Comparison · NCT03182244-f448db24
Gilteritinib vs Salvage Chemotherapy: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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. Gilteritinib vs Salvage Chemotherapy: Number of Participants With Treatment Emergent Adverse Events (TEAEs). Trial comparisons, record NCT03182244-f448db24. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03182244-f448db24
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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 | 1 | 0.972 | 1 | wilson | |
| Risk in group 2 | 1 | 0.969 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0279 | 0.0313 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Gilteritinib | Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles until treatment discontinuation criteria were met. Participants who met the treatment discontinuation criteria, entered the long-term follow-up period. Participants remained in the long-term follow-up period for up to 3 years from the participant's end of treatment visit or until discontinuation from the study. | 134 | 134 | OG000 |
| Group 2 | Salvage Chemotherapy | Participants received salvage chemotherapy in continuous 28-day cycles per institutional guidelines.~Salvage chemotherapy included:~LoDAC: 20 mg cytarabine administered twice daily by SC/IV injection for 10 days.~MEC: mitoxantrone 6 mg/m\^2 per day administered by IV for 5 days (days 1 through 5), etoposide 100 mg/m\^2 per day administered by IV for 5 days (days 1 through 5), cytarabine 1000 mg/m\^2 per day administered by IV for 5 days (days 1 through 5).~FLAG: G-CSF 300 μg/m\^2 per day administered by SC/IV for 5 days (days 1 through 5), fludarabine 30 mg/m\^2 per day administered by IV for 5 days (days 2 through 6), cytarabine 2000 mg/m\^2 per day administered by IV for 5 days (days 2 through 6). Participants who met treatment discontinuation criteria, entered long-term follow-up and remained in the period for up to 3 years from the participant's end of treatment visit/until discontinuation from study.~Based on the outcome of interim analysis, at investigators discretion, participants in the treatment period had the option to enter COE period to receive 120 mg gilteritinib, orally, once a day in continuous 28-day cycles until treatment discontinuation criteria was met. | 119 | 119 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- Description
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug.
- Time frame
- From the date of first dose up to approximately 74 months
- Population
- Safety Analysis Set (SAF): The SAF consisted of all participants who received at least 1 dose of study treatment (gilteritinib or salvage chemotherapy).
Source ClinicalTrials.gov
Trial
- Title
- A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation
- NCT number
- NCT03182244
- Phases
- PHASE3
- Conditions
- AML With FLT3 Mutation
- Interventions
- Gilteritinib, Cytarabine, Mitoxantrone, Etoposide, G-CSF, Fludarabine
- Lead sponsor
- Astellas Pharma Inc
- Results first posted
- 2025-01-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03182244?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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