Comparison · NCT00866281-sae
Cohort 1: Midostaurin (30 Milligrams/Meters^2) vs Cohort 2: Midostaurin (60 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. Cohort 1: Midostaurin (30 Milligrams/Meters^2) vs Cohort 2: Midostaurin (60 mg/m^2): serious adverse events. Trial comparisons, record NCT00866281-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00866281-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 | 0.429 | 0.158 | 0.75 | wilson | |
| Risk in group 2 | 0.4 | 0.198 | 0.643 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0286 | -0.335 | 0.408 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.373 | 3.08 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.183 | 6.93 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort 1: Midostaurin (30 Milligrams/Meters^2) than on Cohort 2: Midostaurin (60 mg/m^2) | 35 | 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 | Cohort 1: Midostaurin (30 Milligrams/Meters^2) | Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m\^2 bid through oral route. The total daily dose in 30 mg/m\^2 bid cohort was 60 mg/m\^2. | 3 | 7 | EG000 |
| Group 2 | Cohort 2: Midostaurin (60 mg/m^2) | Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m\^2 bid through oral route. The total daily dose in 60 mg/m\^2 bid cohort was 120 mg/m\^2. | 6 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious Adverse Events are monitored from date of First Participant First Visit (FPFV) up to Last Participant Last Visit (LPLV), 24 weeks and all other adverse events are monitored from First Participant First Treatment (FPFT) up to LPLV, 20 weeks
Source ClinicalTrials.gov
Trial
- Title
- A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
- NCT number
- NCT00866281
- Phases
- PHASE1, PHASE2
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
- Interventions
- midostaurin
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2015-12-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00866281?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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