NCT02264574 · BASELINE

Baseline characteristics

A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) · Source last updated 2020-09-21

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

denoms

counts
group Id
BG000
value
113
group Id
BG001
value
116
group Id
BG002
value
229
units
Participants

groups

description
Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.
id
BG000
title
IBR+OB
description
Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.
id
BG001
title
CLB+OB
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
22
group Id
BG001
value
24
group Id
BG002
value
46
title
Between 18 and 65 years
measurements
group Id
BG000
value
91
group Id
BG001
value
92
group Id
BG002
value
183
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
47
upper Limit
87
value
70.0
group Id
BG001
lower Limit
40
upper Limit
86
value
72.0
group Id
BG002
lower Limit
40
upper Limit
87
value
71.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
46
group Id
BG001
value
37
group Id
BG002
value
83
title
Female
measurements
group Id
BG000
value
67
group Id
BG001
value
79
group Id
BG002
value
146
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
6
group Id
BG002
value
10
title
Hispanic or Latino
measurements
group Id
BG000
value
109
group Id
BG001
value
110
group Id
BG002
value
219
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
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
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
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Black or African American
measurements
group Id
BG000
value
109
group Id
BG001
value
111
group Id
BG002
value
220
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
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
11
group Id
BG002
value
24
title
United States
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
6
group Id
BG002
value
14
title
Czechia
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
United Kingdom
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
26
title
Spain
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
9
group Id
BG002
value
20
title
Russia
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
9
group Id
BG002
value
9
title
New Zealand
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
5
group Id
BG002
value
8
title
Canada
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
title
Austria
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
3
group Id
BG002
value
11
title
Sweden
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
13
group Id
BG002
value
28
title
Turkey
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Belgium
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Poland
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
113
group Id
BG001
value
116
group Id
BG002
value
229
units
Participants

groups

description
Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.
id
BG000
title
IBR+OB
description
Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.
id
BG001
title
CLB+OB
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
22
group Id
BG001
value
24
group Id
BG002
value
46
title
Between 18 and 65 years
measurements
group Id
BG000
value
91
group Id
BG001
value
92
group Id
BG002
value
183
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
47
upper Limit
87
value
70.0
group Id
BG001
lower Limit
40
upper Limit
86
value
72.0
group Id
BG002
lower Limit
40
upper Limit
87
value
71.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
46
group Id
BG001
value
37
group Id
BG002
value
83
title
Female
measurements
group Id
BG000
value
67
group Id
BG001
value
79
group Id
BG002
value
146
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
6
group Id
BG002
value
10
title
Hispanic or Latino
measurements
group Id
BG000
value
109
group Id
BG001
value
110
group Id
BG002
value
219
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
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
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
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Black or African American
measurements
group Id
BG000
value
109
group Id
BG001
value
111
group Id
BG002
value
220
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
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
11
group Id
BG002
value
24
title
United States
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
6
group Id
BG002
value
14
title
Czechia
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
United Kingdom
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
9
group Id
BG002
value
26
title
Spain
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
9
group Id
BG002
value
20
title
Russia
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
9
group Id
BG002
value
9
title
New Zealand
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
5
group Id
BG002
value
8
title
Canada
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
title
Austria
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
3
group Id
BG002
value
11
title
Sweden
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
13
group Id
BG002
value
28
title
Turkey
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Belgium
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Poland
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

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

Preserved source evidence · Not medical advice