NCT04195750 · ADVERSE EVENTS

Adverse events

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) · Source last updated 2026-05-14

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 49 months
Other-event reporting threshold: 5%

Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all enrolled participants. 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
Belzutifan Randomized participants receive 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.	160 / 372	356 / 372	254 / 374
Everolimus Randomized participants receive 10 mg of Everolimus orally QD, until disease progression or discontinuation.	139 / 360	348 / 360	259 / 372
Safety Run-In Non-Randomized participants enrolled into the Safety Run-in received up to 120 mg of belzutifan QD.	4 / 9	9 / 9	5 / 9

Group identifiers: EG000: Belzutifan · EG001: Everolimus · EG002: Safety Run-In

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 27.0
stats
group Id
EG000
num Affected
20
num At Risk
372
num Events
21
group Id
EG001
num Affected
8
num At Risk
360
num Events
8
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
0
num At Risk
360
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
372
num Events
0
group Id
EG001
num Affected
1
num At Risk
360
num Events
1
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
1
num At Risk
360
num Events
1
group Id
EG002
num Affected
1
num At Risk
9
num Events
1
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
0
num At Risk
360
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
4
num At Risk
372
num Events
5
group Id
EG001
num Affected
5
num At Risk
360
num Events
5
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
372
num Events
0
group Id
EG001
num Affected
2
num At Risk
360
num Events
2
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
0
num At Risk
360
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
372
num Events
2
group Id
EG001
num Affected
3
num At Risk
360
num Events
4
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
0
num At Risk
360
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Pericardial haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
1
num At Risk
360
num Events
1
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
0
num At Risk
360
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Adrenocortical insufficiency acute

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 27.0
stats
group Id
EG000
num Affected
294
num At Risk
372
num Events
503
group Id
EG001
num Affected
200
num At Risk
360
num Events
272
group Id
EG002
num Affected
8
num At Risk
9
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
14
num At Risk
372
num Events
23
group Id
EG001
num Affected
25
num At Risk
360
num Events
34
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
29
num At Risk
372
num Events
38
group Id
EG001
num Affected
21
num At Risk
360
num Events
23
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
63
num At Risk
372
num Events
78
group Id
EG001
num Affected
30
num At Risk
360
num Events
30
group Id
EG002
num Affected
1
num At Risk
9
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
47
num At Risk
372
num Events
63
group Id
EG001
num Affected
71
num At Risk
360
num Events
87
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
68
num At Risk
372
num Events
96
group Id
EG001
num Affected
44
num At Risk
360
num Events
46
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
13
num At Risk
372
num Events
15
group Id
EG001
num Affected
137
num At Risk
360
num Events
173
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
47
num At Risk
372
num Events
62
group Id
EG001
num Affected
31
num At Risk
360
num Events
32
group Id
EG002
num Affected
2
num At Risk
9
num Events
2
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
55
num At Risk
372
num Events
67
group Id
EG001
num Affected
60
num At Risk
360
num Events
63
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
20
num At Risk
372
num Events
21
group Id
EG001
num Affected
10
num At Risk
360
num Events
10
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
120
num At Risk
372
num Events
138
group Id
EG001
num Affected
91
num At Risk
360
num Events
100
group Id
EG002
num Affected
2
num At Risk
9
num Events
2
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
64
num At Risk
372
num Events
74
group Id
EG001
num Affected
65
num At Risk
360
num Events
71
group Id
EG002
num Affected
1
num At Risk
9
num Events
1
term
Oedema peripheral

Complete source fields

description

event Groups

deaths Num Affected
254
deaths Num At Risk
374
description
Randomized participants receive 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.
id
EG000
other Num Affected
356
other Num At Risk
372
serious Num Affected
160
serious Num At Risk
372
title
Belzutifan
deaths Num Affected
259
deaths Num At Risk
372
description
Randomized participants receive 10 mg of Everolimus orally QD, until disease progression or discontinuation.
id
EG001
other Num Affected
348
other Num At Risk
360
serious Num Affected
139
serious Num At Risk
360
title
Everolimus
deaths Num Affected
5
deaths Num At Risk
9
description
Non-Randomized participants enrolled into the Safety Run-in received up to 120 mg of belzutifan QD.
id
EG002
other Num Affected
9
other Num At Risk
9
serious Num Affected
4
serious Num At Risk
9
title
Safety Run-In

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
294
num At Risk
372
num Events
503
group Id
EG001
num Affected
200
num At Risk
360
num Events
272
group Id
EG002
num Affected
8
num At Risk
9
num Events
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
14
num At Risk
372
num Events
23
group Id
EG001
num Affected
25
num At Risk
360
num Events
34
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
29
num At Risk
372
num Events
38
group Id
EG001
num Affected
21
num At Risk
360
num Events
23
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
63
num At Risk
372
num Events
78
group Id
EG001
num Affected
30
num At Risk
360
num Events
30
group Id
EG002
num Affected
1
num At Risk
9
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
47
num At Risk
372
num Events
63
group Id
EG001
num Affected
71
num At Risk
360
num Events
87
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
68
num At Risk
372
num Events
96
group Id
EG001
num Affected
44
num At Risk
360
num Events
46
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
13
num At Risk
372
num Events
15
group Id
EG001
num Affected
137
num At Risk
360
num Events
173
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
47
num At Risk
372
num Events
62
group Id
EG001
num Affected
31
num At Risk
360
num Events
32
group Id
EG002
num Affected
2
num At Risk
9
num Events
2
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
55
num At Risk
372
num Events
67
group Id
EG001
num Affected
60
num At Risk
360
num Events
63
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
20
num At Risk
372
num Events
21
group Id
EG001
num Affected
10
num At Risk
360
num Events
10
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
120
num At Risk
372
num Events
138
group Id
EG001
num Affected
91
num At Risk
360
num Events
100
group Id
EG002
num Affected
2
num At Risk
9
num Events
2
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
64
num At Risk
372
num Events
74
group Id
EG001
num Affected
65
num At Risk
360
num Events
71
group Id
EG002
num Affected
1
num At Risk
9
num Events
1
term
Oedema peripheral

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
20
num At Risk
372
num Events
21
group Id
EG001
num Affected
8
num At Risk
360
num Events
8
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
0
num At Risk
360
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
372
num Events
0
group Id
EG001
num Affected
1
num At Risk
360
num Events
1
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
1
num At Risk
360
num Events
1
group Id
EG002
num Affected
1
num At Risk
9
num Events
1
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
0
num At Risk
360
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
4
num At Risk
372
num Events
5
group Id
EG001
num Affected
5
num At Risk
360
num Events
5
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
372
num Events
0
group Id
EG001
num Affected
2
num At Risk
360
num Events
2
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
0
num At Risk
360
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
372
num Events
2
group Id
EG001
num Affected
3
num At Risk
360
num Events
4
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
0
num At Risk
360
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Pericardial haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
1
num At Risk
360
num Events
1
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
372
num Events
1
group Id
EG001
num Affected
0
num At Risk
360
num Events
0
group Id
EG002
num Affected
0
num At Risk
9
num Events
0
term
Adrenocortical insufficiency acute

time Frame

Up to approximately 49 months

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Preserved source evidence · Not medical advice