Comparison · NCT03713593-sae
Lenvatinib + Pembrolizumab vs Lenvatinib + Placebo: serious adverse events
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. Lenvatinib + Pembrolizumab vs Lenvatinib + Placebo: serious adverse events. Trial comparisons, record NCT03713593-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03713593-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 | 0.468 | 0.42 | 0.518 | wilson | |
| Risk in group 2 | 0.403 | 0.355 | 0.452 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0658 | -0.00329 | 0.134 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.992 | 1.36 | log | |
| Odds ratio, group 1 over group 2 | 1.31 | 0.986 | 1.73 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lenvatinib + Pembrolizumab than on Lenvatinib + Placebo | 15.2 | 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 | Lenvatinib + Pembrolizumab | Participants received lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab was administered for up to 35 cycles (approximately 24 months). Lenvatinib was administered until progressive disease or unacceptable toxicity. | 185 | 395 | EG000 |
| Group 2 | Lenvatinib + Placebo | Participants received lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally QD plus saline placebo by IV infusion on Day 1 Q3W. Saline placebo was administered for up to 35 cycles (approximately 24 months). Lenvatinib was administered until progressive disease or unacceptable toxicity. | 159 | 395 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to ~ 68 months
Source ClinicalTrials.gov
Trial
- Title
Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)
- NCT number
- NCT03713593
- Phases
- PHASE3
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- lenvatinib, pembrolizumab, saline placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-07-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03713593?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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