Comparison · NCT04985604-sae
Melanoma Cohort vs Tissue Agnostic Cohort: 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. Melanoma Cohort vs Tissue Agnostic Cohort: serious adverse events. Trial comparisons, record NCT04985604-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04985604-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 | 0.25 | 0.0715 | 0.591 | wilson | |
| Risk in group 2 | 0.533 | 0.301 | 0.752 | wilson | |
| Risk difference, group 1 minus group 2 | -0.283 | -0.566 | 0.129 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.469 | 0.129 | 1.7 | log | |
| Odds ratio, group 1 over group 2 | 0.292 | 0.0439 | 1.94 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Melanoma Cohort than on Tissue Agnostic Cohort | 3.53 | 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 | Melanoma Cohort | Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW). | 2 | 8 | EG000 |
| Group 2 | Tissue Agnostic Cohort | Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW. | 8 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 23 months
Source ClinicalTrials.gov
Trial
- Title
- Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
- NCT number
- NCT04985604
- Phases
- PHASE2
- Conditions
Melanoma, Solid Tumor, CRAF Gene Amplification, RAF1 Gene Amplification, BRAF Gene Fusion, BRAF Fusion, CRAF Gene Fusion, CRAF Fusion, RAF1 Gene Fusion, RAF1 Fusion, Thyroid Cancer, Papillary, Spitzoid Melanoma, Pilocytic Astrocytoma, Pilocytic Astrocytoma, Adult, Non Small Cell Lung Cancer, Non-Small Cell Adenocarcinoma, Colorectal Cancer, Pancreatic Acinar Carcinoma, Spitzoid Malignant Melanoma, Bladder Cancer, Bladder Urothelial Carcinoma, MAP Kinase Family Gene Mutation, RAF Mutation
- Interventions
- Tovorafenib
- Lead sponsor
- Day One Biopharmaceuticals, Inc.
- Results first posted
- 2025-10-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04985604?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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