Comparison · NCT04452877-sae
Dabrafenib in Combination With Trametinib (On-treatment Period) vs Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase): 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. Dabrafenib in Combination With Trametinib (On-treatment Period) vs Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase): serious adverse events. Trial comparisons, record NCT04452877-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04452877-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 | 0.5 | 0.352 | 0.648 | wilson | |
| Risk in group 2 | 0.0625 | 0.0111 | 0.283 | wilson | |
| Risk difference, group 1 minus group 2 | 0.438 | 0.172 | 0.594 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 8 | 1.17 | 54.7 | log | |
| Odds ratio, group 1 over group 2 | 15 | 1.81 | 125 | log | |
Number needed to harm, for one more participant with a serious adverse event on Dabrafenib in Combination With Trametinib (On-treatment Period) than on Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | 2.29 | 1.68 | 5.82 | 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 | Dabrafenib in Combination With Trametinib (On-treatment Period) | Dabrafenib in combination with trametinib (On-treatment period): Events up to 30 days post-treatment | 20 | 40 | EG000 |
| Group 2 | Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | Dabrafenib in combination with trametinib (Post-treatment follow-up phase): Events in the post-treatment follow-up phase | 1 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 50 months. Deaths were recorded from study start date until end of post-treatment follow-up (end of study), assessed up to approximately 50 months. On-treatment period (up to 30 days after last dose) and post-treatment follow-up phase (thereafter) are reported separately.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC
- NCT number
- NCT04452877
- Phases
- PHASE2
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Dabrafenib, Trametinib
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2025-11-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04452877?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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