Comparison · NCT00656617-sae
Idarubicin + Ara-C + Vorinostat (Phase 1) vs Idarubicin + Ara-C + Vorinostat (Phase 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. Idarubicin + Ara-C + Vorinostat (Phase 1) vs Idarubicin + Ara-C + Vorinostat (Phase 2): serious adverse events. Trial comparisons, record NCT00656617-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00656617-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 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk in group 2 | 0.0303 | 0.0104 | 0.0853 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0303 | -0.0853 | 0.532 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Idarubicin + Ara-C + Vorinostat (Phase 1) than on Idarubicin + Ara-C + Vorinostat (Phase 2) | 33 | 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 | Idarubicin + Ara-C + Vorinostat (Phase 1) | Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3). | 0 | 3 | EG000 |
| Group 2 | Idarubicin + Ara-C + Vorinostat (Phase 2) | Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3). | 3 | 99 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
Source ClinicalTrials.gov
Trial
- Title
- Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
- NCT number
- NCT00656617
- Phases
- PHASE2
- Conditions
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
- Interventions
- Idarubicin, Cytarabine, Vorinostat
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2015-03-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00656617?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
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GET https://conductscience.org/api/comparisons/v1/NCT00656617-sae