Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
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
LEAST_SQUARES_MEAN
Unit
Units on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)
What was measured
The Beck Depression Inventory (BDI)-II is a 21-item self-report scale, with each item rated by participants on a 4-point scale (ranging from 0-3, where 0 indicated lowest depression and 3 indicated severe depression). The scale includes items capturing mood, (loss of pleasure, sadness, and irritability), suicidal ideation, and cognitive signs (punitive thoughts, self-criticism, self-dislike, pessimism, and poor concentration) as well as somatic signs (appetite, sleep, fatigue and libido). Scores were obtained by adding up the total points from the series of answers. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
Analysis population: PRO evaluable analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment. Here, 'Number Analyzed' signifies participants evaluable for specified row.
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.
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)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Reported measurements
Cycle 2 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-2.59
Not reported
-4.82
-0.37
Not reported
EXP-2 (Phase 2)
-3.27
Not reported
-5.52
-1.01
Not reported
EXP-3 (Phase 2)
-2.26
Not reported
-3.77
-0.76
Not reported
EXP-4 (Phase 2)
-2.17
Not reported
-3.89
-0.46
Not reported
EXP-5 (Phase 2)
-1.52
Not reported
-3.60
0.56
Not reported
EXP-6 (Phase 2)
-2.43
Not reported
-4.57
-0.29
Not reported
Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-3.34
Not reported
-5.57
-1.12
Not reported
EXP-2 (Phase 2)
-3.18
Not reported
-5.43
-0.93
Not reported
EXP-3 (Phase 2)
-3.03
Not reported
-4.55
-1.51
Not reported
EXP-4 (Phase 2)
-3.10
Not reported
-4.85
-1.35
Not reported
EXP-5 (Phase 2)
-0.46
Not reported
-2.61
1.69
Not reported
EXP-6 (Phase 2)
-1.24
Not reported
-3.37
0.90
Not reported
Cycle 4 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-3.84
Not reported
-6.07
-1.62
Not reported
EXP-2 (Phase 2)
-4.10
Not reported
-6.38
-1.82
Not reported
EXP-3 (Phase 2)
-2.59
Not reported
-4.14
-1.05
Not reported
EXP-4 (Phase 2)
-1.95
Not reported
-3.72
-0.19
Not reported
EXP-5 (Phase 2)
-1.19
Not reported
-3.38
1.01
Not reported
EXP-6 (Phase 2)
-1.94
Not reported
-4.12
0.24
Not reported
Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-4.47
Not reported
-6.69
-2.24
Not reported
EXP-2 (Phase 2)
-3.96
Not reported
-6.27
-1.66
Not reported
EXP-3 (Phase 2)
-2.75
Not reported
-4.33
-1.16
Not reported
EXP-4 (Phase 2)
-3.03
Not reported
-4.82
-1.25
Not reported
EXP-5 (Phase 2)
-1.51
Not reported
-3.74
0.72
Not reported
EXP-6 (Phase 2)
-1.25
Not reported
-3.46
0.95
Not reported
Cycle 6 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-3.51
Not reported
-5.73
-1.28
Not reported
EXP-2 (Phase 2)
-4.25
Not reported
-6.56
-1.94
Not reported
EXP-3 (Phase 2)
-3.31
Not reported
-4.90
-1.72
Not reported
EXP-4 (Phase 2)
-3.79
Not reported
-5.61
-1.98
Not reported
EXP-5 (Phase 2)
-0.42
Not reported
-2.64
1.81
Not reported
EXP-6 (Phase 2)
-0.29
Not reported
-2.54
1.96
Not reported
Cycle 8 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-4.17
Not reported
-6.41
-1.92
Not reported
EXP-2 (Phase 2)
-4.86
Not reported
-7.23
-2.50
Not reported
EXP-3 (Phase 2)
-2.26
Not reported
-3.86
-0.66
Not reported
EXP-4 (Phase 2)
-4.06
Not reported
-5.90
-2.22
Not reported
EXP-5 (Phase 2)
-1.09
Not reported
-3.34
1.17
Not reported
EXP-6 (Phase 2)
0.17
Not reported
-2.10
2.45
Not reported
Cycle 10 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-3.09
Not reported
-5.38
-0.80
Not reported
EXP-2 (Phase 2)
-4.92
Not reported
-7.28
-2.55
Not reported
EXP-3 (Phase 2)
-1.94
Not reported
-3.54
-0.34
Not reported
EXP-4 (Phase 2)
-4.27
Not reported
-6.14
-2.39
Not reported
EXP-5 (Phase 2)
-2.97
Not reported
-5.29
-0.66
Not reported
EXP-6 (Phase 2)
-0.19
Not reported
-2.60
2.22
Not reported
Cycle 12 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-3.95
Not reported
-6.30
-1.61
Not reported
EXP-2 (Phase 2)
-5.60
Not reported
-7.97
-3.24
Not reported
EXP-3 (Phase 2)
-0.72
Not reported
-2.40
0.95
Not reported
EXP-4 (Phase 2)
-4.80
Not reported
-6.83
-2.77
Not reported
EXP-5 (Phase 2)
-1.94
Not reported
-4.29
0.42
Not reported
EXP-6 (Phase 2)
-1.40
Not reported
-3.81
1.01
Not reported
Cycle 14 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-3.81
Not reported
-6.18
-1.43
Not reported
EXP-2 (Phase 2)
-5.80
Not reported
-8.35
-3.25
Not reported
EXP-3 (Phase 2)
-2.58
Not reported
-4.41
-0.76
Not reported
EXP-4 (Phase 2)
-4.29
Not reported
-6.41
-2.17
Not reported
EXP-5 (Phase 2)
-1.73
Not reported
-4.40
0.94
Not reported
EXP-6 (Phase 2)
-0.08
Not reported
-2.59
2.42
Not reported
Cycle 16 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-1.75
Not reported
-4.40
0.89
Not reported
EXP-2 (Phase 2)
-4.61
Not reported
-7.51
-1.71
Not reported
EXP-3 (Phase 2)
-2.15
Not reported
-4.35
0.06
Not reported
EXP-4 (Phase 2)
-4.65
Not reported
-6.90
-2.41
Not reported
EXP-5 (Phase 2)
-2.22
Not reported
-5.50
1.07
Not reported
EXP-6 (Phase 2)
0.03
Not reported
-2.65
2.71
Not reported
Cycle 18 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-4.49
Not reported
-7.49
-1.49
Not reported
EXP-2 (Phase 2)
-7.02
Not reported
-10.59
-3.46
Not reported
EXP-3 (Phase 2)
-1.96
Not reported
-4.22
0.31
Not reported
EXP-4 (Phase 2)
-2.86
Not reported
-5.21
-0.51
Not reported
EXP-5 (Phase 2)
-1.11
Not reported
-8.25
6.03
Not reported
EXP-6 (Phase 2)
1.88
Not reported
-1.66
5.41
Not reported
Cycle 20 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
0
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-5.01
Not reported
-8.55
-1.46
Not reported
EXP-2 (Phase 2)
-5.17
Not reported
-9.06
-1.29
Not reported
EXP-3 (Phase 2)
-1.82
Not reported
-4.70
1.06
Not reported
EXP-4 (Phase 2)
-3.63
Not reported
-6.31
-0.95
Not reported
EXP-6 (Phase 2)
1.88
Not reported
-1.66
5.41
Not reported
Cycle 22 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
0
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-2.93
Not reported
-6.79
0.94
Not reported
EXP-2 (Phase 2)
-4.63
Not reported
-9.00
-0.26
Not reported
EXP-3 (Phase 2)
-2.36
Not reported
-5.68
0.96
Not reported
EXP-4 (Phase 2)
-5.50
Not reported
-8.87
-2.12
Not reported
EXP-6 (Phase 2)
-2.39
Not reported
-6.73
1.94
Not reported
Cycle 24 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
0
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-7.31
Not reported
-11.66
-2.96
Not reported
EXP-2 (Phase 2)
-5.63
Not reported
-10.00
-1.26
Not reported
EXP-3 (Phase 2)
-2.88
Not reported
-7.04
1.28
Not reported
EXP-4 (Phase 2)
-3.89
Not reported
-8.10
0.32
Not reported
EXP-6 (Phase 2)
2.27
Not reported
-2.06
6.61
Not reported
Cycle 26 Day 1
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
0
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
0
EXP-6 (Phase 2)
0
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-5.50
Not reported
-10.67
-0.33
Not reported
EXP-3 (Phase 2)
-3.03
Not reported
-10.01
3.95
Not reported
EXP-4 (Phase 2)
-4.30
Not reported
-11.31
2.70
Not reported
End of treatment
Analysis denominator · Participants
Group
Source count
EXP-1 (Phase 2)
24
EXP-2 (Phase 2)
24
EXP-3 (Phase 2)
53
EXP-4 (Phase 2)
41
EXP-5 (Phase 2)
28
EXP-6 (Phase 2)
26
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
-4.77
Not reported
-9.23
-0.32
Not reported
EXP-2 (Phase 2)
-0.73
Not reported
-5.61
4.15
Not reported
EXP-3 (Phase 2)
-2.55
Not reported
-5.28
0.18
Not reported
EXP-4 (Phase 2)
-3.22
Not reported
-5.49
-0.95
Not reported
EXP-5 (Phase 2)
0.74
Not reported
-2.70
4.17
Not reported
EXP-6 (Phase 2)
-2.08
Not reported
-5.65
1.50
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
-4.82
upper Limit
-0.37
value
-2.59
group Id
OG001
lower Limit
-5.52
upper Limit
-1.01
value
-3.27
group Id
OG002
lower Limit
-3.77
upper Limit
-0.76
value
-2.26
group Id
OG003
lower Limit
-3.89
upper Limit
-0.46
value
-2.17
group Id
OG004
lower Limit
-3.60
upper Limit
0.56
value
-1.52
group Id
OG005
lower Limit
-4.57
upper Limit
-0.29
value
-2.43
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
lower Limit
-5.57
upper Limit
-1.12
value
-3.34
group Id
OG001
lower Limit
-5.43
upper Limit
-0.93
value
-3.18
group Id
OG002
lower Limit
-4.55
upper Limit
-1.51
value
-3.03
group Id
OG003
lower Limit
-4.85
upper Limit
-1.35
value
-3.10
group Id
OG004
lower Limit
-2.61
upper Limit
1.69
value
-0.46
group Id
OG005
lower Limit
-3.37
upper Limit
0.90
value
-1.24
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
lower Limit
-6.07
upper Limit
-1.62
value
-3.84
group Id
OG001
lower Limit
-6.38
upper Limit
-1.82
value
-4.10
group Id
OG002
lower Limit
-4.14
upper Limit
-1.05
value
-2.59
group Id
OG003
lower Limit
-3.72
upper Limit
-0.19
value
-1.95
group Id
OG004
lower Limit
-3.38
upper Limit
1.01
value
-1.19
group Id
OG005
lower Limit
-4.12
upper Limit
0.24
value
-1.94
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
lower Limit
-6.69
upper Limit
-2.24
value
-4.47
group Id
OG001
lower Limit
-6.27
upper Limit
-1.66
value
-3.96
group Id
OG002
lower Limit
-4.33
upper Limit
-1.16
value
-2.75
group Id
OG003
lower Limit
-4.82
upper Limit
-1.25
value
-3.03
group Id
OG004
lower Limit
-3.74
upper Limit
0.72
value
-1.51
group Id
OG005
lower Limit
-3.46
upper Limit
0.95
value
-1.25
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
lower Limit
-5.73
upper Limit
-1.28
value
-3.51
group Id
OG001
lower Limit
-6.56
upper Limit
-1.94
value
-4.25
group Id
OG002
lower Limit
-4.90
upper Limit
-1.72
value
-3.31
group Id
OG003
lower Limit
-5.61
upper Limit
-1.98
value
-3.79
group Id
OG004
lower Limit
-2.64
upper Limit
1.81
value
-0.42
group Id
OG005
lower Limit
-2.54
upper Limit
1.96
value
-0.29
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 6 Day 1
categories
measurements
group Id
OG000
lower Limit
-6.41
upper Limit
-1.92
value
-4.17
group Id
OG001
lower Limit
-7.23
upper Limit
-2.50
value
-4.86
group Id
OG002
lower Limit
-3.86
upper Limit
-0.66
value
-2.26
group Id
OG003
lower Limit
-5.90
upper Limit
-2.22
value
-4.06
group Id
OG004
lower Limit
-3.34
upper Limit
1.17
value
-1.09
group Id
OG005
lower Limit
-2.10
upper Limit
2.45
value
0.17
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 8 Day 1
categories
measurements
group Id
OG000
lower Limit
-5.38
upper Limit
-0.80
value
-3.09
group Id
OG001
lower Limit
-7.28
upper Limit
-2.55
value
-4.92
group Id
OG002
lower Limit
-3.54
upper Limit
-0.34
value
-1.94
group Id
OG003
lower Limit
-6.14
upper Limit
-2.39
value
-4.27
group Id
OG004
lower Limit
-5.29
upper Limit
-0.66
value
-2.97
group Id
OG005
lower Limit
-2.60
upper Limit
2.22
value
-0.19
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 10 Day 1
categories
measurements
group Id
OG000
lower Limit
-6.30
upper Limit
-1.61
value
-3.95
group Id
OG001
lower Limit
-7.97
upper Limit
-3.24
value
-5.60
group Id
OG002
lower Limit
-2.40
upper Limit
0.95
value
-0.72
group Id
OG003
lower Limit
-6.83
upper Limit
-2.77
value
-4.80
group Id
OG004
lower Limit
-4.29
upper Limit
0.42
value
-1.94
group Id
OG005
lower Limit
-3.81
upper Limit
1.01
value
-1.40
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 12 Day 1
categories
measurements
group Id
OG000
lower Limit
-6.18
upper Limit
-1.43
value
-3.81
group Id
OG001
lower Limit
-8.35
upper Limit
-3.25
value
-5.80
group Id
OG002
lower Limit
-4.41
upper Limit
-0.76
value
-2.58
group Id
OG003
lower Limit
-6.41
upper Limit
-2.17
value
-4.29
group Id
OG004
lower Limit
-4.40
upper Limit
0.94
value
-1.73
group Id
OG005
lower Limit
-2.59
upper Limit
2.42
value
-0.08
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 14 Day 1
categories
measurements
group Id
OG000
lower Limit
-4.40
upper Limit
0.89
value
-1.75
group Id
OG001
lower Limit
-7.51
upper Limit
-1.71
value
-4.61
group Id
OG002
lower Limit
-4.35
upper Limit
0.06
value
-2.15
group Id
OG003
lower Limit
-6.90
upper Limit
-2.41
value
-4.65
group Id
OG004
lower Limit
-5.50
upper Limit
1.07
value
-2.22
group Id
OG005
lower Limit
-2.65
upper Limit
2.71
value
0.03
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 16 Day 1
categories
measurements
group Id
OG000
lower Limit
-7.49
upper Limit
-1.49
value
-4.49
group Id
OG001
lower Limit
-10.59
upper Limit
-3.46
value
-7.02
group Id
OG002
lower Limit
-4.22
upper Limit
0.31
value
-1.96
group Id
OG003
lower Limit
-5.21
upper Limit
-0.51
value
-2.86
group Id
OG004
lower Limit
-8.25
upper Limit
6.03
value
-1.11
group Id
OG005
lower Limit
-1.66
upper Limit
5.41
value
1.88
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
title
Cycle 18 Day 1
categories
measurements
group Id
OG000
lower Limit
-8.55
upper Limit
-1.46
value
-5.01
group Id
OG001
lower Limit
-9.06
upper Limit
-1.29
value
-5.17
group Id
OG002
lower Limit
-4.70
upper Limit
1.06
value
-1.82
group Id
OG003
lower Limit
-6.31
upper Limit
-0.95
value
-3.63
group Id
OG005
lower Limit
-1.66
upper Limit
5.41
value
1.88
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
0
group Id
OG005
value
26
units
Participants
title
Cycle 20 Day 1
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
28
group Id
OG005
value
26
units
Participants
description
The Beck Depression Inventory (BDI)-II is a 21-item self-report scale, with each item rated by participants on a 4-point scale (ranging from 0-3, where 0 indicated lowest depression and 3 indicated severe depression). The scale includes items capturing mood, (loss of pleasure, sadness, and irritability), suicidal ideation, and cognitive signs (punitive thoughts, self-criticism, self-dislike, pessimism, and poor concentration) as well as somatic signs (appetite, sleep, fatigue and libido). Scores were obtained by adding up the total points from the series of answers. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
dispersion Type
95% Confidence Interval
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)
param Type
LEAST_SQUARES_MEAN
population Description
PRO evaluable analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment. Here, 'Number Analyzed' signifies participants evaluable for specified row.
reporting Status
POSTED
time Frame
Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)
title
Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)
Triangle