TriangleNCT02684058 · OUTCOME
HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approx. 3.2 years
What was measured
Percentage of participants in the HGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by central independent assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
Analysis population: All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.
Groups in this outcome
HGG Cohort: Dabrafenib and Trametinib
Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
| Group | Source count |
|---|---|
| HGG Cohort: Dabrafenib and Trametinib | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HGG Cohort: Dabrafenib and Trametinib | 56.1 | Not reported | 39.7 | 71.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 39.7
- upper Limit
- 71.5
- value
- 56.1
- denoms
- counts
- group Id
- OG000
- value
- 41
- units
- Participants
- description
- Percentage of participants in the HGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by central independent assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
- id
- OG000
- title
- HGG Cohort: Dabrafenib and Trametinib
- param Type
- NUMBER
- population Description
- All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approx. 3.2 years
- title
- HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice