A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy · Source last updated 2019-12-20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
Units on a scale
Interval / dispersion
Standard Deviation
Time frame
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
What was measured
EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Analysis population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Groups in this outcome
Docetaxel
Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
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
Docetaxel
425
Atezolizumab
425
Reported measurements
Global Health: Baseline (n= 387, 410)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
60.55
22.25
Not reported
Not reported
Not reported
Atezolizumab
61.24
22.31
Not reported
Not reported
Not reported
Global Health: C2D1(n= 339, 361)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
59.56
22.15
Not reported
Not reported
Not reported
Atezolizumab
58.93
23.57
Not reported
Not reported
Not reported
Global Health: C3D1(n= 255, 304)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
64.64
18.66
Not reported
Not reported
Not reported
Atezolizumab
64.61
20.74
Not reported
Not reported
Not reported
Global Health: C4D1(n= 222, 279)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
63.51
20.67
Not reported
Not reported
Not reported
Atezolizumab
65.11
21.36
Not reported
Not reported
Not reported
Global Health: C5D1(n= 166, 235)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
64.01
18.37
Not reported
Not reported
Not reported
Atezolizumab
66.35
19.84
Not reported
Not reported
Not reported
Global Health: C6D1(n= 151, 223)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
64.51
19.59
Not reported
Not reported
Not reported
Atezolizumab
65.73
21.42
Not reported
Not reported
Not reported
Global Health: C7D1(n= 87, 187)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
64.85
18.13
Not reported
Not reported
Not reported
Atezolizumab
66.93
19.61
Not reported
Not reported
Not reported
Global Health: C8D1(n= 72, 169)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
62.73
20.22
Not reported
Not reported
Not reported
Atezolizumab
67.36
19.45
Not reported
Not reported
Not reported
Global Health: C9D1(n= 50, 152)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
67.17
18.93
Not reported
Not reported
Not reported
Atezolizumab
68.09
19.46
Not reported
Not reported
Not reported
Global Health: C10D1(n= 47, 145)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
66.84
18.67
Not reported
Not reported
Not reported
Atezolizumab
69.37
20.90
Not reported
Not reported
Not reported
Global Health: C11D1(n= 36, 133)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
69.68
17.15
Not reported
Not reported
Not reported
Atezolizumab
68.17
21.24
Not reported
Not reported
Not reported
Global Health: C12D1(n= 30, 131)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
66.67
18.05
Not reported
Not reported
Not reported
Atezolizumab
68.32
20.42
Not reported
Not reported
Not reported
Global Health: C13D1(n= 18, 124)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
69.91
14.33
Not reported
Not reported
Not reported
Atezolizumab
67.74
22.52
Not reported
Not reported
Not reported
Global Health: C14D1(n= 17, 120)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
69.61
14.71
Not reported
Not reported
Not reported
Atezolizumab
67.01
20.62
Not reported
Not reported
Not reported
Global Health: C15D1(n= 15, 113)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
69.44
17.16
Not reported
Not reported
Not reported
Atezolizumab
68.66
20.21
Not reported
Not reported
Not reported
Global Health: C16D1(n= 12, 109)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
62.50
15.69
Not reported
Not reported
Not reported
Atezolizumab
67.97
21.67
Not reported
Not reported
Not reported
Global Health: C17D1(n= 10, 98)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
61.67
19.72
Not reported
Not reported
Not reported
Atezolizumab
68.62
19.84
Not reported
Not reported
Not reported
Global Health: C18D1(n= 10, 92)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
61.67
21.23
Not reported
Not reported
Not reported
Atezolizumab
68.57
18.86
Not reported
Not reported
Not reported
Global Health: C19D1(n= 9, 84)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
65.74
21.43
Not reported
Not reported
Not reported
Atezolizumab
68.25
20.10
Not reported
Not reported
Not reported
Global Health: C20D1(n= 9, 80)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
62.04
26.72
Not reported
Not reported
Not reported
Atezolizumab
68.12
20.10
Not reported
Not reported
Not reported
Global Health: C21D1(n= 9, 75)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
60.19
29.98
Not reported
Not reported
Not reported
Atezolizumab
66.56
21.55
Not reported
Not reported
Not reported
Global Health: C22D1(n= 8, 68)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
54.17
24.80
Not reported
Not reported
Not reported
Atezolizumab
73.28
17.13
Not reported
Not reported
Not reported
Global Health: C23D1(n= 8, 66)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
62.50
19.42
Not reported
Not reported
Not reported
Atezolizumab
70.45
18.09
Not reported
Not reported
Not reported
Global Health: C24D1(n= 5, 65)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
70.00
27.39
Not reported
Not reported
Not reported
Atezolizumab
69.36
19.27
Not reported
Not reported
Not reported
Global Health: C25D1(n= 3, 60)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
66.67
28.87
Not reported
Not reported
Not reported
Atezolizumab
69.03
19.23
Not reported
Not reported
Not reported
Global Health: C26D1(n= 3, 55)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
66.67
28.87
Not reported
Not reported
Not reported
Atezolizumab
68.64
20.60
Not reported
Not reported
Not reported
Global Health: C27D1(n= 3, 52)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
66.67
28.87
Not reported
Not reported
Not reported
Atezolizumab
68.91
21.84
Not reported
Not reported
Not reported
Global Health: C28D1(n= 2, 48)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
87.50
17.68
Not reported
Not reported
Not reported
Atezolizumab
71.87
20.60
Not reported
Not reported
Not reported
Global Health: C29D1(n= 2, 40)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
91.67
11.79
Not reported
Not reported
Not reported
Atezolizumab
72.71
20.06
Not reported
Not reported
Not reported
Global Health: C30D1(n= 1, 30)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
83.33
NA
Not reported
Not reported
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
Atezolizumab
75.28
18.63
Not reported
Not reported
Not reported
Global Health: C31D1(n= 0, 24)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
NA
NA
Not reported
Not reported
Data not reported because no participant was evaluated for this category
Atezolizumab
71.53
21.13
Not reported
Not reported
Not reported
Global Health: C32D1(n= 0, 22)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
NA
NA
Not reported
Not reported
Data not reported because no participant was evaluated for this category
Atezolizumab
70.45
20.21
Not reported
Not reported
Not reported
Global Health: C33D1(n= 0,16)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
NA
NA
Not reported
Not reported
Data not reported because no participant was evaluated for this category
Atezolizumab
67.19
27.30
Not reported
Not reported
Not reported
Global Health: C34D1(n= 0, 14)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
NA
NA
Not reported
Not reported
Data not reported because no participant was evaluated for this category
Atezolizumab
68.45
26.19
Not reported
Not reported
Not reported
Global Health: C35D1(n= 0, 12)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
NA
NA
Not reported
Not reported
Data not reported because no participant was evaluated for this category
Atezolizumab
69.44
26.43
Not reported
Not reported
Not reported
Global Health: C36D1(n= 0, 8)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
NA
NA
Not reported
Not reported
Data not reported because no participant was evaluated for this category
Atezolizumab
80.21
16.63
Not reported
Not reported
Not reported
Global Health: C37D1(n= 0, 5)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
NA
NA
Not reported
Not reported
Data not reported because no participant was evaluated for this category
Atezolizumab
76.67
19.00
Not reported
Not reported
Not reported
Global Health: C38D1(n= 0, 2)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
NA
NA
Not reported
Not reported
Data not reported because no participant was evaluated for this category
Atezolizumab
91.67
11.79
Not reported
Not reported
Not reported
Global Health: EOT(n= 262, 245)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
51.69
24.02
Not reported
Not reported
Not reported
Atezolizumab
52.82
24.48
Not reported
Not reported
Not reported
Global Health: Pro Week 6 Pd(n= 0,1)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
NA
NA
Not reported
Not reported
Data not reported because no participant was evaluated for this category
Atezolizumab
50.00
NA
Not reported
Not reported
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
Global Health: Survival FU 1 (n= 2, 1)
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Docetaxel
58.33
35.36
Not reported
Not reported
Not reported
Atezolizumab
33.33
NA
Not reported
Not reported
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
Complete source fields
classes
categories
measurements
group Id
OG000
spread
22.25
value
60.55
group Id
OG001
spread
22.31
value
61.24
title
Global Health: Baseline (n= 387, 410)
categories
measurements
group Id
OG000
spread
22.15
value
59.56
group Id
OG001
spread
23.57
value
58.93
title
Global Health: C2D1(n= 339, 361)
categories
measurements
group Id
OG000
spread
18.66
value
64.64
group Id
OG001
spread
20.74
value
64.61
title
Global Health: C3D1(n= 255, 304)
categories
measurements
group Id
OG000
spread
20.67
value
63.51
group Id
OG001
spread
21.36
value
65.11
title
Global Health: C4D1(n= 222, 279)
categories
measurements
group Id
OG000
spread
18.37
value
64.01
group Id
OG001
spread
19.84
value
66.35
title
Global Health: C5D1(n= 166, 235)
categories
measurements
group Id
OG000
spread
19.59
value
64.51
group Id
OG001
spread
21.42
value
65.73
title
Global Health: C6D1(n= 151, 223)
categories
measurements
group Id
OG000
spread
18.13
value
64.85
group Id
OG001
spread
19.61
value
66.93
title
Global Health: C7D1(n= 87, 187)
categories
measurements
group Id
OG000
spread
20.22
value
62.73
group Id
OG001
spread
19.45
value
67.36
title
Global Health: C8D1(n= 72, 169)
categories
measurements
group Id
OG000
spread
18.93
value
67.17
group Id
OG001
spread
19.46
value
68.09
title
Global Health: C9D1(n= 50, 152)
categories
measurements
group Id
OG000
spread
18.67
value
66.84
group Id
OG001
spread
20.90
value
69.37
title
Global Health: C10D1(n= 47, 145)
categories
measurements
group Id
OG000
spread
17.15
value
69.68
group Id
OG001
spread
21.24
value
68.17
title
Global Health: C11D1(n= 36, 133)
categories
measurements
group Id
OG000
spread
18.05
value
66.67
group Id
OG001
spread
20.42
value
68.32
title
Global Health: C12D1(n= 30, 131)
denoms
counts
group Id
OG000
value
425
group Id
OG001
value
425
units
Participants
description
EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
dispersion Type
Standard Deviation
groups
description
Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
id
OG000
title
Docetaxel
description
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
id
OG001
title
Atezolizumab
param Type
MEAN
population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
reporting Status
POSTED
time Frame
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Triangle