Comparison · NCT02252042-89ea7c8e
Pembrolizumab vs Standard Treatment: Number of Participants Who Experienced At Least One AE in Participants With PD-L1 ≥1% CPS
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 Standard Treatment: Number of Participants Who Experienced At Least One AE in Participants With PD-L1 ≥1% CPS. Trial comparisons, record NCT02252042-89ea7c8e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02252042-89ea7c8e
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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 | 0.99 | 0.963 | 0.997 | wilson | |
| Risk in group 2 | 0.973 | 0.938 | 0.988 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0171 | -0.0136 | 0.0529 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.989 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 2.71 | 0.519 | 14.1 | log | |
| Number needed to treat, for one more participant with the outcome on Pembrolizumab than on Standard Treatment | 58.6 | 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 intravenous (IV) on Day 1 of each 3-week cycle. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion. | 193 | 195 | OG000 |
| Group 2 | Standard Treatment | Participants received standard treatment of either methotrexate 40 mg/m\^2 IV (could be escalated to 60 mg/m\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\^2 IV loading dose on Day 1 and 250 mg/m\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle. | 178 | 183 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Experienced At Least One AE in Participants With PD-L1 ≥1% CPS
- Description
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable 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 study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants with PD-L1 ≥1% CPS who experienced at least one AE is presented.
- Time frame
- Up to approximately 33 months
- Population
- The safety population consisted of all randomized participants with PD-L1 ≥1% CPS who received at least one dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)
- NCT number
- NCT02252042
- Phases
- PHASE3
- Conditions
- Head and Neck Squamous Cell Cancer
- Interventions
- Pembrolizumab, Methotrexate, Docetaxel, Cetuximab
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2018-08-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02252042?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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