Comparison · NCT02042443-sae
Trametinib vs Chemotherapy: 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. Trametinib vs Chemotherapy: serious adverse events. Trial comparisons, record NCT02042443-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02042443-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 | 0.565 | 0.368 | 0.744 | wilson | |
| Risk in group 2 | 0.05 | 0.00888 | 0.236 | wilson | |
| Risk difference, group 1 minus group 2 | 0.515 | 0.244 | 0.698 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 11.3 | 1.62 | 79 | log | |
| Odds ratio, group 1 over group 2 | 24.7 | 2.81 | 217 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Trametinib than on Chemotherapy | 1.94 | 1.43 | 4.1 | 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 | Trametinib | Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 13 | 23 | EG000 |
| Group 2 | Chemotherapy | Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 1 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 2 years
Source ClinicalTrials.gov
Trial
- Title
- Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
- NCT number
- NCT02042443
- Phases
- PHASE2
- Conditions
Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma, BCLC Stage D Adult Hepatocellular Carcinoma, Hilar Cholangiocarcinoma, Localized Non-Resectable Adult Liver Carcinoma, Recurrent Adult Liver Carcinoma, Recurrent Childhood Liver Cancer, Recurrent Extrahepatic Bile Duct Carcinoma, Recurrent Gallbladder Carcinoma, Stage II Gallbladder Cancer, Stage III Childhood Hepatocellular Carcinoma, Stage IIIA Gallbladder Cancer, Stage IIIB Gallbladder Cancer, Stage IV Childhood Hepatocellular Carcinoma, Stage IV Distal Bile Duct Cancer, Stage IVA Gallbladder Cancer, Stage IVB Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Carcinoma
- Interventions
- Capecitabine, Fluorouracil, Laboratory Biomarker Analysis, Leucovorin Calcium, Trametinib
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2017-08-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02042443?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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