Comparison · NCT02054806-sae
First Course Pembrolizumab 10 mg/kg vs Second Course Pembrolizumab 10 mg/kg: serious adverse events
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. First Course Pembrolizumab 10 mg/kg vs Second Course Pembrolizumab 10 mg/kg: serious adverse events. Trial comparisons, record NCT02054806-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02054806-sae
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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 | 0.337 | 0.296 | 0.381 | wilson | |
| Risk in group 2 | 0.273 | 0.0975 | 0.566 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0641 | -0.232 | 0.245 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.24 | 0.467 | 3.27 | log | |
| Odds ratio, group 1 over group 2 | 1.35 | 0.355 | 5.18 | log | |
| Number needed to harm, for one more participant with a serious adverse event on First Course Pembrolizumab 10 mg/kg than on Second Course Pembrolizumab 10 mg/kg | 15.6 | 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 | First Course Pembrolizumab 10 mg/kg | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. | 160 | 475 | EG000 |
| Group 2 | Second Course Pembrolizumab 10 mg/kg | Qualified participants who completed the first course of pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 10 mg/kg IV Q2W for up to \~1 year. | 3 | 11 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
Source ClinicalTrials.gov
Trial
- Title
- Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)
- NCT number
- NCT02054806
- Phases
- PHASE1
- Conditions
- Solid Tumor
- Interventions
- Pembrolizumab
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-10-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02054806?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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