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NCT02684058 · OUTCOME

LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Fatigue Score

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: MEAN
Unit: Score on a Scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)

What was measured

The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 1 item measuring the fatigue interference of the participants. Fatigue item used a 5-level Likert scale with 1= never and 5= almost always, higher scores indicate worsening fatigue. Raw scores were then converted into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicated a greater level of reported fatigue. Participants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the PROMIS Parent Proxy Global 7+2 Health questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.

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 and contributed to this analysis. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. Number analyzed indicated number of participants with available data for this outcome measure at the specified timepoints.

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 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	61
LGG Cohort: Carboplatin and Vincristine	23

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	61
LGG Cohort: Carboplatin and Vincristine	23

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	53.30	6.731	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	54.37	7.981	Not reported	Not reported	Not reported

Week 5 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	51
LGG Cohort: Carboplatin and Vincristine	18

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	53.96	7.588	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	56.88	6.430	Not reported	Not reported	Not reported

Week 8 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	54
LGG Cohort: Carboplatin and Vincristine	18

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	52.68	6.967	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	58.10	4.823	Not reported	Not reported	Not reported

Week 16 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	48
LGG Cohort: Carboplatin and Vincristine	10

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	51.22	6.983	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	57.81	6.193	Not reported	Not reported	Not reported

Week 24 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	46
LGG Cohort: Carboplatin and Vincristine	10

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	51.04	8.005	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	55.02	7.248	Not reported	Not reported	Not reported

Week 32 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	47
LGG Cohort: Carboplatin and Vincristine	11

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	52.49	7.219	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	57.66	5.899	Not reported	Not reported	Not reported

Week 40 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	40
LGG Cohort: Carboplatin and Vincristine	7

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	52.27	7.450	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	58.49	7.072	Not reported	Not reported	Not reported

Week 48 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	43
LGG Cohort: Carboplatin and Vincristine	10

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	51.65	7.362	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	53.48	8.004	Not reported	Not reported	Not reported

Week 56 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	46
LGG Cohort: Carboplatin and Vincristine	7

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	50.51	7.150	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	57.63	7.254	Not reported	Not reported	Not reported

Week 72 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	40
LGG Cohort: Carboplatin and Vincristine	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	49.93	6.910	Not reported	Not reported	Not reported

Week 88 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	38
LGG Cohort: Carboplatin and Vincristine	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	50.52	7.358	Not reported	Not reported	Not reported

Week 104 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	39
LGG Cohort: Carboplatin and Vincristine	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	51.11	6.899	Not reported	Not reported	Not reported

Week 120 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	33
LGG Cohort: Carboplatin and Vincristine	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	50.40	7.317	Not reported	Not reported	Not reported

Week 136 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	24
LGG Cohort: Carboplatin and Vincristine	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	50.97	8.667	Not reported	Not reported	Not reported

Week 152 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	17
LGG Cohort: Carboplatin and Vincristine	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	47.71	8.037	Not reported	Not reported	Not reported

Week 168 Day 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	13
LGG Cohort: Carboplatin and Vincristine	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	48.21	8.188	Not reported	Not reported	Not reported

EOT

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	50
LGG Cohort: Carboplatin and Vincristine	14

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	52.35	7.565	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	56.88	5.246	Not reported	Not reported	Not reported

Post Treatment Follow-Up 1

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	1
LGG Cohort: Carboplatin and Vincristine	4

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	48.94	Not reported	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	52.36	6.840	Not reported	Not reported	Not reported

Post Treatment Follow-Up 2

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	1
LGG Cohort: Carboplatin and Vincristine	1

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	62.62	Not reported	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	62.62	Not reported	Not reported	Not reported	Not reported

Post Treatment Follow-Up 3

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	1
LGG Cohort: Carboplatin and Vincristine	1

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	48.94	Not reported	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	48.94	Not reported	Not reported	Not reported	Not reported

Post Treatment Follow-Up 4

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	1
LGG Cohort: Carboplatin and Vincristine	2

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	56.07	Not reported	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	48.94	0.000	Not reported	Not reported	Not reported

Post Treatment Follow-Up 5

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	1
LGG Cohort: Carboplatin and Vincristine	1

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	62.62	Not reported	Not reported	Not reported	Not reported
LGG Cohort: Carboplatin and Vincristine	48.94	Not reported	Not reported	Not reported	Not reported

Post Treatment Follow-Up 6

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	0
LGG Cohort: Carboplatin and Vincristine	2

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Carboplatin and Vincristine	55.78	9.673	Not reported	Not reported	Not reported

Post Treatment Follow-Up 7

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	0
LGG Cohort: Carboplatin and Vincristine	0

Post Treatment Follow-Up 8

Analysis denominator · Participants

Group	Source count
LGG Cohort: Dabrafenib and Trametinib	0
LGG Cohort: Carboplatin and Vincristine	1

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Carboplatin and Vincristine	48.94	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
6.731
value
53.30
group Id
OG001
spread
7.981
value
54.37
denoms
counts
group Id
OG000
value
61
group Id
OG001
value
23
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
7.588
value
53.96
group Id
OG001
spread
6.430
value
56.88
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
18
units
Participants
title
Week 5 Day 1
categories
measurements
group Id
OG000
spread
6.967
value
52.68
group Id
OG001
spread
4.823
value
58.10
denoms
counts
group Id
OG000
value
54
group Id
OG001
value
18
units
Participants
title
Week 8 Day 1
categories
measurements
group Id
OG000
spread
6.983
value
51.22
group Id
OG001
spread
6.193
value
57.81
denoms
counts
group Id
OG000
value
48
group Id
OG001
value
10
units
Participants
title
Week 16 Day 1
categories
measurements
group Id
OG000
spread
8.005
value
51.04
group Id
OG001
spread
7.248
value
55.02
denoms
counts
group Id
OG000
value
46
group Id
OG001
value
10
units
Participants
title
Week 24 Day 1
categories
measurements
group Id
OG000
spread
7.219
value
52.49
group Id
OG001
spread
5.899
value
57.66
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
11
units
Participants
title
Week 32 Day 1
categories
measurements
group Id
OG000
spread
7.450
value
52.27
group Id
OG001
spread
7.072
value
58.49
denoms
counts
group Id
OG000
value
40
group Id
OG001
value
7
units
Participants
title
Week 40 Day 1
categories
measurements
group Id
OG000
spread
7.362
value
51.65
group Id
OG001
spread
8.004
value
53.48
denoms
counts
group Id
OG000
value
43
group Id
OG001
value
10
units
Participants
title
Week 48 Day 1
categories
measurements
group Id
OG000
spread
7.150
value
50.51
group Id
OG001
spread
7.254
value
57.63
denoms
counts
group Id
OG000
value
46
group Id
OG001
value
7
units
Participants
title
Week 56 Day 1
categories
measurements
group Id
OG000
spread
6.910
value
49.93
denoms
counts
group Id
OG000
value
40
group Id
OG001
value
0
units
Participants
title
Week 72 Day 1
categories
measurements
group Id
OG000
spread
7.358
value
50.52
denoms
counts
group Id
OG000
value
38
group Id
OG001
value
0
units
Participants
title
Week 88 Day 1
categories
measurements
group Id
OG000
spread
6.899
value
51.11
denoms
counts
group Id
OG000
value
39
group Id
OG001
value
0
units
Participants
title
Week 104 Day 1

denoms

counts
group Id
OG000
value
61
group Id
OG001
value
23
units
Participants

description

The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 1 item measuring the fatigue interference of the participants. Fatigue item used a 5-level Likert scale with 1= never and 5= almost always, higher scores indicate worsening fatigue. Raw scores were then converted into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicated a greater level of reported fatigue. Participants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the PROMIS Parent Proxy Global 7+2 Health questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.

dispersion Type

Standard Deviation

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

MEAN

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 and contributed to this analysis. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. Number analyzed indicated number of participants with available data for this outcome measure at the specified timepoints.

reporting Status

POSTED

time Frame

Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)

title

LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Fatigue Score

type

SECONDARY

unit Of Measure

Score on a Scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice