Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
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 start of study treatment until end of treatment (maximum of 8 years approximately)
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
Phase 1 PRO Evaluable Population
This reporting group includes all Phase 1 participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.
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
Phase 1 PRO Evaluable Population
43
Reported measurements
Improved in global QoL
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
19
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
Phase 1 PRO Evaluable Population
13
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
Phase 1 PRO Evaluable Population
11
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
Phase 1 PRO Evaluable Population
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
Phase 1 PRO Evaluable Population
29
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
Phase 1 PRO Evaluable Population
9
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
Phase 1 PRO Evaluable Population
14
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
Phase 1 PRO Evaluable Population
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
Phase 1 PRO Evaluable Population
14
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
Phase 1 PRO Evaluable Population
15
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
Phase 1 PRO Evaluable Population
21
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
Phase 1 PRO Evaluable Population
7
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
Phase 1 PRO Evaluable Population
8
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
Phase 1 PRO Evaluable Population
21
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
Phase 1 PRO Evaluable Population
14
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
Phase 1 PRO Evaluable Population
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
Phase 1 PRO Evaluable Population
17
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
Phase 1 PRO Evaluable Population
13
Not reported
Not reported
Not reported
Not reported
Improved in fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
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
Phase 1 PRO Evaluable Population
19
Not reported
Not reported
Not reported
Not reported
Worsened in fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
7
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
Phase 1 PRO Evaluable Population
10
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
Phase 1 PRO Evaluable Population
32
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
Phase 1 PRO Evaluable Population
1
Not reported
Not reported
Not reported
Not reported
Improved in pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
17
Not reported
Not reported
Not reported
Not reported
Stable in pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
16
Not reported
Not reported
Not reported
Not reported
Worsened in pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
10
Not reported
Not reported
Not reported
Not reported
Improved in dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
13
Not reported
Not reported
Not reported
Not reported
Stable in dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
19
Not reported
Not reported
Not reported
Not reported
Worsened in dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
11
Not reported
Not reported
Not reported
Not reported
Improved in insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
19
Not reported
Not reported
Not reported
Not reported
Stable in insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
17
Not reported
Not reported
Not reported
Not reported
Worsened in insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
7
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
Phase 1 PRO Evaluable Population
14
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
Phase 1 PRO Evaluable Population
27
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
Phase 1 PRO Evaluable Population
2
Not reported
Not reported
Not reported
Not reported
Improved in constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
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
Phase 1 PRO Evaluable Population
28
Not reported
Not reported
Not reported
Not reported
Worsened in constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
5
Not reported
Not reported
Not reported
Not reported
Improved in diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
9
Not reported
Not reported
Not reported
Not reported
Stable in diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
28
Not reported
Not reported
Not reported
Not reported
Worsened in diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1 PRO Evaluable Population
6
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
Phase 1 PRO Evaluable Population
7
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
Phase 1 PRO Evaluable Population
20
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
Phase 1 PRO Evaluable Population
16
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
19
title
Improved in global QoL
categories
measurements
group Id
OG000
value
13
title
Stable in global QoL
categories
measurements
group Id
OG000
value
11
title
Worsened in global QoL
categories
measurements
group Id
OG000
value
5
title
Improved in physical functioning
categories
measurements
group Id
OG000
value
29
title
Stable in physical functioning
categories
measurements
group Id
OG000
value
9
title
Worsened in physical functioning
categories
measurements
group Id
OG000
value
14
title
Improved in role functioning
categories
measurements
group Id
OG000
value
15
title
Stable in role functioning
categories
measurements
group Id
OG000
value
14
title
Worsened in role functioning
categories
measurements
group Id
OG000
value
15
title
Improved in emotional functioning
categories
measurements
group Id
OG000
value
21
title
Stable in emotional functioning
categories
measurements
group Id
OG000
value
7
title
Worsened in emotional functioning
denoms
counts
group Id
OG000
value
43
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
This reporting group includes all Phase 1 participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.
id
OG000
title
Phase 1 PRO Evaluable Population
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 start of study treatment until end of treatment (maximum of 8 years approximately)
title
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)
Triangle