NCT02335424 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052) · Source last updated 2023-03-02

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 80.5 months
Other-event reporting threshold: 5%

Adverse events=all participants who received ≥1 dose of study treatment; all-cause mortality=all allocated participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" \& "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 Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.	190 / 370	342 / 370	305 / 374
Second Course Pembrolizumab Participants who met the criteria for retreatment received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle for up to 1 year of treatment.	6 / 13	12 / 13	8 / 13

Group identifiers: EG000: Pembrolizumab · EG001: Second Course Pembrolizumab

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 24.1
stats
group Id
EG000
num Affected
6
num At Risk
370
num Events
6
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Atrioventricular block
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Ischaemic cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Pericarditis

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 24.1
stats
group Id
EG000
num Affected
73
num At Risk
370
num Events
84
group Id
EG001
num Affected
3
num At Risk
13
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
370
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Ear swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
42
num At Risk
370
num Events
42
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
370
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
47
num At Risk
370
num Events
57
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
6
num At Risk
370
num Events
6
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
370
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
87
num At Risk
370
num Events
100
group Id
EG001
num Affected
3
num At Risk
13
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
82
num At Risk
370
num Events
121
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
23
num At Risk
370
num Events
23
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
77
num At Risk
370
num Events
89
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
56
num At Risk
370
num Events
79
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Vomiting

Complete source fields

description

event Groups

deaths Num Affected
305
deaths Num At Risk
374
description
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
id
EG000
other Num Affected
342
other Num At Risk
370
serious Num Affected
190
serious Num At Risk
370
title
Pembrolizumab
deaths Num Affected
8
deaths Num At Risk
13
description
Participants who met the criteria for retreatment received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle for up to 1 year of treatment.
id
EG001
other Num Affected
12
other Num At Risk
13
serious Num Affected
6
serious Num At Risk
13
title
Second Course Pembrolizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
73
num At Risk
370
num Events
84
group Id
EG001
num Affected
3
num At Risk
13
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
370
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Ear swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
42
num At Risk
370
num Events
42
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
370
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
47
num At Risk
370
num Events
57
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
6
num At Risk
370
num Events
6
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
370
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
87
num At Risk
370
num Events
100
group Id
EG001
num Affected
3
num At Risk
13
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
82
num At Risk
370
num Events
121
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
23
num At Risk
370
num Events
23
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
77
num At Risk
370
num Events
89
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
56
num At Risk
370
num Events
79
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
6
num At Risk
370
num Events
6
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Atrioventricular block
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Ischaemic cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Pericarditis

time Frame

Up to approximately 80.5 months

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Preserved source evidence · Not medical advice