Comparison · NCT02610777-sae
Azacitidine 75 mg/m^2 vs Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Azacitidine 75 mg/m^2 vs Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2: serious adverse events. Trial comparisons, record NCT02610777-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02610777-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.645 | 0.521 | 0.753 | wilson | |
| Risk in group 2 | 0.69 | 0.562 | 0.794 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0445 | -0.207 | 0.122 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.935 | 0.727 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 0.818 | 0.382 | 1.75 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Azacitidine 75 mg/m^2 than on Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 22.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Azacitidine 75 mg/m^2 | Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML). | 40 | 62 | EG000 |
| Group 2 | Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML). | 40 | 58 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose up to 30 days after administration of the last dose of any study drug (up to approximately 5 years)
Source ClinicalTrials.gov
Trial
- Title
An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)
- NCT number
- NCT02610777
- Phases
- PHASE2
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Interventions
- Azacitidine, Pevonedistat
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Results first posted
- 2020-09-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02610777?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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