NCT00720941 · ADVERSE EVENTS

Adverse events

Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma · Source last updated 2025-03-30

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: Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 28 days post-treat follow-up, assessed up to approximately 129 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 152 months.
Other-event reporting threshold: 5%

Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pazopanib 800 mg Pazopanib 800 mg: Events up to 28 days post-treatment	242 / 554	541 / 554	25 / 557
Sunitinib 50 mg Sunitinib 50 mg: Events up to 28 days post-treatment	227 / 548	535 / 548	22 / 553
Pazopanib 800 mg (Post-Treatment) Pazopanib 800 mg (Post-Treatment) - Deaths in the post-treatment survival follow-up were not considered adverse events.	0 / 0	0 / 0	310 / 529
Sunitinib 50 mg (Post-Treatment) Sunitinib 50 mg (Post-Treatment) - Deaths in the post-treatment survival follow-up were not considered adverse events.	0 / 0	0 / 0	312 / 526

Group identifiers: EG000: Pazopanib 800 mg · EG001: Sunitinib 50 mg · EG002: Pazopanib 800 mg (Post-Treatment) · EG003: Sunitinib 50 mg (Post-Treatment)

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 (24.1)
stats
group Id
EG000
num Affected
9
num At Risk
554
group Id
EG001
num Affected
9
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
2
num At Risk
554
group Id
EG001
num Affected
0
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
554
group Id
EG001
num Affected
1
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
554
group Id
EG001
num Affected
1
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
554
group Id
EG001
num Affected
1
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Microangiopathic haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
2
num At Risk
554
group Id
EG001
num Affected
7
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
2
num At Risk
554
group Id
EG001
num Affected
0
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Polycythaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
4
num At Risk
554
group Id
EG001
num Affected
24
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
3
num At Risk
554
group Id
EG001
num Affected
2
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
2
num At Risk
554
group Id
EG001
num Affected
0
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
554
group Id
EG001
num Affected
1
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
554
group Id
EG001
num Affected
0
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Atrial fibrillation

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 (24.1)
stats
group Id
EG000
num Affected
36
num At Risk
554
group Id
EG001
num Affected
99
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
51
num At Risk
554
group Id
EG001
num Affected
100
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
60
num At Risk
554
group Id
EG001
num Affected
147
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
56
num At Risk
554
group Id
EG001
num Affected
180
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
7
num At Risk
554
group Id
EG001
num Affected
29
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
71
num At Risk
554
group Id
EG001
num Affected
138
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
18
num At Risk
554
group Id
EG001
num Affected
39
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Eyelid oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
24
num At Risk
554
group Id
EG001
num Affected
33
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
34
num At Risk
554
group Id
EG001
num Affected
27
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
72
num At Risk
554
group Id
EG001
num Affected
74
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
69
num At Risk
554
group Id
EG001
num Affected
49
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
97
num At Risk
554
group Id
EG001
num Affected
133
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Constipation

Complete source fields

description

event Groups

deaths Num Affected
25
deaths Num At Risk
557
description
Pazopanib 800 mg: Events up to 28 days post-treatment
id
EG000
other Num Affected
541
other Num At Risk
554
serious Num Affected
242
serious Num At Risk
554
title
Pazopanib 800 mg
deaths Num Affected
22
deaths Num At Risk
553
description
Sunitinib 50 mg: Events up to 28 days post-treatment
id
EG001
other Num Affected
535
other Num At Risk
548
serious Num Affected
227
serious Num At Risk
548
title
Sunitinib 50 mg
deaths Num Affected
310
deaths Num At Risk
529
description
Pazopanib 800 mg (Post-Treatment) - Deaths in the post-treatment survival follow-up were not considered adverse events.
id
EG002
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Pazopanib 800 mg (Post-Treatment)
deaths Num Affected
312
deaths Num At Risk
526
description
Sunitinib 50 mg (Post-Treatment) - Deaths in the post-treatment survival follow-up were not considered adverse events.
id
EG003
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Sunitinib 50 mg (Post-Treatment)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
36
num At Risk
554
group Id
EG001
num Affected
99
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
51
num At Risk
554
group Id
EG001
num Affected
100
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
60
num At Risk
554
group Id
EG001
num Affected
147
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
56
num At Risk
554
group Id
EG001
num Affected
180
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
7
num At Risk
554
group Id
EG001
num Affected
29
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
71
num At Risk
554
group Id
EG001
num Affected
138
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
18
num At Risk
554
group Id
EG001
num Affected
39
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Eyelid oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
24
num At Risk
554
group Id
EG001
num Affected
33
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
34
num At Risk
554
group Id
EG001
num Affected
27
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
72
num At Risk
554
group Id
EG001
num Affected
74
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
69
num At Risk
554
group Id
EG001
num Affected
49
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
97
num At Risk
554
group Id
EG001
num Affected
133
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
9
num At Risk
554
group Id
EG001
num Affected
9
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
2
num At Risk
554
group Id
EG001
num Affected
0
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
554
group Id
EG001
num Affected
1
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
554
group Id
EG001
num Affected
1
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
0
num At Risk
554
group Id
EG001
num Affected
1
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Microangiopathic haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
2
num At Risk
554
group Id
EG001
num Affected
7
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
2
num At Risk
554
group Id
EG001
num Affected
0
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Polycythaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
4
num At Risk
554
group Id
EG001
num Affected
24
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
3
num At Risk
554
group Id
EG001
num Affected
2
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
2
num At Risk
554
group Id
EG001
num Affected
0
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
554
group Id
EG001
num Affected
1
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (24.1)
stats
group Id
EG000
num Affected
1
num At Risk
554
group Id
EG001
num Affected
0
num At Risk
548
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Atrial fibrillation

time Frame

Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 28 days post-treat follow-up, assessed up to approximately 129 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 152 months.

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

Preserved source evidence · Not medical advice