Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. · Source last updated 2026-09-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to approximately 34 months
What was measured
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Analysis population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.
Groups in this outcome
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with FL and MZL were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL and MZL: Placebo + Rituximab + Lenalidomide
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
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
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
326
FL and MZL: Placebo + Rituximab + Lenalidomide
328
Reported measurements
Baseline, Mobility, Score 1
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
212
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
226
Not reported
Not reported
Not reported
Not reported
Baseline, Mobility, Score 2
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
68
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
47
Not reported
Not reported
Not reported
Not reported
Baseline, Mobility, Score 3
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
24
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
30
Not reported
Not reported
Not reported
Not reported
Baseline, Mobility, Score 4
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
10
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
11
Not reported
Not reported
Not reported
Not reported
Baseline, Mobility, Score 5
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
End of Treatment, Mobility, Score 1
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
149
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
149
Not reported
Not reported
Not reported
Not reported
End of Treatment, Mobility, Score 2
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
46
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
47
Not reported
Not reported
Not reported
Not reported
End of Treatment, Mobility, Score 3
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
17
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
22
Not reported
Not reported
Not reported
Not reported
End of Treatment, Mobility, Score 4
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
13
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
10
Not reported
Not reported
Not reported
Not reported
End of Treatment, Mobility, Score 5
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
3
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
Baseline, Self-care, Score 1
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
294
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
284
Not reported
Not reported
Not reported
Not reported
Baseline, Self-care, Score 2
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
12
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
22
Not reported
Not reported
Not reported
Not reported
Baseline, Self-care, Score 3
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
4
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
6
Not reported
Not reported
Not reported
Not reported
Baseline, Self-care, Score 4
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
Baseline, Self-care, Score 5
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
3
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
End of Treatment, Self-care, Score 1
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
198
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
202
Not reported
Not reported
Not reported
Not reported
End of Treatment, Self-care, Score 2
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
15
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
15
Not reported
Not reported
Not reported
Not reported
End of Treatment, Self-care, Score 3
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
9
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
7
Not reported
Not reported
Not reported
Not reported
End of Treatment, Self-care, Score 4
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
5
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
5
Not reported
Not reported
Not reported
Not reported
End of Treatment, Self-care, Score 5
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Baseline, Usual Activities, Score 1
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
207
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
208
Not reported
Not reported
Not reported
Not reported
Baseline, Usual Activities, Score 2
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
74
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
64
Not reported
Not reported
Not reported
Not reported
Baseline, Usual Activities, Score 3
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
23
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
33
Not reported
Not reported
Not reported
Not reported
Baseline, Usual Activities, Score 4
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
6
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
5
Not reported
Not reported
Not reported
Not reported
Baseline, Usual Activities, Score 5
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
5
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
4
Not reported
Not reported
Not reported
Not reported
End of Treatment, Usual Activities, Score 1
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
133
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
135
Not reported
Not reported
Not reported
Not reported
End of Treatment, Usual Activities, Score 2
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
68
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
62
Not reported
Not reported
Not reported
Not reported
End of Treatment, Usual Activities, Score 3
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
15
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
21
Not reported
Not reported
Not reported
Not reported
End of Treatment, Usual Activities, Score 4
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
11
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
6
Not reported
Not reported
Not reported
Not reported
End of Treatment, Usual Activities, Score 5
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
5
Not reported
Not reported
Not reported
Not reported
Baseline, Pain/Discomfort, Score 1
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
168
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
161
Not reported
Not reported
Not reported
Not reported
Baseline, Pain/Discomfort, Score 2
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
108
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
104
Not reported
Not reported
Not reported
Not reported
Baseline, Pain/Discomfort, Score 3
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
35
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
40
Not reported
Not reported
Not reported
Not reported
Baseline, Pain/Discomfort, Score 4
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
3
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
8
Not reported
Not reported
Not reported
Not reported
Baseline, Pain/Discomfort, Score 5
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
End of Treatment, Pain/Discomfort, Score 1
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
129
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
124
Not reported
Not reported
Not reported
Not reported
End of Treatment, Pain/Discomfort, Score 2
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
68
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
70
Not reported
Not reported
Not reported
Not reported
End of Treatment, Pain/Discomfort, Score 3
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
21
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
23
Not reported
Not reported
Not reported
Not reported
End of Treatment, Pain/Discomfort, Score 4
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
10
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
9
Not reported
Not reported
Not reported
Not reported
End of Treatment, Pain/Discomfort, Score 5
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
3
Not reported
Not reported
Not reported
Not reported
Baseline, Anxiety/Depression, Score 1
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
173
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
177
Not reported
Not reported
Not reported
Not reported
Baseline, Anxiety/Depression, Score 2
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
110
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
98
Not reported
Not reported
Not reported
Not reported
Baseline, Anxiety/Depression, Score 3
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
25
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
30
Not reported
Not reported
Not reported
Not reported
Baseline, Anxiety/Depression, Score 4
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
6
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
8
Not reported
Not reported
Not reported
Not reported
Baseline, Anxiety/Depression, Score 5
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
315
FL and MZL: Placebo + Rituximab + Lenalidomide
314
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
End of Treatment, Anxiety/Depression, Score 1
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
136
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
126
Not reported
Not reported
Not reported
Not reported
End of Treatment, Anxiety/Depression, Score 2
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
68
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
74
Not reported
Not reported
Not reported
Not reported
End of Treatment, Anxiety/Depression, Score 3
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
20
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
24
Not reported
Not reported
Not reported
Not reported
End of Treatment, Anxiety/Depression, Score 4
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
5
Not reported
Not reported
Not reported
Not reported
End of Treatment, Anxiety/Depression, Score 5
Analysis denominator · Participants
Group
Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
228
FL and MZL: Placebo + Rituximab + Lenalidomide
229
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
212
group Id
OG001
value
226
denoms
counts
group Id
OG000
value
315
group Id
OG001
value
314
units
Participants
title
Baseline, Mobility, Score 1
categories
measurements
group Id
OG000
value
68
group Id
OG001
value
47
denoms
counts
group Id
OG000
value
315
group Id
OG001
value
314
units
Participants
title
Baseline, Mobility, Score 2
categories
measurements
group Id
OG000
value
24
group Id
OG001
value
30
denoms
counts
group Id
OG000
value
315
group Id
OG001
value
314
units
Participants
title
Baseline, Mobility, Score 3
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
11
denoms
counts
group Id
OG000
value
315
group Id
OG001
value
314
units
Participants
title
Baseline, Mobility, Score 4
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
315
group Id
OG001
value
314
units
Participants
title
Baseline, Mobility, Score 5
categories
measurements
group Id
OG000
value
149
group Id
OG001
value
149
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
229
units
Participants
title
End of Treatment, Mobility, Score 1
categories
measurements
group Id
OG000
value
46
group Id
OG001
value
47
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
229
units
Participants
title
End of Treatment, Mobility, Score 2
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
22
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
229
units
Participants
title
End of Treatment, Mobility, Score 3
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
10
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
229
units
Participants
title
End of Treatment, Mobility, Score 4
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
229
units
Participants
title
End of Treatment, Mobility, Score 5
categories
measurements
group Id
OG000
value
294
group Id
OG001
value
284
denoms
counts
group Id
OG000
value
315
group Id
OG001
value
314
units
Participants
title
Baseline, Self-care, Score 1
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
22
denoms
counts
group Id
OG000
value
315
group Id
OG001
value
314
units
Participants
title
Baseline, Self-care, Score 2
denoms
counts
group Id
OG000
value
326
group Id
OG001
value
328
units
Participants
description
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
groups
description
Participants with FL and MZL were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
id
OG000
title
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
description
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
id
OG001
title
FL and MZL: Placebo + Rituximab + Lenalidomide
param Type
COUNT_OF_PARTICIPANTS
population Description
Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
up to approximately 34 months
title
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Triangle