Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations · Source last updated 2024-08-12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study treatment to end of treatment (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
What was measured
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ)-C30 (version 3.0) consists of 30 questions assessing 5 functional domains (physical, role, emotional, cognitive and social), global quality of life (QoL), disease/treatment related symptoms (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhea), and the perceived financial impact of disease. Each scale was transformed to a range of 0 to 100 using standard EORTC algorithm. For global QoL and functional scales, higher score indicate better performance, and improvement was defined as an increase of at least 10 points, worsening was defined as a decrease of at least 10 points. For symptom scales, higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.
Analysis population: Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.
Groups in this outcome
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
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
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
55
EXP-4 (Phase 2)
60
EXP-5 (Phase 2)
43
EXP-6 (Phase 2)
41
DDI Sub-study
32
Reported measurements
Improved in global QoL
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
25
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
19
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
12
Not reported
Not reported
Not reported
Not reported
Stable in global QoL
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
24
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
18
Not reported
Not reported
Not reported
Not reported
Worsened in global QoL
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
2
Not reported
Not reported
Not reported
Not reported
Missing for global QoL
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in physical functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
24
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
5
Not reported
Not reported
Not reported
Not reported
Stable in physical functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
38
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
24
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
25
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
23
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
23
Not reported
Not reported
Not reported
Not reported
Worsened in physical functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
4
Not reported
Not reported
Not reported
Not reported
Missing for physical functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in role functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
25
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
10
Not reported
Not reported
Not reported
Not reported
Stable in role functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
33
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
15
Not reported
Not reported
Not reported
Not reported
Worsened in role functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
7
Not reported
Not reported
Not reported
Not reported
Missing for role functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in emotional functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
10
Not reported
Not reported
Not reported
Not reported
Stable in emotional functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
32
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
34
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
20
Not reported
Not reported
Not reported
Not reported
Worsened in emotional functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
2
Not reported
Not reported
Not reported
Not reported
Missing for emotional functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in cognitive functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
9
Not reported
Not reported
Not reported
Not reported
Stable in cognitive functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
36
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
34
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
19
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
11
Not reported
Not reported
Not reported
Not reported
Worsened in cognitive functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
12
Not reported
Not reported
Not reported
Not reported
Missing for cognitive functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in social functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
13
Not reported
Not reported
Not reported
Not reported
Stable in social functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
33
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
29
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
21
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
13
Not reported
Not reported
Not reported
Not reported
Worsened in social functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
6
Not reported
Not reported
Not reported
Not reported
Missing for social functioning
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
28
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
26
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
17
Not reported
Not reported
Not reported
Not reported
Stable in fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
25
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
23
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
9
Not reported
Not reported
Not reported
Not reported
Worsened in fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
6
Not reported
Not reported
Not reported
Not reported
Missing for fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in nausea and vomiting
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
6
Not reported
Not reported
Not reported
Not reported
Stable in nausea and vomiting
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
21
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
44
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
39
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
28
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
28
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
24
Not reported
Not reported
Not reported
Not reported
Worsened in nausea and vomiting
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
2
Not reported
Not reported
Not reported
Not reported
Missing for nausea and vomiting
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
23
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
19
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
21
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
14
Not reported
Not reported
Not reported
Not reported
Stable in pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
25
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
28
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
19
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
13
Not reported
Not reported
Not reported
Not reported
Worsened in pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
5
Not reported
Not reported
Not reported
Not reported
Missing for pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
23
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
9
Not reported
Not reported
Not reported
Not reported
Stable in dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
33
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
15
Not reported
Not reported
Not reported
Not reported
Worsened in dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
8
Not reported
Not reported
Not reported
Not reported
Missing for dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
30
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
21
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
19
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
12
Not reported
Not reported
Not reported
Not reported
Stable in insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
28
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
15
Not reported
Not reported
Not reported
Not reported
Worsened in insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
5
Not reported
Not reported
Not reported
Not reported
Missing for insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in appetite loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
29
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
10
Not reported
Not reported
Not reported
Not reported
Stable in appetite loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
36
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
26
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
21
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
20
Not reported
Not reported
Not reported
Not reported
Worsened in appetite loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
2
Not reported
Not reported
Not reported
Not reported
Missing for appetite loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
10
Not reported
Not reported
Not reported
Not reported
Stable in constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
19
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
33
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
33
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
29
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
12
Not reported
Not reported
Not reported
Not reported
Worsened in constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
10
Not reported
Not reported
Not reported
Not reported
Missing for constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
6
Not reported
Not reported
Not reported
Not reported
Stable in diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
21
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
40
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
39
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
27
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
28
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
21
Not reported
Not reported
Not reported
Not reported
Worsened in diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
5
Not reported
Not reported
Not reported
Not reported
Missing for diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in financial difficulties
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
9
Not reported
Not reported
Not reported
Not reported
Stable in financial difficulties
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
19
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
34
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
38
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
26
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
16
Not reported
Not reported
Not reported
Not reported
Worsened in financial difficulties
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
7
Not reported
Not reported
Not reported
Not reported
Missing for financial difficulties
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
11
group Id
OG002
value
18
group Id
OG003
value
25
group Id
OG004
value
17
group Id
OG005
value
19
group Id
OG006
value
12
title
Improved in global QoL
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
12
group Id
OG002
value
24
group Id
OG003
value
22
group Id
OG004
value
16
group Id
OG005
value
15
group Id
OG006
value
18
title
Stable in global QoL
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
13
group Id
OG003
value
13
group Id
OG004
value
10
group Id
OG005
value
6
group Id
OG006
value
2
title
Worsened in global QoL
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
title
Missing for global QoL
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
8
group Id
OG002
value
13
group Id
OG003
value
24
group Id
OG004
value
8
group Id
OG005
value
11
group Id
OG006
value
5
title
Improved in physical functioning
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
17
group Id
OG002
value
38
group Id
OG003
value
24
group Id
OG004
value
25
group Id
OG005
value
23
group Id
OG006
value
23
title
Stable in physical functioning
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
1
group Id
OG002
value
4
group Id
OG003
value
12
group Id
OG004
value
10
group Id
OG005
value
6
group Id
OG006
value
4
title
Worsened in physical functioning
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
title
Missing for physical functioning
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
7
group Id
OG002
value
15
group Id
OG003
value
25
group Id
OG004
value
18
group Id
OG005
value
17
group Id
OG006
value
10
title
Improved in role functioning
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
16
group Id
OG002
value
33
group Id
OG003
value
18
group Id
OG004
value
13
group Id
OG005
value
17
group Id
OG006
value
15
title
Stable in role functioning
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
17
group Id
OG004
value
12
group Id
OG005
value
5
group Id
OG006
value
7
title
Worsened in role functioning
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
0
title
Missing for role functioning
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
26
group Id
OG002
value
55
group Id
OG003
value
60
group Id
OG004
value
43
group Id
OG005
value
41
group Id
OG006
value
32
units
Participants
description
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ)-C30 (version 3.0) consists of 30 questions assessing 5 functional domains (physical, role, emotional, cognitive and social), global quality of life (QoL), disease/treatment related symptoms (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhea), and the perceived financial impact of disease. Each scale was transformed to a range of 0 to 100 using standard EORTC algorithm. For global QoL and functional scales, higher score indicate better performance, and improvement was defined as an increase of at least 10 points, worsening was defined as a decrease of at least 10 points. For symptom scales, higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.
groups
description
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG000
title
EXP-1 (Phase 2)
description
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG001
title
EXP-2 (Phase 2)
description
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG002
title
EXP-3 (Phase 2)
description
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG003
title
EXP-4 (Phase 2)
description
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG004
title
EXP-5 (Phase 2)
description
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG005
title
EXP-6 (Phase 2)
description
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
id
OG006
title
DDI Sub-study
param Type
COUNT_OF_PARTICIPANTS
population Description
Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.
reporting Status
POSTED
time Frame
From first dose of study treatment to end of treatment (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
title
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2 and DDI Sub-study)
Triangle