NCT05722015 · ADVERSE EVENTS

Adverse events

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77) · Source last updated 2026-08-26

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 16 months
Other-event reporting threshold: 5%

All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. 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
Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	98 / 251	236 / 251	61 / 251
Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy.	51 / 126	123 / 126	37 / 126

Group identifiers: EG000: Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy · EG001: Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

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
251
num Events
3
group Id
EG001
num Affected
6
num At Risk
126
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
10
num At Risk
251
num Events
10
group Id
EG001
num Affected
2
num At Risk
126
num Events
2
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
2
num At Risk
251
num Events
2
group Id
EG001
num Affected
0
num At Risk
126
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
7
num At Risk
251
num Events
8
group Id
EG001
num Affected
2
num At Risk
126
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
10
num At Risk
251
num Events
11
group Id
EG001
num Affected
3
num At Risk
126
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
251
num Events
2
group Id
EG001
num Affected
1
num At Risk
126
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
251
num Events
1
group Id
EG001
num Affected
0
num At Risk
126
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
251
num Events
1
group Id
EG001
num Affected
1
num At Risk
126
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
251
num Events
1
group Id
EG001
num Affected
0
num At Risk
126
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
251
num Events
0
group Id
EG001
num Affected
1
num At Risk
126
num Events
1
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
251
num Events
1
group Id
EG001
num Affected
0
num At Risk
126
num Events
0
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
251
num Events
1
group Id
EG001
num Affected
2
num At Risk
126
num Events
2
term
Adrenal insufficiency

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
146
num At Risk
251
num Events
220
group Id
EG001
num Affected
85
num At Risk
126
num Events
111
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
74
num At Risk
251
num Events
192
group Id
EG001
num Affected
33
num At Risk
126
num Events
95
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
105
num At Risk
251
num Events
230
group Id
EG001
num Affected
40
num At Risk
126
num Events
91
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
71
num At Risk
251
num Events
126
group Id
EG001
num Affected
35
num At Risk
126
num Events
62
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
20
num At Risk
251
num Events
20
group Id
EG001
num Affected
6
num At Risk
126
num Events
6
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
35
num At Risk
251
num Events
35
group Id
EG001
num Affected
15
num At Risk
126
num Events
15
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
35
num At Risk
251
num Events
41
group Id
EG001
num Affected
23
num At Risk
126
num Events
28
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
36
num At Risk
251
num Events
45
group Id
EG001
num Affected
17
num At Risk
126
num Events
22
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
63
num At Risk
251
num Events
83
group Id
EG001
num Affected
30
num At Risk
126
num Events
38
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
23
num At Risk
251
num Events
30
group Id
EG001
num Affected
8
num At Risk
126
num Events
9
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
24
num At Risk
251
num Events
24
group Id
EG001
num Affected
16
num At Risk
126
num Events
18
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
14
num At Risk
251
num Events
14
group Id
EG001
num Affected
2
num At Risk
126
num Events
2
term
Chest pain

Complete source fields

description

event Groups

deaths Num Affected
61
deaths Num At Risk
251
description
Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
id
EG000
other Num Affected
236
other Num At Risk
251
serious Num Affected
98
serious Num At Risk
251
title
Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy
deaths Num Affected
37
deaths Num At Risk
126
description
Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy.
id
EG001
other Num Affected
123
other Num At Risk
126
serious Num Affected
51
serious Num At Risk
126
title
Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

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
146
num At Risk
251
num Events
220
group Id
EG001
num Affected
85
num At Risk
126
num Events
111
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
74
num At Risk
251
num Events
192
group Id
EG001
num Affected
33
num At Risk
126
num Events
95
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
105
num At Risk
251
num Events
230
group Id
EG001
num Affected
40
num At Risk
126
num Events
91
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
71
num At Risk
251
num Events
126
group Id
EG001
num Affected
35
num At Risk
126
num Events
62
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
20
num At Risk
251
num Events
20
group Id
EG001
num Affected
6
num At Risk
126
num Events
6
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
35
num At Risk
251
num Events
35
group Id
EG001
num Affected
15
num At Risk
126
num Events
15
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
35
num At Risk
251
num Events
41
group Id
EG001
num Affected
23
num At Risk
126
num Events
28
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
36
num At Risk
251
num Events
45
group Id
EG001
num Affected
17
num At Risk
126
num Events
22
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
63
num At Risk
251
num Events
83
group Id
EG001
num Affected
30
num At Risk
126
num Events
38
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
23
num At Risk
251
num Events
30
group Id
EG001
num Affected
8
num At Risk
126
num Events
9
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
24
num At Risk
251
num Events
24
group Id
EG001
num Affected
16
num At Risk
126
num Events
18
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
14
num At Risk
251
num Events
14
group Id
EG001
num Affected
2
num At Risk
126
num Events
2
term
Chest 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
251
num Events
3
group Id
EG001
num Affected
6
num At Risk
126
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
10
num At Risk
251
num Events
10
group Id
EG001
num Affected
2
num At Risk
126
num Events
2
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
2
num At Risk
251
num Events
2
group Id
EG001
num Affected
0
num At Risk
126
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
7
num At Risk
251
num Events
8
group Id
EG001
num Affected
2
num At Risk
126
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
10
num At Risk
251
num Events
11
group Id
EG001
num Affected
3
num At Risk
126
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
251
num Events
2
group Id
EG001
num Affected
1
num At Risk
126
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
251
num Events
1
group Id
EG001
num Affected
0
num At Risk
126
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
251
num Events
1
group Id
EG001
num Affected
1
num At Risk
126
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
251
num Events
1
group Id
EG001
num Affected
0
num At Risk
126
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
251
num Events
0
group Id
EG001
num Affected
1
num At Risk
126
num Events
1
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
251
num Events
1
group Id
EG001
num Affected
0
num At Risk
126
num Events
0
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
251
num Events
1
group Id
EG001
num Affected
2
num At Risk
126
num Events
2
term
Adrenal insufficiency

time Frame

Up to approximately 16 months

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Preserved source evidence · Not medical advice