NCT03038672 · ADVERSE EVENTS

Adverse events

Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas · Source last updated 2026-05-12

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: 25 months for adverse events and 37 months for mortality
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group I (Nivolumab) Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.	10 / 27	24 / 27	3 / 27
Group II (Varlilumab, Nivolumab) Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.	12 / 27	24 / 27	5 / 27
Cross Over to Group II Treatment (Varlilumab, Nivolumab) Pre cross over patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression. Post cross over patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.	3 / 7	7 / 7	0 / 7

Group identifiers: EG000: Group I (Nivolumab) · EG001: Group II (Varlilumab, Nivolumab) · EG002: Cross Over to Group II Treatment (Varlilumab, Nivolumab)

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
2
num At Risk
7
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Gastric hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Gastric ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Lower gastrointestinal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Upper gastrointestinal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Chills

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
8
num At Risk
27
num Events
8
group Id
EG001
num Affected
13
num At Risk
27
num Events
18
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
3
num At Risk
27
num Events
3
group Id
EG001
num Affected
5
num At Risk
27
num Events
5
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
2
num At Risk
27
num Events
2
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Atrioventricular block complete
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
27
num Events
2
group Id
EG001
num Affected
4
num At Risk
27
num Events
4
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Hearing impaired
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
27
num Events
2
group Id
EG001
num Affected
3
num At Risk
27
num Events
4
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Eye disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Floaters

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
27
description
Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
id
EG000
other Num Affected
24
other Num At Risk
27
serious Num Affected
10
serious Num At Risk
27
title
Group I (Nivolumab)
deaths Num Affected
5
deaths Num At Risk
27
description
Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
24
other Num At Risk
27
serious Num Affected
12
serious Num At Risk
27
title
Group II (Varlilumab, Nivolumab)
deaths Num Affected
0
deaths Num At Risk
7
description
Pre cross over patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression. Post cross over patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Cross Over to Group II Treatment (Varlilumab, Nivolumab)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
8
num At Risk
27
num Events
8
group Id
EG001
num Affected
13
num At Risk
27
num Events
18
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
3
num At Risk
27
num Events
3
group Id
EG001
num Affected
5
num At Risk
27
num Events
5
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
2
num At Risk
27
num Events
2
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Atrioventricular block complete
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
27
num Events
2
group Id
EG001
num Affected
4
num At Risk
27
num Events
4
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Hearing impaired
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
27
num Events
2
group Id
EG001
num Affected
3
num At Risk
27
num Events
4
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Eye disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Floaters

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
2
num At Risk
7
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Gastric hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Gastric ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
1
num At Risk
27
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Lower gastrointestinal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
term
Upper gastrointestinal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
group Id
EG001
num Affected
0
num At Risk
27
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
term
Chills

time Frame

25 months for adverse events and 37 months for mortality

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