Comparison · NCT05116189-sae
Pembrolizumab + Paclitaxel ± Bevacizumab vs Placebo + Paclitaxel ± Bevacizumab: 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. Pembrolizumab + Paclitaxel ± Bevacizumab vs Placebo + Paclitaxel ± Bevacizumab: serious adverse events. Trial comparisons, record NCT05116189-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05116189-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 | 0.556 | 0.501 | 0.61 | wilson | |
| Risk in group 2 | 0.384 | 0.332 | 0.438 | wilson | |
| Risk difference, group 1 minus group 2 | 0.173 | 0.0953 | 0.247 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.45 | 1.22 | 1.72 | log | |
| Odds ratio, group 1 over group 2 | 2.01 | 1.47 | 2.76 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pembrolizumab + Paclitaxel ± Bevacizumab than on Placebo + Paclitaxel ± Bevacizumab | 5.79 | 4.05 | 10.5 | 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 | Pembrolizumab + Paclitaxel ± Bevacizumab | Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion. | 178 | 320 | EG000 |
| Group 2 | Placebo + Paclitaxel ± Bevacizumab | Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion. | 122 | 318 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 38 months
Source ClinicalTrials.gov
Trial
- Title
- Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).
- NCT number
- NCT05116189
- Phases
- PHASE3
- Conditions
- Ovarian Cancer, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
- Interventions
- Pembrolizumab, Paclitaxel, Bevacizumab, Placebo for pembrolizumab, Docetaxel
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2026-03-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05116189?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
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT05116189-sae