NCT03189719 · ADVERSE EVENTS

Adverse events

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590) · Source last updated 2024-10-15

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 70 months
Other-event reporting threshold: 5%

All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab + SOC Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	207 / 370	367 / 370	331 / 373
Placebo + SOC Participants received placebo to pembrolizumab (saline) IV Q3W along with SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	204 / 370	364 / 370	363 / 376

Group identifiers: EG000: Pembrolizumab + SOC · EG001: Placebo + SOC

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 26.0
stats
group Id
EG000
num Affected
3
num At Risk
370
num Events
3
group Id
EG001
num Affected
10
num At Risk
370
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
370
num Events
9
group Id
EG001
num Affected
13
num At Risk
370
num Events
13
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
370
num Events
0
group Id
EG001
num Affected
1
num At Risk
370
num Events
1
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
1
num At Risk
370
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
5
num At Risk
370
num Events
5
group Id
EG001
num Affected
3
num At Risk
370
num Events
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
370
num Events
0
group Id
EG001
num Affected
1
num At Risk
370
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
3
num At Risk
370
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
1
num At Risk
370
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
370
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
370
num Events
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
1
num At Risk
370
num Events
1
term
Arteriospasm coronary
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
370
num Events
0
term
Atrial fibrillation

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 26.0
stats
group Id
EG000
num Affected
185
num At Risk
370
num Events
288
group Id
EG001
num Affected
199
num At Risk
370
num Events
295
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
25
num At Risk
370
num Events
56
group Id
EG001
num Affected
29
num At Risk
370
num Events
72
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
95
num At Risk
370
num Events
190
group Id
EG001
num Affected
90
num At Risk
370
num Events
179
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
28
num At Risk
370
num Events
54
group Id
EG001
num Affected
37
num At Risk
370
num Events
57
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
36
num At Risk
370
num Events
38
group Id
EG001
num Affected
27
num At Risk
370
num Events
30
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
19
num At Risk
370
num Events
19
group Id
EG001
num Affected
3
num At Risk
370
num Events
4
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
40
num At Risk
370
num Events
46
group Id
EG001
num Affected
24
num At Risk
370
num Events
27
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
28
num At Risk
370
num Events
33
group Id
EG001
num Affected
18
num At Risk
370
num Events
21
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
20
num At Risk
370
num Events
21
group Id
EG001
num Affected
27
num At Risk
370
num Events
41
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
147
num At Risk
370
num Events
238
group Id
EG001
num Affected
149
num At Risk
370
num Events
210
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
129
num At Risk
370
num Events
226
group Id
EG001
num Affected
120
num At Risk
370
num Events
190
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
46
num At Risk
370
num Events
56
group Id
EG001
num Affected
53
num At Risk
370
num Events
66
term
Dysphagia

Complete source fields

description

event Groups

deaths Num Affected
331
deaths Num At Risk
373
description
Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
id
EG000
other Num Affected
367
other Num At Risk
370
serious Num Affected
207
serious Num At Risk
370
title
Pembrolizumab + SOC
deaths Num Affected
363
deaths Num At Risk
376
description
Participants received placebo to pembrolizumab (saline) IV Q3W along with SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
id
EG001
other Num Affected
364
other Num At Risk
370
serious Num Affected
204
serious Num At Risk
370
title
Placebo + SOC

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
185
num At Risk
370
num Events
288
group Id
EG001
num Affected
199
num At Risk
370
num Events
295
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
25
num At Risk
370
num Events
56
group Id
EG001
num Affected
29
num At Risk
370
num Events
72
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
95
num At Risk
370
num Events
190
group Id
EG001
num Affected
90
num At Risk
370
num Events
179
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
28
num At Risk
370
num Events
54
group Id
EG001
num Affected
37
num At Risk
370
num Events
57
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
36
num At Risk
370
num Events
38
group Id
EG001
num Affected
27
num At Risk
370
num Events
30
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
19
num At Risk
370
num Events
19
group Id
EG001
num Affected
3
num At Risk
370
num Events
4
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
40
num At Risk
370
num Events
46
group Id
EG001
num Affected
24
num At Risk
370
num Events
27
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
28
num At Risk
370
num Events
33
group Id
EG001
num Affected
18
num At Risk
370
num Events
21
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
20
num At Risk
370
num Events
21
group Id
EG001
num Affected
27
num At Risk
370
num Events
41
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
147
num At Risk
370
num Events
238
group Id
EG001
num Affected
149
num At Risk
370
num Events
210
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
129
num At Risk
370
num Events
226
group Id
EG001
num Affected
120
num At Risk
370
num Events
190
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
46
num At Risk
370
num Events
56
group Id
EG001
num Affected
53
num At Risk
370
num Events
66
term
Dysphagia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
370
num Events
3
group Id
EG001
num Affected
10
num At Risk
370
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
370
num Events
9
group Id
EG001
num Affected
13
num At Risk
370
num Events
13
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
370
num Events
0
group Id
EG001
num Affected
1
num At Risk
370
num Events
1
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
1
num At Risk
370
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
5
num At Risk
370
num Events
5
group Id
EG001
num Affected
3
num At Risk
370
num Events
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
370
num Events
0
group Id
EG001
num Affected
1
num At Risk
370
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
3
num At Risk
370
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
1
num At Risk
370
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
370
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
370
num Events
2
group Id
EG001
num Affected
0
num At Risk
370
num Events
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
1
num At Risk
370
num Events
1
term
Arteriospasm coronary
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
370
num Events
1
group Id
EG001
num Affected
0
num At Risk
370
num Events
0
term
Atrial fibrillation

time Frame

Up to approximately 70 months

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Preserved source evidence · Not medical advice