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NCT03735121 · OUTCOME

Part 2: Change From Baseline in EORTC IL57 Role Functioning Score

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2025-12-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: score on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months)

What was measured

EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF \& GHS/QoL \& 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks \& short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work \& pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health \& QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning \& a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome.

Analysis population: FAS included all randomized participants, with participants grouped according to their assigned treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.

Groups in this outcome

Part 2: Atezolizumab IV 1200 mg

Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.

Part 2: Atezolizumab SC 1875 mg

Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.

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
Part 2: Atezolizumab IV 1200 mg	117
Part 2: Atezolizumab SC 1875 mg	242

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	117
Part 2: Atezolizumab SC 1875 mg	242

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	74.93	25.67	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	74.86	27.51	Not reported	Not reported	Not reported

Change at Day 1 Cycle 2

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	106
Part 2: Atezolizumab SC 1875 mg	218

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	0.31	29.46	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-4.36	24.48	Not reported	Not reported	Not reported

Change at Day 1 Cycle 3

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	86
Part 2: Atezolizumab SC 1875 mg	182

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-3.29	27.51	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-4.67	25.83	Not reported	Not reported	Not reported

Change at Day 1 Cycle 4

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	80
Part 2: Atezolizumab SC 1875 mg	167

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-0.83	26.90	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-6.59	28.63	Not reported	Not reported	Not reported

Change at Day 1 Cycle 5

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	64
Part 2: Atezolizumab SC 1875 mg	134

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	2.34	31.13	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-5.22	30.27	Not reported	Not reported	Not reported

Change at Day 1 Cycle 6

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	58
Part 2: Atezolizumab SC 1875 mg	119

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	0.00	32.14	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-5.74	29.39	Not reported	Not reported	Not reported

Change at Day 1 Cycle 8

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	47
Part 2: Atezolizumab SC 1875 mg	94

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	4.96	29.47	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-1.95	25.50	Not reported	Not reported	Not reported

Change at Day 1 Cycle 10

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	41
Part 2: Atezolizumab SC 1875 mg	81

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	1.63	29.06	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-0.82	24.71	Not reported	Not reported	Not reported

Change at Day 1 Cycle 12

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	35
Part 2: Atezolizumab SC 1875 mg	69

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	4.29	29.80	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-2.66	30.20	Not reported	Not reported	Not reported

Change at Day 1 Cycle 14

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	30
Part 2: Atezolizumab SC 1875 mg	60

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	6.11	22.09	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-3.61	30.24	Not reported	Not reported	Not reported

Change at Day 1 Cycle 16

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	28
Part 2: Atezolizumab SC 1875 mg	53

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-0.60	29.91	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-1.26	27.12	Not reported	Not reported	Not reported

Change at Day 1 Cycle 18

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	23
Part 2: Atezolizumab SC 1875 mg	50

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	0.72	21.60	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-2.00	27.90	Not reported	Not reported	Not reported

Change at Day 1 Cycle 20

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	21
Part 2: Atezolizumab SC 1875 mg	44

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	7.94	30.10	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-2.65	27.83	Not reported	Not reported	Not reported

Change at Day 1 Cycle 22

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	18
Part 2: Atezolizumab SC 1875 mg	36

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	6.48	28.66	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-5.09	34.23	Not reported	Not reported	Not reported

Change at Day 1 Cycle 24

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	16
Part 2: Atezolizumab SC 1875 mg	34

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	3.13	24.51	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-4.41	29.39	Not reported	Not reported	Not reported

Change at Day 1 Cycle 26

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	16
Part 2: Atezolizumab SC 1875 mg	31

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	4.17	36.77	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	0.54	27.38	Not reported	Not reported	Not reported

Change at Day 1 Cycle 28

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	14
Part 2: Atezolizumab SC 1875 mg	23

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	7.14	16.94	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	5.07	29.91	Not reported	Not reported	Not reported

Change at Day 1 Cycle 30

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	13
Part 2: Atezolizumab SC 1875 mg	21

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-2.56	20.24	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	3.17	31.01	Not reported	Not reported	Not reported

Change at Day 1 Cycle 32

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	12
Part 2: Atezolizumab SC 1875 mg	22

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-6.94	19.41	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-0.76	31.49	Not reported	Not reported	Not reported

Change at Day 1 Cycle 34

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	11
Part 2: Atezolizumab SC 1875 mg	20

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-6.06	22.70	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	0.00	34.20	Not reported	Not reported	Not reported

Change at Day 1 Cycle 36

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	11
Part 2: Atezolizumab SC 1875 mg	20

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-3.03	17.98	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	1.67	31.48	Not reported	Not reported	Not reported

Change at Day 1 Cycle 38

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	11
Part 2: Atezolizumab SC 1875 mg	18

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	4.55	16.82	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	5.56	26.20	Not reported	Not reported	Not reported

Change at Day 1 Cycle 40

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	11
Part 2: Atezolizumab SC 1875 mg	18

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	1.52	24.10	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	1.85	28.52	Not reported	Not reported	Not reported

Change at Day 1 Cycle 42

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	8
Part 2: Atezolizumab SC 1875 mg	18

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-6.25	23.46	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	3.70	32.11	Not reported	Not reported	Not reported

Change at Day 1 Cycle 44

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	8
Part 2: Atezolizumab SC 1875 mg	16

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-2.08	16.52	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	7.29	31.60	Not reported	Not reported	Not reported

Change at Day 1 Cycle 46

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	8
Part 2: Atezolizumab SC 1875 mg	17

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	0.00	23.57	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	4.90	32.68	Not reported	Not reported	Not reported

Change at Day 1 Cycle 48

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	7
Part 2: Atezolizumab SC 1875 mg	14

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	2.38	20.25	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	8.33	31.86	Not reported	Not reported	Not reported

Change at Day 1 Cycle 50

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	7
Part 2: Atezolizumab SC 1875 mg	11

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	2.38	20.25	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	13.64	36.38	Not reported	Not reported	Not reported

Change at Day 1 Cycle 52

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	6
Part 2: Atezolizumab SC 1875 mg	10

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	2.78	28.71	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	1.67	24.15	Not reported	Not reported	Not reported

Change at Day 1 Cycle 54

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	3
Part 2: Atezolizumab SC 1875 mg	8

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-11.11	34.69	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	2.08	36.12	Not reported	Not reported	Not reported

Change at Day 1 Cycle 56

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	2
Part 2: Atezolizumab SC 1875 mg	3

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	0.00	23.57	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-5.56	19.25	Not reported	Not reported	Not reported

Change at Day 1 Cycle 58

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	1
Part 2: Atezolizumab SC 1875 mg	2

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-33.33	NA	Not reported	Not reported	SD was not estimable since only 1 participant was evaluated.
Part 2: Atezolizumab SC 1875 mg	0.00	23.57	Not reported	Not reported	Not reported

Change at Day 1 Cycle 60

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	1
Part 2: Atezolizumab SC 1875 mg	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	16.67	NA	Not reported	Not reported	SD was not estimable since only 1 participant was evaluated.
Part 2: Atezolizumab SC 1875 mg	16.67	NA	Not reported	Not reported	SD was not estimable since only 1 participant was evaluated.

Change at Day 1 Cycle 62

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	1
Part 2: Atezolizumab SC 1875 mg	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	16.67	NA	Not reported	Not reported	SD was not estimable since only 1 participant was evaluated.
Part 2: Atezolizumab SC 1875 mg	16.67	NA	Not reported	Not reported	SD was not estimable since only 1 participant was evaluated.

Change at Day 1 Cycle 64

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	0
Part 2: Atezolizumab SC 1875 mg	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab SC 1875 mg	16.67	NA	Not reported	Not reported	SD was not estimable since only 1 participant was evaluated.

Change at Treatment Discontinuation Visit

Analysis denominator · Participants

Group	Source count
Part 2: Atezolizumab IV 1200 mg	74
Part 2: Atezolizumab SC 1875 mg	149

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	-20.27	33.70	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	-21.14	34.80	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
25.67
value
74.93
group Id
OG001
spread
27.51
value
74.86
denoms
counts
group Id
OG000
value
117
group Id
OG001
value
242
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
29.46
value
0.31
group Id
OG001
spread
24.48
value
-4.36
denoms
counts
group Id
OG000
value
106
group Id
OG001
value
218
units
Participants
title
Change at Day 1 Cycle 2
categories
measurements
group Id
OG000
spread
27.51
value
-3.29
group Id
OG001
spread
25.83
value
-4.67
denoms
counts
group Id
OG000
value
86
group Id
OG001
value
182
units
Participants
title
Change at Day 1 Cycle 3
categories
measurements
group Id
OG000
spread
26.90
value
-0.83
group Id
OG001
spread
28.63
value
-6.59
denoms
counts
group Id
OG000
value
80
group Id
OG001
value
167
units
Participants
title
Change at Day 1 Cycle 4
categories
measurements
group Id
OG000
spread
31.13
value
2.34
group Id
OG001
spread
30.27
value
-5.22
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
134
units
Participants
title
Change at Day 1 Cycle 5
categories
measurements
group Id
OG000
spread
32.14
value
0.00
group Id
OG001
spread
29.39
value
-5.74
denoms
counts
group Id
OG000
value
58
group Id
OG001
value
119
units
Participants
title
Change at Day 1 Cycle 6
categories
measurements
group Id
OG000
spread
29.47
value
4.96
group Id
OG001
spread
25.50
value
-1.95
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
94
units
Participants
title
Change at Day 1 Cycle 8
categories
measurements
group Id
OG000
spread
29.06
value
1.63
group Id
OG001
spread
24.71
value
-0.82
denoms
counts
group Id
OG000
value
41
group Id
OG001
value
81
units
Participants
title
Change at Day 1 Cycle 10
categories
measurements
group Id
OG000
spread
29.80
value
4.29
group Id
OG001
spread
30.20
value
-2.66
denoms
counts
group Id
OG000
value
35
group Id
OG001
value
69
units
Participants
title
Change at Day 1 Cycle 12
categories
measurements
group Id
OG000
spread
22.09
value
6.11
group Id
OG001
spread
30.24
value
-3.61
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
60
units
Participants
title
Change at Day 1 Cycle 14
categories
measurements
group Id
OG000
spread
29.91
value
-0.60
group Id
OG001
spread
27.12
value
-1.26
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
53
units
Participants
title
Change at Day 1 Cycle 16
categories
measurements
group Id
OG000
spread
21.60
value
0.72
group Id
OG001
spread
27.90
value
-2.00
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
50
units
Participants
title
Change at Day 1 Cycle 18

denoms

counts
group Id
OG000
value
117
group Id
OG001
value
242
units
Participants

description

EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF \& GHS/QoL \& 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks \& short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work \& pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health \& QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning \& a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome.

dispersion Type

Standard Deviation

groups

description
Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
id
OG000
title
Part 2: Atezolizumab IV 1200 mg
description
Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
id
OG001
title
Part 2: Atezolizumab SC 1875 mg

param Type

MEAN

population Description

FAS included all randomized participants, with participants grouped according to their assigned treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.

reporting Status

POSTED

time Frame

Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months)

title

Part 2: Change From Baseline in EORTC IL57 Role Functioning Score

type

SECONDARY

unit Of Measure

score on a scale

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

Preserved source evidence · Not medical advice