Comparison · NCT01979523-6eb3a501
Arm A (Trametinib) vs Arm B (Trametinib, Akt Inhibitor GSK2141795): Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm A (Trametinib) vs Arm B (Trametinib, Akt Inhibitor GSK2141795): Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent. Trial comparisons, record NCT01979523-6eb3a501. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01979523-6eb3a501
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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 | 1 | 0.845 | 1 | wilson | |
| Risk in group 2 | 1 | 0.845 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.155 | 0.155 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 A (Trametinib) | Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO | 21 | 21 | OG000 |
| Group 2 | Arm B (Trametinib, Akt Inhibitor GSK2141795) | Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Trametinib: Given PO~Uprosertib: Given PO | 21 | 21 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent
- Description
- Graded according to the National Cancer Institute CTCAE v4.0. Please see AE/SAE Section for specifics.
- Time frame
- From date of randomization until the date of death from any cause or 4 weeks from last treatment of the initial treatment assignment, whichever came first, assessed up to 12 months
- Population
- This assessment corresponds to the participants' initial treatment assignment.
Source ClinicalTrials.gov
Trial
- Title
- Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma
- NCT number
- NCT01979523
- Phases
- PHASE2
- Conditions
- Recurrent Uveal Melanoma, Stage IV Uveal Melanoma AJCC v7
- Interventions
- Laboratory Biomarker Analysis, Pharmacological Study, Trametinib, Uprosertib
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2020-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01979523?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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