Comparison · NCT02460198-8f5d40cb
Cohort A - Pembrolizumab 200 mg vs Cohort B - Pembrolizumab 200 mg: Number of Participants Who Discontinued Study Treatment Due to an 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. Cohort A - Pembrolizumab 200 mg vs Cohort B - Pembrolizumab 200 mg: Number of Participants Who Discontinued Study Treatment Due to an AE. Trial comparisons, record NCT02460198-8f5d40cb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02460198-8f5d40cb
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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 | 0.082 | 0.0355 | 0.178 | wilson | |
| Risk in group 2 | 0.0794 | 0.0344 | 0.173 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0026 | -0.102 | 0.109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.315 | 3.39 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.284 | 3.77 | log | |
| Number needed to treat, for one more participant with the outcome on Cohort A - Pembrolizumab 200 mg than on Cohort B - Pembrolizumab 200 mg | 384 | 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 | Cohort A - Pembrolizumab 200 mg | Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years). | 5 | 61 | OG000 |
| Group 2 | Cohort B - Pembrolizumab 200 mg | Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years). | 5 | 63 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Discontinued Study Treatment Due to an AE.
- Description
An adverse event (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 occurred during the course of the study.
- Time frame
- Up to approximately 36 months
- Population
- The analysis population consisted of all participants who received at least one dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
- NCT number
- NCT02460198
- Phases
- PHASE2
- Conditions
- Colorectal Carcinoma
- Interventions
- Pembrolizumab
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2020-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02460198?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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