Comparison · NCT00110019-sae
Arm I (Carboplatin + Paclitaxel + Sorafenib) vs Arm II (Carboplatin + Paclitaxel+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. Arm I (Carboplatin + Paclitaxel + Sorafenib) vs Arm II (Carboplatin + Paclitaxel+Placebo): serious adverse events. Trial comparisons, record NCT00110019-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00110019-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 | 0.845 | 0.806 | 0.877 | wilson | |
| Risk in group 2 | 0.783 | 0.74 | 0.821 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0614 | 0.00708 | 0.115 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 1.01 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 1.51 | 1.05 | 2.16 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (Carboplatin + Paclitaxel + Sorafenib) than on Arm II (Carboplatin + Paclitaxel+Placebo) | 16.3 | 8.67 | 141 | 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 I (Carboplatin + Paclitaxel + Sorafenib) | Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19. | 332 | 393 | EG000 |
| Group 2 | Arm II (Carboplatin + Paclitaxel+Placebo) | Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19. | 311 | 397 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
Source ClinicalTrials.gov
Trial
- Title
- Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
- NCT number
- NCT00110019
- Phases
- PHASE3
- Conditions
- Mucosal Melanoma, Recurrent Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma, Stage IV Skin Melanoma
- Interventions
- Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Pharmacological Study, Placebo, Sorafenib Tosylate
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2012-09-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00110019?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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