NCT03254927 · ADVERSE EVENTS

Adverse events

A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma · Source last updated 2023-04-03

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: Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
CDX-3379 and Cetuximab During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.	13 / 30	30 / 30	26 / 30

Group identifiers: EG000: CDX-3379 and Cetuximab

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
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
3
num At Risk
30
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Lung abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Small intestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Femoral neck fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Gastrostomy tube site complication
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Tracheal obstruction

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 (23.1)
stats
group Id
EG000
num Affected
24
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
10
num At Risk
30
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
5
num At Risk
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
8
num At Risk
30
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
5
num At Risk
30
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
3
num At Risk
30
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
3
num At Risk
30
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
16
num At Risk
30
term
Hypomagnesaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
14
num At Risk
30
term
Hypokalaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
8
num At Risk
30
term
Hypocalcaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
5
num At Risk
30
term
Hypercalcaemia

Complete source fields

event Groups

deaths Num Affected
26
deaths Num At Risk
30
description
During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
id
EG000
other Num Affected
30
other Num At Risk
30
serious Num Affected
13
serious Num At Risk
30
title
CDX-3379 and Cetuximab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
24
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
10
num At Risk
30
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
5
num At Risk
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
8
num At Risk
30
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
5
num At Risk
30
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
3
num At Risk
30
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
3
num At Risk
30
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
16
num At Risk
30
term
Hypomagnesaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
14
num At Risk
30
term
Hypokalaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
8
num At Risk
30
term
Hypocalcaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
5
num At Risk
30
term
Hypercalcaemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
3
num At Risk
30
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Lung abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Small intestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Mucosal inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Femoral neck fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Gastrostomy tube site complication
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Tracheal obstruction

time Frame

Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.

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Preserved source evidence · Not medical advice