NCT04590963 · ADVERSE EVENTS

Adverse events

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer · Source last updated 2026-09-09

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: Day 1 through 21.4 months (maximum observed duration)
Other-event reporting threshold: 5%

All-Cause Mortality (ACM) reports data for ARP set; AE/SAE data is reported for SAS. Two participants died in follow-up period in each arm, after consent withdrawal from study, so number of deaths reported in ACM is different than of participant flow. TEAEs: Events from first dose of study drug (SD) up to 90 days after last dose of SD received or up to start date of any subsequent anticancer therapy following discontinuation of SD or final safety DCO of 01Sep22, whichever occurred first.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	77 / 246	213 / 246	120 / 247
Placebo Q2W + Cetuximab 400 mg/m^2 Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	27 / 122	111 / 122	61 / 123

Group identifiers: EG000: Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 · EG001: Placebo Q2W + Cetuximab 400 mg/m^2

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 25.0
stats
group Id
EG000
num Affected
2
num At Risk
246
num Events
2
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Stevens-johnson syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Urticaria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
122
num Events
1
term
Venous thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
1
num At Risk
122
num Events
1
term
Duodenal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Faecaloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Haematemesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Intestinal ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
122
num Events
1
term
Mouth haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Nausea

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 25.0
stats
group Id
EG000
num Affected
27
num At Risk
246
num Events
32
group Id
EG001
num Affected
14
num At Risk
122
num Events
17
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
32
num At Risk
246
num Events
35
group Id
EG001
num Affected
18
num At Risk
122
num Events
21
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
56
num At Risk
246
num Events
60
group Id
EG001
num Affected
27
num At Risk
122
num Events
29
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
9
num At Risk
246
num Events
9
group Id
EG001
num Affected
7
num At Risk
122
num Events
8
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
246
num Events
21
group Id
EG001
num Affected
9
num At Risk
122
num Events
9
term
Skin fissures
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
26
num At Risk
246
num Events
32
group Id
EG001
num Affected
20
num At Risk
122
num Events
24
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
31
num At Risk
246
num Events
33
group Id
EG001
num Affected
16
num At Risk
122
num Events
18
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
23
num At Risk
246
num Events
27
group Id
EG001
num Affected
9
num At Risk
122
num Events
12
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
33
num At Risk
246
num Events
42
group Id
EG001
num Affected
15
num At Risk
122
num Events
17
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
19
num At Risk
246
num Events
19
group Id
EG001
num Affected
9
num At Risk
122
num Events
12
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
48
num At Risk
246
num Events
53
group Id
EG001
num Affected
20
num At Risk
122
num Events
24
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
15
num At Risk
246
num Events
17
group Id
EG001
num Affected
10
num At Risk
122
num Events
10
term
Pyrexia

Complete source fields

description

event Groups

deaths Num Affected
120
deaths Num At Risk
247
description
Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
id
EG000
other Num Affected
213
other Num At Risk
246
serious Num Affected
77
serious Num At Risk
246
title
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
deaths Num Affected
61
deaths Num At Risk
123
description
Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
id
EG001
other Num Affected
111
other Num At Risk
122
serious Num Affected
27
serious Num At Risk
122
title
Placebo Q2W + Cetuximab 400 mg/m^2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
27
num At Risk
246
num Events
32
group Id
EG001
num Affected
14
num At Risk
122
num Events
17
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
32
num At Risk
246
num Events
35
group Id
EG001
num Affected
18
num At Risk
122
num Events
21
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
56
num At Risk
246
num Events
60
group Id
EG001
num Affected
27
num At Risk
122
num Events
29
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
9
num At Risk
246
num Events
9
group Id
EG001
num Affected
7
num At Risk
122
num Events
8
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
246
num Events
21
group Id
EG001
num Affected
9
num At Risk
122
num Events
9
term
Skin fissures
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
26
num At Risk
246
num Events
32
group Id
EG001
num Affected
20
num At Risk
122
num Events
24
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
31
num At Risk
246
num Events
33
group Id
EG001
num Affected
16
num At Risk
122
num Events
18
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
23
num At Risk
246
num Events
27
group Id
EG001
num Affected
9
num At Risk
122
num Events
12
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
33
num At Risk
246
num Events
42
group Id
EG001
num Affected
15
num At Risk
122
num Events
17
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
19
num At Risk
246
num Events
19
group Id
EG001
num Affected
9
num At Risk
122
num Events
12
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
48
num At Risk
246
num Events
53
group Id
EG001
num Affected
20
num At Risk
122
num Events
24
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
15
num At Risk
246
num Events
17
group Id
EG001
num Affected
10
num At Risk
122
num Events
10
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
246
num Events
2
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Stevens-johnson syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Urticaria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
122
num Events
1
term
Venous thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
1
num At Risk
122
num Events
1
term
Duodenal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Faecaloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Haematemesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Intestinal ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
122
num Events
1
term
Mouth haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
122
num Events
0
term
Nausea

time Frame

Day 1 through 21.4 months (maximum observed duration)

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Preserved source evidence · Not medical advice