NCT02559687 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180) · Source last updated 2022-09-14

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 67 months
Other-event reporting threshold: 5%

All-Cause Mortality was reported for all allocated participants. Serious AEs and Other AEs were reported for all allocated participants who received at least 1 dose of study treatment. 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 200 mg First Course Participants received pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).	47 / 121	107 / 121	116 / 121
Pembrolizumab 200 mg Second Course Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).	0 / 1	1 / 1	0 / 1

Group identifiers: EG000: Pembrolizumab 200 mg First Course · EG001: Pembrolizumab 200 mg Second Course

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 24.1
stats
group Id
EG000
num Affected
2
num At Risk
121
num Events
2
group Id
EG001
num Affected
0
num At Risk
1
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
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Tracheo-oesophageal fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
121
num Events
2
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Hypopituitarism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Inappropriate antidiuretic hormone secretion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
2
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Haematochezia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Intestinal pseudo-obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Melaena
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Nausea

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
18
num At Risk
121
num Events
22
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
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
121
num Events
0
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
term
Deafness neurosensory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
11
num At Risk
121
num Events
13
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
9
num At Risk
121
num Events
9
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
23
num At Risk
121
num Events
24
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
18
num At Risk
121
num Events
22
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
7
num At Risk
121
num Events
7
group Id
EG001
num Affected
0
num At Risk
1
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
8
num At Risk
121
num Events
8
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
22
num At Risk
121
num Events
26
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
3
num At Risk
121
num Events
3
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
19
num At Risk
121
num Events
25
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Vomiting

Complete source fields

description

event Groups

deaths Num Affected
116
deaths Num At Risk
121
description
Participants received pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
id
EG000
other Num Affected
107
other Num At Risk
121
serious Num Affected
47
serious Num At Risk
121
title
Pembrolizumab 200 mg First Course
deaths Num Affected
0
deaths Num At Risk
1
description
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Pembrolizumab 200 mg Second Course

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
18
num At Risk
121
num Events
22
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
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
121
num Events
0
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
term
Deafness neurosensory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
11
num At Risk
121
num Events
13
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
9
num At Risk
121
num Events
9
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
23
num At Risk
121
num Events
24
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
18
num At Risk
121
num Events
22
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
7
num At Risk
121
num Events
7
group Id
EG001
num Affected
0
num At Risk
1
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
8
num At Risk
121
num Events
8
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
22
num At Risk
121
num Events
26
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
3
num At Risk
121
num Events
3
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
19
num At Risk
121
num Events
25
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
121
num Events
2
group Id
EG001
num Affected
0
num At Risk
1
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
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Tracheo-oesophageal fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
121
num Events
2
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Hypopituitarism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Inappropriate antidiuretic hormone secretion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
2
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Haematochezia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Intestinal pseudo-obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Melaena
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
121
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
term
Nausea

time Frame

Up to approximately 67 months

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

Preserved source evidence · Not medical advice