NCT02684058 · OUTCOME
HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Immediate Reaction Once the Medication Was Placed Into the Mouth
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
- Week 1 and Week 5
What was measured
Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the immediate reaction once the medication was placed into their mouth, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.
Analysis population: Participants who received at least one dose of dabrafenib as dispersible tablet for oral suspension and completed the palatability questionnaire for dabrafenib at week 1 or 5.
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)
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)
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 |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 8 |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 32 |
|---|
Reported measurements
Week 1
Very good, good, and neither good nor bad
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Bad
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Very bad
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to answer question
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 5
Very good, good, and neither good nor bad
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
Bad
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Very bad
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to answer question
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HGG Cohort: Dabrafenib and Trametinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| LGG Cohort: Dabrafenib and Trametinib | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 13
- title
- Very good, good, and neither good nor bad
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- title
- Bad
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Very bad
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- title
- Unable to answer question
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 10
- title
- Missing
- title
- Week 1
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 18
- title
- Very good, good, and neither good nor bad
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Bad
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Very bad
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- Unable to answer question
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 11
- title
- Missing
- title
- Week 5
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 32
- units
- Participants
- description
- Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the immediate reaction once the medication was placed into their mouth, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.
- 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
- 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
- OG001
- title
- LGG Cohort: Dabrafenib and Trametinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received at least one dose of dabrafenib as dispersible tablet for oral suspension and completed the palatability questionnaire for dabrafenib at week 1 or 5.
- reporting Status
- POSTED
- time Frame
- Week 1 and Week 5
- title
- HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Immediate Reaction Once the Medication Was Placed Into the Mouth
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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