NCT01732913 · BASELINE

Baseline characteristics

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas · Source last updated 2018-11-16

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

denoms

counts
group Id
BG000
value
198
group Id
BG001
value
97
group Id
BG002
value
295
units
Participants

groups

description
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
id
BG000
title
Idelalisib + Rituximab
description
Placebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
id
BG001
title
Placebo + Rituximab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
11.4
value
64
group Id
BG001
spread
11.4
value
67
group Id
BG002
spread
11.4
value
65
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
99
group Id
BG001
value
48
group Id
BG002
value
147
title
Female
measurements
group Id
BG000
value
99
group Id
BG001
value
49
group Id
BG002
value
148
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
35
group Id
BG001
value
17
group Id
BG002
value
52
title
Asian
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Black or African American
categories
measurements
group Id
BG000
value
123
group Id
BG001
value
54
group Id
BG002
value
177
title
White
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Other
categories
measurements
group Id
BG000
value
32
group Id
BG001
value
19
group Id
BG002
value
51
title
Not Permitted
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
3
group Id
BG002
value
15
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
150
group Id
BG001
value
75
group Id
BG002
value
225
title
Not Hispanic or Latino
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
19
group Id
BG002
value
55
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
2
group Id
BG002
value
9
title
Russian Federation
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Singapore
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Romania
categories
measurements
group Id
BG000
value
24
group Id
BG001
value
6
group Id
BG002
value
30
title
Hungary
categories
measurements
group Id
BG000
value
65
group Id
BG001
value
34
group Id
BG002
value
99
title
United States
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
9
group Id
BG002
value
32
title
Japan
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
United Kingdom
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Portugal
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
0
group Id
BG002
value
6
title
Spain
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
title
Czech Republic
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
2
group Id
BG002
value
8
title
Sweden
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Taiwan
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

population Description

Intent-to-Treat (ITT) Analysis Set: all participants who were randomized regardless of whether they received any study treatment

Complete source fields

denoms

counts
group Id
BG000
value
198
group Id
BG001
value
97
group Id
BG002
value
295
units
Participants

groups

description
Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
id
BG000
title
Idelalisib + Rituximab
description
Placebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
id
BG001
title
Placebo + Rituximab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
11.4
value
64
group Id
BG001
spread
11.4
value
67
group Id
BG002
spread
11.4
value
65
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
99
group Id
BG001
value
48
group Id
BG002
value
147
title
Female
measurements
group Id
BG000
value
99
group Id
BG001
value
49
group Id
BG002
value
148
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
35
group Id
BG001
value
17
group Id
BG002
value
52
title
Asian
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Black or African American
categories
measurements
group Id
BG000
value
123
group Id
BG001
value
54
group Id
BG002
value
177
title
White
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Other
categories
measurements
group Id
BG000
value
32
group Id
BG001
value
19
group Id
BG002
value
51
title
Not Permitted
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
3
group Id
BG002
value
15
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
150
group Id
BG001
value
75
group Id
BG002
value
225
title
Not Hispanic or Latino
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
19
group Id
BG002
value
55
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
2
group Id
BG002
value
9
title
Russian Federation
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Singapore
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Romania
categories
measurements
group Id
BG000
value
24
group Id
BG001
value
6
group Id
BG002
value
30
title
Hungary
categories
measurements
group Id
BG000
value
65
group Id
BG001
value
34
group Id
BG002
value
99
title
United States
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
9
group Id
BG002
value
32
title
Japan
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
United Kingdom
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Portugal
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
0
group Id
BG002
value
6
title
Spain
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
title
Czech Republic
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
2
group Id
BG002
value
8
title
Sweden
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Taiwan
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

population Description

Intent-to-Treat (ITT) Analysis Set: all participants who were randomized regardless of whether they received any study treatment

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Preserved source evidence · Not medical advice