NCT02252042 · ADVERSE EVENTS

Adverse events

Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040) · Source last updated 2023-07-17

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 92 months
Other-event reporting threshold: 5%

All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported according to treatment course for all randomized participants who received ≥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 First Course Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to approximately 24 months.	110 / 246	215 / 246	228 / 247
Standard Treatment First Course Participants received standard treatment of either methotrexate 40 mg/m\^2 IV (could be escalated to 60 mg/m\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\^2 IV loading dose on Day 1 and 250 mg/m\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.	92 / 234	211 / 234	243 / 248
Pembrolizumab Second Course Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to approximately 24 months) with SD or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to approximately 1 additional year.	0 / 2	0 / 2	2 / 2

Group identifiers: EG000: Pembrolizumab First Course · EG001: Standard Treatment First Course · EG002: Pembrolizumab 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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
246
num Events
5
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
3
group Id
EG001
num Affected
0
num At Risk
234
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
9
num At Risk
234
num Events
9
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Lymph node haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
3
num At Risk
246
num Events
3
group Id
EG001
num Affected
2
num At Risk
234
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Hypercalcaemia of malignancy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
234
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Autoimmune colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
246
num Events
7
group Id
EG001
num Affected
2
num At Risk
234
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Diarrhoea

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 25.0
stats
group Id
EG000
num Affected
61
num At Risk
246
num Events
77
group Id
EG001
num Affected
53
num At Risk
234
num Events
72
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
41
num At Risk
246
num Events
45
group Id
EG001
num Affected
10
num At Risk
234
num Events
10
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
9
num At Risk
246
num Events
12
group Id
EG001
num Affected
12
num At Risk
234
num Events
12
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
43
num At Risk
246
num Events
49
group Id
EG001
num Affected
37
num At Risk
234
num Events
43
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
37
num At Risk
246
num Events
57
group Id
EG001
num Affected
42
num At Risk
234
num Events
51
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
15
num At Risk
246
num Events
15
group Id
EG001
num Affected
6
num At Risk
234
num Events
6
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
21
num At Risk
246
num Events
22
group Id
EG001
num Affected
15
num At Risk
234
num Events
16
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
36
num At Risk
246
num Events
45
group Id
EG001
num Affected
44
num At Risk
234
num Events
52
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
7
num At Risk
246
num Events
9
group Id
EG001
num Affected
26
num At Risk
234
num Events
34
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
24
num At Risk
246
num Events
28
group Id
EG001
num Affected
23
num At Risk
234
num Events
34
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
40
num At Risk
246
num Events
50
group Id
EG001
num Affected
42
num At Risk
234
num Events
54
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
49
num At Risk
246
num Events
53
group Id
EG001
num Affected
63
num At Risk
234
num Events
81
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Fatigue

Complete source fields

description

event Groups

deaths Num Affected
228
deaths Num At Risk
247
description
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to approximately 24 months.
id
EG000
other Num Affected
215
other Num At Risk
246
serious Num Affected
110
serious Num At Risk
246
title
Pembrolizumab First Course
deaths Num Affected
243
deaths Num At Risk
248
description
Participants received standard treatment of either methotrexate 40 mg/m\^2 IV (could be escalated to 60 mg/m\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\^2 IV loading dose on Day 1 and 250 mg/m\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
id
EG001
other Num Affected
211
other Num At Risk
234
serious Num Affected
92
serious Num At Risk
234
title
Standard Treatment First Course
deaths Num Affected
2
deaths Num At Risk
2
description
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to approximately 24 months) with SD or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to approximately 1 additional year.
id
EG002
other Num Affected
0
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Pembrolizumab Second Course

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
61
num At Risk
246
num Events
77
group Id
EG001
num Affected
53
num At Risk
234
num Events
72
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
41
num At Risk
246
num Events
45
group Id
EG001
num Affected
10
num At Risk
234
num Events
10
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
9
num At Risk
246
num Events
12
group Id
EG001
num Affected
12
num At Risk
234
num Events
12
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
43
num At Risk
246
num Events
49
group Id
EG001
num Affected
37
num At Risk
234
num Events
43
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
37
num At Risk
246
num Events
57
group Id
EG001
num Affected
42
num At Risk
234
num Events
51
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
15
num At Risk
246
num Events
15
group Id
EG001
num Affected
6
num At Risk
234
num Events
6
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
21
num At Risk
246
num Events
22
group Id
EG001
num Affected
15
num At Risk
234
num Events
16
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
36
num At Risk
246
num Events
45
group Id
EG001
num Affected
44
num At Risk
234
num Events
52
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
7
num At Risk
246
num Events
9
group Id
EG001
num Affected
26
num At Risk
234
num Events
34
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
24
num At Risk
246
num Events
28
group Id
EG001
num Affected
23
num At Risk
234
num Events
34
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
40
num At Risk
246
num Events
50
group Id
EG001
num Affected
42
num At Risk
234
num Events
54
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
49
num At Risk
246
num Events
53
group Id
EG001
num Affected
63
num At Risk
234
num Events
81
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
246
num Events
5
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
3
group Id
EG001
num Affected
0
num At Risk
234
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
9
num At Risk
234
num Events
9
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Lymph node haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
3
num At Risk
246
num Events
3
group Id
EG001
num Affected
2
num At Risk
234
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Hypercalcaemia of malignancy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
0
num At Risk
234
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Autoimmune colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
246
num Events
1
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
246
num Events
0
group Id
EG001
num Affected
1
num At Risk
234
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
246
num Events
7
group Id
EG001
num Affected
2
num At Risk
234
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Diarrhoea

time Frame

Up to approximately 92 months

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

Preserved source evidence · Not medical advice