Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS)
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 25 (cycle duration of 3 weeks), and end of treatment (up to 599 days)
What was measured
Composed of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the 15-item LymS. The FACT-G questionnaire contains 27 items covering 4 core health related quality of life (QoL) subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The LymS addresses issues including pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. Score range for the LymS was 0 - 60, where a higher score indicates less symptoms. The LymS score is reported. A positive change from baseline indicates an improvement in health related QoL.
Analysis population: PRO population. Only participants with data available for analysis are included. Overall number of participants analyzed represents 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
110
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
0.95
7.114
Not reported
Not reported
Not reported
Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
78
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
1.34
8.764
Not reported
Not reported
Not reported
Cycle 4 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
60
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
2.09
8.832
Not reported
Not reported
Not reported
Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
47
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
0.16
8.506
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
1.16
9.918
Not reported
Not reported
Not reported
Cycle 7 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
29
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
1.00
11.474
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
3.43
10.141
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
2.17
9.498
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
3.18
11.769
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
4.35
13.053
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
4.90
11.140
Not reported
Not reported
Not reported
Cycle 13 Day 1
Analysis denominator · Participants
Group
Source count
Loncastuximab Tesirine
9
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Loncastuximab Tesirine
2.01
16.871
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
0.63
17.442
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
-3.27
7.691
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
-8.04
10.561
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
-6.88
9.360
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
-5.00
7.937
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
-1.00
4.243
Not reported
Not reported
Not reported
Cycle 20 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
-2.25
4.596
Not reported
Not reported
Not reported
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
-0.50
2.121
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
-1.00
2.828
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
1.00
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
0
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
1.00
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
-1.19
9.042
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
7.114
value
0.95
denoms
counts
group Id
OG000
value
110
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
8.764
value
1.34
denoms
counts
group Id
OG000
value
78
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
8.832
value
2.09
denoms
counts
group Id
OG000
value
60
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
8.506
value
0.16
denoms
counts
group Id
OG000
value
47
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
9.918
value
1.16
denoms
counts
group Id
OG000
value
33
units
Participants
title
Cycle 6 Day 1
categories
measurements
group Id
OG000
spread
11.474
value
1.00
denoms
counts
group Id
OG000
value
29
units
Participants
title
Cycle 7 Day 1
categories
measurements
group Id
OG000
spread
10.141
value
3.43
denoms
counts
group Id
OG000
value
22
units
Participants
title
Cycle 8 Day 1
categories
measurements
group Id
OG000
spread
9.498
value
2.17
denoms
counts
group Id
OG000
value
20
units
Participants
title
Cycle 9 Day 1
categories
measurements
group Id
OG000
spread
11.769
value
3.18
denoms
counts
group Id
OG000
value
13
units
Participants
title
Cycle 10 Day 1
categories
measurements
group Id
OG000
spread
13.053
value
4.35
denoms
counts
group Id
OG000
value
12
units
Participants
title
Cycle 11 Day 1
categories
measurements
group Id
OG000
spread
11.140
value
4.90
denoms
counts
group Id
OG000
value
10
units
Participants
title
Cycle 12 Day 1
categories
measurements
group Id
OG000
spread
16.871
value
2.01
denoms
counts
group Id
OG000
value
9
units
Participants
title
Cycle 13 Day 1
denoms
counts
group Id
OG000
value
130
units
Participants
description
Composed of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the 15-item LymS. The FACT-G questionnaire contains 27 items covering 4 core health related quality of life (QoL) subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The LymS addresses issues including pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. Score range for the LymS was 0 - 60, where a higher score indicates less symptoms. The LymS score is reported. 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
PRO population. Only participants with data available for analysis are included. Overall number of participants analyzed represents 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 25 (cycle duration of 3 weeks), and end of treatment (up to 599 days)
title
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS)
Triangle