NCT02504372 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091) · Source last updated 2026-03-17

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 approximately 86 months
Other-event reporting threshold: 5%

All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	142 / 580	510 / 580	136 / 590
Placebo Participants received placebo, IV, every 3 weeks, for one year.	90 / 581	458 / 581	154 / 587

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
2
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
580
num Events
2
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
1
group Id
EG001
num Affected
1
num At Risk
581
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
580
num Events
0
group Id
EG001
num Affected
1
num At Risk
581
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
1
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
1
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
2
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Cardiogenic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
580
num Events
0
group Id
EG001
num Affected
1
num At Risk
581
num Events
1
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
580
num Events
3
group Id
EG001
num Affected
3
num At Risk
581
num Events
3
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
2
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
5
num At Risk
580
num Events
7
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
1
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Pericardial effusion

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 25.1
stats
group Id
EG000
num Affected
62
num At Risk
580
num Events
65
group Id
EG001
num Affected
17
num At Risk
581
num Events
18
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
120
num At Risk
580
num Events
148
group Id
EG001
num Affected
27
num At Risk
581
num Events
29
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
35
num At Risk
580
num Events
38
group Id
EG001
num Affected
41
num At Risk
581
num Events
53
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
104
num At Risk
580
num Events
179
group Id
EG001
num Affected
82
num At Risk
581
num Events
160
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
52
num At Risk
580
num Events
64
group Id
EG001
num Affected
37
num At Risk
581
num Events
48
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
44
num At Risk
580
num Events
66
group Id
EG001
num Affected
32
num At Risk
581
num Events
39
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
96
num At Risk
580
num Events
131
group Id
EG001
num Affected
89
num At Risk
581
num Events
118
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
34
num At Risk
580
num Events
39
group Id
EG001
num Affected
32
num At Risk
581
num Events
36
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
31
num At Risk
580
num Events
34
group Id
EG001
num Affected
32
num At Risk
581
num Events
48
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
50
num At Risk
580
num Events
65
group Id
EG001
num Affected
32
num At Risk
581
num Events
44
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
52
num At Risk
580
num Events
63
group Id
EG001
num Affected
55
num At Risk
581
num Events
68
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
46
num At Risk
580
num Events
75
group Id
EG001
num Affected
34
num At Risk
581
num Events
42
term
Alanine aminotransferase increased

Complete source fields

description

event Groups

deaths Num Affected
136
deaths Num At Risk
590
description
Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
id
EG000
other Num Affected
510
other Num At Risk
580
serious Num Affected
142
serious Num At Risk
580
title
Pembrolizumab
deaths Num Affected
154
deaths Num At Risk
587
description
Participants received placebo, IV, every 3 weeks, for one year.
id
EG001
other Num Affected
458
other Num At Risk
581
serious Num Affected
90
serious Num At Risk
581
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
62
num At Risk
580
num Events
65
group Id
EG001
num Affected
17
num At Risk
581
num Events
18
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
120
num At Risk
580
num Events
148
group Id
EG001
num Affected
27
num At Risk
581
num Events
29
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
35
num At Risk
580
num Events
38
group Id
EG001
num Affected
41
num At Risk
581
num Events
53
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
104
num At Risk
580
num Events
179
group Id
EG001
num Affected
82
num At Risk
581
num Events
160
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
52
num At Risk
580
num Events
64
group Id
EG001
num Affected
37
num At Risk
581
num Events
48
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
44
num At Risk
580
num Events
66
group Id
EG001
num Affected
32
num At Risk
581
num Events
39
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
96
num At Risk
580
num Events
131
group Id
EG001
num Affected
89
num At Risk
581
num Events
118
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
34
num At Risk
580
num Events
39
group Id
EG001
num Affected
32
num At Risk
581
num Events
36
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
31
num At Risk
580
num Events
34
group Id
EG001
num Affected
32
num At Risk
581
num Events
48
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
50
num At Risk
580
num Events
65
group Id
EG001
num Affected
32
num At Risk
581
num Events
44
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
52
num At Risk
580
num Events
63
group Id
EG001
num Affected
55
num At Risk
581
num Events
68
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
46
num At Risk
580
num Events
75
group Id
EG001
num Affected
34
num At Risk
581
num Events
42
term
Alanine aminotransferase increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
2
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
580
num Events
2
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
1
group Id
EG001
num Affected
1
num At Risk
581
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
580
num Events
0
group Id
EG001
num Affected
1
num At Risk
581
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
1
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
1
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
2
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Cardiogenic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
580
num Events
0
group Id
EG001
num Affected
1
num At Risk
581
num Events
1
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
580
num Events
3
group Id
EG001
num Affected
3
num At Risk
581
num Events
3
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
2
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
5
num At Risk
580
num Events
7
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
580
num Events
1
group Id
EG001
num Affected
0
num At Risk
581
num Events
0
term
Pericardial effusion

time Frame

Up to approximately 86 months

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Preserved source evidence · Not medical advice