NCT04680052 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)
Other-event reporting threshold: 5%

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. Safety was not expected to be different between each histological subtype (FL versus MZL).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tafasitamab + Rituximab + Lenalidomide Participants with follicular lymphoma (FL) or marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (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 once daily (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/meters squared (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.	125 / 327	318 / 327	22 / 327
Placebo + Rituximab + Lenalidomide Participants with FL or 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.	110 / 325	315 / 325	24 / 325
Total Total	235 / 652	633 / 652	46 / 652

Group identifiers: EG000: Tafasitamab + Rituximab + Lenalidomide · EG001: Placebo + Rituximab + Lenalidomide · EG002: Total

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
5
num At Risk
325
num Events
5
group Id
EG002
num Affected
5
num At Risk
652
num Events
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
9
num At Risk
327
num Events
9
group Id
EG001
num Affected
6
num At Risk
325
num Events
6
group Id
EG002
num Affected
15
num At Risk
652
num Events
15
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
2
num At Risk
325
num Events
2
group Id
EG002
num Affected
3
num At Risk
652
num Events
3
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
325
num Events
0
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Acute pulmonary oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
325
num Events
0
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Adenocarcinoma gastric
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
3
num At Risk
327
num Events
3
group Id
EG001
num Affected
2
num At Risk
325
num Events
2
group Id
EG002
num Affected
5
num At Risk
652
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Anal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Anal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Anxiety

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
25
num At Risk
327
num Events
33
group Id
EG001
num Affected
28
num At Risk
325
num Events
30
group Id
EG002
num Affected
53
num At Risk
652
num Events
63
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
19
num At Risk
327
num Events
28
group Id
EG001
num Affected
23
num At Risk
325
num Events
36
group Id
EG002
num Affected
42
num At Risk
652
num Events
64
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
53
num At Risk
327
num Events
97
group Id
EG001
num Affected
46
num At Risk
325
num Events
73
group Id
EG002
num Affected
99
num At Risk
652
num Events
170
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
24
num At Risk
327
num Events
25
group Id
EG001
num Affected
27
num At Risk
325
num Events
36
group Id
EG002
num Affected
51
num At Risk
652
num Events
61
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
44
num At Risk
327
num Events
58
group Id
EG001
num Affected
35
num At Risk
325
num Events
48
group Id
EG002
num Affected
79
num At Risk
652
num Events
106
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
32
num At Risk
327
num Events
41
group Id
EG001
num Affected
18
num At Risk
325
num Events
21
group Id
EG002
num Affected
50
num At Risk
652
num Events
62
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
17
num At Risk
327
num Events
21
group Id
EG001
num Affected
14
num At Risk
325
num Events
14
group Id
EG002
num Affected
31
num At Risk
652
num Events
35
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
86
num At Risk
327
num Events
98
group Id
EG001
num Affected
72
num At Risk
325
num Events
81
group Id
EG002
num Affected
158
num At Risk
652
num Events
179
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
14
num At Risk
327
num Events
14
group Id
EG001
num Affected
17
num At Risk
325
num Events
18
group Id
EG002
num Affected
31
num At Risk
652
num Events
32
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
90
num At Risk
327
num Events
110
group Id
EG001
num Affected
81
num At Risk
325
num Events
100
group Id
EG002
num Affected
171
num At Risk
652
num Events
210
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
62
num At Risk
327
num Events
81
group Id
EG001
num Affected
55
num At Risk
325
num Events
69
group Id
EG002
num Affected
117
num At Risk
652
num Events
150
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
36
num At Risk
327
num Events
39
group Id
EG001
num Affected
30
num At Risk
325
num Events
32
group Id
EG002
num Affected
66
num At Risk
652
num Events
71
term
Decreased appetite

Complete source fields

description

event Groups

deaths Num Affected
22
deaths Num At Risk
327
description
Participants with follicular lymphoma (FL) or marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (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 once daily (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/meters squared (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
EG000
other Num Affected
318
other Num At Risk
327
serious Num Affected
125
serious Num At Risk
327
title
Tafasitamab + Rituximab + Lenalidomide
deaths Num Affected
24
deaths Num At Risk
325
description
Participants with FL or 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
EG001
other Num Affected
315
other Num At Risk
325
serious Num Affected
110
serious Num At Risk
325
title
Placebo + Rituximab + Lenalidomide
deaths Num Affected
46
deaths Num At Risk
652
description
Total
id
EG002
other Num Affected
633
other Num At Risk
652
serious Num Affected
235
serious Num At Risk
652
title
Total

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
25
num At Risk
327
num Events
33
group Id
EG001
num Affected
28
num At Risk
325
num Events
30
group Id
EG002
num Affected
53
num At Risk
652
num Events
63
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
19
num At Risk
327
num Events
28
group Id
EG001
num Affected
23
num At Risk
325
num Events
36
group Id
EG002
num Affected
42
num At Risk
652
num Events
64
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
53
num At Risk
327
num Events
97
group Id
EG001
num Affected
46
num At Risk
325
num Events
73
group Id
EG002
num Affected
99
num At Risk
652
num Events
170
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
24
num At Risk
327
num Events
25
group Id
EG001
num Affected
27
num At Risk
325
num Events
36
group Id
EG002
num Affected
51
num At Risk
652
num Events
61
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
44
num At Risk
327
num Events
58
group Id
EG001
num Affected
35
num At Risk
325
num Events
48
group Id
EG002
num Affected
79
num At Risk
652
num Events
106
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
32
num At Risk
327
num Events
41
group Id
EG001
num Affected
18
num At Risk
325
num Events
21
group Id
EG002
num Affected
50
num At Risk
652
num Events
62
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
17
num At Risk
327
num Events
21
group Id
EG001
num Affected
14
num At Risk
325
num Events
14
group Id
EG002
num Affected
31
num At Risk
652
num Events
35
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
86
num At Risk
327
num Events
98
group Id
EG001
num Affected
72
num At Risk
325
num Events
81
group Id
EG002
num Affected
158
num At Risk
652
num Events
179
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
14
num At Risk
327
num Events
14
group Id
EG001
num Affected
17
num At Risk
325
num Events
18
group Id
EG002
num Affected
31
num At Risk
652
num Events
32
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
90
num At Risk
327
num Events
110
group Id
EG001
num Affected
81
num At Risk
325
num Events
100
group Id
EG002
num Affected
171
num At Risk
652
num Events
210
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
62
num At Risk
327
num Events
81
group Id
EG001
num Affected
55
num At Risk
325
num Events
69
group Id
EG002
num Affected
117
num At Risk
652
num Events
150
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
36
num At Risk
327
num Events
39
group Id
EG001
num Affected
30
num At Risk
325
num Events
32
group Id
EG002
num Affected
66
num At Risk
652
num Events
71
term
Decreased appetite

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
5
num At Risk
325
num Events
5
group Id
EG002
num Affected
5
num At Risk
652
num Events
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
9
num At Risk
327
num Events
9
group Id
EG001
num Affected
6
num At Risk
325
num Events
6
group Id
EG002
num Affected
15
num At Risk
652
num Events
15
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
2
num At Risk
325
num Events
2
group Id
EG002
num Affected
3
num At Risk
652
num Events
3
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
325
num Events
0
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Acute pulmonary oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
325
num Events
0
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Adenocarcinoma gastric
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
3
num At Risk
327
num Events
3
group Id
EG001
num Affected
2
num At Risk
325
num Events
2
group Id
EG002
num Affected
5
num At Risk
652
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Anal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Anal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 26
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
325
num Events
1
group Id
EG002
num Affected
1
num At Risk
652
num Events
1
term
Anxiety

time Frame

from signing of the Informed Consent Form to up to 90 days post-treatment (up to approximately 3 years)

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

Preserved source evidence · Not medical advice