Comparison · NCT03675737-a97e319f
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) vs Placebo + Chemotherapy (FP or CAPOX Regimen): Number of Participants Who Discontinued Study Treatment 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. Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) vs Placebo + Chemotherapy (FP or CAPOX Regimen): Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE). Trial comparisons, record NCT03675737-a97e319f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03675737-a97e319f
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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 | 0.34 | 0.308 | 0.374 | wilson | |
| Risk in group 2 | 0.262 | 0.232 | 0.294 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0784 | 0.033 | 0.123 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.3 | 1.12 | 1.51 | log | |
| Odds ratio, group 1 over group 2 | 1.45 | 1.17 | 1.81 | log | |
| Number needed to treat, for one more participant with the outcome on Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) than on Placebo + Chemotherapy (FP or CAPOX Regimen) | 12.8 | 8.11 | 30.3 | 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 + Chemotherapy (FP or CAPOX Regimen) | Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).~Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year). | 267 | 785 | OG000 |
| Group 2 | Placebo + Chemotherapy (FP or CAPOX Regimen) | Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen). | 206 | 787 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
- Description
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.
- Time frame
- Up to approximately 46.3 months
- Population
- The analysis population included all participants who received at least one dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
- NCT number
- NCT03675737
- Phases
- PHASE3
- Conditions
- Stomach Neoplasms
- Interventions
- Pembrolizumab, Cisplatin, 5-fluorouracil, oxaliplatin, capecitabine, Placebo for Pembrolizumab
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03675737?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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