Comparison · NCT01015833-sae
Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) vs Arm II (Sorafenib Tosylate): 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 I (Doxorubicin Hydrochloride, Sorafenib Tosylate) vs Arm II (Sorafenib Tosylate): serious adverse events. Trial comparisons, record NCT01015833-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01015833-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 | 0.425 | 0.353 | 0.501 | wilson | |
| Risk in group 2 | 0.333 | 0.267 | 0.407 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0918 | -0.0115 | 0.193 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 0.968 | 1.68 | log | |
| Odds ratio, group 1 over group 2 | 1.48 | 0.951 | 2.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) than on Arm II (Sorafenib Tosylate) | 10.9 | 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 | Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate) | Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity. | 71 | 167 | EG000 |
| Group 2 | Arm II (Sorafenib Tosylate) | Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 57 | 171 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 3 years.
Source ClinicalTrials.gov
Trial
- Title
- Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer
- NCT number
- NCT01015833
- Phases
- PHASE3
- Conditions
Advanced Adult Hepatocellular Carcinoma, Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7, Stage IIIA Hepatocellular Carcinoma AJCC v7, Stage IIIB Hepatocellular Carcinoma AJCC v7, Stage IIIC Hepatocellular Carcinoma AJCC v7, Stage IV Hepatocellular Carcinoma AJCC v7, Stage IVA Hepatocellular Carcinoma AJCC v7, Stage IVB Hepatocellular Carcinoma AJCC v7, Unresectable Hepatocellular Carcinoma
- Interventions
- Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Pharmacogenomic Study, Sorafenib Tosylate
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2018-05-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01015833?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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