Comparison · NCT01004978-sae
Arm A (Sorafenib and TACE) vs Arm B (Placebo and TACE): 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. Arm A (Sorafenib and TACE) vs Arm B (Placebo and TACE): serious adverse events. Trial comparisons, record NCT01004978-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01004978-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 | 0.497 | 0.678 | wilson | |
| Risk in group 2 | 0.38 | 0.294 | 0.474 | wilson | |
| Risk difference, group 1 minus group 2 | 0.211 | 0.0786 | 0.334 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.56 | 1.17 | 2.07 | log | |
| Odds ratio, group 1 over group 2 | 2.36 | 1.37 | 4.07 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A (Sorafenib and TACE) than on Arm B (Placebo and TACE) | 4.73 | 3 | 12.7 | 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 | Arm A (Sorafenib and TACE) | Patients receive sorafenib tosylate PO BID in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of sorafenib tosylate is reached, patients undergo TACE comprising doxorubicin hydrochloride, mitomycin C, and cisplatin (this option may only be utilized for patients registered prior to addendum #3); conventional chemoembolization comprising doxorubicin hydrochloride only; or chemoembolization comprising LC bead and doxorubicin. Treatment with TACE repeats approximately every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. | 65 | 110 | EG000 |
| Group 2 | Arm B (Placebo and TACE) | Patients receive placebo PO BID in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of placebo is reached, patients undergo TACE as in Arm A. | 41 | 108 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, and then every 6 months up to 4 years
Source ClinicalTrials.gov
Trial
- Title
- Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
- NCT number
- NCT01004978
- Phases
- PHASE3
- Conditions
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma
- Interventions
Cisplatin, Computed Tomography, Doxorubicin Hydrochloride, Doxorubicin-Eluting Beads, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Mitomycin, Pharmacological Study, Placebo Administration, Sorafenib Tosylate
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2023-02-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01004978?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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GET https://conductscience.org/api/comparisons/v1/NCT01004978-sae