NCT02755597 · BASELINE

Baseline characteristics

A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy · Source last updated 2023-08-22

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

denoms

counts
group Id
BG000
value
194
group Id
BG001
value
97
group Id
BG002
value
291
units
Participants

groups

description
Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23
id
BG000
title
Venetoclax + Bortezomib and Dexamethasone
description
Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
id
BG001
title
Placebo + Bortezomib and Dexamethasone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.41
value
65.9
group Id
BG001
spread
7.81
value
65.9
group Id
BG002
spread
8.90
value
65.9
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
97
group Id
BG001
value
42
group Id
BG002
value
139
title
Female
measurements
group Id
BG000
value
97
group Id
BG001
value
55
group Id
BG002
value
152
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
7
group Id
BG002
value
32
title
Hispanic or Latino
measurements
group Id
BG000
value
169
group Id
BG001
value
90
group Id
BG002
value
259
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
calculate Pct
false
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
59
group Id
BG001
value
28
group Id
BG002
value
87
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
9
group Id
BG001
value
3
group Id
BG002
value
12
title
Black or African American
measurements
group Id
BG000
value
124
group Id
BG001
value
66
group Id
BG002
value
190
title
White
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
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
lower Limit
62.0
upper Limit
8356.0
value
1263.5
group Id
BG001
lower Limit
195.0
upper Limit
4906.0
value
1461.0
group Id
BG002
lower Limit
62.0
upper Limit
8356.0
value
1318.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Time since diagnosis
unit Of Measure
days
classes
categories
measurements
group Id
BG000
lower Limit
1.0
upper Limit
3.0
value
1.0
group Id
BG001
lower Limit
1.0
upper Limit
3.0
value
2.0
group Id
BG002
lower Limit
1.0
upper Limit
3.0
value
1.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Number of prior lines of therapy
unit Of Measure
number of prior lines of therapy
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
91
group Id
BG001
value
44
group Id
BG002
value
135
title
1 line
categories
measurements
group Id
BG000
value
103
group Id
BG001
value
53
group Id
BG002
value
156
title
2-3 lines
param Type
COUNT_OF_PARTICIPANTS
title
Number of prior lines of multiple myeloma therapy
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Refractory
categories
measurements
group Id
BG000
value
131
group Id
BG001
value
66
group Id
BG002
value
197
title
Sensitive
categories
measurements
group Id
BG000
value
61
group Id
BG001
value
28
group Id
BG002
value
89
title
Naïve
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
title
Unknown
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
MISSING
param Type
COUNT_OF_PARTICIPANTS
title
Prior exposure to proteasome inhibitors (PI)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
64
group Id
BG001
value
36
group Id
BG002
value
100
title
Refractory
categories
measurements
group Id
BG000
value
67
group Id
BG001
value
29
group Id
BG002
value
96
title
Sensitive
categories
measurements
group Id
BG000
value
63
group Id
BG001
value
30
group Id
BG002
value
93
title
Naïve
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Unknown
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
MISSING
param Type
COUNT_OF_PARTICIPANTS
title
Prior exposure to an immunomodulatory drug (IMID)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
title
Refractory
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Sensitive
categories
measurements
group Id
BG000
value
185
group Id
BG001
value
95
group Id
BG002
value
280
title
Naïve
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
MISSING
param Type
COUNT_OF_PARTICIPANTS
title
Prior exposure to an anti-CD38 monoclonal antibody
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
81
group Id
BG001
value
48
group Id
BG002
value
129
title
Stage I
categories
measurements
group Id
BG000
value
69
group Id
BG001
value
32
group Id
BG002
value
101
title
Stage II
categories
measurements
group Id
BG000
value
39
group Id
BG001
value
13
group Id
BG002
value
52
title
Stage III
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
Not evaluable
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
MISSING
description
The International Staging System for multiple myeloma: Stage I: Serum β2 microglobulin (Sβ2M), \< 3.5 mg/L; serum albumin ≥ 3.5 g/dL Stage II: Not ISS Stage I or III Stage III: Sβ2M \> 5.5 mg/L Stage I represents the mildest form of multiple myeloma (best prognosis) and Stage III the most severe form (worst prognosis).
param Type
COUNT_OF_PARTICIPANTS
title
Multiple myeloma International Staging System(ISS) stage
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
18
group Id
BG002
value
49
title
High
categories
measurements
group Id
BG000
value
141
group Id
BG001
value
72
group Id
BG002
value
213
title
Standard
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
4
group Id
BG002
value
13
title
Unknown
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
3
group Id
BG002
value
16
title
MISSING
description
A 4 mL bone marrow aspirate sample was collected for baseline assessment of chromosomal abnormalities, including t(11;14), t(4;14), t(14;16), del 17p, 5+, 9+, 15+
param Type
COUNT_OF_PARTICIPANTS
title
Chromosomal abnormality (CA) risk by fluorescent in situ hybridization (FISH)
unit Of Measure
Participants

population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization

Complete source fields

denoms

counts
group Id
BG000
value
194
group Id
BG001
value
97
group Id
BG002
value
291
units
Participants

groups

description
Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23
id
BG000
title
Venetoclax + Bortezomib and Dexamethasone
description
Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
id
BG001
title
Placebo + Bortezomib and Dexamethasone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.41
value
65.9
group Id
BG001
spread
7.81
value
65.9
group Id
BG002
spread
8.90
value
65.9
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
97
group Id
BG001
value
42
group Id
BG002
value
139
title
Female
measurements
group Id
BG000
value
97
group Id
BG001
value
55
group Id
BG002
value
152
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
7
group Id
BG002
value
32
title
Hispanic or Latino
measurements
group Id
BG000
value
169
group Id
BG001
value
90
group Id
BG002
value
259
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
calculate Pct
false
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
59
group Id
BG001
value
28
group Id
BG002
value
87
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
9
group Id
BG001
value
3
group Id
BG002
value
12
title
Black or African American
measurements
group Id
BG000
value
124
group Id
BG001
value
66
group Id
BG002
value
190
title
White
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
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
lower Limit
62.0
upper Limit
8356.0
value
1263.5
group Id
BG001
lower Limit
195.0
upper Limit
4906.0
value
1461.0
group Id
BG002
lower Limit
62.0
upper Limit
8356.0
value
1318.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Time since diagnosis
unit Of Measure
days
classes
categories
measurements
group Id
BG000
lower Limit
1.0
upper Limit
3.0
value
1.0
group Id
BG001
lower Limit
1.0
upper Limit
3.0
value
2.0
group Id
BG002
lower Limit
1.0
upper Limit
3.0
value
1.0
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Number of prior lines of therapy
unit Of Measure
number of prior lines of therapy
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
91
group Id
BG001
value
44
group Id
BG002
value
135
title
1 line
categories
measurements
group Id
BG000
value
103
group Id
BG001
value
53
group Id
BG002
value
156
title
2-3 lines
param Type
COUNT_OF_PARTICIPANTS
title
Number of prior lines of multiple myeloma therapy
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Refractory
categories
measurements
group Id
BG000
value
131
group Id
BG001
value
66
group Id
BG002
value
197
title
Sensitive
categories
measurements
group Id
BG000
value
61
group Id
BG001
value
28
group Id
BG002
value
89
title
Naïve
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
title
Unknown
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
MISSING
param Type
COUNT_OF_PARTICIPANTS
title
Prior exposure to proteasome inhibitors (PI)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
64
group Id
BG001
value
36
group Id
BG002
value
100
title
Refractory
categories
measurements
group Id
BG000
value
67
group Id
BG001
value
29
group Id
BG002
value
96
title
Sensitive
categories
measurements
group Id
BG000
value
63
group Id
BG001
value
30
group Id
BG002
value
93
title
Naïve
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Unknown
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
MISSING
param Type
COUNT_OF_PARTICIPANTS
title
Prior exposure to an immunomodulatory drug (IMID)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
title
Refractory
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Sensitive
categories
measurements
group Id
BG000
value
185
group Id
BG001
value
95
group Id
BG002
value
280
title
Naïve
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
MISSING
param Type
COUNT_OF_PARTICIPANTS
title
Prior exposure to an anti-CD38 monoclonal antibody
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
81
group Id
BG001
value
48
group Id
BG002
value
129
title
Stage I
categories
measurements
group Id
BG000
value
69
group Id
BG001
value
32
group Id
BG002
value
101
title
Stage II
categories
measurements
group Id
BG000
value
39
group Id
BG001
value
13
group Id
BG002
value
52
title
Stage III
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
title
Not evaluable
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
MISSING
description
The International Staging System for multiple myeloma: Stage I: Serum β2 microglobulin (Sβ2M), \< 3.5 mg/L; serum albumin ≥ 3.5 g/dL Stage II: Not ISS Stage I or III Stage III: Sβ2M \> 5.5 mg/L Stage I represents the mildest form of multiple myeloma (best prognosis) and Stage III the most severe form (worst prognosis).
param Type
COUNT_OF_PARTICIPANTS
title
Multiple myeloma International Staging System(ISS) stage
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
18
group Id
BG002
value
49
title
High
categories
measurements
group Id
BG000
value
141
group Id
BG001
value
72
group Id
BG002
value
213
title
Standard
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
4
group Id
BG002
value
13
title
Unknown
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
3
group Id
BG002
value
16
title
MISSING
description
A 4 mL bone marrow aspirate sample was collected for baseline assessment of chromosomal abnormalities, including t(11;14), t(4;14), t(14;16), del 17p, 5+, 9+, 15+
param Type
COUNT_OF_PARTICIPANTS
title
Chromosomal abnormality (CA) risk by fluorescent in situ hybridization (FISH)
unit Of Measure
Participants

population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization

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Preserved source evidence · Not medical advice