NCT01539512 · BASELINE

Baseline characteristics

A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) · Source last updated 2019-05-14

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

denoms

counts
group Id
BG000
value
110
group Id
BG001
value
110
group Id
BG002
value
220
units
Participants

groups

description
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
id
BG000
title
Idelalisib + Rituximab
description
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
id
BG001
title
Placebo + Rituximab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
7.7
value
71
group Id
BG001
spread
8.1
value
70
group Id
BG002
spread
7.9
value
71
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
27
group Id
BG002
value
48
title
< 65 years
categories
measurements
group Id
BG000
value
89
group Id
BG001
value
83
group Id
BG002
value
172
title
≥ 65 years
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
34
group Id
BG001
value
42
group Id
BG002
value
76
title
Female
measurements
group Id
BG000
value
76
group Id
BG001
value
68
group Id
BG002
value
144
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
101
group Id
BG001
value
102
group Id
BG002
value
203
title
Not Hispanic or Latino
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
title
Not Permitted
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
100
group Id
BG001
value
98
group Id
BG002
value
198
title
White
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Black or African American
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Other
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
7
group Id
BG002
value
12
title
Not Permitted
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
France
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
12
title
Germany
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
Italy
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
14
group Id
BG002
value
32
title
United Kingdom
categories
measurements
group Id
BG000
value
80
group Id
BG001
value
83
group Id
BG002
value
163
title
United States
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
40
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
50
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
5
group Id
BG002
value
11
title
60
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
13
group Id
BG002
value
33
title
70
categories
measurements
group Id
BG000
value
42
group Id
BG001
value
46
group Id
BG002
value
88
title
80
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
28
group Id
BG002
value
51
title
90
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
13
group Id
BG002
value
28
title
100
description
Classifies patients according to their functional impairment. Scores range from 0-100; the lower the score, the worse the survival for most serious illnesses.
param Type
NUMBER
title
Karnofsky Performance Status
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
62.28
value
108.3
group Id
BG001
spread
52.73
value
106.4
group Id
BG002
spread
57.58
value
107.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Time Since Diagnosis
unit Of Measure
months
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Rai Stage 0
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
19
group Id
BG002
value
37
title
Rai Stage 1
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
10
group Id
BG002
value
26
title
Rai Stage 2
categories
measurements
group Id
BG000
value
22
group Id
BG001
value
18
group Id
BG002
value
40
title
Rai Stage 3
categories
measurements
group Id
BG000
value
48
group Id
BG001
value
54
group Id
BG002
value
102
title
Rai Stage 4
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
8
group Id
BG002
value
14
title
Missing
description
Rai staging categorizes the disease progression of chronic lymphocytic leukemia (CLL), with classifications of low- (Stage 0), intermediate- (Stage 1 and 2), and high-risk (Stages 3 and 4) categories. Rai Stage 0: high number of lymphocytes in the blood (lymphocytosis) only. Rai Stage 1: lymphocytosis with enlarged lymphoid tissues (lymphadenopathy). Rai Stage 2: lymphocytosis with enlarged liver (hepatomegaly) or spleen (splenomegaly). Rai Stage 3: lymphocytosis with low red blood cell count (anemia). Rai Stage 4: lymphocytosis with low number of blood platelets (thrombocytopenia).
param Type
NUMBER
title
Rai Stage at Screening
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
4
group Id
BG002
value
11
title
Binet Stage A
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
32
group Id
BG002
value
61
title
Binet Stage B
categories
measurements
group Id
BG000
value
63
group Id
BG001
value
60
group Id
BG002
value
123
title
Binet Stage C
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
25
title
Missing
description
Binet staging classifies CLL according to the number of lymphoid tissues involved, as well as the presence of anemia or thrombocytopenia. Stage A: fewer than three areas of enlarged lymphoid tissue; enlarged lymph nodes of the neck, underarms, and groin, as well as the spleen, are each considered "one group" whether unilateral (one-sided) or bilateral (on both sides). Binet Stage B: more than three areas of enlarged lymphoid tissue. Binet Stage C: anemia plus thrombocytopenia.
param Type
NUMBER
title
Binet Stage at Screening
unit Of Measure
participants

population Description

ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.

Complete source fields

denoms

counts
group Id
BG000
value
110
group Id
BG001
value
110
group Id
BG002
value
220
units
Participants

groups

description
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
id
BG000
title
Idelalisib + Rituximab
description
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
id
BG001
title
Placebo + Rituximab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
7.7
value
71
group Id
BG001
spread
8.1
value
70
group Id
BG002
spread
7.9
value
71
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
27
group Id
BG002
value
48
title
< 65 years
categories
measurements
group Id
BG000
value
89
group Id
BG001
value
83
group Id
BG002
value
172
title
≥ 65 years
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
34
group Id
BG001
value
42
group Id
BG002
value
76
title
Female
measurements
group Id
BG000
value
76
group Id
BG001
value
68
group Id
BG002
value
144
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
101
group Id
BG001
value
102
group Id
BG002
value
203
title
Not Hispanic or Latino
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
title
Not Permitted
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
100
group Id
BG001
value
98
group Id
BG002
value
198
title
White
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Black or African American
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Other
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
7
group Id
BG002
value
12
title
Not Permitted
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
France
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
12
title
Germany
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
Italy
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
14
group Id
BG002
value
32
title
United Kingdom
categories
measurements
group Id
BG000
value
80
group Id
BG001
value
83
group Id
BG002
value
163
title
United States
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
40
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
50
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
5
group Id
BG002
value
11
title
60
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
13
group Id
BG002
value
33
title
70
categories
measurements
group Id
BG000
value
42
group Id
BG001
value
46
group Id
BG002
value
88
title
80
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
28
group Id
BG002
value
51
title
90
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
13
group Id
BG002
value
28
title
100
description
Classifies patients according to their functional impairment. Scores range from 0-100; the lower the score, the worse the survival for most serious illnesses.
param Type
NUMBER
title
Karnofsky Performance Status
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
62.28
value
108.3
group Id
BG001
spread
52.73
value
106.4
group Id
BG002
spread
57.58
value
107.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Time Since Diagnosis
unit Of Measure
months
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Rai Stage 0
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
19
group Id
BG002
value
37
title
Rai Stage 1
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
10
group Id
BG002
value
26
title
Rai Stage 2
categories
measurements
group Id
BG000
value
22
group Id
BG001
value
18
group Id
BG002
value
40
title
Rai Stage 3
categories
measurements
group Id
BG000
value
48
group Id
BG001
value
54
group Id
BG002
value
102
title
Rai Stage 4
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
8
group Id
BG002
value
14
title
Missing
description
Rai staging categorizes the disease progression of chronic lymphocytic leukemia (CLL), with classifications of low- (Stage 0), intermediate- (Stage 1 and 2), and high-risk (Stages 3 and 4) categories. Rai Stage 0: high number of lymphocytes in the blood (lymphocytosis) only. Rai Stage 1: lymphocytosis with enlarged lymphoid tissues (lymphadenopathy). Rai Stage 2: lymphocytosis with enlarged liver (hepatomegaly) or spleen (splenomegaly). Rai Stage 3: lymphocytosis with low red blood cell count (anemia). Rai Stage 4: lymphocytosis with low number of blood platelets (thrombocytopenia).
param Type
NUMBER
title
Rai Stage at Screening
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
4
group Id
BG002
value
11
title
Binet Stage A
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
32
group Id
BG002
value
61
title
Binet Stage B
categories
measurements
group Id
BG000
value
63
group Id
BG001
value
60
group Id
BG002
value
123
title
Binet Stage C
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
25
title
Missing
description
Binet staging classifies CLL according to the number of lymphoid tissues involved, as well as the presence of anemia or thrombocytopenia. Stage A: fewer than three areas of enlarged lymphoid tissue; enlarged lymph nodes of the neck, underarms, and groin, as well as the spleen, are each considered "one group" whether unilateral (one-sided) or bilateral (on both sides). Binet Stage B: more than three areas of enlarged lymphoid tissue. Binet Stage C: anemia plus thrombocytopenia.
param Type
NUMBER
title
Binet Stage at Screening
unit Of Measure
participants

population Description

ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.

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Preserved source evidence · Not medical advice