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NCT02755597 · OUTCOME

Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain

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.

Measure: MEAN
Unit: units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

What was measured

The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement.

Analysis population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit

Groups in this outcome

Venetoclax + Bortezomib and Dexamethasone

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

Placebo + Bortezomib and Dexamethasone

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	184
Placebo + Bortezomib and Dexamethasone	92

Reported measurements

Cycle 3, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	162
Placebo + Bortezomib and Dexamethasone	79

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.6	2.59	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.5	2.46	Not reported	Not reported	Not reported

Cycle 5, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	140
Placebo + Bortezomib and Dexamethasone	70

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.0	2.65	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.2	3.15	Not reported	Not reported	Not reported

Cycle 7, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	126
Placebo + Bortezomib and Dexamethasone	70

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.1	2.56	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.2	2.98	Not reported	Not reported	Not reported

Cycle 9, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	113
Placebo + Bortezomib and Dexamethasone	65

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.2	3.11	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.0	2.88	Not reported	Not reported	Not reported

Cycle 11, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	98
Placebo + Bortezomib and Dexamethasone	55

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.4	2.57	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.1	3.45	Not reported	Not reported	Not reported

Cycle 13, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	82
Placebo + Bortezomib and Dexamethasone	43

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.2	2.71	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.1	3.22	Not reported	Not reported	Not reported

Cycle 15, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	76
Placebo + Bortezomib and Dexamethasone	31

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.2	2.92	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.0	3.08	Not reported	Not reported	Not reported

Cycle 17, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	66
Placebo + Bortezomib and Dexamethasone	27

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.3	2.54	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.1	2.06	Not reported	Not reported	Not reported

Cycle 19, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	67
Placebo + Bortezomib and Dexamethasone	22

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.1	2.59	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.2	1.95	Not reported	Not reported	Not reported

Cycle 21, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	59
Placebo + Bortezomib and Dexamethasone	18

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.1	2.39	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.3	2.89	Not reported	Not reported	Not reported

Cycle 23, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	55
Placebo + Bortezomib and Dexamethasone	17

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.0	3.20	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.2	2.61	Not reported	Not reported	Not reported

Cycle 25, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	47
Placebo + Bortezomib and Dexamethasone	13

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.4	2.65	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.2	3.00	Not reported	Not reported	Not reported

Cycle 27, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	37
Placebo + Bortezomib and Dexamethasone	14

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.2	2.53	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.1	1.92	Not reported	Not reported	Not reported

Cycle 29, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	40
Placebo + Bortezomib and Dexamethasone	15

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.2	2.83	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.3	2.15	Not reported	Not reported	Not reported

Cycle 31, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	39
Placebo + Bortezomib and Dexamethasone	9

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.0	3.11	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.6	1.33	Not reported	Not reported	Not reported

Cycle 33, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	37
Placebo + Bortezomib and Dexamethasone	7

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.2	2.88	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.4	1.40	Not reported	Not reported	Not reported

Cycle 35, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	34
Placebo + Bortezomib and Dexamethasone	6

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.1	2.77	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.2	1.33	Not reported	Not reported	Not reported

Cycle 37, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	31
Placebo + Bortezomib and Dexamethasone	4

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.4	2.78	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	1.5	2.65	Not reported	Not reported	Not reported

Cycle 39, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	26
Placebo + Bortezomib and Dexamethasone	3

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.1	2.70	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	-0.3	1.15	Not reported	Not reported	Not reported

Cycle 41, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	21
Placebo + Bortezomib and Dexamethasone	3

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.1	3.00	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.3	1.15	Not reported	Not reported	Not reported

Cycle 43, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	17
Placebo + Bortezomib and Dexamethasone	2

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.1	3.07	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.5	0.71	Not reported	Not reported	Not reported

Cycle 45, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	9
Placebo + Bortezomib and Dexamethasone	2

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-0.7	3.64	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	1.0	0.00	Not reported	Not reported	Not reported

Cycle 47, Day 1

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	4
Placebo + Bortezomib and Dexamethasone	1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	-2.8	3.77	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	1.0	Not reported	Not reported	Not reported	Not reported

Final visit

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	175
Placebo + Bortezomib and Dexamethasone	87

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	0.3	3.28	Not reported	Not reported	Not reported
Placebo + Bortezomib and Dexamethasone	0.4	3.55	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
2.59
value
-0.6
group Id
OG001
spread
2.46
value
-0.5
denoms
counts
group Id
OG000
value
162
group Id
OG001
value
79
units
Participants
title
Cycle 3, Day 1
categories
measurements
group Id
OG000
spread
2.65
value
0.0
group Id
OG001
spread
3.15
value
-0.2
denoms
counts
group Id
OG000
value
140
group Id
OG001
value
70
units
Participants
title
Cycle 5, Day 1
categories
measurements
group Id
OG000
spread
2.56
value
-0.1
group Id
OG001
spread
2.98
value
0.2
denoms
counts
group Id
OG000
value
126
group Id
OG001
value
70
units
Participants
title
Cycle 7, Day 1
categories
measurements
group Id
OG000
spread
3.11
value
-0.2
group Id
OG001
spread
2.88
value
0.0
denoms
counts
group Id
OG000
value
113
group Id
OG001
value
65
units
Participants
title
Cycle 9, Day 1
categories
measurements
group Id
OG000
spread
2.57
value
-0.4
group Id
OG001
spread
3.45
value
0.1
denoms
counts
group Id
OG000
value
98
group Id
OG001
value
55
units
Participants
title
Cycle 11, Day 1
categories
measurements
group Id
OG000
spread
2.71
value
-0.2
group Id
OG001
spread
3.22
value
-0.1
denoms
counts
group Id
OG000
value
82
group Id
OG001
value
43
units
Participants
title
Cycle 13, Day 1
categories
measurements
group Id
OG000
spread
2.92
value
-0.2
group Id
OG001
spread
3.08
value
-0.0
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
31
units
Participants
title
Cycle 15, Day 1
categories
measurements
group Id
OG000
spread
2.54
value
-0.3
group Id
OG001
spread
2.06
value
-0.1
denoms
counts
group Id
OG000
value
66
group Id
OG001
value
27
units
Participants
title
Cycle 17, Day 1
categories
measurements
group Id
OG000
spread
2.59
value
-0.1
group Id
OG001
spread
1.95
value
-0.2
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Cycle 19, Day 1
categories
measurements
group Id
OG000
spread
2.39
value
-0.1
group Id
OG001
spread
2.89
value
-0.3
denoms
counts
group Id
OG000
value
59
group Id
OG001
value
18
units
Participants
title
Cycle 21, Day 1
categories
measurements
group Id
OG000
spread
3.20
value
-0.0
group Id
OG001
spread
2.61
value
-0.2
denoms
counts
group Id
OG000
value
55
group Id
OG001
value
17
units
Participants
title
Cycle 23, Day 1
categories
measurements
group Id
OG000
spread
2.65
value
0.4
group Id
OG001
spread
3.00
value
0.2
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
13
units
Participants
title
Cycle 25, Day 1

denoms

counts
group Id
OG000
value
184
group Id
OG001
value
92
units
Participants

description

The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement.

dispersion Type

Standard Deviation

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
OG000
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
OG001
title
Placebo + Bortezomib and Dexamethasone

param Type

MEAN

population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit

reporting Status

POSTED

time Frame

Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

title

Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice