NCT03765918 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) · Source last updated 2026-07-31

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: Up to ~66 months
Other-event reporting threshold: 5%

All-Cause Mortality includes all randomized participants. Serious and Other AEs include the safety analysis population. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab + Standard of Care (SOC) Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).	179 / 361	335 / 361	113 / 363
Standard of Care (SOC) Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).	116 / 315	290 / 315	131 / 351

Group identifiers: EG000: Pembrolizumab + Standard of Care (SOC) · EG001: Standard of Care (SOC)

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 27.0
stats
group Id
EG000
num Affected
3
num At Risk
361
num Events
3
group Id
EG001
num Affected
3
num At Risk
315
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
0
num At Risk
315
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
5
num At Risk
315
num Events
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
0
num At Risk
315
num Events
0
term
Hypercoagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
361
num Events
0
group Id
EG001
num Affected
1
num At Risk
315
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
0
num At Risk
315
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
361
num Events
0
group Id
EG001
num Affected
1
num At Risk
315
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
0
num At Risk
315
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
361
num Events
2
group Id
EG001
num Affected
1
num At Risk
315
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
0
num At Risk
315
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
361
num Events
0
group Id
EG001
num Affected
1
num At Risk
315
num Events
1
term
Bradyarrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
361
num Events
0
group Id
EG001
num Affected
1
num At Risk
315
num Events
1
term
Bradycardia

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 27.0
stats
group Id
EG000
num Affected
121
num At Risk
361
num Events
147
group Id
EG001
num Affected
102
num At Risk
315
num Events
117
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
20
num At Risk
361
num Events
23
group Id
EG001
num Affected
16
num At Risk
315
num Events
16
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
32
num At Risk
361
num Events
33
group Id
EG001
num Affected
10
num At Risk
315
num Events
10
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
89
num At Risk
361
num Events
94
group Id
EG001
num Affected
17
num At Risk
315
num Events
19
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
96
num At Risk
361
num Events
115
group Id
EG001
num Affected
70
num At Risk
315
num Events
81
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
75
num At Risk
361
num Events
99
group Id
EG001
num Affected
31
num At Risk
315
num Events
34
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
81
num At Risk
361
num Events
87
group Id
EG001
num Affected
81
num At Risk
315
num Events
82
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
22
num At Risk
361
num Events
24
group Id
EG001
num Affected
10
num At Risk
315
num Events
10
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
99
num At Risk
361
num Events
108
group Id
EG001
num Affected
98
num At Risk
315
num Events
101
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
87
num At Risk
361
num Events
112
group Id
EG001
num Affected
84
num At Risk
315
num Events
106
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
31
num At Risk
361
num Events
34
group Id
EG001
num Affected
30
num At Risk
315
num Events
33
term
Odynophagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
48
num At Risk
361
num Events
56
group Id
EG001
num Affected
28
num At Risk
315
num Events
28
term
Oral pain

Complete source fields

description

event Groups

deaths Num Affected
113
deaths Num At Risk
363
description
Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
id
EG000
other Num Affected
335
other Num At Risk
361
serious Num Affected
179
serious Num At Risk
361
title
Pembrolizumab + Standard of Care (SOC)
deaths Num Affected
131
deaths Num At Risk
351
description
Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
id
EG001
other Num Affected
290
other Num At Risk
315
serious Num Affected
116
serious Num At Risk
315
title
Standard of Care (SOC)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
121
num At Risk
361
num Events
147
group Id
EG001
num Affected
102
num At Risk
315
num Events
117
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
20
num At Risk
361
num Events
23
group Id
EG001
num Affected
16
num At Risk
315
num Events
16
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
32
num At Risk
361
num Events
33
group Id
EG001
num Affected
10
num At Risk
315
num Events
10
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
89
num At Risk
361
num Events
94
group Id
EG001
num Affected
17
num At Risk
315
num Events
19
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
96
num At Risk
361
num Events
115
group Id
EG001
num Affected
70
num At Risk
315
num Events
81
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
75
num At Risk
361
num Events
99
group Id
EG001
num Affected
31
num At Risk
315
num Events
34
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
81
num At Risk
361
num Events
87
group Id
EG001
num Affected
81
num At Risk
315
num Events
82
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
22
num At Risk
361
num Events
24
group Id
EG001
num Affected
10
num At Risk
315
num Events
10
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
99
num At Risk
361
num Events
108
group Id
EG001
num Affected
98
num At Risk
315
num Events
101
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
87
num At Risk
361
num Events
112
group Id
EG001
num Affected
84
num At Risk
315
num Events
106
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
31
num At Risk
361
num Events
34
group Id
EG001
num Affected
30
num At Risk
315
num Events
33
term
Odynophagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
48
num At Risk
361
num Events
56
group Id
EG001
num Affected
28
num At Risk
315
num Events
28
term
Oral pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
3
num At Risk
361
num Events
3
group Id
EG001
num Affected
3
num At Risk
315
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
0
num At Risk
315
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
5
num At Risk
315
num Events
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
0
num At Risk
315
num Events
0
term
Hypercoagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
361
num Events
0
group Id
EG001
num Affected
1
num At Risk
315
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
0
num At Risk
315
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
361
num Events
0
group Id
EG001
num Affected
1
num At Risk
315
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
0
num At Risk
315
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
361
num Events
2
group Id
EG001
num Affected
1
num At Risk
315
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
361
num Events
1
group Id
EG001
num Affected
0
num At Risk
315
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
361
num Events
0
group Id
EG001
num Affected
1
num At Risk
315
num Events
1
term
Bradyarrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
361
num Events
0
group Id
EG001
num Affected
1
num At Risk
315
num Events
1
term
Bradycardia

time Frame

Up to ~66 months

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Preserved source evidence · Not medical advice