NCT01866319 · ADVERSE EVENTS

Adverse events

Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006) · Source last updated 2020-06-02

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 69 months (through End of Trial Analysis data cut-off date of 03-Jun-2019)
Other-event reporting threshold: 5%

All-Cause Mortality table includes all randomized participants. Serious and Other adverse events (AEs) tables include all randomized participants who received at least 1 dose of study drug. 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
Ipilimumab Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).	77 / 256	220 / 256	173 / 278
Pembrolizumab Q2W Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.	89 / 278	257 / 278	166 / 279
Pembrolizumab Q3W Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.	90 / 277	247 / 277	162 / 277

Group identifiers: EG000: Ipilimumab · EG001: Pembrolizumab Q2W · EG002: Pembrolizumab Q3W

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 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
2
num At Risk
278
num Events
2
group Id
EG002
num Affected
2
num At Risk
277
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
3
num At Risk
277
num Events
3
term
Anaemia aggravated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
278
num Events
1
group Id
EG002
num Affected
0
num At Risk
277
num Events
0
term
Lymph nodes enlarged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
2
num At Risk
277
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
1
num At Risk
277
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
1
num At Risk
277
num Events
1
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
278
num Events
1
group Id
EG002
num Affected
0
num At Risk
277
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
0
num At Risk
277
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
1
num At Risk
277
num Events
1
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
1
num At Risk
277
num Events
2
term
Congestive cardiac failure aggravated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
278
num Events
1
group Id
EG002
num Affected
2
num At Risk
277
num Events
2
term
Decompensation cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
278
num Events
1
group Id
EG002
num Affected
0
num At Risk
277
num Events
0
term
Heart attack

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 22.0
stats
group Id
EG000
num Affected
12
num At Risk
256
num Events
14
group Id
EG001
num Affected
34
num At Risk
278
num Events
44
group Id
EG002
num Affected
23
num At Risk
277
num Events
28
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
6
num At Risk
256
num Events
6
group Id
EG001
num Affected
17
num At Risk
278
num Events
19
group Id
EG002
num Affected
12
num At Risk
277
num Events
12
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
5
num At Risk
256
num Events
5
group Id
EG001
num Affected
29
num At Risk
278
num Events
31
group Id
EG002
num Affected
25
num At Risk
277
num Events
26
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
16
num At Risk
256
num Events
19
group Id
EG001
num Affected
29
num At Risk
278
num Events
37
group Id
EG002
num Affected
18
num At Risk
277
num Events
19
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
29
num At Risk
256
num Events
32
group Id
EG001
num Affected
53
num At Risk
278
num Events
78
group Id
EG002
num Affected
39
num At Risk
277
num Events
47
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
69
num At Risk
256
num Events
91
group Id
EG001
num Affected
82
num At Risk
278
num Events
162
group Id
EG002
num Affected
76
num At Risk
277
num Events
116
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
26
num At Risk
278
num Events
27
group Id
EG002
num Affected
20
num At Risk
277
num Events
21
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
55
num At Risk
256
num Events
66
group Id
EG001
num Affected
73
num At Risk
278
num Events
90
group Id
EG002
num Affected
70
num At Risk
277
num Events
88
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
31
num At Risk
256
num Events
35
group Id
EG001
num Affected
45
num At Risk
278
num Events
66
group Id
EG002
num Affected
27
num At Risk
277
num Events
32
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
26
num At Risk
256
num Events
29
group Id
EG001
num Affected
45
num At Risk
278
num Events
92
group Id
EG002
num Affected
41
num At Risk
277
num Events
56
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
73
num At Risk
256
num Events
78
group Id
EG001
num Affected
90
num At Risk
278
num Events
125
group Id
EG002
num Affected
85
num At Risk
277
num Events
116
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
20
num At Risk
256
num Events
22
group Id
EG001
num Affected
29
num At Risk
278
num Events
40
group Id
EG002
num Affected
21
num At Risk
277
num Events
35
term
Fever

Complete source fields

description

event Groups

deaths Num Affected
173
deaths Num At Risk
278
description
Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
id
EG000
other Num Affected
220
other Num At Risk
256
serious Num Affected
77
serious Num At Risk
256
title
Ipilimumab
deaths Num Affected
166
deaths Num At Risk
279
description
Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
id
EG001
other Num Affected
257
other Num At Risk
278
serious Num Affected
89
serious Num At Risk
278
title
Pembrolizumab Q2W
deaths Num Affected
162
deaths Num At Risk
277
description
Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.
id
EG002
other Num Affected
247
other Num At Risk
277
serious Num Affected
90
serious Num At Risk
277
title
Pembrolizumab Q3W

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
12
num At Risk
256
num Events
14
group Id
EG001
num Affected
34
num At Risk
278
num Events
44
group Id
EG002
num Affected
23
num At Risk
277
num Events
28
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
6
num At Risk
256
num Events
6
group Id
EG001
num Affected
17
num At Risk
278
num Events
19
group Id
EG002
num Affected
12
num At Risk
277
num Events
12
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
5
num At Risk
256
num Events
5
group Id
EG001
num Affected
29
num At Risk
278
num Events
31
group Id
EG002
num Affected
25
num At Risk
277
num Events
26
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
16
num At Risk
256
num Events
19
group Id
EG001
num Affected
29
num At Risk
278
num Events
37
group Id
EG002
num Affected
18
num At Risk
277
num Events
19
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
29
num At Risk
256
num Events
32
group Id
EG001
num Affected
53
num At Risk
278
num Events
78
group Id
EG002
num Affected
39
num At Risk
277
num Events
47
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
69
num At Risk
256
num Events
91
group Id
EG001
num Affected
82
num At Risk
278
num Events
162
group Id
EG002
num Affected
76
num At Risk
277
num Events
116
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
26
num At Risk
278
num Events
27
group Id
EG002
num Affected
20
num At Risk
277
num Events
21
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
55
num At Risk
256
num Events
66
group Id
EG001
num Affected
73
num At Risk
278
num Events
90
group Id
EG002
num Affected
70
num At Risk
277
num Events
88
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
31
num At Risk
256
num Events
35
group Id
EG001
num Affected
45
num At Risk
278
num Events
66
group Id
EG002
num Affected
27
num At Risk
277
num Events
32
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
26
num At Risk
256
num Events
29
group Id
EG001
num Affected
45
num At Risk
278
num Events
92
group Id
EG002
num Affected
41
num At Risk
277
num Events
56
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
73
num At Risk
256
num Events
78
group Id
EG001
num Affected
90
num At Risk
278
num Events
125
group Id
EG002
num Affected
85
num At Risk
277
num Events
116
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
20
num At Risk
256
num Events
22
group Id
EG001
num Affected
29
num At Risk
278
num Events
40
group Id
EG002
num Affected
21
num At Risk
277
num Events
35
term
Fever

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
2
num At Risk
278
num Events
2
group Id
EG002
num Affected
2
num At Risk
277
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
3
num At Risk
277
num Events
3
term
Anaemia aggravated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
278
num Events
1
group Id
EG002
num Affected
0
num At Risk
277
num Events
0
term
Lymph nodes enlarged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
2
num At Risk
277
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
1
num At Risk
277
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
1
num At Risk
277
num Events
1
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
278
num Events
1
group Id
EG002
num Affected
0
num At Risk
277
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
0
num At Risk
277
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
1
num At Risk
277
num Events
1
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
0
num At Risk
278
num Events
0
group Id
EG002
num Affected
1
num At Risk
277
num Events
2
term
Congestive cardiac failure aggravated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
278
num Events
1
group Id
EG002
num Affected
2
num At Risk
277
num Events
2
term
Decompensation cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
278
num Events
1
group Id
EG002
num Affected
0
num At Risk
277
num Events
0
term
Heart attack

time Frame

Up to approximately 69 months (through End of Trial Analysis data cut-off date of 03-Jun-2019)

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

Preserved source evidence · Not medical advice