NCT03046953 · ADVERSE EVENTS

Adverse events

Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma · Source last updated 2024-07-16

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: Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Other-event reporting threshold: 5%

Safety data for this trial was collected in accordance with CTCAE criteria version 4.0

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Avelumab Avelumab (an anti-PDL1 antibody) 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.	18 / 32	31 / 32	24 / 32

Group identifiers: EG000: Avelumab

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
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Dacrocystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Gastric perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Immune-mediated colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
4
num At Risk
32
num Events
6
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Edema-groin,scrotum
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Hepatic failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Lung/skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Eye infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Infection (blood culture positive)

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
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
32
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
5
num At Risk
32
num Events
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
5
num At Risk
32
num Events
5
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
32
num Events
3
term
Mucositis Oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
6
num At Risk
32
num Events
8
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
5
num At Risk
32
num Events
7
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
3
num At Risk
32
num Events
3
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
32
num Events
2
term
Edema Limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
8
num At Risk
32
num Events
12
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
8
num At Risk
32
num Events
11
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
32
num Events
2
term
Flu Like Symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
7
num At Risk
32
num Events
7
term
Infusion Related Reaction

Complete source fields

description

Safety data for this trial was collected in accordance with CTCAE criteria version 4.0

event Groups

deaths Num Affected
24
deaths Num At Risk
32
description
Avelumab (an anti-PDL1 antibody) 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
id
EG000
other Num Affected
31
other Num At Risk
32
serious Num Affected
18
serious Num At Risk
32
title
Avelumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
32
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
5
num At Risk
32
num Events
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
5
num At Risk
32
num Events
5
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
32
num Events
3
term
Mucositis Oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
6
num At Risk
32
num Events
8
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
5
num At Risk
32
num Events
7
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
3
num At Risk
32
num Events
3
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
32
num Events
2
term
Edema Limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
8
num At Risk
32
num Events
12
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
8
num At Risk
32
num Events
11
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
32
num Events
2
term
Flu Like Symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
7
num At Risk
32
num Events
7
term
Infusion Related Reaction

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Dacrocystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Gastric perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Immune-mediated colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
4
num At Risk
32
num Events
6
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Edema-groin,scrotum
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Hepatic failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Lung/skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Eye infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
term
Infection (blood culture positive)

time Frame

Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.

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