NCT01848834 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012) · Source last updated 2021-06-28

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: Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
Other-event reporting threshold: 5%

All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A: Triple Negative Breast Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.	13 / 32	31 / 32	25 / 32
Cohort B: Head & Neck Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.	27 / 60	58 / 60	54 / 61
Cohort C: Urothelial Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.	21 / 33	32 / 33	29 / 33
Cohort D: Gastric Cancer Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.	17 / 39	37 / 39	34 / 39
Cohort B2: Head & Neck Cancer Expansion Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.	60 / 132	124 / 132	110 / 132

Group identifiers: EG000: Cohort A: Triple Negative Breast Cancer · EG001: Cohort B: Head & Neck Cancer · EG002: Cohort C: Urothelial Cancer · EG003: Cohort D: Gastric Cancer · EG004: Cohort B2: Head & Neck Cancer Expansion

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 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
2
num At Risk
60
num Events
2
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
1
num At Risk
39
num Events
1
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
2
num At Risk
60
num Events
2
group Id
EG002
num Affected
1
num At Risk
33
num Events
1
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
2
num At Risk
60
num Events
3
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
1
num At Risk
39
num Events
1
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
2
term
Hypercalcaemia of malignancy

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 23.0
stats
group Id
EG000
num Affected
3
num At Risk
32
num Events
3
group Id
EG001
num Affected
19
num At Risk
60
num Events
22
group Id
EG002
num Affected
7
num At Risk
33
num Events
7
group Id
EG003
num Affected
4
num At Risk
39
num Events
5
group Id
EG004
num Affected
27
num At Risk
132
num Events
32
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
5
group Id
EG001
num Affected
5
num At Risk
60
num Events
6
group Id
EG002
num Affected
1
num At Risk
33
num Events
1
group Id
EG003
num Affected
1
num At Risk
39
num Events
1
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
4
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
2
num At Risk
39
num Events
10
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
group Id
EG002
num Affected
2
num At Risk
33
num Events
2
group Id
EG003
num Affected
2
num At Risk
39
num Events
2
group Id
EG004
num Affected
5
num At Risk
132
num Events
5
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
3
num At Risk
39
num Events
3
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
9
num At Risk
60
num Events
10
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
5
num At Risk
39
num Events
5
group Id
EG004
num Affected
19
num At Risk
132
num Events
20
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
1
num At Risk
33
num Events
1
group Id
EG003
num Affected
4
num At Risk
39
num Events
5
group Id
EG004
num Affected
2
num At Risk
132
num Events
3
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
32
num Events
3
group Id
EG001
num Affected
4
num At Risk
60
num Events
4
group Id
EG002
num Affected
1
num At Risk
33
num Events
2
group Id
EG003
num Affected
3
num At Risk
39
num Events
3
group Id
EG004
num Affected
3
num At Risk
132
num Events
4
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
32
num Events
2
group Id
EG001
num Affected
3
num At Risk
60
num Events
3
group Id
EG002
num Affected
6
num At Risk
33
num Events
7
group Id
EG003
num Affected
13
num At Risk
39
num Events
16
group Id
EG004
num Affected
8
num At Risk
132
num Events
8
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
4
num At Risk
39
num Events
4
group Id
EG004
num Affected
3
num At Risk
132
num Events
3
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
3
num At Risk
39
num Events
3
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
6
num At Risk
32
num Events
6
group Id
EG001
num Affected
15
num At Risk
60
num Events
17
group Id
EG002
num Affected
10
num At Risk
33
num Events
11
group Id
EG003
num Affected
7
num At Risk
39
num Events
10
group Id
EG004
num Affected
21
num At Risk
132
num Events
22
term
Constipation

Complete source fields

description

event Groups

deaths Num Affected
25
deaths Num At Risk
32
description
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
id
EG000
other Num Affected
31
other Num At Risk
32
serious Num Affected
13
serious Num At Risk
32
title
Cohort A: Triple Negative Breast Cancer
deaths Num Affected
54
deaths Num At Risk
61
description
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
id
EG001
other Num Affected
58
other Num At Risk
60
serious Num Affected
27
serious Num At Risk
60
title
Cohort B: Head & Neck Cancer
deaths Num Affected
29
deaths Num At Risk
33
description
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
id
EG002
other Num Affected
32
other Num At Risk
33
serious Num Affected
21
serious Num At Risk
33
title
Cohort C: Urothelial Cancer
deaths Num Affected
34
deaths Num At Risk
39
description
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
id
EG003
other Num Affected
37
other Num At Risk
39
serious Num Affected
17
serious Num At Risk
39
title
Cohort D: Gastric Cancer
deaths Num Affected
110
deaths Num At Risk
132
description
Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
id
EG004
other Num Affected
124
other Num At Risk
132
serious Num Affected
60
serious Num At Risk
132
title
Cohort B2: Head & Neck Cancer Expansion

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
32
num Events
3
group Id
EG001
num Affected
19
num At Risk
60
num Events
22
group Id
EG002
num Affected
7
num At Risk
33
num Events
7
group Id
EG003
num Affected
4
num At Risk
39
num Events
5
group Id
EG004
num Affected
27
num At Risk
132
num Events
32
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
5
group Id
EG001
num Affected
5
num At Risk
60
num Events
6
group Id
EG002
num Affected
1
num At Risk
33
num Events
1
group Id
EG003
num Affected
1
num At Risk
39
num Events
1
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
4
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
2
num At Risk
39
num Events
10
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
group Id
EG002
num Affected
2
num At Risk
33
num Events
2
group Id
EG003
num Affected
2
num At Risk
39
num Events
2
group Id
EG004
num Affected
5
num At Risk
132
num Events
5
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
3
num At Risk
39
num Events
3
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
9
num At Risk
60
num Events
10
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
5
num At Risk
39
num Events
5
group Id
EG004
num Affected
19
num At Risk
132
num Events
20
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
1
num At Risk
33
num Events
1
group Id
EG003
num Affected
4
num At Risk
39
num Events
5
group Id
EG004
num Affected
2
num At Risk
132
num Events
3
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
32
num Events
3
group Id
EG001
num Affected
4
num At Risk
60
num Events
4
group Id
EG002
num Affected
1
num At Risk
33
num Events
2
group Id
EG003
num Affected
3
num At Risk
39
num Events
3
group Id
EG004
num Affected
3
num At Risk
132
num Events
4
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
32
num Events
2
group Id
EG001
num Affected
3
num At Risk
60
num Events
3
group Id
EG002
num Affected
6
num At Risk
33
num Events
7
group Id
EG003
num Affected
13
num At Risk
39
num Events
16
group Id
EG004
num Affected
8
num At Risk
132
num Events
8
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
4
num At Risk
39
num Events
4
group Id
EG004
num Affected
3
num At Risk
132
num Events
3
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
3
num At Risk
39
num Events
3
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
6
num At Risk
32
num Events
6
group Id
EG001
num Affected
15
num At Risk
60
num Events
17
group Id
EG002
num Affected
10
num At Risk
33
num Events
11
group Id
EG003
num Affected
7
num At Risk
39
num Events
10
group Id
EG004
num Affected
21
num At Risk
132
num Events
22
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
2
num At Risk
60
num Events
2
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
1
num At Risk
39
num Events
1
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
1
num At Risk
60
num Events
1
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
2
num At Risk
60
num Events
2
group Id
EG002
num Affected
1
num At Risk
33
num Events
1
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
2
num At Risk
60
num Events
3
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
1
num At Risk
39
num Events
1
group Id
EG004
num Affected
0
num At Risk
132
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
32
num Events
1
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
32
num Events
0
group Id
EG001
num Affected
0
num At Risk
60
num Events
0
group Id
EG002
num Affected
0
num At Risk
33
num Events
0
group Id
EG003
num Affected
0
num At Risk
39
num Events
0
group Id
EG004
num Affected
1
num At Risk
132
num Events
2
term
Hypercalcaemia of malignancy

time Frame

Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).

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

Preserved source evidence · Independent clinical review pending · Not medical advice