TriangleNCT02684058 · OUTCOME
LGG Cohort: ORR by Investigator 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 years and up to approx 4.2 years
What was measured
Percentage of participants in the LGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by investigator 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 LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.
Groups in this outcome
LGG Cohort: Dabrafenib and Trametinib
Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
LGG Cohort: Carboplatin and Vincristine
Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.
| Group | Source count |
|---|---|
| LGG Cohort: Dabrafenib and Trametinib | 73 |
| LGG Cohort: Carboplatin and Vincristine | 37 |
Reported measurements
Up to approx. 3 years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LGG Cohort: Dabrafenib and Trametinib | 54.8 | Not reported | 42.7 | 66.5 | Not reported |
| LGG Cohort: Carboplatin and Vincristine | 13.5 | Not reported | 4.5 | 28.8 | Not reported |
Up to approx. 4.2 years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LGG Cohort: Dabrafenib and Trametinib | 58.9 | Not reported | 46.8 | 70.3 | Not reported |
| LGG Cohort: Carboplatin and Vincristine | 18.9 | Not reported | 8.0 | 35.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 42.7
- upper Limit
- 66.5
- value
- 54.8
- group Id
- OG001
- lower Limit
- 4.5
- upper Limit
- 28.8
- value
- 13.5
- title
- Up to approx. 3 years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.8
- upper Limit
- 70.3
- value
- 58.9
- group Id
- OG001
- lower Limit
- 8.0
- upper Limit
- 35.2
- value
- 18.9
- title
- Up to approx. 4.2 years
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 37
- units
- Participants
- description
- Percentage of participants in the LGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by investigator 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 LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
- id
- OG000
- title
- LGG Cohort: Dabrafenib and Trametinib
- description
- Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.
- id
- OG001
- title
- LGG Cohort: Carboplatin and Vincristine
- param Type
- NUMBER
- population Description
- All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.
- reporting Status
- POSTED
- time Frame
- Up to approx. 3 years and up to approx 4.2 years
- title
- LGG Cohort: ORR by Investigator Assessment Using RANO Criteria
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice