NCT02811861 · ADVERSE EVENTS

Adverse events

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma · Source last updated 2026-02-23

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: From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months)
Other-event reporting threshold: 5%

Safety analysis set included all participants who received at least 1 dose of any study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Lenvatinib 18 mg Plus Everolimus 5 mg Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.	164 / 355	353 / 355	119 / 355
Lenvatinib 20 mg Plus Pembrolizumab 200 mg Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.	178 / 352	351 / 352	78 / 352
Sunitinib 50 mg Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.	113 / 340	332 / 340	99 / 340

Group identifiers: EG000: Lenvatinib 18 mg Plus Everolimus 5 mg · EG001: Lenvatinib 20 mg Plus Pembrolizumab 200 mg · EG002: Sunitinib 50 mg

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 23.0
stats
group Id
EG000
num Affected
3
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
4
num At Risk
340
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
1
num At Risk
340
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Eosinophilia myalgia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
1
num At Risk
340
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
1
num At Risk
340
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
352
group Id
EG002
num Affected
5
num At Risk
340
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
2
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
5
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Arrhythmia

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
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
233
num At Risk
355
group Id
EG001
num Affected
214
num At Risk
352
group Id
EG002
num Affected
166
num At Risk
340
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
169
num At Risk
355
group Id
EG001
num Affected
122
num At Risk
352
group Id
EG002
num Affected
131
num At Risk
340
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
139
num At Risk
355
group Id
EG001
num Affected
125
num At Risk
352
group Id
EG002
num Affected
113
num At Risk
340
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
107
num At Risk
355
group Id
EG001
num Affected
91
num At Risk
352
group Id
EG002
num Affected
67
num At Risk
340
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
73
num At Risk
355
group Id
EG001
num Affected
87
num At Risk
352
group Id
EG002
num Affected
64
num At Risk
340
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
72
num At Risk
355
group Id
EG001
num Affected
72
num At Risk
352
group Id
EG002
num Affected
28
num At Risk
340
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
34
num At Risk
355
group Id
EG001
num Affected
39
num At Risk
352
group Id
EG002
num Affected
55
num At Risk
340
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
45
num At Risk
355
group Id
EG001
num Affected
34
num At Risk
352
group Id
EG002
num Affected
26
num At Risk
340
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
23
num At Risk
355
group Id
EG001
num Affected
36
num At Risk
352
group Id
EG002
num Affected
11
num At Risk
340
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
16
num At Risk
355
group Id
EG001
num Affected
16
num At Risk
352
group Id
EG002
num Affected
30
num At Risk
340
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
24
num At Risk
355
group Id
EG001
num Affected
19
num At Risk
352
group Id
EG002
num Affected
9
num At Risk
340
term
Toothache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
19
num At Risk
355
group Id
EG001
num Affected
20
num At Risk
352
group Id
EG002
num Affected
11
num At Risk
340
term
Haemorrhoids

Complete source fields

description

Safety analysis set included all participants who received at least 1 dose of any study drug.

event Groups

deaths Num Affected
119
deaths Num At Risk
355
description
Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
id
EG000
other Num Affected
353
other Num At Risk
355
serious Num Affected
164
serious Num At Risk
355
title
Lenvatinib 18 mg Plus Everolimus 5 mg
deaths Num Affected
78
deaths Num At Risk
352
description
Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
id
EG001
other Num Affected
351
other Num At Risk
352
serious Num Affected
178
serious Num At Risk
352
title
Lenvatinib 20 mg Plus Pembrolizumab 200 mg
deaths Num Affected
99
deaths Num At Risk
340
description
Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
id
EG002
other Num Affected
332
other Num At Risk
340
serious Num Affected
113
serious Num At Risk
340
title
Sunitinib 50 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
233
num At Risk
355
group Id
EG001
num Affected
214
num At Risk
352
group Id
EG002
num Affected
166
num At Risk
340
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
169
num At Risk
355
group Id
EG001
num Affected
122
num At Risk
352
group Id
EG002
num Affected
131
num At Risk
340
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
139
num At Risk
355
group Id
EG001
num Affected
125
num At Risk
352
group Id
EG002
num Affected
113
num At Risk
340
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
107
num At Risk
355
group Id
EG001
num Affected
91
num At Risk
352
group Id
EG002
num Affected
67
num At Risk
340
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
73
num At Risk
355
group Id
EG001
num Affected
87
num At Risk
352
group Id
EG002
num Affected
64
num At Risk
340
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
72
num At Risk
355
group Id
EG001
num Affected
72
num At Risk
352
group Id
EG002
num Affected
28
num At Risk
340
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
34
num At Risk
355
group Id
EG001
num Affected
39
num At Risk
352
group Id
EG002
num Affected
55
num At Risk
340
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
45
num At Risk
355
group Id
EG001
num Affected
34
num At Risk
352
group Id
EG002
num Affected
26
num At Risk
340
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
23
num At Risk
355
group Id
EG001
num Affected
36
num At Risk
352
group Id
EG002
num Affected
11
num At Risk
340
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
16
num At Risk
355
group Id
EG001
num Affected
16
num At Risk
352
group Id
EG002
num Affected
30
num At Risk
340
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
24
num At Risk
355
group Id
EG001
num Affected
19
num At Risk
352
group Id
EG002
num Affected
9
num At Risk
340
term
Toothache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
19
num At Risk
355
group Id
EG001
num Affected
20
num At Risk
352
group Id
EG002
num Affected
11
num At Risk
340
term
Haemorrhoids

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
4
num At Risk
340
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
1
num At Risk
340
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Eosinophilia myalgia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
1
num At Risk
340
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
1
num At Risk
340
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
352
group Id
EG002
num Affected
5
num At Risk
340
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
2
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
5
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
352
group Id
EG002
num Affected
0
num At Risk
340
term
Arrhythmia

time Frame

From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months)

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Preserved source evidence · Not medical advice