Comparison · NCT06964165-sae
Platinum-taxane vs Niraparib: 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. Platinum-taxane vs Niraparib: serious adverse events. Trial comparisons, record NCT06964165-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06964165-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 | 0.235 | 0.0956 | 0.473 | wilson | |
| Risk in group 2 | 0.105 | 0.0294 | 0.314 | wilson | |
| Risk difference, group 1 minus group 2 | 0.13 | -0.121 | 0.379 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.24 | 0.467 | 10.7 | log | |
| Odds ratio, group 1 over group 2 | 2.62 | 0.413 | 16.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Platinum-taxane than on Niraparib | 7.69 | 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 | Platinum-taxane | Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1. | 4 | 17 | EG000 |
| Group 2 | Niraparib | Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib. | 2 | 19 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-cause mortality, Treatment-Emergent Serious Adverse Events (TESAEs), and TE Non-SAEs were collected up to approximately 154 weeks.
Source ClinicalTrials.gov
Trial
- Title
- A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)
- NCT number
- NCT06964165
- Phases
- PHASE2
- Conditions
- Ovarian Neoplasms
- Interventions
- Niraparib, Carboplatin, Paclitaxel
- Lead sponsor
- Tesaro, Inc.
- Results first posted
- 2025-07-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06964165?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
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GET https://conductscience.org/api/comparisons/v1/NCT06964165-sae