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NCT01721746 · OUTCOME

Mean Change From Baseline in Health-related Quality of Life (HRQoL)

A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037) · Source last updated 2022-04-19

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: From Baseline (Day1) to second Follow-Up (Up to 96 months)

What was measured

Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric. Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline. A 10 point difference on a 100 point scale between treatments was considered clinically significant.

Analysis population: All randomized participants

Groups in this outcome

Nivolumab

Nivolumab 3 mg/kg IV over 60 minutes Q2W

Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W

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
Nivolumab	272
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	133

Reported measurements

Physical Functioning Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	22

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-7.97	20.49	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-12.73	21.47	Not reported	Not reported	Not reported

Physical Functioning Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-3.66	16.05	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-7.14	16.02	Not reported	Not reported	Not reported

Role Functioning Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	22

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-14.94	31.13	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-15.91	29.76	Not reported	Not reported	Not reported

Role Functioning Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-7.80	25.56	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-8.33	21.52	Not reported	Not reported	Not reported

Emotional Functioning Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	21

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-5.09	21.59	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-15.48	24.48	Not reported	Not reported	Not reported

Emotional Functioning Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-0.94	19.15	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-5.36	25.98	Not reported	Not reported	Not reported

Cognitive Functioning Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	21

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-7.58	16.79	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-7.94	17.17	Not reported	Not reported	Not reported

Cognitive Functioning Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-3.49	15.43	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-1.19	13.55	Not reported	Not reported	Not reported

Social Functioning Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	21

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-8.66	29.45	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-18.25	26.82	Not reported	Not reported	Not reported

Social Functioning Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-1.61	29.52	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-4.17	24.69	Not reported	Not reported	Not reported

Global Health Status Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	21

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-8.23	22.44	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-10.71	17.71	Not reported	Not reported	Not reported

Global Health Status Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-1.61	18.53	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-3.27	12.07	Not reported	Not reported	Not reported

Dyspnea Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	22

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	6.06	27.96	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	16.67	24.67	Not reported	Not reported	Not reported

Dyspnea Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	5.91	22.20	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	7.14	24.61	Not reported	Not reported	Not reported

Insomnia Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	22

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	3.46	32.26	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	0.00	30.86	Not reported	Not reported	Not reported

Insomnia Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-4.84	25.50	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	0.00	30.09	Not reported	Not reported	Not reported

Apatite loss Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	22

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	6.93	28.79	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	13.64	24.47	Not reported	Not reported	Not reported

Apatite loss Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	5.91	30.49	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	2.38	22.09	Not reported	Not reported	Not reported

Constipation Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	21

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	7.36	28.93	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	0.00	23.57	Not reported	Not reported	Not reported

Constipation Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	2.15	22.48	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-2.38	29.99	Not reported	Not reported	Not reported

Diarrhea Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	21

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-0.43	19.86	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	6.35	22.65	Not reported	Not reported	Not reported

Diarrhea Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	1.08	20.88	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	1.19	16.93	Not reported	Not reported	Not reported

Financial Difficulties Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	21

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-1.73	25.87	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	4.76	39.84	Not reported	Not reported	Not reported

Financial Difficulties Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	-1.08	22.56	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-2.38	28.59	Not reported	Not reported	Not reported

Fatigue Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	22

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	8.95	23.78	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	15.66	28.00	Not reported	Not reported	Not reported

Fatigue Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	62
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	4.84	22.55	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	7.14	21.85	Not reported	Not reported	Not reported

Nausea and Vomiting Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	22

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	2.81	17.19	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	10.61	25.48	Not reported	Not reported	Not reported

Nausea and Vomiting Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	272
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	133

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	0.00	15.39	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	2.98	18.73	Not reported	Not reported	Not reported

Pain Follow-Up 1

Analysis denominator · Participants

Group	Source count
Nivolumab	77
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	22

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	6.06	31.17	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	6.82	25.02	Not reported	Not reported	Not reported

Pain Follow-Up 2

Analysis denominator · Participants

Group	Source count
Nivolumab	272
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	133

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Nivolumab	5.38	24.84	Not reported	Not reported	Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	-1.79	14.59	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
20.49
value
-7.97
group Id
OG001
spread
21.47
value
-12.73
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
22
units
Participants
title
Physical Functioning Follow-Up 1
categories
measurements
group Id
OG000
spread
16.05
value
-3.66
group Id
OG001
spread
16.02
value
-7.14
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
28
units
Participants
title
Physical Functioning Follow-Up 2
categories
measurements
group Id
OG000
spread
31.13
value
-14.94
group Id
OG001
spread
29.76
value
-15.91
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
22
units
Participants
title
Role Functioning Follow-Up 1
categories
measurements
group Id
OG000
spread
25.56
value
-7.80
group Id
OG001
spread
21.52
value
-8.33
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
28
units
Participants
title
Role Functioning Follow-Up 2
categories
measurements
group Id
OG000
spread
21.59
value
-5.09
group Id
OG001
spread
24.48
value
-15.48
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
21
units
Participants
title
Emotional Functioning Follow-Up 1
categories
measurements
group Id
OG000
spread
19.15
value
-0.94
group Id
OG001
spread
25.98
value
-5.36
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
28
units
Participants
title
Emotional Functioning Follow-Up 2
categories
measurements
group Id
OG000
spread
16.79
value
-7.58
group Id
OG001
spread
17.17
value
-7.94
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
21
units
Participants
title
Cognitive Functioning Follow-Up 1
categories
measurements
group Id
OG000
spread
15.43
value
-3.49
group Id
OG001
spread
13.55
value
-1.19
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
28
units
Participants
title
Cognitive Functioning Follow-Up 2
categories
measurements
group Id
OG000
spread
29.45
value
-8.66
group Id
OG001
spread
26.82
value
-18.25
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
21
units
Participants
title
Social Functioning Follow-Up 1
categories
measurements
group Id
OG000
spread
29.52
value
-1.61
group Id
OG001
spread
24.69
value
-4.17
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
28
units
Participants
title
Social Functioning Follow-Up 2
categories
measurements
group Id
OG000
spread
22.44
value
-8.23
group Id
OG001
spread
17.71
value
-10.71
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
21
units
Participants
title
Global Health Status Follow-Up 1
categories
measurements
group Id
OG000
spread
18.53
value
-1.61
group Id
OG001
spread
12.07
value
-3.27
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
28
units
Participants
title
Global Health Status Follow-Up 2

denoms

counts
group Id
OG000
value
272
group Id
OG001
value
133
units
Participants

description

Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric. Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline. A 10 point difference on a 100 point scale between treatments was considered clinically significant.

dispersion Type

Standard Deviation

groups

description
Nivolumab 3 mg/kg IV over 60 minutes Q2W
id
OG000
title
Nivolumab
description
Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W
id
OG001
title
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

param Type

MEAN

population Description

All randomized participants

reporting Status

POSTED

time Frame

From Baseline (Day1) to second Follow-Up (Up to 96 months)

title

Mean Change From Baseline in Health-related Quality of Life (HRQoL)

type

SECONDARY

unit Of Measure

Units on a scale

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

Preserved source evidence · Not medical advice