Comparison · NCT02504372-7ab4f242
Pembrolizumab vs Placebo: Number of Participants Who Experienced 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
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ConductScience Library. Pembrolizumab vs Placebo: Number of Participants Who Experienced an Adverse Event (AE). Trial comparisons, record NCT02504372-7ab4f242. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02504372-7ab4f242
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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 | 0.959 | 0.939 | 0.972 | wilson | |
| Risk in group 2 | 0.91 | 0.885 | 0.931 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0481 | 0.0198 | 0.0774 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 1.02 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 2.28 | 1.38 | 3.75 | log | |
| Number needed to treat, for one more participant with the outcome on Pembrolizumab than on Placebo | 20.8 | 12.9 | 50.5 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pembrolizumab | Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year. | 556 | 580 | OG000 |
| Group 2 | Placebo | Participants received placebo, IV, every 3 weeks, for one year. | 529 | 581 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Experienced an Adverse Event (AE)
- Description
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. The number of participants who experienced an AE were reported.
- Time frame
- Up to approximately 22 months
- Population
- All randomized participants who received at least one dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091)
- NCT number
- NCT02504372
- Phases
- PHASE3
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Pembrolizumab, Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2024-02-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02504372?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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