Trial · NCT03268954
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-Free Survival (EFS) | From randomization until transformation to acute myeloid leukemia, or death due to any cause: up to approximately 42 months | ITT Population included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 6.9 years | ITT Population included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates of Six-Month Survival Rate | Month 6 | ITT Population included all participants who were randomized. Overall number analyzed is the number of participants with data available for analyses. | percentage probability | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of One-Year Survival Rate | Year 1 | ITT Population included all participants who were randomized. Overall number analyzed is the number of participants with data available for analyses. | percentage probability | NUMBER |
| SECONDARY | Thirty-Day Mortality Reported as Number of Participants Who Died Up to Day 30 | Up to Day 30 | Safety Population included all enrolled participants who received at least 1 dose of azacitidine alone or pevonedistat + azacitidine. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sixty-Day Mortality Reported as Number of Participants Who Died Up to Day 60 | Up to Day 60 | Safety Population included all enrolled participants who received at least 1 dose of azacitidine alone or pevonedistat + azacitidine. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Acute Myelogenous Leukemia (AML) Transformation in Higher-Risk Myelodysplastic Syndromes (HR MDS), Higher-Risk Chronic Myelomonocytic Leukemias (HR CMML) and HR MDS/CMML Participants | From randomization until transformation to AML (up to approximately 42 months) | ITT Population included all participants who were randomized. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis for the given category. | months | MEDIAN |
| SECONDARY | Number of Participants With Complete Remission (CR) and CR+ Complete Remission With Incomplete Blood Count Recovery (CRi) | From randomization until CR (up to approximately 42 months) | Response-Evaluable Population (REP) included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With CR and Marrow CR | From randomization until CR or marrow CR (up to approximately 42 months) | REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With CR, Partial Remission (PR) and Hematologic Improvement (HI) | From randomization until, CR, PR or HI (up to approximately 42 months) | REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With CR and Marrow CR and PR | From randomization until CR or Marrow CR and PR (up to approximately 42 months) | REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With CR and Marrow CR, PR and Hematologic Improvement (HI) | From randomization until CR, marrow CR, PR or HI (up to approximately 42 months) | REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response (OR) | From randomization until CR and PR or CR, CRi and PR (up to approximately 42 months) | REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response 2 (OR2) | From randomization until, CR, PR or HI or CR, CRi or PR (up to approximately 42 months) | REP: all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Data is reported for responders. Three participants were not counted as responders for OR2 as the IRC assessed these participants as non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Complete Remission (CR) | From CR until first documentation of PD or relapse from CR or relapse after CR or PR (up to approximately 42 months) | REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Data is reported for participants with complete remission. | months | MEDIAN |
| SECONDARY | Duration of Complete Remission + Complete Remission With Incomplete Blood Count Recovery (CRi) | From CR until first documentation of PD or relapse from CR or relapse after CR or PR (up to approximately 42 months) | REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Data is reported for participants with CR and CRi. | months | MEDIAN |
| SECONDARY | Duration of Overall Response (OR) | Up to approximately 42 months | REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Data is reported for responders. | months | MEDIAN |
| SECONDARY | Duration of Overall Response 2 (OR2) | Up to approximately 42 months | REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Three participants who were non-responders (for OR2) as per the IRC were included in this outcome measure as they had assessment of HI and duration of OR2 for these participants could still be derived based on the pre-specified criteria for HR MDS/CMML participants. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Red Blood Cells (RBCs) and Platelet-transfusion Independence | Up to approximately 42 months | ITT Population included all participants who were randomized. Overall number analyzed is the number of participants from a subset of the ITT Population who were transfusion dependent at Baseline. Number analyzed is the number of participants who were transfusion dependent at Baseline for the specified category. | percentage of participants | NUMBER |
| SECONDARY | Duration of Red Blood Cells (RBCs) and Duration of Platelet-transfusion Independence and Duration of Red Blood Cells (RBCs) and Platelet-transfusion Independence | Up to approximately 42 months | ITT Population included all participants who were randomized. Number analyzed is the number of participants who achieved transfusion independence for the specified category, with data available for analysis. | months | MEDIAN |
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.
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