Comparison · NCT02564263-624dab36
Pembrolizumab vs Chemotherapy: Number of Participants Experiencing 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 vs Chemotherapy: Number of Participants Experiencing an Adverse Event (AE). Trial comparisons, record NCT02564263-624dab36. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02564263-624dab36
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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 | 0.93 | 0.976 | wilson | |
| Risk in group 2 | 0.973 | 0.948 | 0.986 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0144 | -0.0455 | 0.0162 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.985 | 0.956 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.643 | 0.263 | 1.57 | log | |
| Number needed to treat, for one fewer participant with the outcome on Pembrolizumab than on Chemotherapy | 69.6 | 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 | Pembrolizumab | Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months). | 301 | 314 | OG000 |
| Group 2 | Chemotherapy | Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months). | 288 | 296 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Experiencing an Adverse Event (AE)
- Description
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who experienced ≥1 AE is presented.
- Time frame
- Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years)
- Population
- The analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were included in the treatment group to which they were randomized.
Source ClinicalTrials.gov
Trial
- Title
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)
- NCT number
- NCT02564263
- Phases
- PHASE3
- Conditions
- Esophageal Carcinoma, Esophagogastric Junction Carcinoma
- Interventions
- pembrolizumab, paclitaxel, docetaxel, irinotecan
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2019-11-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02564263?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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