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NCT02928224 · OUTCOME

(Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Participants (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, Cycle(C)1 Day(D)1 , C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

What was measured

The EORTC QLQ-C30 questionnaire consisted of 30 questions generating 5 functional scores (physical, role, cognitive, emotional, \& social); a global health (GH) status/global quality of life scale score; 3 symptom scale scores (fatigue, pain, \& nausea \& vomiting); \& 6 standalone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, \& diarrhea) \& perceived financial burden. All items were graded by severity experienced during previous week \& used 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0-100. Higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity).

Analysis population: The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row.

Groups in this outcome

Phase 3: Triplet Arm

Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

Phase 3:Doublet Arm

Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.

Phase 3:Control Arm

Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.

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
Phase 3: Triplet Arm	224
Phase 3:Doublet Arm	220
Phase 3:Control Arm	221

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	209
Phase 3:Doublet Arm	201
Phase 3:Control Arm	200

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	62.8	22.18	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	60.7	21.33	Not reported	Not reported	Not reported
Phase 3:Control Arm	62.8	21.82	Not reported	Not reported	Not reported

Change at Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	138
Phase 3:Doublet Arm	133
Phase 3:Control Arm	120

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-2.4	13.44	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-4.3	16.27	Not reported	Not reported	Not reported
Phase 3:Control Arm	-3.4	15.60	Not reported	Not reported	Not reported

Change at Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	181
Phase 3:Doublet Arm	180
Phase 3:Control Arm	123

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.6	19.06	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	3.8	18.46	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.9	22.45	Not reported	Not reported	Not reported

Change at Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	148
Phase 3:Doublet Arm	142
Phase 3:Control Arm	51

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.7	18.86	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	3.5	19.96	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.2	24.07	Not reported	Not reported	Not reported

Change at Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	119
Phase 3:Doublet Arm	105
Phase 3:Control Arm	37

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.2	15.63	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	4.2	22.17	Not reported	Not reported	Not reported
Phase 3:Control Arm	1.4	21.65	Not reported	Not reported	Not reported

Change at Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	99
Phase 3:Doublet Arm	81
Phase 3:Control Arm	26

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.1	18.66	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	4.3	22.09	Not reported	Not reported	Not reported
Phase 3:Control Arm	-2.2	22.06	Not reported	Not reported	Not reported

Change at Cycle 6 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	68
Phase 3:Doublet Arm	60
Phase 3:Control Arm	13

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-4.0	16.76	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	5.6	23.25	Not reported	Not reported	Not reported
Phase 3:Control Arm	-4.5	19.43	Not reported	Not reported	Not reported

Change at Cycle 7 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	47
Phase 3:Doublet Arm	50
Phase 3:Control Arm	10

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-2.5	16.01	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	4.3	21.77	Not reported	Not reported	Not reported
Phase 3:Control Arm	1.7	12.30	Not reported	Not reported	Not reported

Change at Cycle 8 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	39
Phase 3:Doublet Arm	40
Phase 3:Control Arm	7

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-2.6	14.83	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	4.2	16.98	Not reported	Not reported	Not reported
Phase 3:Control Arm	0.0	27.64	Not reported	Not reported	Not reported

Change at Cycle 9 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	33
Phase 3:Doublet Arm	31
Phase 3:Control Arm	7

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-5.8	17.74	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-5.6	16.44	Not reported	Not reported	Not reported
Phase 3:Control Arm	-4.8	12.60	Not reported	Not reported	Not reported

Change at Cycle 10 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	23
Phase 3:Doublet Arm	24
Phase 3:Control Arm	4

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-3.3	17.90	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-2.8	16.97	Not reported	Not reported	Not reported
Phase 3:Control Arm	2.1	20.83	Not reported	Not reported	Not reported

Change at Cycle 11 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	16
Phase 3:Doublet Arm	19
Phase 3:Control Arm	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-5.2	20.38	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	3.9	15.31	Not reported	Not reported	Not reported
Phase 3:Control Arm	33.3	NA	Not reported	Not reported	Number analyzed is 1 so standard deviation (SD) is not available.

Change at Cycle 12 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	14
Phase 3:Doublet Arm	18
Phase 3:Control Arm	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.0	22.41	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-4.6	13.77	Not reported	Not reported	Not reported
Phase 3:Control Arm	4.2	53.03	Not reported	Not reported	Not reported

Change at Cycle 13 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	9
Phase 3:Doublet Arm	13
Phase 3:Control Arm	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.0	20.41	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-3.2	14.25	Not reported	Not reported	Not reported
Phase 3:Control Arm	0.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 14 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	7
Phase 3:Doublet Arm	7
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.2	24.26	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-6.0	15.00	Not reported	Not reported	Not reported

Change at Cycle 15 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	7
Phase 3:Doublet Arm	6
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	3.6	33.63	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	2.8	8.61	Not reported	Not reported	Not reported

Change at Cycle 16 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	5
Phase 3:Doublet Arm	3
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-16.7	42.08	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-5.6	9.62	Not reported	Not reported	Not reported

Change at Cycle 17 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	3
Phase 3:Doublet Arm	3
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-27.8	20.97	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-2.8	12.73	Not reported	Not reported	Not reported

Change at Cycle 18 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	3
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-16.7	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-8.3	8.33	Not reported	Not reported	Not reported

Change at Cycle 19 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	2
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-8.3	11.79	Not reported	Not reported	Not reported

Change at Cycle 20 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-25	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-8	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 21 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-16.7	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 22 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	0
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3:Doublet Arm	-16.7	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 23 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	0
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3:Doublet Arm	0.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at End of Treatment

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	74
Phase 3:Doublet Arm	72
Phase 3:Control Arm	79

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-14.1	22.66	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-13.1	21.61	Not reported	Not reported	Not reported
Phase 3:Control Arm	-15.5	27.04	Not reported	Not reported	Not reported

Change at 30 Day Follow Up

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	24
Phase 3:Doublet Arm	16
Phase 3:Control Arm	21

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-17.4	22.51	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-10.4	15.96	Not reported	Not reported	Not reported
Phase 3:Control Arm	-24.6	24.08	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
22.18
value
62.8
group Id
OG001
spread
21.33
value
60.7
group Id
OG002
spread
21.82
value
62.8
denoms
counts
group Id
OG000
value
209
group Id
OG001
value
201
group Id
OG002
value
200
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
13.44
value
-2.4
group Id
OG001
spread
16.27
value
-4.3
group Id
OG002
spread
15.60
value
-3.4
denoms
counts
group Id
OG000
value
138
group Id
OG001
value
133
group Id
OG002
value
120
units
Participants
title
Change at Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
19.06
value
-1.6
group Id
OG001
spread
18.46
value
3.8
group Id
OG002
spread
22.45
value
-1.9
denoms
counts
group Id
OG000
value
181
group Id
OG001
value
180
group Id
OG002
value
123
units
Participants
title
Change at Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
18.86
value
0.7
group Id
OG001
spread
19.96
value
3.5
group Id
OG002
spread
24.07
value
-0.2
denoms
counts
group Id
OG000
value
148
group Id
OG001
value
142
group Id
OG002
value
51
units
Participants
title
Change at Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
15.63
value
0.2
group Id
OG001
spread
22.17
value
4.2
group Id
OG002
spread
21.65
value
1.4
denoms
counts
group Id
OG000
value
119
group Id
OG001
value
105
group Id
OG002
value
37
units
Participants
title
Change at Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
18.66
value
-1.1
group Id
OG001
spread
22.09
value
4.3
group Id
OG002
spread
22.06
value
-2.2
denoms
counts
group Id
OG000
value
99
group Id
OG001
value
81
group Id
OG002
value
26
units
Participants
title
Change at Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
16.76
value
-4.0
group Id
OG001
spread
23.25
value
5.6
group Id
OG002
spread
19.43
value
-4.5
denoms
counts
group Id
OG000
value
68
group Id
OG001
value
60
group Id
OG002
value
13
units
Participants
title
Change at Cycle 6 Day 1
categories
measurements
group Id
OG000
spread
16.01
value
-2.5
group Id
OG001
spread
21.77
value
4.3
group Id
OG002
spread
12.30
value
1.7
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
50
group Id
OG002
value
10
units
Participants
title
Change at Cycle 7 Day 1
categories
measurements
group Id
OG000
spread
14.83
value
-2.6
group Id
OG001
spread
16.98
value
4.2
group Id
OG002
spread
27.64
value
0.0
denoms
counts
group Id
OG000
value
39
group Id
OG001
value
40
group Id
OG002
value
7
units
Participants
title
Change at Cycle 8 Day 1
categories
measurements
group Id
OG000
spread
17.74
value
-5.8
group Id
OG001
spread
16.44
value
-5.6
group Id
OG002
spread
12.60
value
-4.8
denoms
counts
group Id
OG000
value
33
group Id
OG001
value
31
group Id
OG002
value
7
units
Participants
title
Change at Cycle 9 Day 1
categories
measurements
group Id
OG000
spread
17.90
value
-3.3
group Id
OG001
spread
16.97
value
-2.8
group Id
OG002
spread
20.83
value
2.1
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
24
group Id
OG002
value
4
units
Participants
title
Change at Cycle 10 Day 1
categories
measurements
group Id
OG000
spread
20.38
value
-5.2
group Id
OG001
spread
15.31
value
3.9
comment
Number analyzed is 1 so standard deviation (SD) is not available.
group Id
OG002
spread
NA
value
33.3
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
19
group Id
OG002
value
1
units
Participants
title
Change at Cycle 11 Day 1

denoms

counts
group Id
OG000
value
224
group Id
OG001
value
220
group Id
OG002
value
221
units
Participants

description

The EORTC QLQ-C30 questionnaire consisted of 30 questions generating 5 functional scores (physical, role, cognitive, emotional, \& social); a global health (GH) status/global quality of life scale score; 3 symptom scale scores (fatigue, pain, \& nausea \& vomiting); \& 6 standalone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, \& diarrhea) \& perceived financial burden. All items were graded by severity experienced during previous week \& used 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0-100. Higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity).

dispersion Type

Standard Deviation

groups

description
Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
id
OG000
title
Phase 3: Triplet Arm
description
Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
id
OG001
title
Phase 3:Doublet Arm
description
Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.
id
OG002
title
Phase 3:Control Arm

param Type

MEAN

population Description

The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row.

reporting Status

POSTED

time Frame

Baseline, Cycle(C)1 Day(D)1 , C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

title

(Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Participants (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

type

SECONDARY

unit Of Measure

Units on a scale

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

Preserved source evidence · Independent clinical review pending · Not medical advice