Comparison · NCT03226418-sae
Group I vs Group II: 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. Group I vs Group II: serious adverse events. Trial comparisons, record NCT03226418-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03226418-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 | 0.625 | 0.306 | 0.863 | wilson | |
| Risk in group 2 | 0.631 | 0.509 | 0.738 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00577 | -0.342 | 0.262 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.991 | 0.561 | 1.75 | log | |
| Odds ratio, group 1 over group 2 | 0.976 | 0.214 | 4.45 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Group I than on Group II | 173 | 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 | Group I | INTENSIVE INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7 and idarubicin over 10-15 minutes on days 1-3 (7+3), or liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3 and 5. Gemtuzumab or midostaurin are added to 7+3 as per the standard of care. Treatment continues for 1 course in the absence of unacceptable toxicity.~INTENSIVE CONSOLIDATION THERAPY: Patients who go into remission, receive cytarabine IV over 1-3 hours twice daily (BID) on days 1, 3, and 5. Treatment repeats every 4 weeks for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients treated with liposome-encapsulated daunorubicin-cytarabine receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 5-8 weeks for 2 courses in the absence of disease progression, unacceptable toxicity.~Cytarabine: Given IV~Idarubicin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Liposome-encapsulated Daunorubicin-Cytarabine: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies | 5 | 8 | EG000 |
| Group 2 | Group II | LOW-INTENSITY: Patients receive venetoclax in combination with azacitidine or decitabine or other standard of care low-intensity therapy such as azacitidine or decitabine alone or in combination with FLT3 inhibitor such as midostaurin, low-dose cytarabine in combination with glasdegib.~Venetoclax dose varies depending on drug interaction with antifungal agents. Given daily continuous for \>= 3 months orally. Glasdegib dose is 100 mg oral daily.~Decitabine IV over 1-3 hours daily for 5-10 days. Treatment repeats every 4-5 weeks for \>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant. Azacitidine IV infusion over 10 to 40 minutes days 1 -7. Treatment repeats every 4-5 weeks for \>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant.~Decitabine: Given IV~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Azacitidine: Given by infusion~Venetoclax: oral tablet~glasdegib: oral tablet | 41 | 65 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Ongoing from initiation of study drug until 30 days after last administration of study drug, up to 20 weeks
Source ClinicalTrials.gov
Trial
- Title
- Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia
- NCT number
- NCT03226418
- Phases
- PHASE2
- Conditions
- Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia
- Interventions
Cytarabine, Decitabine, Idarubicin, Laboratory Biomarker Analysis, Liposome-encapsulated Daunorubicin-Cytarabine, Quality-of-Life Assessment, Questionnaire Administration, Azacitidine, Venetoclax, glasdegib
- Lead sponsor
- University of Nebraska
- Results first posted
- 2025-11-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03226418?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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