Comparison · NCT02564263-a7b29356
Pembrolizumab vs Chemotherapy: Number of Participants Discontinuing Study Treatment Due 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 Chemotherapy: Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE). Trial comparisons, record NCT02564263-a7b29356. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02564263-a7b29356
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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 | 0.127 | 0.095 | 0.169 | wilson | |
| Risk in group 2 | 0.142 | 0.107 | 0.186 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0145 | -0.0694 | 0.0398 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.898 | 0.6 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 0.883 | 0.554 | 1.41 | log | |
| Number needed to treat, for one fewer participant with the outcome on Pembrolizumab than on Chemotherapy | 68.9 | 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). | 40 | 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). | 42 | 296 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Discontinuing Study Treatment Due 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 discontinued study treatment due to an 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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