NCT02684058 · OUTCOME
All-collected Deaths
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors · Source last updated 2023-12-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- On-treatment: Up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment: Up to 4.6 years (LGG) and 5.1 years (HGG).Crossover arm: on-treatment: up to 4.2 years
What was measured
On-treatment deaths were collected from 1st dose to 30 days after last dose of treatment (or start of crossover treatment), up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment (efficacy/survival) follow-up deaths were collected from 31 days post-treatment to end of study (or start of crossover treatment), up to 4.6 years (LGG) and 5.1 years (HGG). For participants in the LGG cohort who crossed over to dabrafenib and trametinib, on-treatment deaths were collected from 1st dose to 30 days after last dose of crossover treatment, up to 4.2 years. None of the patients who crossed-over were included in the crossover post-treatment efficacy/survival follow-up.
Analysis population: Safety set including all participants who received at least one dose of study treatment
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.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 73 |
|---|
| LGG Cohort: Carboplatin and Vincristine | 33 |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 41 |
|---|
Reported measurements
On- treatment deaths
Analysis denominator · Participants
| Group | Source count |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 73 |
|---|
| LGG Cohort: Carboplatin and Vincristine | 33 |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 41 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Carboplatin and Vincristine | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Post-treatment efficacy/survival follow-up deaths
Analysis denominator · Participants
| Group | Source count |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 11 |
|---|
| LGG Cohort: Carboplatin and Vincristine | 16 |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 13 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Carboplatin and Vincristine | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Crossover on-treatment deaths
Analysis denominator · Participants
| Group | Source count |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 0 |
|---|
| LGG Cohort: Carboplatin and Vincristine | 12 |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 0 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LGG Cohort: Carboplatin and Vincristine | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Crossover post-treatment efficacy/survival follow-up deaths
Analysis denominator · Participants
| Group | Source count |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 0 |
|---|
| LGG Cohort: Carboplatin and Vincristine | 0 |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 0 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Carboplatin and Vincristine | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
All deaths
Analysis denominator · Participants
| Group | Source count |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 73 |
|---|
| LGG Cohort: Carboplatin and Vincristine | 33 |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 41 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Carboplatin and Vincristine | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 41
- units
- Participants
- title
- On- treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 13
- units
- Participants
- title
- Post-treatment efficacy/survival follow-up deaths
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Crossover on-treatment deaths
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Crossover post-treatment efficacy/survival follow-up deaths
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 17
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 41
- units
- Participants
- title
- All deaths
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 41
- units
- Participants
- description
- On-treatment deaths were collected from 1st dose to 30 days after last dose of treatment (or start of crossover treatment), up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment (efficacy/survival) follow-up deaths were collected from 31 days post-treatment to end of study (or start of crossover treatment), up to 4.6 years (LGG) and 5.1 years (HGG). For participants in the LGG cohort who crossed over to dabrafenib and trametinib, on-treatment deaths were collected from 1st dose to 30 days after last dose of crossover treatment, up to 4.2 years. None of the patients who crossed-over were included in the crossover post-treatment efficacy/survival follow-up.
- 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
- 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
- OG002
- title
- HGG Cohort: Dabrafenib and Trametinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety set including all participants who received at least one dose of study treatment
- reporting Status
- POSTED
- time Frame
- On-treatment: Up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment: Up to 4.6 years (LGG) and 5.1 years (HGG).Crossover arm: on-treatment: up to 4.2 years
- title
- All-collected Deaths
- type
- POST_HOC
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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