Comparison · NCT03382600-bc1058cb
Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) vs Pembrolizumab + Cisplatin +TS-1 (Cohort 2): Number of Participants With ≥1 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 + Oxaliplatin +TS-1 (Cohort 1) vs Pembrolizumab + Cisplatin +TS-1 (Cohort 2): Number of Participants With ≥1 Adverse Event (AE). Trial comparisons, record NCT03382600-bc1058cb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03382600-bc1058cb
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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 | 1 | 0.934 | 1 | wilson | |
| Risk in group 2 | 1 | 0.923 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0664 | 0.0771 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 + Oxaliplatin +TS-1 (Cohort 1) | Participants received pembrolizumab 200 mg Q3W plus oxaliplatin 130 mg/m\^2 Q3W by IV infusion plus TS-1 BID by continuous oral administration for 14 days, followed by a recovery period of 7 days. Study treatment started on Day 1 of each 3-week course, and continued for up to \~3 years. | 54 | 54 | OG000 |
| Group 2 | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) | Participants received pembrolizumab 200 mg Q3W plus cisplatin 60 mg/m\^2 Q3W by IV infusion plus TS-1 BID by continuous oral administration for 14 days, followed by a recovery period of 7 days. Study treatment started on Day 1 of each 3-week course, and continued for up to \~3 years. | 46 | 46 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With ≥1 Adverse Event (AE)
- Description
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment
- Time frame
- Up to ~36 months
- Population
- All participants who received ≥1 dose of study drug are included.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as First Line Chemotherapy in Gastric Cancer (MK-3475-659/KEYNOTE-659)
- NCT number
- NCT03382600
- Phases
- PHASE2
- Conditions
- Gastric Cancer
- Interventions
- Pembrolizumab, Oxaliplatin, TS-1, Cisplatin
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-12-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03382600?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.govNone 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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