NCT02124772 · OUTCOME
Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire
Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations · Source last updated 2021-07-14
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
- After the first dose of trametinib oral solution and no later than Day 8 (±3 days)
What was measured
For subjects ≥ 12 years of age who received the trametinib oral solution, the subject completed a form to evaluate the various properties of the solution (e.g., bitterness, sweetness, appearance, texture and overall taste). For subjects \< 12 years of age who received the solution, their caregiver (e.g. parent or guardian) evaluated the solution with the child based on verbal and non-verbal feedback. The questionnaire was completed after the first dose of study drug and no later than Day 8 (±3 days). Subjects completed a form for each drug separately if enrolled in Parts C and D.
Analysis population: All subjects who received at least one dose of trametinib oral solution and filled in the palatability questionnaire.
All palatability questionnaire results were combined and reported based on drug dose to better determine the acceptability and palatability of the formulation.
Groups in this outcome
TMT 0.0125 mg/kg/Day
Participants treated with trametinib oral solution at a dose level of 0.0125 mg/kg/day
TMT 0.025 mg/kg/Day
Participants treated with trametinib oral solution at a dose level of 0.025 mg/kg/day
TMT 0.032 mg/kg/Day
Participants treated with trametinib oral solution at a dose level of 0.032 mg/kg/day
TMT 0.04 mg/kg/Day
Participants treated with trametinib oral solution at a dose level of 0.04 mg/kg/day
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 |
|---|
| TMT 0.0125 mg/kg/Day | 2 |
|---|
| TMT 0.025 mg/kg/Day | 29 |
|---|
| TMT 0.032 mg/kg/Day | 21 |
|---|
| TMT 0.04 mg/kg/Day | 4 |
|---|
Reported measurements
Was the medicine difficult to mix?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine difficult to measure?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine difficult to administer?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did the subject like the taste of the medicine?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Did the subject have difficulty in taking the medicine?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did the subject resist taking the medicine?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine bitter?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine sweet?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine sour?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine gritty?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine difficult to swallow?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.025 mg/kg/Day | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.04 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Yes
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 4
- title
- No
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- missing
- title
- Was the medicine difficult to mix?
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- title
- Yes
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 4
- title
- No
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- missing
- title
- Was the medicine difficult to measure?
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 1
- title
- Yes
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 3
- title
- No
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- missing
- title
- Was the medicine difficult to administer?
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 2
- title
- Yes
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 1
- title
- No
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- title
- missing
- title
- Did the subject like the taste of the medicine?
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- title
- Yes
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 3
- title
- No
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- missing
- title
- Did the subject have difficulty in taking the medicine?
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- title
- Yes
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 3
- title
- No
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- missing
- title
- Did the subject resist taking the medicine?
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Yes
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- No
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 4
- title
- missing
- title
- Was the medicine bitter?
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Yes
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- No
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 4
- title
- missing
- title
- Was the medicine sweet?
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Yes
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- No
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 4
- title
- missing
- title
- Was the medicine sour?
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Yes
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- No
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 4
- title
- missing
- title
- Was the medicine gritty?
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Yes
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- No
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 4
- title
- missing
- title
- Was the medicine difficult to swallow?
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 4
- units
- Participants
- description
- For subjects ≥ 12 years of age who received the trametinib oral solution, the subject completed a form to evaluate the various properties of the solution (e.g., bitterness, sweetness, appearance, texture and overall taste). For subjects \< 12 years of age who received the solution, their caregiver (e.g. parent or guardian) evaluated the solution with the child based on verbal and non-verbal feedback. The questionnaire was completed after the first dose of study drug and no later than Day 8 (±3 days). Subjects completed a form for each drug separately if enrolled in Parts C and D.
- groups
- description
- Participants treated with trametinib oral solution at a dose level of 0.0125 mg/kg/day
- id
- OG000
- title
- TMT 0.0125 mg/kg/Day
- description
- Participants treated with trametinib oral solution at a dose level of 0.025 mg/kg/day
- id
- OG001
- title
- TMT 0.025 mg/kg/Day
- description
- Participants treated with trametinib oral solution at a dose level of 0.032 mg/kg/day
- id
- OG002
- title
- TMT 0.032 mg/kg/Day
- description
- Participants treated with trametinib oral solution at a dose level of 0.04 mg/kg/day
- id
- OG003
- title
- TMT 0.04 mg/kg/Day
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All subjects who received at least one dose of trametinib oral solution and filled in the palatability questionnaire.
All palatability questionnaire results were combined and reported based on drug dose to better determine the acceptability and palatability of the formulation.
- reporting Status
- POSTED
- time Frame
- After the first dose of trametinib oral solution and no later than Day 8 (±3 days)
- title
- Palatability of Trametinib Oral Solution in Pediatric Subjects Assessed by Palatability Questionnaire
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
Triangle