NCT01980888 · BASELINE

Baseline characteristics

Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia · Source last updated 2018-11-19

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

denoms

counts
group Id
BG000
value
157
group Id
BG001
value
154
group Id
BG002
value
311
units
Participants

groups

description
Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
id
BG000
title
Idelalisib+Bendamustine+Rituximab
description
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
id
BG001
title
Placebo+Bendamustine+Rituximab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.7
value
64
group Id
BG001
spread
10.0
value
63
group Id
BG002
spread
9.4
value
64
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
57
group Id
BG001
value
48
group Id
BG002
value
105
title
Female
measurements
group Id
BG000
value
100
group Id
BG001
value
106
group Id
BG002
value
206
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Asian
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Black or African American
categories
measurements
group Id
BG000
value
152
group Id
BG001
value
150
group Id
BG002
value
302
title
White
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Other
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Not Permitted
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
2
group Id
BG002
value
13
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
146
group Id
BG001
value
149
group Id
BG002
value
295
title
Not Hispanic or Latino
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
Not Permitted
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Romania
categories
measurements
group Id
BG000
value
24
group Id
BG001
value
21
group Id
BG002
value
45
title
Hungary
categories
measurements
group Id
BG000
value
35
group Id
BG001
value
25
group Id
BG002
value
60
title
United States
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
13
group Id
BG002
value
20
title
United Kingdom
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
15
group Id
BG002
value
34
title
Spain
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
8
group Id
BG002
value
19
title
Canada
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
17
group Id
BG002
value
27
title
Czech Republic
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Belgium
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
18
group Id
BG002
value
33
title
Poland
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
Italy
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
19
group Id
BG002
value
34
title
Australia
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
France
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
30
group Id
BG002
value
58
title
Stage I
categories
measurements
group Id
BG000
value
66
group Id
BG001
value
58
group Id
BG002
value
124
title
Stage II
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
32
group Id
BG002
value
57
title
Stage III
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
34
group Id
BG002
value
72
title
Stage IV
description
Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL) with higher stages reflecting increasing severity. Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis with lymphadenopathy, Rai Stage II: Lymphocytosis with hepatomegaly or splenomegaly, Rai Stage III: Lymphocytosis with anemia, Rai Stage IV: Lymphocytosis with thrombocytopenia.
param Type
COUNT_OF_PARTICIPANTS
title
Rai Stage at Screening
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
title
Mutated
categories
measurements
group Id
BG000
value
102
group Id
BG001
value
100
group Id
BG002
value
202
title
Unmutated
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Missing
description
The mutation status of the unique immunoglobulin gene (IgHV) rearrangement in the monoclonal proliferation of B-cells in CLL can be used to predict aggressiveness of the disease. Participants with a mutated IgHV gene usually have a less aggressive and more indolent disease, with longer overall survival. Participants with an unmutated IgHV gene usually have a more aggressive disease and shorter overall survival.
param Type
COUNT_OF_PARTICIPANTS
title
IgHV Mutation
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
146
group Id
BG001
value
145
group Id
BG002
value
291
title
Absent
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
9
group Id
BG002
value
19
title
Present
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Missing
description
Participants with CLL who have a 17p deletion lack a portion of the chromosome that acts to suppress cancer growth and is a recognized negative prognostic risk factor.
param Type
COUNT_OF_PARTICIPANTS
title
17p Deletion in CLL Cells
unit Of Measure
Participants

population Description

Intent-to-Treat (ITT) Analysis Set: who were randomized regardless of whether subjects received any study drug(s), or received a different regimen from the regimen to which they were randomized.

Complete source fields

denoms

counts
group Id
BG000
value
157
group Id
BG001
value
154
group Id
BG002
value
311
units
Participants

groups

description
Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
id
BG000
title
Idelalisib+Bendamustine+Rituximab
description
Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 6 total cycles) + rituximab intravenously (375 mg/m\^2 on Day 1 and 500 mg/m\^2 thereafter for at total of 6 infusions)
id
BG001
title
Placebo+Bendamustine+Rituximab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.7
value
64
group Id
BG001
spread
10.0
value
63
group Id
BG002
spread
9.4
value
64
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
57
group Id
BG001
value
48
group Id
BG002
value
105
title
Female
measurements
group Id
BG000
value
100
group Id
BG001
value
106
group Id
BG002
value
206
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Asian
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Black or African American
categories
measurements
group Id
BG000
value
152
group Id
BG001
value
150
group Id
BG002
value
302
title
White
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Other
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Not Permitted
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
2
group Id
BG002
value
13
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
146
group Id
BG001
value
149
group Id
BG002
value
295
title
Not Hispanic or Latino
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
Not Permitted
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Romania
categories
measurements
group Id
BG000
value
24
group Id
BG001
value
21
group Id
BG002
value
45
title
Hungary
categories
measurements
group Id
BG000
value
35
group Id
BG001
value
25
group Id
BG002
value
60
title
United States
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
13
group Id
BG002
value
20
title
United Kingdom
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
15
group Id
BG002
value
34
title
Spain
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
8
group Id
BG002
value
19
title
Canada
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
17
group Id
BG002
value
27
title
Czech Republic
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Belgium
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
18
group Id
BG002
value
33
title
Poland
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
Italy
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
19
group Id
BG002
value
34
title
Australia
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
France
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
30
group Id
BG002
value
58
title
Stage I
categories
measurements
group Id
BG000
value
66
group Id
BG001
value
58
group Id
BG002
value
124
title
Stage II
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
32
group Id
BG002
value
57
title
Stage III
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
34
group Id
BG002
value
72
title
Stage IV
description
Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL) with higher stages reflecting increasing severity. Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis with lymphadenopathy, Rai Stage II: Lymphocytosis with hepatomegaly or splenomegaly, Rai Stage III: Lymphocytosis with anemia, Rai Stage IV: Lymphocytosis with thrombocytopenia.
param Type
COUNT_OF_PARTICIPANTS
title
Rai Stage at Screening
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
title
Mutated
categories
measurements
group Id
BG000
value
102
group Id
BG001
value
100
group Id
BG002
value
202
title
Unmutated
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Missing
description
The mutation status of the unique immunoglobulin gene (IgHV) rearrangement in the monoclonal proliferation of B-cells in CLL can be used to predict aggressiveness of the disease. Participants with a mutated IgHV gene usually have a less aggressive and more indolent disease, with longer overall survival. Participants with an unmutated IgHV gene usually have a more aggressive disease and shorter overall survival.
param Type
COUNT_OF_PARTICIPANTS
title
IgHV Mutation
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
146
group Id
BG001
value
145
group Id
BG002
value
291
title
Absent
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
9
group Id
BG002
value
19
title
Present
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Missing
description
Participants with CLL who have a 17p deletion lack a portion of the chromosome that acts to suppress cancer growth and is a recognized negative prognostic risk factor.
param Type
COUNT_OF_PARTICIPANTS
title
17p Deletion in CLL Cells
unit Of Measure
Participants

population Description

Intent-to-Treat (ITT) Analysis Set: who were randomized regardless of whether subjects received any study drug(s), or received a different regimen from the regimen to which they were randomized.

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Preserved source evidence · Not medical advice