Comparison · NCT00313586-sae
Arm A (Azacitidine) vs Arm B (Azacitidine + Entinostat): 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. Arm A (Azacitidine) vs Arm B (Azacitidine + Entinostat): serious adverse events. Trial comparisons, record NCT00313586-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00313586-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 | 0.929 | 0.861 | 0.965 | wilson | |
| Risk in group 2 | 0.949 | 0.886 | 0.978 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0197 | -0.0937 | 0.0528 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.979 | 0.912 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.707 | 0.216 | 2.31 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A (Azacitidine) than on Arm B (Azacitidine + Entinostat) | 50.8 | 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 | Arm A (Azacitidine) | Patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle. | 92 | 99 | EG000 |
| Group 2 | Arm B (Azacitidine + Entinostat) | Patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle. | 93 | 98 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Source ClinicalTrials.gov
Trial
- Title
- Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
- NCT number
- NCT00313586
- Phases
- PHASE2
- Conditions
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL, Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA, Alkylating Agent-Related Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome, Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome, Untreated Adult Acute Myeloid Leukemia
- Interventions
- Azacitidine, Entinostat, Laboratory Biomarker Analysis
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2014-11-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00313586?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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GET https://conductscience.org/api/comparisons/v1/NCT00313586-sae