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Comparison · NCT03836209-deaths

Arm A vs Arm B: deaths from any cause

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. Arm A vs Arm B: deaths from any cause. Trial comparisons, record NCT03836209-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03836209-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.2560.1770.354wilson
Risk in group 20.310.2230.414wilson
Risk difference, group 1 minus group 2-0.0548-0.1850.0772newcombe hybrid score
Risk ratio, group 1 over group 20.8230.5141.32log
Odds ratio, group 1 over group 20.7630.3961.47log
Number needed to treat, for one fewer death from any cause on Arm A than on Arm B18.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm A
Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given.~Consolidation: High-dose cytarabine and gilteritinib.~Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8~Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles)~Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3~Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3~Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1~Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1~Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
2390EG000
Group 2Arm B
Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given.~Consolidation: High-dose cytarabine and midostaurin.~Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8~Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles)~Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3~Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3~Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1~Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1~Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
2787EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Adverse events (AEs) are monitored during the 9 month treatment period for each patient, and for 30 days post-final dose, until resolution to ≤ grade 1 or stabilization, for a total of 10 months.

Source ClinicalTrials.gov

Trial

Title
Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
NCT number
NCT03836209
Phases
PHASE2
Conditions
Acute Myeloid Leukemia
Interventions
Gilteritinib, Midostaurin, Daunorubicin, Cytarabine
Lead sponsor
PrECOG, LLC.
Results first posted
2025-02-28

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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