Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)
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
FACT/GOG-NTX questionnaire consists of questions for dimensions related to physical, social, emotional, and functional well-being which contains 11 items, with responses scored on a Likert scale from 0 (not at all) to 4 (very much) designed to capture the symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The summed scores of each item were reverted into standardized scores ranging from 0 to 44, with a higher score indicating a lower level of neurological toxicity and less effect on quality of life (ie, higher scores indicate better quality of life). The trial outcome index consists of two subscales from the FACT-G: Physical Well Being (7 items) and Functional Well Being (7 items), plus the Cervix Cancer-specific subscale (15 items). Each item in the trial outcome index scored using a 5-point scale (0=not at all to 4=very much). The summed scores of each item were reverted into standardized scores ranging from 0 to 116. 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
Physical Well-being Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
218
Physician's Choice
111
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
21.7
5.1
Not reported
Not reported
Not reported
Physician's Choice
21.6
5.7
Not reported
Not reported
Not reported
Physical Well-being Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
173
Physician's Choice
81
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
19.0
5.7
Not reported
Not reported
Not reported
Physician's Choice
21.4
5.5
Not reported
Not reported
Not reported
Physical Well-being 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
20.1
4.9
Not reported
Not reported
Not reported
Physician's Choice
21.5
5.2
Not reported
Not reported
Not reported
Physical Well-being Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
106
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.4
5.2
Not reported
Not reported
Not reported
Physician's Choice
21.3
6.1
Not reported
Not reported
Not reported
Physical Well-being Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
85
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.2
5.1
Not reported
Not reported
Not reported
Physician's Choice
21.2
6.3
Not reported
Not reported
Not reported
Physical Well-being 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
19.9
5.5
Not reported
Not reported
Not reported
Physician's Choice
22.6
6.6
Not reported
Not reported
Not reported
Physical Well-being Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
63
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.5
4.9
Not reported
Not reported
Not reported
Physician's Choice
22.6
6.2
Not reported
Not reported
Not reported
Physical Well-being 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
20.8
4.6
Not reported
Not reported
Not reported
Physician's Choice
22.4
6.1
Not reported
Not reported
Not reported
Physical Well-being Score at Week 65
Analysis denominator · Participants
Group
Source count
MEK 162
39
Physician's Choice
11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
21.3
4.7
Not reported
Not reported
Not reported
Physician's Choice
20.2
7.2
Not reported
Not reported
Not reported
Physical Well-being Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
31
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
21.8
4.5
Not reported
Not reported
Not reported
Physician's Choice
20.8
8.4
Not reported
Not reported
Not reported
Physical Well-being Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
107
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
17.8
6.7
Not reported
Not reported
Not reported
Physician's Choice
19.4
7.4
Not reported
Not reported
Not reported
Physical Well-being Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
40
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
19.6
6.5
Not reported
Not reported
Not reported
Physician's Choice
23.1
4.7
Not reported
Not reported
Not reported
Social Well-being Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
216
Physician's Choice
111
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.7
4.8
Not reported
Not reported
Not reported
Physician's Choice
20.7
4.9
Not reported
Not reported
Not reported
Social Well-being Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
172
Physician's Choice
81
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.0
4.6
Not reported
Not reported
Not reported
Physician's Choice
20.3
5.0
Not reported
Not reported
Not reported
Social Well-being 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
19.7
5.1
Not reported
Not reported
Not reported
Physician's Choice
20.6
4.4
Not reported
Not reported
Not reported
Social Well-being Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
105
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.3
4.6
Not reported
Not reported
Not reported
Physician's Choice
20.2
4.6
Not reported
Not reported
Not reported
Social Well-being Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
85
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.3
5.5
Not reported
Not reported
Not reported
Physician's Choice
21.0
5.0
Not reported
Not reported
Not reported
Social Well-being 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
20.7
5.0
Not reported
Not reported
Not reported
Physician's Choice
21.3
4.9
Not reported
Not reported
Not reported
Social Well-being Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
63
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.6
4.6
Not reported
Not reported
Not reported
Physician's Choice
21.4
4.8
Not reported
Not reported
Not reported
Social Well-being 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
20.0
5.9
Not reported
Not reported
Not reported
Physician's Choice
21.5
5.1
Not reported
Not reported
Not reported
Social Well-being Score at Week 65
Analysis denominator · Participants
Group
Source count
MEK 162
39
Physician's Choice
11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.5
5.4
Not reported
Not reported
Not reported
Physician's Choice
20.6
5.4
Not reported
Not reported
Not reported
Social Well-being Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
31
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.0
6.1
Not reported
Not reported
Not reported
Physician's Choice
22.1
5.0
Not reported
Not reported
Not reported
Peripheral neuropathy Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
107
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
19.3
4.7
Not reported
Not reported
Not reported
Physician's Choice
20.7
4.5
Not reported
Not reported
Not reported
Peripheral neuropathy Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
40
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
20.5
4.3
Not reported
Not reported
Not reported
Physician's Choice
21.0
4.9
Not reported
Not reported
Not reported
Emotional Well-being Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
217
Physician's Choice
110
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
16.1
5.1
Not reported
Not reported
Not reported
Physician's Choice
15.4
5.0
Not reported
Not reported
Not reported
Emotional Well-being 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
16.5
4.7
Not reported
Not reported
Not reported
Physician's Choice
16.4
4.7
Not reported
Not reported
Not reported
Emotional Well-being Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
132
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
17.2
4.2
Not reported
Not reported
Not reported
Physician's Choice
17.0
4.1
Not reported
Not reported
Not reported
Emotional Well-being Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
104
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
17.3
4.4
Not reported
Not reported
Not reported
Physician's Choice
17.5
3.9
Not reported
Not reported
Not reported
Emotional Well-being Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
85
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
17.3
4.3
Not reported
Not reported
Not reported
Physician's Choice
18.0
4.8
Not reported
Not reported
Not reported
Emotional Well-being 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
16.9
4.4
Not reported
Not reported
Not reported
Physician's Choice
18.0
4.9
Not reported
Not reported
Not reported
Emotional Well-being 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
17.4
3.8
Not reported
Not reported
Not reported
Physician's Choice
18.1
4.6
Not reported
Not reported
Not reported
Emotional Well-being 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
17.5
4.1
Not reported
Not reported
Not reported
Physician's Choice
19.2
3.2
Not reported
Not reported
Not reported
Emotional Well-being 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
18.1
3.8
Not reported
Not reported
Not reported
Physician's Choice
17.7
3.6
Not reported
Not reported
Not reported
Emotional Well-being Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
30
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
18.3
3.2
Not reported
Not reported
Not reported
Physician's Choice
17.3
5.8
Not reported
Not reported
Not reported
Emotional Well-being Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
106
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
14.5
5.9
Not reported
Not reported
Not reported
Physician's Choice
15.4
5.6
Not reported
Not reported
Not reported
Emotional Well-being Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
39
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
15.4
5.4
Not reported
Not reported
Not reported
Physician's Choice
17.3
4.7
Not reported
Not reported
Not reported
Functional Well-being 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
18.0
6.0
Not reported
Not reported
Not reported
Physician's Choice
18.3
6.5
Not reported
Not reported
Not reported
Functional Well-being Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
172
Physician's Choice
81
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
16.2
6.2
Not reported
Not reported
Not reported
Physician's Choice
18.1
6.0
Not reported
Not reported
Not reported
Functional Well-being Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
132
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
16.9
5.7
Not reported
Not reported
Not reported
Physician's Choice
17.3
5.8
Not reported
Not reported
Not reported
Functional Well-being Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
105
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
17.4
5.3
Not reported
Not reported
Not reported
Physician's Choice
17.7
5.8
Not reported
Not reported
Not reported
Functional Well-being Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
85
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
17.5
5.7
Not reported
Not reported
Not reported
Physician's Choice
18.8
6.1
Not reported
Not reported
Not reported
Functional Well-being 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
17.5
5.3
Not reported
Not reported
Not reported
Physician's Choice
19.8
7.4
Not reported
Not reported
Not reported
Functional Well-being 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
18.0
5.0
Not reported
Not reported
Not reported
Physician's Choice
19.1
6.3
Not reported
Not reported
Not reported
Functional Well-being 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
17.0
6.3
Not reported
Not reported
Not reported
Physician's Choice
20.4
6.6
Not reported
Not reported
Not reported
Functional Well-being 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
18.3
5.7
Not reported
Not reported
Not reported
Physician's Choice
18.9
6.1
Not reported
Not reported
Not reported
Functional Well-being Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
30
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
18.7
5.4
Not reported
Not reported
Not reported
Physician's Choice
19.8
5.8
Not reported
Not reported
Not reported
Functional Well-being Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
106
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
15.0
6.0
Not reported
Not reported
Not reported
Physician's Choice
17.0
7.0
Not reported
Not reported
Not reported
Functional Well-being Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
39
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
16.5
6.1
Not reported
Not reported
Not reported
Physician's Choice
18.8
6.5
Not reported
Not reported
Not reported
Neurotoxicity Subscale 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
38.0
6.4
Not reported
Not reported
Not reported
Physician's Choice
39.0
6.0
Not reported
Not reported
Not reported
Neurotoxicity Subscale Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
172
Physician's Choice
81
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
36.2
6.5
Not reported
Not reported
Not reported
Physician's Choice
37.8
6.4
Not reported
Not reported
Not reported
Neurotoxicity Subscale Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
131
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
35.9
7.1
Not reported
Not reported
Not reported
Physician's Choice
37.1
5.9
Not reported
Not reported
Not reported
Neurotoxicity Subscale Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
105
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
35.1
7.6
Not reported
Not reported
Not reported
Physician's Choice
36.6
6.1
Not reported
Not reported
Not reported
Neurotoxicity Subscale Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
85
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
35.2
6.8
Not reported
Not reported
Not reported
Physician's Choice
36.6
7.5
Not reported
Not reported
Not reported
Neurotoxicity Subscale Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
74
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
35.6
7.2
Not reported
Not reported
Not reported
Physician's Choice
37.7
5.9
Not reported
Not reported
Not reported
Neurotoxicity Subscale 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
35.1
7.1
Not reported
Not reported
Not reported
Physician's Choice
37.6
7.9
Not reported
Not reported
Not reported
Neurotoxicity Subscale 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
35.9
7.3
Not reported
Not reported
Not reported
Physician's Choice
37.3
7.4
Not reported
Not reported
Not reported
Neurotoxicity Subscale 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
36.6
7.4
Not reported
Not reported
Not reported
Physician's Choice
35.5
7.1
Not reported
Not reported
Not reported
Neurotoxicity Subscale Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
30
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
37.5
6.7
Not reported
Not reported
Not reported
Physician's Choice
34.3
8.8
Not reported
Not reported
Not reported
Neurotoxicity Subscale Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
106
Physician's Choice
45
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
34.6
7.8
Not reported
Not reported
Not reported
Physician's Choice
36.0
7.3
Not reported
Not reported
Not reported
Neurotoxicity Subscale Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
39
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
34.7
9.0
Not reported
Not reported
Not reported
Physician's Choice
37.8
7.5
Not reported
Not reported
Not reported
Trial Outcome Index Score at Screening
Analysis denominator · Participants
Group
Source count
MEK 162
215
Physician's Choice
111
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
78.0
13.6
Not reported
Not reported
Not reported
Physician's Choice
78.9
15.3
Not reported
Not reported
Not reported
Trial Outcome Index Score at Week 9
Analysis denominator · Participants
Group
Source count
MEK 162
169
Physician's Choice
81
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
71.5
14.4
Not reported
Not reported
Not reported
Physician's Choice
77.3
15.2
Not reported
Not reported
Not reported
Trial Outcome Index Score at Week 17
Analysis denominator · Participants
Group
Source count
MEK 162
131
Physician's Choice
67
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
72.9
13.5
Not reported
Not reported
Not reported
Physician's Choice
76.0
14.2
Not reported
Not reported
Not reported
Trial Outcome Index Score at Week 25
Analysis denominator · Participants
Group
Source count
MEK 162
105
Physician's Choice
46
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
72.8
15.0
Not reported
Not reported
Not reported
Physician's Choice
75.7
16.1
Not reported
Not reported
Not reported
Trial Outcome Index Score at Week 33
Analysis denominator · Participants
Group
Source count
MEK 162
85
Physician's Choice
32
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
72.9
14.7
Not reported
Not reported
Not reported
Physician's Choice
76.6
17.4
Not reported
Not reported
Not reported
Trial Outcome Index Score at Week 41
Analysis denominator · Participants
Group
Source count
MEK 162
74
Physician's Choice
25
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
73.3
13.8
Not reported
Not reported
Not reported
Physician's Choice
80.1
18.0
Not reported
Not reported
Not reported
Trial Outcome Index Score at Week 49
Analysis denominator · Participants
Group
Source count
MEK 162
63
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
74.1
13.4
Not reported
Not reported
Not reported
Physician's Choice
79.3
17.6
Not reported
Not reported
Not reported
Trial Outcome Index 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
74.4
13.9
Not reported
Not reported
Not reported
Physician's Choice
80.1
17.1
Not reported
Not reported
Not reported
Trial Outcome Index Score at Week 65
Analysis denominator · Participants
Group
Source count
MEK 162
39
Physician's Choice
11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
77.2
13.5
Not reported
Not reported
Not reported
Physician's Choice
74.6
16.4
Not reported
Not reported
Not reported
Trial Outcome Index Score at Week 73
Analysis denominator · Participants
Group
Source count
MEK 162
30
Physician's Choice
8
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
77.9
14.2
Not reported
Not reported
Not reported
Physician's Choice
74.8
20.9
Not reported
Not reported
Not reported
Trial Outcome Index Score at Treatment Discontinuation Visit
Analysis denominator · Participants
Group
Source count
MEK 162
106
Physician's Choice
45
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
67.5
16.5
Not reported
Not reported
Not reported
Physician's Choice
72.1
18.0
Not reported
Not reported
Not reported
Trial Outcome Index Score at 30-Day Safety Follow-up
Analysis denominator · Participants
Group
Source count
MEK 162
39
Physician's Choice
18
Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
MEK 162
70.8
17.5
Not reported
Not reported
Not reported
Physician's Choice
79.8
15.7
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
5.1
value
21.7
group Id
OG001
spread
5.7
value
21.6
denoms
counts
group Id
OG000
value
218
group Id
OG001
value
111
units
Participants
title
Physical Well-being Score at Screening
categories
measurements
group Id
OG000
spread
5.7
value
19.0
group Id
OG001
spread
5.5
value
21.4
denoms
counts
group Id
OG000
value
173
group Id
OG001
value
81
units
Participants
title
Physical Well-being Score at Week 9
categories
measurements
group Id
OG000
spread
4.9
value
20.1
group Id
OG001
spread
5.2
value
21.5
denoms
counts
group Id
OG000
value
134
group Id
OG001
value
67
units
Participants
title
Physical Well-being Score at Week 17
categories
measurements
group Id
OG000
spread
5.2
value
20.4
group Id
OG001
spread
6.1
value
21.3
denoms
counts
group Id
OG000
value
106
group Id
OG001
value
46
units
Participants
title
Physical Well-being Score at Week 25
categories
measurements
group Id
OG000
spread
5.1
value
20.2
group Id
OG001
spread
6.3
value
21.2
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
32
units
Participants
title
Physical Well-being Score at Week 33
categories
measurements
group Id
OG000
spread
5.5
value
19.9
group Id
OG001
spread
6.6
value
22.6
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
25
units
Participants
title
Physical Well-being Score at Week 41
categories
measurements
group Id
OG000
spread
4.9
value
20.5
group Id
OG001
spread
6.2
value
22.6
denoms
counts
group Id
OG000
value
63
group Id
OG001
value
18
units
Participants
title
Physical Well-being Score at Week 49
categories
measurements
group Id
OG000
spread
4.6
value
20.8
group Id
OG001
spread
6.1
value
22.4
denoms
counts
group Id
OG000
value
42
group Id
OG001
value
16
units
Participants
title
Physical Well-being Score at Week 57
categories
measurements
group Id
OG000
spread
4.7
value
21.3
group Id
OG001
spread
7.2
value
20.2
denoms
counts
group Id
OG000
value
39
group Id
OG001
value
11
units
Participants
title
Physical Well-being Score at Week 65
categories
measurements
group Id
OG000
spread
4.5
value
21.8
group Id
OG001
spread
8.4
value
20.8
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
8
units
Participants
title
Physical Well-being Score at Week 73
categories
measurements
group Id
OG000
spread
6.7
value
17.8
group Id
OG001
spread
7.4
value
19.4
denoms
counts
group Id
OG000
value
107
group Id
OG001
value
46
units
Participants
title
Physical Well-being Score at Treatment Discontinuation Visit
categories
measurements
group Id
OG000
spread
6.5
value
19.6
group Id
OG001
spread
4.7
value
23.1
denoms
counts
group Id
OG000
value
40
group Id
OG001
value
18
units
Participants
title
Physical Well-being Score at 30-Day Safety Follow-up
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
113
units
Participants
description
FACT/GOG-NTX questionnaire consists of questions for dimensions related to physical, social, emotional, and functional well-being which contains 11 items, with responses scored on a Likert scale from 0 (not at all) to 4 (very much) designed to capture the symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The summed scores of each item were reverted into standardized scores ranging from 0 to 44, with a higher score indicating a lower level of neurological toxicity and less effect on quality of life (ie, higher scores indicate better quality of life). The trial outcome index consists of two subscales from the FACT-G: Physical Well Being (7 items) and Functional Well Being (7 items), plus the Cervix Cancer-specific subscale (15 items). Each item in the trial outcome index scored using a 5-point scale (0=not at all to 4=very much). The summed scores of each item were reverted into standardized scores ranging from 0 to 116. 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 Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)
Triangle