Comparison · NCT01936363-sae
Pimasertib (Once Daily) Plus SAR245409 vs Pimasertib (Twice Daily) Plus SAR245409 Placebo: 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. Pimasertib (Once Daily) Plus SAR245409 vs Pimasertib (Twice Daily) Plus SAR245409 Placebo: serious adverse events. Trial comparisons, record NCT01936363-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01936363-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 | 0.5 | 0.336 | 0.664 | wilson | |
| Risk in group 2 | 0.563 | 0.393 | 0.718 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0625 | -0.289 | 0.173 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.889 | 0.56 | 1.41 | log | |
| Odds ratio, group 1 over group 2 | 0.778 | 0.291 | 2.08 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Pimasertib (Once Daily) Plus SAR245409 than on Pimasertib (Twice Daily) Plus SAR245409 Placebo | 16 | 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 | Pimasertib (Once Daily) Plus SAR245409 | Participants received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. | 16 | 32 | EG000 |
| Group 2 | Pimasertib (Twice Daily) Plus SAR245409 Placebo | Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. | 18 | 32 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- First dose of study drug up to 52 months
Source ClinicalTrials.gov
Trial
- Title
- Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
- NCT number
- NCT01936363
- Phases
- PHASE2
- Conditions
- Ovarian Cancer
- Interventions
- Pimasertib once daily, Pimasertib placebo, SAR245409 placebo, SAR245409, Pimasertib twice daily
- Lead sponsor
- EMD Serono
- Results first posted
- 2017-04-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01936363?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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