Comparison · NCT03268954-67cdc3fc
Azacitidine 75 mg/m^2 vs Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2: Number of Participants With Overall Response 2 (OR2)
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 Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2: Number of Participants With Overall Response 2 (OR2). Trial comparisons, record NCT03268954-67cdc3fc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03268954-67cdc3fc
On this page
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 | 0.456 | 0.39 | 0.525 | wilson | |
| Risk in group 2 | 0.452 | 0.386 | 0.52 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00439 | -0.0907 | 0.0994 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.817 | 1.25 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.691 | 1.5 | log | |
| Number needed to treat, for one more participant with the outcome on Azacitidine 75 mg/m^2 than on Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 228 | 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 | Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles. | 94 | 206 | OG000 |
| Group 2 | Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles. | 94 | 208 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Overall Response 2 (OR2)
- Description
OR2=participant with best overall response of CR+PR+HI in HR MDS/CMML participants,or of CR+CRi+PR in low-blast AML participants.CR:≤5% myeloblasts with normal maturation of all bone marrow(BM)cell lines,≥11g/dL Hgb,≥100\*10\^9/L pl,≥1.0\*10\^9/L neutrophils,0% blasts in peripheral blood;PR:all CR criteria met except BM blasts ≥50% decrease over pretreatment but still \>5%;HI:Hgb increase(inc) ≥1.5g/dL if baseline(BL)\<11 g/dL;pl inc≥30\*10\^9/L if BL\>20\*10\^9/L or inc from \<20\*10\^9/L to \>20\*10\^9/L and by 100%;neutrophil inc by 100%;absolute inc of \>0.5\*10\^9/L if BL\<100\*10\^9/L.For low-blast AML-CR:morphologic leukemia-free state \>1.0\*10\^9 neutrophils,≥100\*10\^9/L pl,transfusion independence,no residual evidence of extramedullary leukemia;CR with incomplete blood count recovery:fulfill CR criteria except residual neutropenia \<1.0\*10\^9/L or pl\<100\*10\^9/L;PR:all CR hematological values but ≥50% decrease in BM aspirate.Number of responders determined by independent review committee(IRC) assessment.
- Time frame
- From randomization until, CR, PR or HI or CR, CRi or PR (up to approximately 42 months)
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
- NCT number
- NCT03268954
- Phases
- PHASE3
- Conditions
- Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Interventions
- Azacitidine, Pevonedistat
- Lead sponsor
- Takeda
- Results first posted
- 2022-09-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03268954?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03268954-67cdc3fc