Trial · NCT01106833
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Treatment Success | 6 months and 24 months post-randomization | Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. |
| Secondary | Percentage of Participants With Overall Survival | 6 months and 24 months post-randomization | Overall survival is defined as survival of death from any cause. |
| Secondary | Percentage of Participants With Progression-free Survival | 6 months and 24 months post-randomization | Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint. |
| Secondary | Percentage of Participants With Failure-free Survival | 6 months and 24 months post-randomization | Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint. |
| Secondary | Percentage of Participants With Relapse | 6 months and 24 months post-randomization | Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint. |
| Secondary | Percentage of Participants With Secondary Immunosuppressive Therapy Initiated | 6 months and 24 months post-randomization | The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint. |
| Secondary | Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years | 2 years post-randomization | The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint. |
| Secondary | Prednisone Dose | Baseline, 6 months, and 1 year post-randomization | Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization. |
| Secondary | Change in Prednisone Dose From Baseline | 6 months and 1 year post-randomization | Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization. |
| Secondary | Serum Creatinine Level | Baseline, 6 months, and 1 year post-randomization | Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization. |
| Secondary | Change in Serum Creatinine Level From Baseline | 6 months and 1 year post-randomization | Change in creatinine level from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization. |
| Secondary | Patient-reported Chronic GVHD Severity | Baseline, 6 months, 1 year, and 2 years post-randomization | Each patient's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe. |
| Secondary | Provider-reported Chronic GVHD Severity | Baseline, 6 months, 1 year, and 2 years post-randomization | Each patient's care provider's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe. |
| Secondary | NIH Consensus Criteria Chronic GVHD Severity | Baseline, 6 months, 1 year, and 2 years post-randomization | Chronic GVHD severity was determined at baseline and at 6 months, 1 year, and 2 years post-randomization per the 2005 NIH Consensus Criteria (Filipovich et al. 2005). Severity is categorized as none, mild, moderate, and severe. |
| Secondary | SF-36 Physical Component Summary | Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization | The Medical Outcome Study SF-36 Physical Component Summary (PCS) is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being. |
| Secondary | SF-36 Mental Component Summary | Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization | The Medical Outcome Study SF-36 Mental Component Summary (MCS) is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being. |
| Secondary | FACT-BMT Score | Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization | The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being. |
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/NCT01106833/registered