NCT03000179 · ADVERSE EVENTS

Adverse events

Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma · Source last updated 2022-04-14

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 study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Avelumab Monotherapy Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks. Avelumab: Avelumab through a vein once every 2 weeks	7 / 8	8 / 8	6 / 8

Group identifiers: EG000: Avelumab Monotherapy

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
Endocrine disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Diabetic Ketoacidos
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Thromboembolic event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Ataxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Bacteremia bloodstream infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Colonic obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Sepsis

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
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
5
num At Risk
8
num Events
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
5
num At Risk
8
num Events
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
8
num Events
6
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
8
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
8
num Events
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Gastrointestinal fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Small intestinal mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
7
num At Risk
8
num Events
20
term
Anemia

Complete source fields

event Groups

deaths Num Affected
6
deaths Num At Risk
8
description
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks. Avelumab: Avelumab through a vein once every 2 weeks
id
EG000
other Num Affected
8
other Num At Risk
8
serious Num Affected
7
serious Num At Risk
8
title
Avelumab Monotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
5
num At Risk
8
num Events
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
5
num At Risk
8
num Events
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
8
num Events
6
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
8
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
8
num Events
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Gastrointestinal fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Small intestinal mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
7
num At Risk
8
num Events
20
term
Anemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Diabetic Ketoacidos
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Thromboembolic event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Ataxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Bacteremia bloodstream infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Colonic obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
term
Sepsis

time Frame

From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice