NCT02853331 · ADVERSE EVENTS

Adverse events

Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426) · Source last updated 2026-02-02

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: Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
Other-event reporting threshold: 5%

Population: All participants who received ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "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 + Axitinib Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	173 / 429	417 / 429	59 / 432
Sunitinib Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.	133 / 425	415 / 425	97 / 429

Group identifiers: EG000: Pembrolizumab + Axitinib · EG001: Sunitinib

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 21.0
stats
group Id
EG000
num Affected
2
num At Risk
429
num Events
2
group Id
EG001
num Affected
3
num At Risk
425
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
1
num At Risk
425
num Events
1
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
429
num Events
1
group Id
EG001
num Affected
0
num At Risk
425
num Events
0
term
Cytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
1
num At Risk
425
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
4
num At Risk
425
num Events
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
1
num At Risk
425
num Events
1
term
Thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
2
num At Risk
425
num Events
2
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
429
num Events
1
group Id
EG001
num Affected
0
num At Risk
425
num Events
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
4
num At Risk
429
num Events
4
group Id
EG001
num Affected
0
num At Risk
425
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
429
num Events
1
group Id
EG001
num Affected
1
num At Risk
425
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
1
num At Risk
425
num Events
1
term
Cardiac amyloidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
429
num Events
1
group Id
EG001
num Affected
2
num At Risk
425
num Events
2
term
Cardiac arrest

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 21.0
stats
group Id
EG000
num Affected
32
num At Risk
429
num Events
34
group Id
EG001
num Affected
97
num At Risk
425
num Events
152
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
6
num At Risk
429
num Events
11
group Id
EG001
num Affected
41
num At Risk
425
num Events
79
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
8
num At Risk
429
num Events
11
group Id
EG001
num Affected
82
num At Risk
425
num Events
152
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
11
num At Risk
429
num Events
13
group Id
EG001
num Affected
95
num At Risk
425
num Events
164
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
53
num At Risk
429
num Events
58
group Id
EG001
num Affected
16
num At Risk
425
num Events
18
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
152
num At Risk
429
num Events
177
group Id
EG001
num Affected
133
num At Risk
425
num Events
172
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
48
num At Risk
429
num Events
64
group Id
EG001
num Affected
29
num At Risk
425
num Events
32
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
26
num At Risk
429
num Events
35
group Id
EG001
num Affected
26
num At Risk
425
num Events
31
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
89
num At Risk
429
num Events
107
group Id
EG001
num Affected
62
num At Risk
425
num Events
70
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
231
num At Risk
429
num Events
496
group Id
EG001
num Affected
191
num At Risk
425
num Events
380
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
25
num At Risk
429
num Events
27
group Id
EG001
num Affected
25
num At Risk
425
num Events
26
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
22
num At Risk
429
num Events
26
group Id
EG001
num Affected
62
num At Risk
425
num Events
73
term
Dyspepsia

Complete source fields

description

event Groups

deaths Num Affected
59
deaths Num At Risk
432
description
Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
id
EG000
other Num Affected
417
other Num At Risk
429
serious Num Affected
173
serious Num At Risk
429
title
Pembrolizumab + Axitinib
deaths Num Affected
97
deaths Num At Risk
429
description
Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
id
EG001
other Num Affected
415
other Num At Risk
425
serious Num Affected
133
serious Num At Risk
425
title
Sunitinib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
32
num At Risk
429
num Events
34
group Id
EG001
num Affected
97
num At Risk
425
num Events
152
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
6
num At Risk
429
num Events
11
group Id
EG001
num Affected
41
num At Risk
425
num Events
79
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
8
num At Risk
429
num Events
11
group Id
EG001
num Affected
82
num At Risk
425
num Events
152
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
11
num At Risk
429
num Events
13
group Id
EG001
num Affected
95
num At Risk
425
num Events
164
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
53
num At Risk
429
num Events
58
group Id
EG001
num Affected
16
num At Risk
425
num Events
18
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
152
num At Risk
429
num Events
177
group Id
EG001
num Affected
133
num At Risk
425
num Events
172
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
48
num At Risk
429
num Events
64
group Id
EG001
num Affected
29
num At Risk
425
num Events
32
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
26
num At Risk
429
num Events
35
group Id
EG001
num Affected
26
num At Risk
425
num Events
31
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
89
num At Risk
429
num Events
107
group Id
EG001
num Affected
62
num At Risk
425
num Events
70
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
231
num At Risk
429
num Events
496
group Id
EG001
num Affected
191
num At Risk
425
num Events
380
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
25
num At Risk
429
num Events
27
group Id
EG001
num Affected
25
num At Risk
425
num Events
26
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
22
num At Risk
429
num Events
26
group Id
EG001
num Affected
62
num At Risk
425
num Events
73
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
2
num At Risk
429
num Events
2
group Id
EG001
num Affected
3
num At Risk
425
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
1
num At Risk
425
num Events
1
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
429
num Events
1
group Id
EG001
num Affected
0
num At Risk
425
num Events
0
term
Cytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
1
num At Risk
425
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
4
num At Risk
425
num Events
4
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
1
num At Risk
425
num Events
1
term
Thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
2
num At Risk
425
num Events
2
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
429
num Events
1
group Id
EG001
num Affected
0
num At Risk
425
num Events
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
4
num At Risk
429
num Events
4
group Id
EG001
num Affected
0
num At Risk
425
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
429
num Events
1
group Id
EG001
num Affected
1
num At Risk
425
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
429
num Events
0
group Id
EG001
num Affected
1
num At Risk
425
num Events
1
term
Cardiac amyloidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
429
num Events
1
group Id
EG001
num Affected
2
num At Risk
425
num Events
2
term
Cardiac arrest

time Frame

Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

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

Preserved source evidence · Not medical advice