Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer · Source last updated 2023-10-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
Scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
What was measured
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a global health status/quality of life (QOL) scale, and 6 single-item scales. The global health status/QOL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for global health status/QOL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. In this study, global health status/QOL scale score was identified as the primary patient-reported outcome variable of interest. Physical functioning, emotional functioning, and social functioning scale scores were considered as secondary. Higher scores indicate better quality of life.
Analysis population: Analysis population included all randomized participants (228 participants in MEK162 group, 113 participants in physician's choice group).
Groups in this outcome
MEK 162
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
Physician's Choice
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
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
MEK 162
228
Physician's Choice
113
Reported measurements
Global health status/QOL Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
224
Physician's Choice
111
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
67.2
19.9
Not reported
Not reported
Not reported
Physician's Choice
66.4
24.5
Not reported
Not reported
Not reported
Global health status/QOL Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
180
Physician's Choice
82
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
57.4
19.4
Not reported
Not reported
Not reported
Physician's Choice
66.4
20.4
Not reported
Not reported
Not reported
Global health status/QOL Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
135
Physician's Choice
68
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
58.4
19.9
Not reported
Not reported
Not reported
Physician's Choice
65.4
17.5
Not reported
Not reported
Not reported
Global health status/QOL Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
108
Physician's Choice
47
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
60.5
18.7
Not reported
Not reported
Not reported
Physician's Choice
65.4
19.6
Not reported
Not reported
Not reported
Global health status/QOL Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
31
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
60.4
20.0
Not reported
Not reported
Not reported
Physician's Choice
63.7
18.9
Not reported
Not reported
Not reported
Global health status/QOL Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
77
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
60.4
18.6
Not reported
Not reported
Not reported
Physician's Choice
73.0
18.5
Not reported
Not reported
Not reported
Global health status/QOL Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
65
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
60.9
19.4
Not reported
Not reported
Not reported
Physician's Choice
69.9
17.9
Not reported
Not reported
Not reported
Global health status/QOL Score at Week 57
Analysis denominator · Participants
Group
Source count
MEK 162
43
Physician's Choice
16
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
62.4
18.3
Not reported
Not reported
Not reported
Physician's Choice
76.6
20.9
Not reported
Not reported
Not reported
Global health status/QOL Score at Week 65
Analysis denominator · Participants
Group
Source count
MEK 162
40
Physician's Choice
11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
60.8
18.9
Not reported
Not reported
Not reported
Physician's Choice
65.9
22.8
Not reported
Not reported
Not reported
Global health status/QOL Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
34
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
62.0
19.7
Not reported
Not reported
Not reported
Physician's Choice
67.7
21.6
Not reported
Not reported
Not reported
Global health status/QOL Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
114
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
47.0
21.4
Not reported
Not reported
Not reported
Physician's Choice
60.9
25.6
Not reported
Not reported
Not reported
Global health status/QOL Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
41
Physician's Choice
19
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
59.8
19.1
Not reported
Not reported
Not reported
Physician's Choice
69.3
18.0
Not reported
Not reported
Not reported
Physical functioning Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
225
Physician's Choice
111
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
80.2
19.2
Not reported
Not reported
Not reported
Physician's Choice
82.6
18.7
Not reported
Not reported
Not reported
Physical functioning Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
180
Physician's Choice
83
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
74.8
20.3
Not reported
Not reported
Not reported
Physician's Choice
81.4
18.4
Not reported
Not reported
Not reported
Physical functioning Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
138
Physician's Choice
68
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
75.3
19.5
Not reported
Not reported
Not reported
Physician's Choice
79.4
20.9
Not reported
Not reported
Not reported
Physical functioning Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
109
Physician's Choice
47
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
75.5
20.8
Not reported
Not reported
Not reported
Physician's Choice
80.2
19.9
Not reported
Not reported
Not reported
Physical functioning Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
31
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
76.6
19.6
Not reported
Not reported
Not reported
Physician's Choice
81.5
23.3
Not reported
Not reported
Not reported
Physical functioning Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
77
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
75.1
19.9
Not reported
Not reported
Not reported
Physician's Choice
83.7
21.9
Not reported
Not reported
Not reported
Physical functioning Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
65
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
77.5
18.0
Not reported
Not reported
Not reported
Physician's Choice
83.7
20.5
Not reported
Not reported
Not reported
Physical functioning Score at Week 57
Analysis denominator · Participants
Group
Source count
MEK 162
44
Physician's Choice
16
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
74.8
19.4
Not reported
Not reported
Not reported
Physician's Choice
83.3
20.7
Not reported
Not reported
Not reported
Physical functioning Score at Week 65
Analysis denominator · Participants
Group
Source count
MEK 162
41
Physician's Choice
11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
77.2
19.7
Not reported
Not reported
Not reported
Physician's Choice
81.8
20.2
Not reported
Not reported
Not reported
Physical functioning Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
34
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
77.2
21.1
Not reported
Not reported
Not reported
Physician's Choice
78.3
25.6
Not reported
Not reported
Not reported
Physical functioning Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
114
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
66.6
23.8
Not reported
Not reported
Not reported
Physician's Choice
71.0
25.0
Not reported
Not reported
Not reported
Physical functioning Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
41
Physician's Choice
19
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
71.7
21.5
Not reported
Not reported
Not reported
Physician's Choice
78.6
23.4
Not reported
Not reported
Not reported
Emotional functioning Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
225
Physician's Choice
111
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
75.8
21.2
Not reported
Not reported
Not reported
Physician's Choice
71.7
24.0
Not reported
Not reported
Not reported
Emotional functioning Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
180
Physician's Choice
82
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
73.1
21.6
Not reported
Not reported
Not reported
Physician's Choice
75.8
22.9
Not reported
Not reported
Not reported
Emotional functioning Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
136
Physician's Choice
68
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
73.9
20.2
Not reported
Not reported
Not reported
Physician's Choice
77.7
19.1
Not reported
Not reported
Not reported
Emotional functioning Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
109
Physician's Choice
47
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
76.7
20.0
Not reported
Not reported
Not reported
Physician's Choice
78.7
20.9
Not reported
Not reported
Not reported
Emotional functioning Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
31
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
75.1
21.6
Not reported
Not reported
Not reported
Physician's Choice
81.6
20.4
Not reported
Not reported
Not reported
Emotional functioning Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
77
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
74.7
22.0
Not reported
Not reported
Not reported
Physician's Choice
79.0
24.9
Not reported
Not reported
Not reported
Emotional functioning Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
65
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
77.6
18.6
Not reported
Not reported
Not reported
Physician's Choice
79.2
24.0
Not reported
Not reported
Not reported
Emotional functioning Score at Week 57
Analysis denominator · Participants
Group
Source count
MEK 162
43
Physician's Choice
16
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
77.7
18.7
Not reported
Not reported
Not reported
Physician's Choice
81.8
26.6
Not reported
Not reported
Not reported
Emotional functioning Score at Week 65
Analysis denominator · Participants
Group
Source count
MEK 162
40
Physician's Choice
11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
77.1
17.6
Not reported
Not reported
Not reported
Physician's Choice
80.3
28.7
Not reported
Not reported
Not reported
Emotional functioning Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
34
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
73.4
22.5
Not reported
Not reported
Not reported
Physician's Choice
69.8
31.5
Not reported
Not reported
Not reported
Emotional functioning Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
114
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
63.6
28.2
Not reported
Not reported
Not reported
Physician's Choice
70.3
23.2
Not reported
Not reported
Not reported
Emotional functioning Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
41
Physician's Choice
19
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
70.5
24.7
Not reported
Not reported
Not reported
Physician's Choice
82.0
17.4
Not reported
Not reported
Not reported
Social functioning Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
223
Physician's Choice
111
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
79.9
23.9
Not reported
Not reported
Not reported
Physician's Choice
79.0
24.8
Not reported
Not reported
Not reported
Social functioning Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
179
Physician's Choice
82
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
69.5
26.0
Not reported
Not reported
Not reported
Physician's Choice
76.2
28.0
Not reported
Not reported
Not reported
Social functioning Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
136
Physician's Choice
68
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
75.6
21.8
Not reported
Not reported
Not reported
Physician's Choice
77.7
23.9
Not reported
Not reported
Not reported
Social functioning Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
109
Physician's Choice
47
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
78.7
21.3
Not reported
Not reported
Not reported
Physician's Choice
76.6
23.2
Not reported
Not reported
Not reported
Social functioning Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
31
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
76.0
23.8
Not reported
Not reported
Not reported
Physician's Choice
79.0
26.5
Not reported
Not reported
Not reported
Social functioning Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
77
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
73.4
25.0
Not reported
Not reported
Not reported
Physician's Choice
83.3
25.5
Not reported
Not reported
Not reported
Social functioning Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
65
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
78.5
20.6
Not reported
Not reported
Not reported
Physician's Choice
81.5
16.1
Not reported
Not reported
Not reported
Social functioning Score at Week 57
Analysis denominator · Participants
Group
Source count
MEK 162
43
Physician's Choice
16
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
74.0
24.2
Not reported
Not reported
Not reported
Physician's Choice
77.1
27.1
Not reported
Not reported
Not reported
Social functioning Score at Week 65
Analysis denominator · Participants
Group
Source count
MEK 162
40
Physician's Choice
11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
78.3
23.9
Not reported
Not reported
Not reported
Physician's Choice
72.7
31.9
Not reported
Not reported
Not reported
Social functioning Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
34
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
75.5
25.4
Not reported
Not reported
Not reported
Physician's Choice
75.0
28.2
Not reported
Not reported
Not reported
Social functioning Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
114
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
63.5
32.7
Not reported
Not reported
Not reported
Physician's Choice
66.7
31.2
Not reported
Not reported
Not reported
Social functioning Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
41
Physician's Choice
19
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
71.1
27.9
Not reported
Not reported
Not reported
Physician's Choice
78.1
27.2
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
19.9
value
67.2
group Id
OG001
spread
24.5
value
66.4
denoms
counts
group Id
OG000
value
224
group Id
OG001
value
111
units
Participants
title
Global health status/QOL Score at Screening
categories
measurements
group Id
OG000
spread
19.4
value
57.4
group Id
OG001
spread
20.4
value
66.4
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
82
units
Participants
title
Global health status/QOL Score at Week 9
categories
measurements
group Id
OG000
spread
19.9
value
58.4
group Id
OG001
spread
17.5
value
65.4
denoms
counts
group Id
OG000
value
135
group Id
OG001
value
68
units
Participants
title
Global health status/QOL Score at Week 17
categories
measurements
group Id
OG000
spread
18.7
value
60.5
group Id
OG001
spread
19.6
value
65.4
denoms
counts
group Id
OG000
value
108
group Id
OG001
value
47
units
Participants
title
Global health status/QOL Score at Week 25
categories
measurements
group Id
OG000
spread
20.0
value
60.4
group Id
OG001
spread
18.9
value
63.7
denoms
counts
group Id
OG000
value
86
group Id
OG001
value
31
units
Participants
title
Global health status/QOL Score at Week 33
categories
measurements
group Id
OG000
spread
18.6
value
60.4
group Id
OG001
spread
18.5
value
73.0
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
25
units
Participants
title
Global health status/QOL Score at Week 41
categories
measurements
group Id
OG000
spread
19.4
value
60.9
group Id
OG001
spread
17.9
value
69.9
denoms
counts
group Id
OG000
value
65
group Id
OG001
value
18
units
Participants
title
Global health status/QOL Score at Week 49
categories
measurements
group Id
OG000
spread
18.3
value
62.4
group Id
OG001
spread
20.9
value
76.6
denoms
counts
group Id
OG000
value
43
group Id
OG001
value
16
units
Participants
title
Global health status/QOL Score at Week 57
categories
measurements
group Id
OG000
spread
18.9
value
60.8
group Id
OG001
spread
22.8
value
65.9
denoms
counts
group Id
OG000
value
40
group Id
OG001
value
11
units
Participants
title
Global health status/QOL Score at Week 65
categories
measurements
group Id
OG000
spread
19.7
value
62.0
group Id
OG001
spread
21.6
value
67.7
denoms
counts
group Id
OG000
value
34
group Id
OG001
value
8
units
Participants
title
Global health status/QOL Score at Week 73
categories
measurements
group Id
OG000
spread
21.4
value
47.0
group Id
OG001
spread
25.6
value
60.9
denoms
counts
group Id
OG000
value
114
group Id
OG001
value
46
units
Participants
title
Global health status/QOL Score at Treatment Discontinuation Visit
categories
measurements
group Id
OG000
spread
19.1
value
59.8
group Id
OG001
spread
18.0
value
69.3
denoms
counts
group Id
OG000
value
41
group Id
OG001
value
19
units
Participants
title
Global health status/QOL Score at 30-Day Safety Follow-up
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
113
units
Participants
description
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a global health status/quality of life (QOL) scale, and 6 single-item scales. The global health status/QOL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for global health status/QOL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. In this study, global health status/QOL scale score was identified as the primary patient-reported outcome variable of interest. Physical functioning, emotional functioning, and social functioning scale scores were considered as secondary. Higher scores indicate better quality of life.
dispersion Type
Standard Deviation
groups
description
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
id
OG000
title
MEK 162
description
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
id
OG001
title
Physician's Choice
param Type
MEAN
population Description
Analysis population included all randomized participants (228 participants in MEK162 group, 113 participants in physician's choice group).
reporting Status
POSTED
time Frame
Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
title
Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
Triangle