Comparison · NCT01721876-sae
Subjects Assigned to Placebo + Low-dose Cytarabine vs Subjects Assigned to Volasertib + Low-dose 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. Subjects Assigned to Placebo + Low-dose Cytarabine vs Subjects Assigned to Volasertib + Low-dose Cytarabine: serious adverse events. Trial comparisons, record NCT01721876-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01721876-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 | 0.734 | 0.673 | 0.788 | wilson | |
| Risk in group 2 | 0.866 | 0.831 | 0.894 | wilson | |
| Risk difference, group 1 minus group 2 | -0.131 | -0.199 | -0.0672 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.848 | 0.777 | 0.926 | log | |
| Odds ratio, group 1 over group 2 | 0.429 | 0.286 | 0.643 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Subjects Assigned to Placebo + Low-dose Cytarabine than on Subjects Assigned to Volasertib + Low-dose Cytarabine | 7.61 | 5.01 | 14.9 | from the risk difference interval |
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 | Subjects Assigned to Placebo + Low-dose Cytarabine | Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle. | 163 | 222 | EG000 |
| Group 2 | Subjects Assigned to Volasertib + Low-dose Cytarabine | Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle. | 380 | 439 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months.
Source ClinicalTrials.gov
Trial
- Title
Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)
- NCT number
- NCT01721876
- Phases
- PHASE3
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- Placebo, Volasertib, Cytarabine
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2021-11-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01721876?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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