Comparison · NCT03280030-9ff3c601
Midostaurin: Part 2 vs Placebo: Part 2: Percentage of Participants With Cumulative Incidence of Relapse (CIR)
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. Midostaurin: Part 2 vs Placebo: Part 2: Percentage of Participants With Cumulative Incidence of Relapse (CIR). Trial comparisons, record NCT03280030-9ff3c601. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03280030-9ff3c601
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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 | 0.7 | 0.521 | 0.833 | wilson | |
| Risk in group 2 | 0.781 | 0.612 | 0.89 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0813 | -0.29 | 0.134 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.896 | 0.665 | 1.21 | log | |
| Odds ratio, group 1 over group 2 | 0.653 | 0.208 | 2.05 | log | |
| Number needed to treat, for one fewer participant with the outcome on Midostaurin: Part 2 than on Placebo: Part 2 | 12.3 | 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 | Midostaurin: Part 2 | Patients took study drug on day 8-21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase | 21 | 30 | OG000 |
| Group 2 | Placebo: Part 2 | Patients took Placebo on day 8 - 21 during induction and consolidation phase, then on days 1-28 for 12 cycles in the continuation (post-consolidation) phase. | 25 | 32 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Participants With Cumulative Incidence of Relapse (CIR)
- Description
- CIR (only for patients who achieved CR after study treatment initiation), is measured from the date of first CR to relapse or death due to AML, whichever occurs first.
- Time frame
- up to 3 years after last patient started treatment
- Population
FAS: The FAS comprised of all subjects to whom study drug (midostaurin/placebo) had been assigned by randomization. Therefore, all Japanese subjects treated during Part 1 were not eligible for the FAS. This analysis was on FAS but only on participants who had achieved a CR.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
- NCT number
- NCT03280030
- Phases
- PHASE2
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Midostaurin, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2025-02-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03280030?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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