Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS)
Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma · Source last updated 2023-08-29
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 1 of Cycles 2 to 26 (cycle duration of 3 weeks), and end of treatment (up to 599 days)
What was measured
EQ-5D-5L is designed as an international, standardized, instrument for describing and evaluating quality of life (QoL). In the EQ-5D-5L VAS participants are asked to indicate their health state today on a VAS with the endpoints labeled 'the best health you can imagine' (score 100) and 'the worst health you can imagine' (score 0).
A higher score on the VAS indicates better health related QoL. A positive change from baseline indicates an improvement in health related QoL.
Analysis population: Patient reported outcome (PRO) population. Only participants with data available for analysis are included. Overall number of participants analyzed prepresents all participants who contributed data to this assessment, though not all participants contributed data to each time point.
Groups in this outcome
Loncastuximab Tesirine
Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
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
Loncastuximab Tesirine
130
Reported measurements
Cycle 2 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
108
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
-0.1
15.97
Not reported
Not reported
Not reported
Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
76
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
1.3
16.85
Not reported
Not reported
Not reported
Cycle 4 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
58
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
2.8
15.00
Not reported
Not reported
Not reported
Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
44
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
2.8
13.50
Not reported
Not reported
Not reported
Cycle 6 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
33
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
3.0
17.45
Not reported
Not reported
Not reported
Cycle 7 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
28
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
4.0
12.91
Not reported
Not reported
Not reported
Cycle 8 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
22
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
7.3
12.87
Not reported
Not reported
Not reported
Cycle 9 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
20
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
7.7
15.69
Not reported
Not reported
Not reported
Cycle 10 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
13
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
12.2
15.64
Not reported
Not reported
Not reported
Cycle 11 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
12
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
11.8
17.62
Not reported
Not reported
Not reported
Cycle 12 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
10
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
16.3
16.06
Not reported
Not reported
Not reported
Cycle 13 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
8
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
6.0
16.54
Not reported
Not reported
Not reported
Cycle 14 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
6
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
12.2
15.43
Not reported
Not reported
Not reported
Cycle 15 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
5
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
6.6
12.36
Not reported
Not reported
Not reported
Cycle 16 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
4
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
5.5
13.70
Not reported
Not reported
Not reported
Cycle 17 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
4
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
8.3
13.62
Not reported
Not reported
Not reported
Cycle 18 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
3
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
11.0
11.53
Not reported
Not reported
Not reported
Cycle 19 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
2
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
11.5
16.26
Not reported
Not reported
Not reported
Cycle 20 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
1
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
23.0
NA
Not reported
Not reported
Standard deviation could not be calculated as n = 1.
Cycle 21 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
2
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
16.5
9.19
Not reported
Not reported
Not reported
Cycle 22 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
2
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
16.5
9.19
Not reported
Not reported
Not reported
Cycle 23 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
1
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
23.0
NA
Not reported
Not reported
Standard deviation could not be calculated as n = 1.
Cycle 24 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
1
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
23.0
NA
Not reported
Not reported
Standard deviation could not be calculated as n = 1.
Cycle 25 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
1
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
23.0
NA
Not reported
Not reported
Standard deviation could not be calculated as n = 1.
Cycle 26 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
1
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
23.0
NA
Not reported
Not reported
Standard deviation could not be calculated as n = 1.
End of treatment
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
98
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
-8.3
19.85
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
15.97
value
-0.1
denoms
counts
group Id
OG000
value
108
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
16.85
value
1.3
denoms
counts
group Id
OG000
value
76
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
15.00
value
2.8
denoms
counts
group Id
OG000
value
58
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
13.50
value
2.8
denoms
counts
group Id
OG000
value
44
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
17.45
value
3.0
denoms
counts
group Id
OG000
value
33
units
Participants
title
Cycle 6 Day 1
categories
measurements
group Id
OG000
spread
12.91
value
4.0
denoms
counts
group Id
OG000
value
28
units
Participants
title
Cycle 7 Day 1
categories
measurements
group Id
OG000
spread
12.87
value
7.3
denoms
counts
group Id
OG000
value
22
units
Participants
title
Cycle 8 Day 1
categories
measurements
group Id
OG000
spread
15.69
value
7.7
denoms
counts
group Id
OG000
value
20
units
Participants
title
Cycle 9 Day 1
categories
measurements
group Id
OG000
spread
15.64
value
12.2
denoms
counts
group Id
OG000
value
13
units
Participants
title
Cycle 10 Day 1
categories
measurements
group Id
OG000
spread
17.62
value
11.8
denoms
counts
group Id
OG000
value
12
units
Participants
title
Cycle 11 Day 1
categories
measurements
group Id
OG000
spread
16.06
value
16.3
denoms
counts
group Id
OG000
value
10
units
Participants
title
Cycle 12 Day 1
categories
measurements
group Id
OG000
spread
16.54
value
6.0
denoms
counts
group Id
OG000
value
8
units
Participants
title
Cycle 13 Day 1
denoms
counts
group Id
OG000
value
130
units
Participants
description
EQ-5D-5L is designed as an international, standardized, instrument for describing and evaluating quality of life (QoL). In the EQ-5D-5L VAS participants are asked to indicate their health state today on a VAS with the endpoints labeled 'the best health you can imagine' (score 100) and 'the worst health you can imagine' (score 0).
A higher score on the VAS indicates better health related QoL. A positive change from baseline indicates an improvement in health related QoL.
dispersion Type
Standard Deviation
groups
description
Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
id
OG000
title
Loncastuximab Tesirine
param Type
MEAN
population Description
Patient reported outcome (PRO) population. Only participants with data available for analysis are included. Overall number of participants analyzed prepresents all participants who contributed data to this assessment, though not all participants contributed data to each time point.
reporting Status
POSTED
time Frame
Baseline, Day 1 of Cycles 2 to 26 (cycle duration of 3 weeks), and end of treatment (up to 599 days)
title
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS)
Triangle