Comparison · NCT02853331-90dbc4ac
Pembrolizumab + Axitinib vs Sunitinib: Number of Participants Who Discontinued Study Drug 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
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ConductScience Library. Pembrolizumab + Axitinib vs Sunitinib: Number of Participants Who Discontinued Study Drug Due to an AE. Trial comparisons, record NCT02853331-90dbc4ac. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02853331-90dbc4ac
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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 | 0.305 | 0.264 | 0.351 | wilson | |
| Risk in group 2 | 0.139 | 0.109 | 0.175 | wilson | |
| Risk difference, group 1 minus group 2 | 0.167 | 0.111 | 0.221 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.2 | 1.67 | 2.9 | log | |
| Odds ratio, group 1 over group 2 | 2.73 | 1.93 | 3.84 | log | |
| Number needed to treat, for one more participant with the outcome on Pembrolizumab + Axitinib than on Sunitinib | 6 | 4.53 | 8.98 | from the risk difference interval |
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 + Axitinib | Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily. | 131 | 429 | OG000 |
| Group 2 | Sunitinib | Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks. | 59 | 425 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Discontinued Study Drug Due to an AE
- 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 was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented.
- Time frame
- Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
- Population
- The analysis population consisted of all participants who received ≥1 dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)
- NCT number
- NCT02853331
- Phases
- PHASE3
- Conditions
- Renal Cell Carcinoma
- Interventions
- Pembrolizumab, Axitinib, Sunitinib
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2019-11-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02853331?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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