Comparison · NCT04003636-6ae8fdcf
Arm A (Pembrolizumab+Gemcitabine+Cisplatin) vs Arm B (Placebo+Gemcitabine+Cisplatin): Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
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. Arm A (Pembrolizumab+Gemcitabine+Cisplatin) vs Arm B (Placebo+Gemcitabine+Cisplatin): Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE). Trial comparisons, record NCT04003636-6ae8fdcf. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04003636-6ae8fdcf
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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 | 0.261 | 0.225 | 0.3 | wilson | |
| Risk in group 2 | 0.228 | 0.195 | 0.266 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0324 | -0.0193 | 0.0839 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.924 | 1.41 | log | |
| Odds ratio, group 1 over group 2 | 1.19 | 0.901 | 1.58 | log | |
| Number needed to treat, for one more participant with the outcome on Arm A (Pembrolizumab+Gemcitabine+Cisplatin) than on Arm B (Placebo+Gemcitabine+Cisplatin) | 30.9 | 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 | Arm A (Pembrolizumab+Gemcitabine+Cisplatin) | 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. Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion. | 138 | 529 | OG000 |
| Group 2 | Arm B (Placebo+Gemcitabine+Cisplatin) | 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. | 122 | 534 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
- Description
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study.
- Time frame
- Up to approximately 38 months
- Population
- All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention.
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)
- NCT number
- NCT04003636
- Phases
- PHASE3
- Conditions
- Biliary Tract Carcinoma
- Interventions
- Pembrolizumab, Gemcitabine, Cisplatin, Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-12-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04003636?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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