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NCT01970865 · OUTCOME

Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (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

EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. 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: 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 dyspnea

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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 dyspnea

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	23	Not reported	Not reported	Not reported	Not reported

Worsened in dyspnea

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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 coughing

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	23	Not reported	Not reported	Not reported	Not reported

Stable in coughing

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	12	Not reported	Not reported	Not reported	Not reported

Worsened in coughing

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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

Improved in hemoptysis

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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

Stable in hemoptysis

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	42	Not reported	Not reported	Not reported	Not reported

Worsened in hemoptysis

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	0	Not reported	Not reported	Not reported	Not reported

Improved in sore mouth

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	0	Not reported	Not reported	Not reported	Not reported

Stable in sore mouth

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	40	Not reported	Not reported	Not reported	Not reported

Worsened in sore mouth

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	3	Not reported	Not reported	Not reported	Not reported

Improved in dysphagia

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	4	Not reported	Not reported	Not reported	Not reported

Stable in dysphagia

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	37	Not reported	Not reported	Not reported	Not reported

Worsened in dysphagia

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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 peripheral neuropathy

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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

Stable in peripheral neuropathy

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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 peripheral neuropathy

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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

Improved in alopecia

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	42

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	4	Not reported	Not reported	Not reported	Not reported

Stable in alopecia

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	42

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 alopecia

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	42

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 chest pain

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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

Stable in chest pain

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	22	Not reported	Not reported	Not reported	Not reported

Worsened in chest pain

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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 arm or shoulder pain

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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 arm or shoulder pain

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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 arm or shoulder pain

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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 pain in other parts

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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

Stable in pain in other parts

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 PRO Evaluable Population	12	Not reported	Not reported	Not reported	Not reported

Worsened in pain in other parts

Analysis denominator · Participants

Group	Source count
Phase 1 PRO Evaluable Population	43

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

Complete source fields

classes

categories
measurements
group Id
OG000
value
9
denoms
counts
group Id
OG000
value
43
units
Participants
title
Improved in dyspnea
categories
measurements
group Id
OG000
value
23
denoms
counts
group Id
OG000
value
43
units
Participants
title
Stable in dyspnea
categories
measurements
group Id
OG000
value
11
denoms
counts
group Id
OG000
value
43
units
Participants
title
Worsened in dyspnea
categories
measurements
group Id
OG000
value
23
denoms
counts
group Id
OG000
value
43
units
Participants
title
Improved in coughing
categories
measurements
group Id
OG000
value
12
denoms
counts
group Id
OG000
value
43
units
Participants
title
Stable in coughing
categories
measurements
group Id
OG000
value
8
denoms
counts
group Id
OG000
value
43
units
Participants
title
Worsened in coughing
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
43
units
Participants
title
Improved in hemoptysis
categories
measurements
group Id
OG000
value
42
denoms
counts
group Id
OG000
value
43
units
Participants
title
Stable in hemoptysis
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
43
units
Participants
title
Worsened in hemoptysis
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
43
units
Participants
title
Improved in sore mouth
categories
measurements
group Id
OG000
value
40
denoms
counts
group Id
OG000
value
43
units
Participants
title
Stable in sore mouth
categories
measurements
group Id
OG000
value
3
denoms
counts
group Id
OG000
value
43
units
Participants
title
Worsened in sore mouth

denoms

counts
group Id
OG000
value
43
units
Participants

description

EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. 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

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-LC13 (Phase 1)

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice