Comparison · NCT00651261-sae
Induction and Consolidation Chemotherapy Plus Midostaurin vs Induction and Consolidation Chemotherapy Plus Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Induction and Consolidation Chemotherapy Plus Midostaurin vs Induction and Consolidation Chemotherapy Plus Placebo: serious adverse events. Trial comparisons, record NCT00651261-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00651261-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 | 0.442 | 0.391 | 0.494 | wilson | |
| Risk in group 2 | 0.435 | 0.384 | 0.487 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00723 | -0.0655 | 0.0798 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.861 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.765 | 1.39 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Induction and Consolidation Chemotherapy Plus Midostaurin than on Induction and Consolidation Chemotherapy Plus Placebo | 138 | 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 | Induction and Consolidation Chemotherapy Plus Midostaurin | Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily. | 157 | 355 | EG000 |
| Group 2 | Induction and Consolidation Chemotherapy Plus Placebo | Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily. | 154 | 354 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
- NCT number
- NCT00651261
- Phases
- PHASE3
- Conditions
- Leukemia
- Interventions
- cytarabine, daunorubicin, midostaurin, placebo, dexamethasone acetate
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Results first posted
- 2017-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00651261?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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