TriangleNCT02684058 · OUTCOME
LGG Cohort: 2-year OS Estimate
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
- 2 years from first dose
What was measured
OS was defined as the time from the first dose to death due to any cause in the LGG cohort. The 2-year Kaplan-Meier OS estimate represented the estimated percentage of participants remaining free from OS events for up to 2 years. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LGG Cohort: Dabrafenib and Trametinib | 100.0 | Not reported | 100.0 | 100.0 | Not reported |
| LGG Cohort: Carboplatin and Vincristine | 96.9 | Not reported | 79.8 | 99.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 100.0
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG001
- lower Limit
- 79.8
- upper Limit
- 99.6
- value
- 96.9
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 37
- units
- Participants
- description
- OS was defined as the time from the first dose to death due to any cause in the LGG cohort. The 2-year Kaplan-Meier OS estimate represented the estimated percentage of participants remaining free from OS events for up to 2 years. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact
- 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
- 2 years from first dose
- title
- LGG Cohort: 2-year OS Estimate
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice