incidence of Cytomegalovirus (CMV) Reactivation | Year 1 | |
| Secondary | Cumulative Incidence of a Severe/Life-threatening/Fatal Infections | Year 1 | |
| Secondary | Disease-Free Survival (DFS) Post-Randomization | Year 1 | DFS includes death or progression/relapse of malignancy |
| Secondary | Treatment Related Mortality (TRM) | Year 1 | |
| Secondary | Change in Patient Reported Outcomes From Enrollment to Day 56 | Day 56 |
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/NCT01002742/registered