Comparison · NCT00901901-sae
Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) vs Sorafenib (Nexavar, BAY43-9006) + 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. Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) vs Sorafenib (Nexavar, BAY43-9006) + Placebo: serious adverse events. Trial comparisons, record NCT00901901-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00901901-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 | 0.591 | 0.54 | 0.641 | wilson | |
| Risk in group 2 | 0.558 | 0.506 | 0.609 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0334 | -0.0388 | 0.105 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.934 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 1.15 | 0.853 | 1.54 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) than on Sorafenib (Nexavar, BAY43-9006) + Placebo | 29.9 | 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 | Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) | Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd). | 214 | 362 | EG000 |
| Group 2 | Sorafenib (Nexavar, BAY43-9006) + Placebo | Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd). | 198 | 355 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of treatment up to 30 days after the last dose of study medication
Source ClinicalTrials.gov
Trial
- Title
- Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
- NCT number
- NCT00901901
- Phases
- PHASE3
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Sorafenib (Nexavar, BAY43-9006), Erlotinib (Tarceva), Placebo
- Lead sponsor
- Bayer
- Results first posted
- 2013-09-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00901901?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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