Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28)
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-OV28 contains 28 items which assess a comprehensive range of relevant issues: abdominal/gastrointestinal (GI) symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning. The score for each domain and component score were scaled from 0 (minimum) to 100 (maximum). Higher scores indicate lower quality of life except for sexual functioning where 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
Abdominal/GI Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
220
Physician's Choice
111
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
22.8
18.6
Not reported
Not reported
Not reported
Physician's Choice
25.7
22.5
Not reported
Not reported
Not reported
Abdominal/GI Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
171
Physician's Choice
81
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
29.3
20.1
Not reported
Not reported
Not reported
Physician's Choice
22.3
17.7
Not reported
Not reported
Not reported
Abdominal/GI Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
134
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
26.7
19.6
Not reported
Not reported
Not reported
Physician's Choice
20.3
15.9
Not reported
Not reported
Not reported
Abdominal/GI Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
108
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
22.1
18.6
Not reported
Not reported
Not reported
Physician's Choice
20.9
17.2
Not reported
Not reported
Not reported
Abdominal/GI Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
27.2
20.3
Not reported
Not reported
Not reported
Physician's Choice
15.6
18.3
Not reported
Not reported
Not reported
Abdominal/GI Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
76
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
26.9
20.3
Not reported
Not reported
Not reported
Physician's Choice
18.7
23.0
Not reported
Not reported
Not reported
Abdominal/GI Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
64
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
23.5
20.5
Not reported
Not reported
Not reported
Physician's Choice
17.6
20.7
Not reported
Not reported
Not reported
Abdominal/GI 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
26.1
20.4
Not reported
Not reported
Not reported
Physician's Choice
18.4
19.3
Not reported
Not reported
Not reported
Abdominal/GI 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
26.0
19.4
Not reported
Not reported
Not reported
Physician's Choice
23.7
23.1
Not reported
Not reported
Not reported
Abdominal/GI Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
33
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
23.0
20.3
Not reported
Not reported
Not reported
Physician's Choice
31.3
29.1
Not reported
Not reported
Not reported
Abdominal/GI Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
109
Physician's Choice
45
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
31.6
22.0
Not reported
Not reported
Not reported
Physician's Choice
24.1
20.4
Not reported
Not reported
Not reported
Abdominal/GI 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
31.8
24.6
Not reported
Not reported
Not reported
Physician's Choice
17.5
22.1
Not reported
Not reported
Not reported
Peripheral neuropathy Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
220
Physician's Choice
110
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
16.6
26.1
Not reported
Not reported
Not reported
Physician's Choice
14.5
22.4
Not reported
Not reported
Not reported
Peripheral neuropathy Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
171
Physician's Choice
81
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
26.7
29.9
Not reported
Not reported
Not reported
Physician's Choice
19.5
23.5
Not reported
Not reported
Not reported
Peripheral neuropathy Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
134
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
27.1
28.8
Not reported
Not reported
Not reported
Physician's Choice
20.9
21.6
Not reported
Not reported
Not reported
Peripheral neuropathy Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
108
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
30.2
31.0
Not reported
Not reported
Not reported
Physician's Choice
21.0
24.2
Not reported
Not reported
Not reported
Peripheral neuropathy Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
30.4
28.7
Not reported
Not reported
Not reported
Physician's Choice
21.4
24.4
Not reported
Not reported
Not reported
Peripheral neuropathy Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
76
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
25.2
30.1
Not reported
Not reported
Not reported
Physician's Choice
14.0
16.4
Not reported
Not reported
Not reported
Peripheral neuropathy Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
64
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
25.0
24.1
Not reported
Not reported
Not reported
Physician's Choice
16.7
18.1
Not reported
Not reported
Not reported
Peripheral neuropathy 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
22.5
27.9
Not reported
Not reported
Not reported
Physician's Choice
15.6
23.9
Not reported
Not reported
Not reported
Peripheral neuropathy 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
18.7
24.8
Not reported
Not reported
Not reported
Physician's Choice
22.7
26.1
Not reported
Not reported
Not reported
Peripheral neuropathy Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
33
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
17.2
27.2
Not reported
Not reported
Not reported
Physician's Choice
25.0
30.9
Not reported
Not reported
Not reported
Peripheral neuropathy Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
108
Physician's Choice
45
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
28.5
32.4
Not reported
Not reported
Not reported
Physician's Choice
22.6
24.4
Not reported
Not reported
Not reported
Peripheral neuropathy 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
28.9
29.8
Not reported
Not reported
Not reported
Physician's Choice
23.7
32.5
Not reported
Not reported
Not reported
Hormonal Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
220
Physician's Choice
110
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
22.0
25.5
Not reported
Not reported
Not reported
Physician's Choice
23.3
28.4
Not reported
Not reported
Not reported
Hormonal Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
171
Physician's Choice
81
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
10.2
15.5
Not reported
Not reported
Not reported
Physician's Choice
23.7
28.9
Not reported
Not reported
Not reported
Hormonal Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
134
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
9.3
16.8
Not reported
Not reported
Not reported
Physician's Choice
23.1
28.1
Not reported
Not reported
Not reported
Hormonal Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
108
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
6.2
11.5
Not reported
Not reported
Not reported
Physician's Choice
23.2
26.2
Not reported
Not reported
Not reported
Hormonal Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
11.6
20.0
Not reported
Not reported
Not reported
Physician's Choice
23.4
29.0
Not reported
Not reported
Not reported
Hormonal Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
76
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
13.4
22.9
Not reported
Not reported
Not reported
Physician's Choice
21.3
29.9
Not reported
Not reported
Not reported
Hormonal Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
64
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
13.8
22.3
Not reported
Not reported
Not reported
Physician's Choice
25.9
34.4
Not reported
Not reported
Not reported
Hormonal 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
11.2
16.6
Not reported
Not reported
Not reported
Physician's Choice
33.3
38.0
Not reported
Not reported
Not reported
Hormonal 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
9.8
15.8
Not reported
Not reported
Not reported
Physician's Choice
25.8
38.3
Not reported
Not reported
Not reported
Hormonal Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
33
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
8.1
13.3
Not reported
Not reported
Not reported
Physician's Choice
14.6
28.8
Not reported
Not reported
Not reported
Hormonal Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
108
Physician's Choice
45
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
14.8
21.7
Not reported
Not reported
Not reported
Physician's Choice
26.7
34.0
Not reported
Not reported
Not reported
Hormonal 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
22.4
27.8
Not reported
Not reported
Not reported
Physician's Choice
14.9
21.4
Not reported
Not reported
Not reported
Body image Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
217
Physician's Choice
111
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
28.9
29.3
Not reported
Not reported
Not reported
Physician's Choice
31.4
31.9
Not reported
Not reported
Not reported
Body image Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
170
Physician's Choice
80
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
42.1
32.1
Not reported
Not reported
Not reported
Physician's Choice
36.0
30.1
Not reported
Not reported
Not reported
Body image Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
133
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
40.1
29.6
Not reported
Not reported
Not reported
Physician's Choice
32.6
29.9
Not reported
Not reported
Not reported
Body image Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
107
Physician's Choice
47
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
37.4
29.1
Not reported
Not reported
Not reported
Physician's Choice
27.7
25.4
Not reported
Not reported
Not reported
Body image Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
36.2
25.7
Not reported
Not reported
Not reported
Physician's Choice
28.6
29.1
Not reported
Not reported
Not reported
Body image Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
76
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
40.4
26.8
Not reported
Not reported
Not reported
Physician's Choice
30.0
31.2
Not reported
Not reported
Not reported
Body image Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
64
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
36.2
25.8
Not reported
Not reported
Not reported
Physician's Choice
25.9
32.5
Not reported
Not reported
Not reported
Body image Score at Week 57
Analysis denominator · Participants
Group
Source count
MEK 162
42
Physician's Choice
16
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
36.1
27.0
Not reported
Not reported
Not reported
Physician's Choice
16.7
26.5
Not reported
Not reported
Not reported
Body image 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
33.7
28.0
Not reported
Not reported
Not reported
Physician's Choice
25.8
30.2
Not reported
Not reported
Not reported
Body image Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
33
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
27.8
23.4
Not reported
Not reported
Not reported
Physician's Choice
33.3
34.5
Not reported
Not reported
Not reported
Body image Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
109
Physician's Choice
45
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
46.9
32.9
Not reported
Not reported
Not reported
Physician's Choice
37.0
32.0
Not reported
Not reported
Not reported
Body image 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
35.0
30.5
Not reported
Not reported
Not reported
Physician's Choice
23.7
26.8
Not reported
Not reported
Not reported
Attitude to disease/treatment Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
216
Physician's Choice
110
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
48.0
28.6
Not reported
Not reported
Not reported
Physician's Choice
51.4
29.1
Not reported
Not reported
Not reported
Attitude to disease/treatment Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
169
Physician's Choice
80
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
49.5
25.5
Not reported
Not reported
Not reported
Physician's Choice
47.6
26.5
Not reported
Not reported
Not reported
Attitude to disease/treatment Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
133
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
46.1
24.2
Not reported
Not reported
Not reported
Physician's Choice
51.6
26.1
Not reported
Not reported
Not reported
Attitude to disease/treatment Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
107
Physician's Choice
47
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
39.0
22.2
Not reported
Not reported
Not reported
Physician's Choice
44.1
26.5
Not reported
Not reported
Not reported
Attitude to disease/treatment Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
41.8
22.9
Not reported
Not reported
Not reported
Physician's Choice
44.4
24.8
Not reported
Not reported
Not reported
Attitude to disease/treatment Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
76
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
44.3
23.1
Not reported
Not reported
Not reported
Physician's Choice
40.4
23.1
Not reported
Not reported
Not reported
Attitude to disease/treatment Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
64
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
37.2
19.7
Not reported
Not reported
Not reported
Physician's Choice
38.9
23.6
Not reported
Not reported
Not reported
Attitude to disease/treatment Score at Week 57
Analysis denominator · Participants
Group
Source count
MEK 162
42
Physician's Choice
16
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
38.8
20.0
Not reported
Not reported
Not reported
Physician's Choice
32.6
27.1
Not reported
Not reported
Not reported
Attitude to disease/treatment 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
37.4
21.6
Not reported
Not reported
Not reported
Physician's Choice
45.5
28.7
Not reported
Not reported
Not reported
Attitude to disease/treatment Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
33
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
37.7
25.3
Not reported
Not reported
Not reported
Physician's Choice
51.4
43.6
Not reported
Not reported
Not reported
Attitude to disease/treatment Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
109
Physician's Choice
45
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
55.8
27.5
Not reported
Not reported
Not reported
Physician's Choice
53.8
29.3
Not reported
Not reported
Not reported
Attitude to disease/treatment 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
49.3
27.0
Not reported
Not reported
Not reported
Physician's Choice
50.3
24.9
Not reported
Not reported
Not reported
Chemotherapy Side Effects Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
220
Physician's Choice
110
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
17.7
16.0
Not reported
Not reported
Not reported
Physician's Choice
17.1
14.7
Not reported
Not reported
Not reported
Chemotherapy Side Effects Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
171
Physician's Choice
81
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
28.6
16.4
Not reported
Not reported
Not reported
Physician's Choice
22.6
16.2
Not reported
Not reported
Not reported
Chemotherapy Side Effects Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
134
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
27.1
15.3
Not reported
Not reported
Not reported
Physician's Choice
24.1
15.2
Not reported
Not reported
Not reported
Chemotherapy Side Effects Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
108
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
27.7
17.5
Not reported
Not reported
Not reported
Physician's Choice
25.3
18.1
Not reported
Not reported
Not reported
Chemotherapy Side Effects Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
28.8
18.4
Not reported
Not reported
Not reported
Physician's Choice
24.1
17.1
Not reported
Not reported
Not reported
Chemotherapy Side Effects Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
75
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
30.1
19.2
Not reported
Not reported
Not reported
Physician's Choice
23.5
20.8
Not reported
Not reported
Not reported
Chemotherapy Side Effects Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
64
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
29.5
16.5
Not reported
Not reported
Not reported
Physician's Choice
23.0
18.6
Not reported
Not reported
Not reported
Chemotherapy Side Effects 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
27.9
19.5
Not reported
Not reported
Not reported
Physician's Choice
23.1
18.3
Not reported
Not reported
Not reported
Chemotherapy Side Effects 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
25.5
19.1
Not reported
Not reported
Not reported
Physician's Choice
25.5
15.4
Not reported
Not reported
Not reported
Chemotherapy Side Effects Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
33
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
27.7
19.4
Not reported
Not reported
Not reported
Physician's Choice
29.2
20.5
Not reported
Not reported
Not reported
Chemotherapy Side Effects Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
108
Physician's Choice
45
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
30.4
19.6
Not reported
Not reported
Not reported
Physician's Choice
28.0
19.4
Not reported
Not reported
Not reported
Chemotherapy Side Effects 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
27.5
19.5
Not reported
Not reported
Not reported
Physician's Choice
17.9
14.7
Not reported
Not reported
Not reported
Other Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
220
Physician's Choice
111
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
11.8
16.5
Not reported
Not reported
Not reported
Physician's Choice
14.5
19.6
Not reported
Not reported
Not reported
Other Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
171
Physician's Choice
81
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
22.0
17.4
Not reported
Not reported
Not reported
Physician's Choice
23.3
20.6
Not reported
Not reported
Not reported
Other Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
134
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
26.1
22.2
Not reported
Not reported
Not reported
Physician's Choice
20.1
19.1
Not reported
Not reported
Not reported
Other Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
108
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
22.9
21.1
Not reported
Not reported
Not reported
Physician's Choice
18.7
17.5
Not reported
Not reported
Not reported
Other Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
86
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
22.3
21.3
Not reported
Not reported
Not reported
Physician's Choice
16.7
19.4
Not reported
Not reported
Not reported
Other Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
76
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
19.1
20.2
Not reported
Not reported
Not reported
Physician's Choice
14.3
15.1
Not reported
Not reported
Not reported
Other Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
64
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
19.0
18.6
Not reported
Not reported
Not reported
Physician's Choice
12.8
13.6
Not reported
Not reported
Not reported
Other 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
16.3
15.5
Not reported
Not reported
Not reported
Physician's Choice
16.8
17.0
Not reported
Not reported
Not reported
Other 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
15.4
12.9
Not reported
Not reported
Not reported
Physician's Choice
22.0
24.5
Not reported
Not reported
Not reported
Other Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
33
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
15.7
15.0
Not reported
Not reported
Not reported
Physician's Choice
22.2
22.0
Not reported
Not reported
Not reported
Other Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
109
Physician's Choice
45
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
22.1
16.9
Not reported
Not reported
Not reported
Physician's Choice
22.7
20.1
Not reported
Not reported
Not reported
Other 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
17.2
17.0
Not reported
Not reported
Not reported
Physician's Choice
14.6
20.4
Not reported
Not reported
Not reported
Sexuality Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
200
Physician's Choice
106
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.2
20.3
Not reported
Not reported
Not reported
Physician's Choice
19.2
21.9
Not reported
Not reported
Not reported
Sexuality Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
151
Physician's Choice
78
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
18.7
20.4
Not reported
Not reported
Not reported
Physician's Choice
18.1
21.9
Not reported
Not reported
Not reported
Sexuality Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
113
Physician's Choice
65
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
19.6
20.3
Not reported
Not reported
Not reported
Physician's Choice
18.3
21.6
Not reported
Not reported
Not reported
Sexuality Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
91
Physician's Choice
44
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
21.8
21.5
Not reported
Not reported
Not reported
Physician's Choice
22.0
23.8
Not reported
Not reported
Not reported
Sexuality Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
75
Physician's Choice
29
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
25.8
23.0
Not reported
Not reported
Not reported
Physician's Choice
21.3
21.7
Not reported
Not reported
Not reported
Sexuality Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
68
Physician's Choice
23
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
21.3
20.0
Not reported
Not reported
Not reported
Physician's Choice
19.2
23.1
Not reported
Not reported
Not reported
Sexuality Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
57
Physician's Choice
17
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
23.0
21.9
Not reported
Not reported
Not reported
Physician's Choice
20.6
23.0
Not reported
Not reported
Not reported
Sexuality Score at Week 57
Analysis denominator · Participants
Group
Source count
MEK 162
37
Physician's Choice
15
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
21.8
21.8
Not reported
Not reported
Not reported
Physician's Choice
18.9
24.7
Not reported
Not reported
Not reported
Sexuality Score at Week 65
Analysis denominator · Participants
Group
Source count
MEK 162
36
Physician's Choice
10
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
21.3
20.7
Not reported
Not reported
Not reported
Physician's Choice
12.5
15.8
Not reported
Not reported
Not reported
Sexuality Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
30
Physician's Choice
7
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.8
21.6
Not reported
Not reported
Not reported
Physician's Choice
11.9
16.6
Not reported
Not reported
Not reported
Sexuality Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
95
Physician's Choice
42
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
14.2
19.4
Not reported
Not reported
Not reported
Physician's Choice
23.2
23.0
Not reported
Not reported
Not reported
Sexuality Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
38
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
15.6
19.8
Not reported
Not reported
Not reported
Physician's Choice
26.1
25.8
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
18.6
value
22.8
group Id
OG001
spread
22.5
value
25.7
denoms
counts
group Id
OG000
value
220
group Id
OG001
value
111
units
Participants
title
Abdominal/GI Score at Screening
categories
measurements
group Id
OG000
spread
20.1
value
29.3
group Id
OG001
spread
17.7
value
22.3
denoms
counts
group Id
OG000
value
171
group Id
OG001
value
81
units
Participants
title
Abdominal/GI Score at Week 9
categories
measurements
group Id
OG000
spread
19.6
value
26.7
group Id
OG001
spread
15.9
value
20.3
denoms
counts
group Id
OG000
value
134
group Id
OG001
value
67
units
Participants
title
Abdominal/GI Score at Week 17
categories
measurements
group Id
OG000
spread
18.6
value
22.1
group Id
OG001
spread
17.2
value
20.9
denoms
counts
group Id
OG000
value
108
group Id
OG001
value
46
units
Participants
title
Abdominal/GI Score at Week 25
categories
measurements
group Id
OG000
spread
20.3
value
27.2
group Id
OG001
spread
18.3
value
15.6
denoms
counts
group Id
OG000
value
86
group Id
OG001
value
32
units
Participants
title
Abdominal/GI Score at Week 33
categories
measurements
group Id
OG000
spread
20.3
value
26.9
group Id
OG001
spread
23.0
value
18.7
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
25
units
Participants
title
Abdominal/GI Score at Week 41
categories
measurements
group Id
OG000
spread
20.5
value
23.5
group Id
OG001
spread
20.7
value
17.6
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
18
units
Participants
title
Abdominal/GI Score at Week 49
categories
measurements
group Id
OG000
spread
20.4
value
26.1
group Id
OG001
spread
19.3
value
18.4
denoms
counts
group Id
OG000
value
43
group Id
OG001
value
16
units
Participants
title
Abdominal/GI Score at Week 57
categories
measurements
group Id
OG000
spread
19.4
value
26.0
group Id
OG001
spread
23.1
value
23.7
denoms
counts
group Id
OG000
value
41
group Id
OG001
value
11
units
Participants
title
Abdominal/GI Score at Week 65
categories
measurements
group Id
OG000
spread
20.3
value
23.0
group Id
OG001
spread
29.1
value
31.3
denoms
counts
group Id
OG000
value
33
group Id
OG001
value
8
units
Participants
title
Abdominal/GI Score at Week 73
categories
measurements
group Id
OG000
spread
22.0
value
31.6
group Id
OG001
spread
20.4
value
24.1
denoms
counts
group Id
OG000
value
109
group Id
OG001
value
45
units
Participants
title
Abdominal/GI Score at Treatment Discontinuation Visit
categories
measurements
group Id
OG000
spread
24.6
value
31.8
group Id
OG001
spread
22.1
value
17.5
denoms
counts
group Id
OG000
value
41
group Id
OG001
value
19
units
Participants
title
Abdominal/GI Score at 30-Day Safety Follow-up
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
113
units
Participants
description
EORTC QLQ-OV28 contains 28 items which assess a comprehensive range of relevant issues: abdominal/gastrointestinal (GI) symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning. The score for each domain and component score were scaled from 0 (minimum) to 100 (maximum). Higher scores indicate lower quality of life except for sexual functioning where 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 - Ovarian Cancer Module (QLQ-OV28)
Triangle