Comparison · NCT01682083-deaths
Dabrafenib + Trametinib Combination Therapy vs Dabrafenib and Trametinib Placebos: deaths from any cause
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. Dabrafenib + Trametinib Combination Therapy vs Dabrafenib and Trametinib Placebos: deaths from any cause. Trial comparisons, record NCT01682083-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01682083-deaths
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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 | 0.0092 | 0.00358 | 0.0234 | wilson | |
| Risk in group 2 | 0.00231 | 0.000409 | 0.013 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00688 | -0.00518 | 0.0212 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.97 | 0.446 | 35.4 | log | |
| Odds ratio, group 1 over group 2 | 4 | 0.445 | 35.9 | log | |
| Number needed to harm, for one more death from any cause on Dabrafenib + Trametinib Combination Therapy than on Dabrafenib and Trametinib Placebos | 145 | 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 | Dabrafenib + Trametinib Combination Therapy | Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months. | 4 | 435 | EG000 |
| Group 2 | Dabrafenib and Trametinib Placebos | Subjects received matching placebos orally for 12 months | 1 | 432 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
Adverse events (AEs) were collected from the time the first dose of study treatment is administered until 30 days after discontinuation of study treatment. Serious AEs (SAEs) were reported over the same time period as AEs except SAEs assessed as related to study participation, study treatment or concomitant medication were recorded from the time a subject consents to participate in the study up to and including any follow-up contact.
Source ClinicalTrials.gov
Trial
- Title
- Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
- NCT number
- NCT01682083
- Phases
- PHASE3
- Conditions
- Melanoma
- Interventions
- Dabrafenib, Trametinib, Placebos
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2018-09-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01682083?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT01682083-deaths