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NCT02928224 · OUTCOME

(Phase 3) Change From Baseline in the EuroQol-5D-5L Visual Analog Scale (EQ-5D-5L VAS) in 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 EQ-5D-5L contains 1 item for each of 5 dimensions of health-related QoL (i.e., mobility, self-care, usual activities, pain or discomfort and anxiety or depression). Response options for each item varied from having no problems to moderate problems or extreme problems. The EQ-5D-5L (v4.0) is a standardized measure of health utility that provides a single index value for one's health status. The EQ-5D-5L is frequently used for economic evaluations of health care and has been recognized as a valid and reliable instrument for this purpose. The EQ visual analog scale (VAS) is a score that is directly reported by the participant and ranges from 0 to 100 (higher is better quality health).

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	210
Phase 3:Doublet Arm	203
Phase 3:Control Arm	199

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	69.0	19.03	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	66.5	19.51	Not reported	Not reported	Not reported
Phase 3:Control Arm	68.3	19.71	Not reported	Not reported	Not reported

Change at Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	141
Phase 3:Doublet Arm	135
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	0.8	10.89	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.9	14.09	Not reported	Not reported	Not reported
Phase 3:Control Arm	-2.1	15.02	Not reported	Not reported	Not reported

Change at Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	183
Phase 3:Doublet Arm	181
Phase 3:Control Arm	124

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	1.4	14.74	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	1.9	14.81	Not reported	Not reported	Not reported
Phase 3:Control Arm	-2.4	17.20	Not reported	Not reported	Not reported

Change at Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	150
Phase 3:Doublet Arm	141
Phase 3:Control Arm	52

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	3.0	13.94	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	4.2	17.32	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.4	17.40	Not reported	Not reported	Not reported

Change at Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	118
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	4.0	13.06	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	5.6	14.87	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.4	15.14	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	80
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	3.3	14.66	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	5.1	15.11	Not reported	Not reported	Not reported
Phase 3:Control Arm	2.5	11.17	Not reported	Not reported	Not reported

Change at Cycle 6 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	66
Phase 3:Doublet Arm	58
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	1.3	13.33	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	2.9	16.84	Not reported	Not reported	Not reported
Phase 3:Control Arm	-3.6	13.26	Not reported	Not reported	Not reported

Change at Cycle 7 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	46
Phase 3:Doublet Arm	47
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	1.4	13.64	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	3.6	16.71	Not reported	Not reported	Not reported
Phase 3:Control Arm	2.4	7.44	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	39
Phase 3:Control Arm	8

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	4.1	10.77	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	2.0	16.11	Not reported	Not reported	Not reported
Phase 3:Control Arm	-2.8	12.95	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	30
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	0.3	15.16	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-4.0	12.99	Not reported	Not reported	Not reported
Phase 3:Control Arm	-8.1	8.80	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	23
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	0.2	13.34	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-8.1	13.68	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.8	2.36	Not reported	Not reported	Not reported

Change at Cycle 11 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	17
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	0.2	13.87	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.1	10.15	Not reported	Not reported	Not reported
Phase 3:Control Arm	4.0	8.49	Not reported	Not reported	Not reported

Change at Cycle 12 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	13
Phase 3:Doublet Arm	17
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	-4.0	20.11	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.6	11.67	Not reported	Not reported	Not reported
Phase 3:Control Arm	1.5	12.02	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	12
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	-3.0	17.17	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-4.1	14.41	Not reported	Not reported	Not reported
Phase 3:Control Arm	-2.0	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	-4.0	18.06	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.4	13.99	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	-3.4	14.67	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	4.2	7.36	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	-10.4	24.87	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	3.3	2.89	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	-18.3	20.21	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	1.7	5.77	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	7.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-3.3	2.89	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	8.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-5.5	13.44	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	8.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	2.0	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	8.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-5.0	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	-5.0	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	-5.0	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	75
Phase 3:Doublet Arm	72
Phase 3:Control Arm	80

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-8.5	17.40	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-8.0	18.99	Not reported	Not reported	Not reported
Phase 3:Control Arm	-12.7	21.34	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	-11.1	20.23	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-5.9	20.18	Not reported	Not reported	Not reported
Phase 3:Control Arm	-11.0	17.51	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
19.03
value
69.0
group Id
OG001
spread
19.51
value
66.5
group Id
OG002
spread
19.71
value
68.3
denoms
counts
group Id
OG000
value
210
group Id
OG001
value
203
group Id
OG002
value
199
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
10.89
value
0.8
group Id
OG001
spread
14.09
value
-0.9
group Id
OG002
spread
15.02
value
-2.1
denoms
counts
group Id
OG000
value
141
group Id
OG001
value
135
group Id
OG002
value
120
units
Participants
title
Change at Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
14.74
value
1.4
group Id
OG001
spread
14.81
value
1.9
group Id
OG002
spread
17.20
value
-2.4
denoms
counts
group Id
OG000
value
183
group Id
OG001
value
181
group Id
OG002
value
124
units
Participants
title
Change at Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
13.94
value
3.0
group Id
OG001
spread
17.32
value
4.2
group Id
OG002
spread
17.40
value
-1.4
denoms
counts
group Id
OG000
value
150
group Id
OG001
value
141
group Id
OG002
value
52
units
Participants
title
Change at Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
13.06
value
4.0
group Id
OG001
spread
14.87
value
5.6
group Id
OG002
spread
15.14
value
-0.4
denoms
counts
group Id
OG000
value
118
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
14.66
value
3.3
group Id
OG001
spread
15.11
value
5.1
group Id
OG002
spread
11.17
value
2.5
denoms
counts
group Id
OG000
value
99
group Id
OG001
value
80
group Id
OG002
value
26
units
Participants
title
Change at Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
13.33
value
1.3
group Id
OG001
spread
16.84
value
2.9
group Id
OG002
spread
13.26
value
-3.6
denoms
counts
group Id
OG000
value
66
group Id
OG001
value
58
group Id
OG002
value
13
units
Participants
title
Change at Cycle 6 Day 1
categories
measurements
group Id
OG000
spread
13.64
value
1.4
group Id
OG001
spread
16.71
value
3.6
group Id
OG002
spread
7.44
value
2.4
denoms
counts
group Id
OG000
value
46
group Id
OG001
value
47
group Id
OG002
value
10
units
Participants
title
Change at Cycle 7 Day 1
categories
measurements
group Id
OG000
spread
10.77
value
4.1
group Id
OG001
spread
16.11
value
2.0
group Id
OG002
spread
12.95
value
-2.8
denoms
counts
group Id
OG000
value
39
group Id
OG001
value
39
group Id
OG002
value
8
units
Participants
title
Change at Cycle 8 Day 1
categories
measurements
group Id
OG000
spread
15.16
value
0.3
group Id
OG001
spread
12.99
value
-4.0
group Id
OG002
spread
8.80
value
-8.1
denoms
counts
group Id
OG000
value
33
group Id
OG001
value
30
group Id
OG002
value
7
units
Participants
title
Change at Cycle 9 Day 1
categories
measurements
group Id
OG000
spread
13.34
value
0.2
group Id
OG001
spread
13.68
value
-8.1
group Id
OG002
spread
2.36
value
-1.8
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
23
group Id
OG002
value
4
units
Participants
title
Change at Cycle 10 Day 1
categories
measurements
group Id
OG000
spread
13.87
value
0.2
group Id
OG001
spread
10.15
value
-0.1
group Id
OG002
spread
8.49
value
4.0
denoms
counts
group Id
OG000
value
17
group Id
OG001
value
18
group Id
OG002
value
2
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 EQ-5D-5L contains 1 item for each of 5 dimensions of health-related QoL (i.e., mobility, self-care, usual activities, pain or discomfort and anxiety or depression). Response options for each item varied from having no problems to moderate problems or extreme problems. The EQ-5D-5L (v4.0) is a standardized measure of health utility that provides a single index value for one's health status. The EQ-5D-5L is frequently used for economic evaluations of health care and has been recognized as a valid and reliable instrument for this purpose. The EQ visual analog scale (VAS) is a score that is directly reported by the participant and ranges from 0 to 100 (higher is better quality health).

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 EuroQol-5D-5L Visual Analog Scale (EQ-5D-5L VAS) in 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