NCT03284424 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629) · Source last updated 2024-08-23

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 56 months
Other-event reporting threshold: 5%

The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).	87 / 159	139 / 159	97 / 159
Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	2 / 3	2 / 3	1 / 3

Group identifiers: EG000: Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course · EG001: Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC 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 26.0
stats
group Id
EG000
num Affected
3
num At Risk
159
num Events
3
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Anaemia
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
159
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Haemolytic anaemia
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
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
159
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
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
1
num At Risk
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
159
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
159
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Cardiac failure chronic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
159
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Ventricular extrasystoles
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Adrenal insufficiency

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
18
num At Risk
159
num Events
26
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
14
num At Risk
159
num Events
16
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
13
num At Risk
159
num Events
14
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
40
num At Risk
159
num Events
47
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
31
num At Risk
159
num Events
38
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
23
num At Risk
159
num Events
29
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
16
num At Risk
159
num Events
22
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
35
num At Risk
159
num Events
44
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
8
num At Risk
159
num Events
8
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
35
num At Risk
159
num Events
39
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
17
num At Risk
159
num Events
21
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
14
num At Risk
159
num Events
17
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Pyrexia

Complete source fields

description

event Groups

deaths Num Affected
97
deaths Num At Risk
159
description
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
id
EG000
other Num Affected
139
other Num At Risk
159
serious Num Affected
87
serious Num At Risk
159
title
Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course
deaths Num Affected
1
deaths Num At Risk
3
description
Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
id
EG001
other Num Affected
2
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course

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
18
num At Risk
159
num Events
26
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
14
num At Risk
159
num Events
16
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
13
num At Risk
159
num Events
14
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
40
num At Risk
159
num Events
47
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
31
num At Risk
159
num Events
38
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
23
num At Risk
159
num Events
29
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
16
num At Risk
159
num Events
22
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
35
num At Risk
159
num Events
44
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
8
num At Risk
159
num Events
8
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
35
num At Risk
159
num Events
39
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
17
num At Risk
159
num Events
21
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
14
num At Risk
159
num Events
17
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Pyrexia

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
159
num Events
3
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Anaemia
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
159
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Haemolytic anaemia
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
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
159
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
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
1
num At Risk
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
159
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
159
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Cardiac failure chronic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
159
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Ventricular extrasystoles
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
159
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Adrenal insufficiency

time Frame

Up to approximately 56 months

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

Preserved source evidence · Not medical advice