Comparison · NCT02658487-sae
Treatment (Vosaroxin, Cytarabine) Induction 1 vs Induction 2: 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. Treatment (Vosaroxin, Cytarabine) Induction 1 vs Induction 2: serious adverse events. Trial comparisons, record NCT02658487-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02658487-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 | 0.303 | 0.174 | 0.473 | wilson | |
| Risk in group 2 | 0.556 | 0.267 | 0.811 | wilson | |
| Risk difference, group 1 minus group 2 | -0.253 | -0.539 | 0.0829 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.545 | 0.25 | 1.19 | log | |
| Odds ratio, group 1 over group 2 | 0.348 | 0.0768 | 1.57 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment (Vosaroxin, Cytarabine) Induction 1 than on Induction 2 | 3.96 | 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 | Treatment (Vosaroxin, Cytarabine) Induction 1 | Patients receive vosaroxin IV on days 1 and 4 and cytarabine IV continuously on days 1-7 (Induction I).~Cytarabine: Given IV~Vosaroxin: Given IV | 10 | 33 | EG000 |
| Group 2 | Induction 2 | Patients with residual leukemia and for whom a second course is indicated in the judgment of the investigator may undergo a second course of treatment (Induction II) 14-57 days after day 1 of Induction I. | 5 | 9 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
Source ClinicalTrials.gov
Trial
- Title
- Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia
- NCT number
- NCT02658487
- Phases
- PHASE2
- Conditions
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia With Multilineage Dysplasia, Myeloid Sarcoma, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia, Therapy-Related Myelodysplastic Syndrome
- Interventions
- Cytarabine, Vosaroxin
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Results first posted
- 2020-06-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02658487?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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