Comparison · NCT01761266-sae
Lenvatinib vs Sorafenib: 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. Lenvatinib vs Sorafenib: serious adverse events. Trial comparisons, record NCT01761266-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01761266-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 | 0.439 | 0.395 | 0.484 | wilson | |
| Risk in group 2 | 0.314 | 0.274 | 0.357 | wilson | |
| Risk difference, group 1 minus group 2 | 0.125 | 0.0639 | 0.186 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 1.18 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 1.71 | 1.31 | 2.23 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lenvatinib than on Sorafenib | 7.98 | 5.39 | 15.7 | 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 | Lenvatinib | Participants received lenvatinib capsules 12 mg based on the participant's body weight \>=60 kg or 8 mg based on the participant's body weight \<60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. | 209 | 476 | EG000 |
| Group 2 | Sorafenib | Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. | 149 | 475 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All treatment-emergent adverse events were collected from first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 8 years)
Source ClinicalTrials.gov
Trial
- Title
- A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma
- NCT number
- NCT01761266
- Phases
- PHASE3
- Conditions
- Hepatocellular Carcinoma (HCC)
- Interventions
- Lenvatinib, Sorafenib
- Lead sponsor
- Eisai Limited
- Results first posted
- 2018-09-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01761266?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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