Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-04-10
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, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
What was measured
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement.
Analysis population: Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit
Groups in this outcome
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
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
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
16
Reported measurements
Cycle 3, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
16
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
-5.2
25.44
Not reported
Not reported
Not reported
Cycle 5, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
10
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
6.7
5.27
Not reported
Not reported
Not reported
Cycle 7, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
8
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
3.1
7.63
Not reported
Not reported
Not reported
Cycle 9, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
8
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
8.3
11.79
Not reported
Not reported
Not reported
Cycle 11, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
7
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
0.0
11.79
Not reported
Not reported
Not reported
Cycle 13, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
7
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
-6.0
6.30
Not reported
Not reported
Not reported
Cycle 15, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
7
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
4.8
8.13
Not reported
Not reported
Not reported
Cycle 17, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
6
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
-1.4
12.27
Not reported
Not reported
Not reported
Cycle 19, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
3
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
-19.4
4.81
Not reported
Not reported
Not reported
Cycle 21, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
2
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
-33.3
23.57
Not reported
Not reported
Not reported
Cycle 23, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
2
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
-8.3
0.00
Not reported
Not reported
Not reported
Cycle 25, Day 1
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
1
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
-8.3
Not reported
Not reported
Not reported
Not reported
Final visit
Analysis denominator · Participants
Group
Source count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
16
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
-11.5
23.55
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
25.44
value
-5.2
denoms
counts
group Id
OG000
value
16
units
Participants
title
Cycle 3, Day 1
categories
measurements
group Id
OG000
spread
5.27
value
6.7
denoms
counts
group Id
OG000
value
10
units
Participants
title
Cycle 5, Day 1
categories
measurements
group Id
OG000
spread
7.63
value
3.1
denoms
counts
group Id
OG000
value
8
units
Participants
title
Cycle 7, Day 1
categories
measurements
group Id
OG000
spread
11.79
value
8.3
denoms
counts
group Id
OG000
value
8
units
Participants
title
Cycle 9, Day 1
categories
measurements
group Id
OG000
spread
11.79
value
0.0
denoms
counts
group Id
OG000
value
7
units
Participants
title
Cycle 11, Day 1
categories
measurements
group Id
OG000
spread
6.30
value
-6.0
denoms
counts
group Id
OG000
value
7
units
Participants
title
Cycle 13, Day 1
categories
measurements
group Id
OG000
spread
8.13
value
4.8
denoms
counts
group Id
OG000
value
7
units
Participants
title
Cycle 15, Day 1
categories
measurements
group Id
OG000
spread
12.27
value
-1.4
denoms
counts
group Id
OG000
value
6
units
Participants
title
Cycle 17, Day 1
categories
measurements
group Id
OG000
spread
4.81
value
-19.4
denoms
counts
group Id
OG000
value
3
units
Participants
title
Cycle 19, Day 1
categories
measurements
group Id
OG000
spread
23.57
value
-33.3
denoms
counts
group Id
OG000
value
2
units
Participants
title
Cycle 21, Day 1
categories
measurements
group Id
OG000
spread
0.00
value
-8.3
denoms
counts
group Id
OG000
value
2
units
Participants
title
Cycle 23, Day 1
categories
measurements
group Id
OG000
value
-8.3
denoms
counts
group Id
OG000
value
1
units
Participants
title
Cycle 25, Day 1
denoms
counts
group Id
OG000
value
16
units
Participants
description
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement.
dispersion Type
Standard Deviation
groups
description
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
id
OG000
title
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
param Type
MEAN
population Description
Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; 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, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
title
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Triangle