NCT04153565 · ADVERSE EVENTS

Adverse events

A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17) · Source last updated 2025-07-17

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 34 months
Other-event reporting threshold: 5%

All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab + Pemetrexed + Cisplatin Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.	7 / 19	19 / 19	13 / 19

Group identifiers: EG000: Pembrolizumab + Pemetrexed + Cisplatin

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 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Uveitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Facial paralysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
term
Pneumonia bacterial

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 25.0
stats
group Id
EG000
num Affected
11
num At Risk
19
num Events
11
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
6
num At Risk
19
num Events
13
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
13
num At Risk
19
num Events
15
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
10
num At Risk
19
num Events
12
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Lip dry
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
19
num Events
21
term
Nausea

Complete source fields

description

event Groups

deaths Num Affected
13
deaths Num At Risk
19
description
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
id
EG000
other Num Affected
19
other Num At Risk
19
serious Num Affected
7
serious Num At Risk
19
title
Pembrolizumab + Pemetrexed + Cisplatin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
11
num At Risk
19
num Events
11
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
6
num At Risk
19
num Events
13
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
13
num At Risk
19
num Events
15
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
10
num At Risk
19
num Events
12
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Lip dry
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
19
num Events
21
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Uveitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Facial paralysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
term
Pneumonia bacterial

time Frame

Up to approximately 34 months

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Preserved source evidence · Not medical advice