NCT02362594 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054) · Source last updated 2026-03-05

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 29 months (through database cut-off date of 02-Oct-2017)
Other-event reporting threshold: 5%

All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.	128 / 509	443 / 509	25 / 514
Placebo In Part 1, participants received placebo IV as post-surgery therapy Q3W.	82 / 502	409 / 502	35 / 505

Group identifiers: EG000: Pembrolizumab · EG001: Placebo

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
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
509
num Events
0
group Id
EG001
num Affected
1
num At Risk
502
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
2
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Autoimmune pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Adrenocortical insufficiency acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
3
num At Risk
509
num Events
3
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Hypophysitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Hypopituitarism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
509
num Events
0
group Id
EG001
num Affected
1
num At Risk
502
num Events
1
term
Secondary adrenocortical insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
509
num Events
2
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Thyroiditis

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
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
52
num At Risk
509
num Events
61
group Id
EG001
num Affected
6
num At Risk
502
num Events
6
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
75
num At Risk
509
num Events
93
group Id
EG001
num Affected
14
num At Risk
502
num Events
14
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
37
num At Risk
509
num Events
40
group Id
EG001
num Affected
31
num At Risk
502
num Events
37
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
34
num At Risk
509
num Events
37
group Id
EG001
num Affected
29
num At Risk
502
num Events
32
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
140
num At Risk
509
num Events
238
group Id
EG001
num Affected
129
num At Risk
502
num Events
234
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
30
num At Risk
509
num Events
32
group Id
EG001
num Affected
10
num At Risk
502
num Events
10
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
88
num At Risk
509
num Events
112
group Id
EG001
num Affected
73
num At Risk
502
num Events
103
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
40
num At Risk
509
num Events
55
group Id
EG001
num Affected
22
num At Risk
502
num Events
25
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
56
num At Risk
509
num Events
93
group Id
EG001
num Affected
42
num At Risk
502
num Events
71
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
168
num At Risk
509
num Events
247
group Id
EG001
num Affected
168
num At Risk
502
num Events
232
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
55
num At Risk
509
num Events
73
group Id
EG001
num Affected
38
num At Risk
502
num Events
47
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
44
num At Risk
509
num Events
54
group Id
EG001
num Affected
25
num At Risk
502
num Events
26
term
Nasopharyngitis

Complete source fields

description

event Groups

deaths Num Affected
25
deaths Num At Risk
514
description
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
id
EG000
other Num Affected
443
other Num At Risk
509
serious Num Affected
128
serious Num At Risk
509
title
Pembrolizumab
deaths Num Affected
35
deaths Num At Risk
505
description
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
id
EG001
other Num Affected
409
other Num At Risk
502
serious Num Affected
82
serious Num At Risk
502
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
52
num At Risk
509
num Events
61
group Id
EG001
num Affected
6
num At Risk
502
num Events
6
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
75
num At Risk
509
num Events
93
group Id
EG001
num Affected
14
num At Risk
502
num Events
14
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
37
num At Risk
509
num Events
40
group Id
EG001
num Affected
31
num At Risk
502
num Events
37
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
34
num At Risk
509
num Events
37
group Id
EG001
num Affected
29
num At Risk
502
num Events
32
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
140
num At Risk
509
num Events
238
group Id
EG001
num Affected
129
num At Risk
502
num Events
234
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
30
num At Risk
509
num Events
32
group Id
EG001
num Affected
10
num At Risk
502
num Events
10
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
88
num At Risk
509
num Events
112
group Id
EG001
num Affected
73
num At Risk
502
num Events
103
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
40
num At Risk
509
num Events
55
group Id
EG001
num Affected
22
num At Risk
502
num Events
25
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
56
num At Risk
509
num Events
93
group Id
EG001
num Affected
42
num At Risk
502
num Events
71
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
168
num At Risk
509
num Events
247
group Id
EG001
num Affected
168
num At Risk
502
num Events
232
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
55
num At Risk
509
num Events
73
group Id
EG001
num Affected
38
num At Risk
502
num Events
47
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
44
num At Risk
509
num Events
54
group Id
EG001
num Affected
25
num At Risk
502
num Events
26
term
Nasopharyngitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
509
num Events
0
group Id
EG001
num Affected
1
num At Risk
502
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
2
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Autoimmune pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Adrenocortical insufficiency acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
3
num At Risk
509
num Events
3
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Hypophysitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
509
num Events
1
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Hypopituitarism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
509
num Events
0
group Id
EG001
num Affected
1
num At Risk
502
num Events
1
term
Secondary adrenocortical insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
509
num Events
2
group Id
EG001
num Affected
0
num At Risk
502
num Events
0
term
Thyroiditis

time Frame

Up to 29 months (through database cut-off date of 02-Oct-2017)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice