Comparison · NCT04924062-sae
Pembrolizumab + Chemotherapy First Course vs Placebo + Chemotherapy First Course: 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 + Chemotherapy First Course vs Placebo + Chemotherapy First Course: serious adverse events. Trial comparisons, record NCT04924062-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04924062-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 | 0.378 | 0.276 | 0.492 | wilson | |
| Risk in group 2 | 0.354 | 0.259 | 0.462 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0247 | -0.124 | 0.173 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.708 | 1.62 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.579 | 2.14 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pembrolizumab + Chemotherapy First Course than on Placebo + Chemotherapy First Course | 40.5 | 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 | Pembrolizumab + Chemotherapy First Course | Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. | 28 | 74 | EG000 |
| Group 2 | Placebo + Chemotherapy First Course | Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. | 29 | 82 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 29 months
Source ClinicalTrials.gov
Trial
- Title
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study
- NCT number
- NCT04924062
- Phases
- PHASE3
- Conditions
- Biliary Tract Carcinoma
- Interventions
- Pembrolizumab, Gemcitabine, Cisplatin, Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-12-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04924062?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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