Comparison · NCT01191801-sae
Group A (Vosaroxin/Cytarabine) vs Group B (Placebo/Cytarabine): 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. Group A (Vosaroxin/Cytarabine) vs Group B (Placebo/Cytarabine): serious adverse events. Trial comparisons, record NCT01191801-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01191801-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 | 0.555 | 0.503 | 0.606 | wilson | |
| Risk in group 2 | 0.357 | 0.309 | 0.409 | wilson | |
| Risk difference, group 1 minus group 2 | 0.198 | 0.125 | 0.268 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.55 | 1.31 | 1.84 | log | |
| Odds ratio, group 1 over group 2 | 2.24 | 1.66 | 3.04 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Group A (Vosaroxin/Cytarabine) than on Group B (Placebo/Cytarabine) | 5.06 | 3.73 | 8.03 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Group A (Vosaroxin/Cytarabine) | Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5 | 197 | 355 | EG000 |
| Group 2 | Group B (Placebo/Cytarabine) | Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5 | 125 | 350 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Event reported below reflects time from first patient randomization 17 December 2010 to database lock for primary analysis 26 September 2014. The Tables show Incidence of Treatment Emergent Adverse Events.
Source ClinicalTrials.gov
Trial
- Title
- Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
- NCT number
- NCT01191801
- Phases
- PHASE3
- Conditions
- Acute Myeloid Leukemia
- Interventions
- vosaroxin + cytarabine, placebo + cytarabine
- Lead sponsor
- Sunesis Pharmaceuticals
- Results first posted
- 2017-05-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01191801?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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