NCT02763579 · BASELINE

Baseline characteristics

A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC) · Source last updated 2023-07-28

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

denoms

counts
group Id
BG000
value
251
group Id
BG001
value
252
group Id
BG002
value
503
units
Participants

groups

description
All participants in the Global or China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
id
BG000
title
Placebo + Carboplatin + Etoposide - All
description
All participants in the Global or China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
id
BG001
title
Atezolizumab + Carboplatin + Etoposide - All
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.0
value
63.6
group Id
BG001
spread
8.8
value
63.8
group Id
BG002
spread
8.9
value
63.7
denoms
counts
group Id
BG000
value
202
group Id
BG001
value
201
group Id
BG002
value
403
units
Participants
title
Global
categories
measurements
group Id
BG000
spread
8.8
value
60.7
group Id
BG001
spread
9.0
value
59.7
group Id
BG002
spread
8.9
value
60.2
denoms
counts
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
units
Participants
title
China
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
70
group Id
BG001
value
72
group Id
BG002
value
142
title
Female
measurements
group Id
BG000
value
132
group Id
BG001
value
129
group Id
BG002
value
261
title
Male
denoms
counts
group Id
BG000
value
202
group Id
BG001
value
201
group Id
BG002
value
403
units
Participants
title
Global
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
11
group Id
BG002
value
23
title
Female
measurements
group Id
BG000
value
41
group Id
BG001
value
46
group Id
BG002
value
87
title
Male
denoms
counts
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
units
Participants
title
China
description
As reported from Electronic Case Report Form (eCRF).
param Type
COUNT_OF_PARTICIPANTS
population Description
The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
8
group Id
BG002
value
16
title
Hispanic or Latino
measurements
group Id
BG000
value
185
group Id
BG001
value
187
group Id
BG002
value
372
title
Not Hispanic or Latino
measurements
group Id
BG000
value
9
group Id
BG001
value
6
group Id
BG002
value
15
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
202
group Id
BG001
value
201
group Id
BG002
value
403
units
Participants
title
Global
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Hispanic or Latino
measurements
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
units
Participants
title
China
param Type
COUNT_OF_PARTICIPANTS
population Description
The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
36
group Id
BG001
value
33
group Id
BG002
value
69
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Black or African American
measurements
group Id
BG000
value
159
group Id
BG001
value
163
group Id
BG002
value
322
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
4
group Id
BG001
value
4
group Id
BG002
value
8
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
202
group Id
BG001
value
201
group Id
BG002
value
403
units
Participants
title
Global
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Black or African American
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
units
Participants
title
China
param Type
COUNT_OF_PARTICIPANTS
population Description
The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
title
Race (NIH/OMB)
unit Of Measure
Participants

population Description

The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension. Separate analyses were performed for the Global population and the China population in the study.

Complete source fields

denoms

counts
group Id
BG000
value
251
group Id
BG001
value
252
group Id
BG002
value
503
units
Participants

groups

description
All participants in the Global or China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
id
BG000
title
Placebo + Carboplatin + Etoposide - All
description
All participants in the Global or China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
id
BG001
title
Atezolizumab + Carboplatin + Etoposide - All
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.0
value
63.6
group Id
BG001
spread
8.8
value
63.8
group Id
BG002
spread
8.9
value
63.7
denoms
counts
group Id
BG000
value
202
group Id
BG001
value
201
group Id
BG002
value
403
units
Participants
title
Global
categories
measurements
group Id
BG000
spread
8.8
value
60.7
group Id
BG001
spread
9.0
value
59.7
group Id
BG002
spread
8.9
value
60.2
denoms
counts
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
units
Participants
title
China
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
70
group Id
BG001
value
72
group Id
BG002
value
142
title
Female
measurements
group Id
BG000
value
132
group Id
BG001
value
129
group Id
BG002
value
261
title
Male
denoms
counts
group Id
BG000
value
202
group Id
BG001
value
201
group Id
BG002
value
403
units
Participants
title
Global
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
11
group Id
BG002
value
23
title
Female
measurements
group Id
BG000
value
41
group Id
BG001
value
46
group Id
BG002
value
87
title
Male
denoms
counts
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
units
Participants
title
China
description
As reported from Electronic Case Report Form (eCRF).
param Type
COUNT_OF_PARTICIPANTS
population Description
The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
8
group Id
BG002
value
16
title
Hispanic or Latino
measurements
group Id
BG000
value
185
group Id
BG001
value
187
group Id
BG002
value
372
title
Not Hispanic or Latino
measurements
group Id
BG000
value
9
group Id
BG001
value
6
group Id
BG002
value
15
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
202
group Id
BG001
value
201
group Id
BG002
value
403
units
Participants
title
Global
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Hispanic or Latino
measurements
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
units
Participants
title
China
param Type
COUNT_OF_PARTICIPANTS
population Description
The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
36
group Id
BG001
value
33
group Id
BG002
value
69
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Black or African American
measurements
group Id
BG000
value
159
group Id
BG001
value
163
group Id
BG002
value
322
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
4
group Id
BG001
value
4
group Id
BG002
value
8
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
202
group Id
BG001
value
201
group Id
BG002
value
403
units
Participants
title
Global
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Black or African American
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
53
group Id
BG001
value
57
group Id
BG002
value
110
units
Participants
title
China
param Type
COUNT_OF_PARTICIPANTS
population Description
The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
title
Race (NIH/OMB)
unit Of Measure
Participants

population Description

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Preserved source evidence · Not medical advice