Comparison · NCT03504410-sae
CPI-613 + HD Cytarabine and Mitoxantrone vs Control (HAM) and Control Sub-groups (MEC and FLAG): 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. CPI-613 + HD Cytarabine and Mitoxantrone vs Control (HAM) and Control Sub-groups (MEC and FLAG): serious adverse events. Trial comparisons, record NCT03504410-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03504410-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 | 0.375 | 0.285 | 0.475 | wilson | |
| Risk in group 2 | 0.351 | 0.263 | 0.45 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0245 | -0.109 | 0.157 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.736 | 1.56 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.618 | 2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on CPI-613 + HD Cytarabine and Mitoxantrone than on Control (HAM) and Control Sub-groups (MEC and FLAG) | 40.8 | 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 | CPI-613 + HD Cytarabine and Mitoxantrone | CPI-613 + High Dose Cytarabine and Mitoxantrone~CPI-613 at 2,000 mg/m2/day from day 1 to 5.~Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 2nd and 5th doses of Cytarabine. | 36 | 96 | EG000 |
| Group 2 | Control (HAM) and Control Sub-groups (MEC and FLAG) | High Dose Cytarabine and Mitoxantrone~Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 3rd and 5th doses of Cytarabine.~Mitoxantrone, Etoposide and Cytarabine~Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6~Fludarabine, Cytarabine and Filgrastim~Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5 | 34 | 97 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 38 months
Source ClinicalTrials.gov
Trial
- Title
- Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML
- NCT number
- NCT03504410
- Phases
- PHASE3
- Conditions
- Relapsed/Refractory Acute Myeloid Leukemia
- Interventions
- CPI-613 + High Dose Cytarabine and Mitoxantrone, High Dose Cytarabine and Mitoxantrone, Mitoxantrone, Etoposide and Cytarabine, Fludarabine, Cytarabine, Filgrastim
- Lead sponsor
- Cornerstone Pharmaceuticals
- Results first posted
- 2022-12-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03504410?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03504410-sae