NCT02475681 · BASELINE

Baseline characteristics

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL · Source last updated 2026-08-25

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

denoms

counts
group Id
BG000
value
177
group Id
BG001
value
179
group Id
BG002
value
179
group Id
BG003
value
535
units
Participants

groups

description
Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 1 Day 1. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. Obinutuzumab Chlorambucil
id
BG000
title
Obinutuzumab in Combination With Chlorambucil
description
Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 2 Day 1. Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity. Acalabrutinib Obinutuzumab
id
BG001
title
Acalabrutinib in Combination With Obinutuzumab
description
Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
id
BG002
title
Acalabrutinib Monotherapy
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
<=18 years
measurements
group Id
BG000
value
24
group Id
BG001
value
35
group Id
BG002
value
28
group Id
BG003
value
87
title
Between 18 and 65 years
measurements
group Id
BG000
value
153
group Id
BG001
value
144
group Id
BG002
value
151
group Id
BG003
value
448
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
71
group Id
BG001
value
68
group Id
BG002
value
68
group Id
BG003
value
207
title
Female
measurements
group Id
BG000
value
106
group Id
BG001
value
111
group Id
BG002
value
111
group Id
BG003
value
328
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
2
group Id
BG002
value
11
group Id
BG003
value
24
title
Hispanic or Latino
measurements
group Id
BG000
value
156
group Id
BG001
value
169
group Id
BG002
value
156
group Id
BG003
value
481
title
Not Hispanic or Latino
measurements
group Id
BG000
value
10
group Id
BG001
value
8
group Id
BG002
value
12
group Id
BG003
value
30
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
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
0
group Id
BG003
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
0
group Id
BG003
value
3
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
4
group Id
BG003
value
13
title
Black or African American
measurements
group Id
BG000
value
165
group Id
BG001
value
164
group Id
BG002
value
170
group Id
BG003
value
499
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
More than one race
measurements
group Id
BG000
value
6
group Id
BG001
value
7
group Id
BG002
value
5
group Id
BG003
value
18
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
3
group Id
BG003
value
13
title
Belgium
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
1
group Id
BG003
value
7
title
France
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
3
group Id
BG003
value
7
title
Germany
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
9
group Id
BG002
value
5
group Id
BG003
value
25
title
Italy
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
3
group Id
BG002
value
3
group Id
BG003
value
13
title
Spain
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
3
group Id
BG003
value
7
title
Sweden
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
16
group Id
BG002
value
17
group Id
BG003
value
45
title
United Kingdom
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
5
group Id
BG003
value
14
title
Brazil
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
3
group Id
BG003
value
5
title
Chile
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Colombia
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
8
group Id
BG002
value
7
group Id
BG003
value
22
title
Canada
categories
measurements
group Id
BG000
value
54
group Id
BG001
value
56
group Id
BG002
value
63
group Id
BG003
value
173
title
United States
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
21
group Id
BG002
value
19
group Id
BG003
value
57
title
Yes
measurements
group Id
BG000
value
160
group Id
BG001
value
158
group Id
BG002
value
160
group Id
BG003
value
478
title
No
param Type
COUNT_OF_PARTICIPANTS
title
IXRS Randomization Stratification Factor: Presence of 17p Deletion
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
168
group Id
BG001
value
169
group Id
BG002
value
167
group Id
BG003
value
504
title
0-1 (0=Fully Active; 1 =Restricted in Physically Strenuous Activity)
measurements
group Id
BG000
value
9
group Id
BG001
value
10
group Id
BG002
value
12
group Id
BG003
value
31
title
2 (2=Ambulatory and capable of all selfcare but unable to carry out any work activities)
description
Lower Grade is Better. 0=Fully active; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities;
param Type
COUNT_OF_PARTICIPANTS
title
IXRS Randomization Stratification Factor: ECOG Performance Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
103
group Id
BG001
value
104
group Id
BG002
value
105
group Id
BG003
value
312
title
North America and West Europe
measurements
group Id
BG000
value
74
group Id
BG001
value
75
group Id
BG002
value
74
group Id
BG003
value
223
title
Other
param Type
COUNT_OF_PARTICIPANTS
title
IXRS Randomization Stratification Factor: Geographic Region
unit Of Measure
Participants

population Description

Analysis was performed on intent-to-treat (ITT) population, which included all randomized participants grouped according to assigned treatment.

Complete source fields

denoms

counts
group Id
BG000
value
177
group Id
BG001
value
179
group Id
BG002
value
179
group Id
BG003
value
535
units
Participants

groups

description
Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 1 Day 1. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. Obinutuzumab Chlorambucil
id
BG000
title
Obinutuzumab in Combination With Chlorambucil
description
Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 2 Day 1. Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity. Acalabrutinib Obinutuzumab
id
BG001
title
Acalabrutinib in Combination With Obinutuzumab
description
Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
id
BG002
title
Acalabrutinib Monotherapy
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
<=18 years
measurements
group Id
BG000
value
24
group Id
BG001
value
35
group Id
BG002
value
28
group Id
BG003
value
87
title
Between 18 and 65 years
measurements
group Id
BG000
value
153
group Id
BG001
value
144
group Id
BG002
value
151
group Id
BG003
value
448
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
71
group Id
BG001
value
68
group Id
BG002
value
68
group Id
BG003
value
207
title
Female
measurements
group Id
BG000
value
106
group Id
BG001
value
111
group Id
BG002
value
111
group Id
BG003
value
328
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
2
group Id
BG002
value
11
group Id
BG003
value
24
title
Hispanic or Latino
measurements
group Id
BG000
value
156
group Id
BG001
value
169
group Id
BG002
value
156
group Id
BG003
value
481
title
Not Hispanic or Latino
measurements
group Id
BG000
value
10
group Id
BG001
value
8
group Id
BG002
value
12
group Id
BG003
value
30
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
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
0
group Id
BG003
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
0
group Id
BG003
value
3
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
4
group Id
BG003
value
13
title
Black or African American
measurements
group Id
BG000
value
165
group Id
BG001
value
164
group Id
BG002
value
170
group Id
BG003
value
499
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
More than one race
measurements
group Id
BG000
value
6
group Id
BG001
value
7
group Id
BG002
value
5
group Id
BG003
value
18
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
3
group Id
BG003
value
13
title
Belgium
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
1
group Id
BG003
value
7
title
France
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
3
group Id
BG003
value
7
title
Germany
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
9
group Id
BG002
value
5
group Id
BG003
value
25
title
Italy
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
3
group Id
BG002
value
3
group Id
BG003
value
13
title
Spain
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
3
group Id
BG003
value
7
title
Sweden
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
16
group Id
BG002
value
17
group Id
BG003
value
45
title
United Kingdom
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
5
group Id
BG003
value
14
title
Brazil
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
3
group Id
BG003
value
5
title
Chile
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Colombia
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
8
group Id
BG002
value
7
group Id
BG003
value
22
title
Canada
categories
measurements
group Id
BG000
value
54
group Id
BG001
value
56
group Id
BG002
value
63
group Id
BG003
value
173
title
United States
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
21
group Id
BG002
value
19
group Id
BG003
value
57
title
Yes
measurements
group Id
BG000
value
160
group Id
BG001
value
158
group Id
BG002
value
160
group Id
BG003
value
478
title
No
param Type
COUNT_OF_PARTICIPANTS
title
IXRS Randomization Stratification Factor: Presence of 17p Deletion
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
168
group Id
BG001
value
169
group Id
BG002
value
167
group Id
BG003
value
504
title
0-1 (0=Fully Active; 1 =Restricted in Physically Strenuous Activity)
measurements
group Id
BG000
value
9
group Id
BG001
value
10
group Id
BG002
value
12
group Id
BG003
value
31
title
2 (2=Ambulatory and capable of all selfcare but unable to carry out any work activities)
description
Lower Grade is Better. 0=Fully active; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities;
param Type
COUNT_OF_PARTICIPANTS
title
IXRS Randomization Stratification Factor: ECOG Performance Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
103
group Id
BG001
value
104
group Id
BG002
value
105
group Id
BG003
value
312
title
North America and West Europe
measurements
group Id
BG000
value
74
group Id
BG001
value
75
group Id
BG002
value
74
group Id
BG003
value
223
title
Other
param Type
COUNT_OF_PARTICIPANTS
title
IXRS Randomization Stratification Factor: Geographic Region
unit Of Measure
Participants

population Description

Analysis was performed on intent-to-treat (ITT) population, which included all randomized participants grouped according to assigned treatment.

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Preserved source evidence · Not medical advice