NCT00738530 · ADVERSE EVENTS

Adverse events

A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy · Source last updated 2016-06-23

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: Baseline up to 4.25 years
Other-event reporting threshold: 5%

Safety population: all participants randomized and exposed to study drug (8 randomized participants did not receive study treatment and were not included, 2 in bevacizumab and 6 in placebo group). 12 participants randomized to placebo received bevacizumab, were included in bevacizumab arm. n=number of evaluable participants at specified time point.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bevacizumab + IFN-Alfa-2A Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.	103 / 337	319 / 337	Not reported / Not reported
Placebo + IFN-Alfa-2A Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.	51 / 304	279 / 304	Not reported / Not reported

Group identifiers: EG000: Bevacizumab + IFN-Alfa-2A · EG001: Placebo + IFN-Alfa-2A

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
8
num At Risk
337
group Id
EG001
num Affected
0
num At Risk
304
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
3
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
2
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
0
num At Risk
337
group Id
EG001
num Affected
2
num At Risk
304
term
Lower respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
1
num At Risk
337
group Id
EG001
num Affected
0
num At Risk
304
term
Infection anal abscess
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
0
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Bronchopneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
0
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Gastroenteritis salmonella
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
0
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Hepatitis C
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
1
num At Risk
337
group Id
EG001
num Affected
0
num At Risk
304
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
0
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Labyrinthitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
1
num At Risk
337
group Id
EG001
num Affected
0
num At Risk
304
term
Localised infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
1
num At Risk
337
group Id
EG001
num Affected
0
num At Risk
304
term
Postoperative abscess

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
149
num At Risk
337
group Id
EG001
num Affected
130
num At Risk
304
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
108
num At Risk
337
group Id
EG001
num Affected
83
num At Risk
304
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
107
num At Risk
337
group Id
EG001
num Affected
83
num At Risk
304
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
84
num At Risk
337
group Id
EG001
num Affected
78
num At Risk
304
term
Influenza like illness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
53
num At Risk
337
group Id
EG001
num Affected
54
num At Risk
304
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
18
num At Risk
337
group Id
EG001
num Affected
11
num At Risk
304
term
Mucosal inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
97
num At Risk
337
group Id
EG001
num Affected
78
num At Risk
304
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
70
num At Risk
337
group Id
EG001
num Affected
48
num At Risk
304
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
47
num At Risk
337
group Id
EG001
num Affected
42
num At Risk
304
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
39
num At Risk
337
group Id
EG001
num Affected
25
num At Risk
304
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
28
num At Risk
337
group Id
EG001
num Affected
25
num At Risk
304
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
23
num At Risk
337
group Id
EG001
num Affected
13
num At Risk
304
term
Abdominal pain upper

Complete source fields

description

event Groups

description
Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
id
EG000
other Num Affected
319
other Num At Risk
337
serious Num Affected
103
serious Num At Risk
337
title
Bevacizumab + IFN-Alfa-2A
description
Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
id
EG001
other Num Affected
279
other Num At Risk
304
serious Num Affected
51
serious Num At Risk
304
title
Placebo + IFN-Alfa-2A

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
149
num At Risk
337
group Id
EG001
num Affected
130
num At Risk
304
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
108
num At Risk
337
group Id
EG001
num Affected
83
num At Risk
304
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
107
num At Risk
337
group Id
EG001
num Affected
83
num At Risk
304
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
84
num At Risk
337
group Id
EG001
num Affected
78
num At Risk
304
term
Influenza like illness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
53
num At Risk
337
group Id
EG001
num Affected
54
num At Risk
304
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
18
num At Risk
337
group Id
EG001
num Affected
11
num At Risk
304
term
Mucosal inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
97
num At Risk
337
group Id
EG001
num Affected
78
num At Risk
304
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
70
num At Risk
337
group Id
EG001
num Affected
48
num At Risk
304
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
47
num At Risk
337
group Id
EG001
num Affected
42
num At Risk
304
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
39
num At Risk
337
group Id
EG001
num Affected
25
num At Risk
304
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
28
num At Risk
337
group Id
EG001
num Affected
25
num At Risk
304
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
23
num At Risk
337
group Id
EG001
num Affected
13
num At Risk
304
term
Abdominal pain upper

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
8
num At Risk
337
group Id
EG001
num Affected
0
num At Risk
304
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
3
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
2
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
0
num At Risk
337
group Id
EG001
num Affected
2
num At Risk
304
term
Lower respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
1
num At Risk
337
group Id
EG001
num Affected
0
num At Risk
304
term
Infection anal abscess
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
0
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Bronchopneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
0
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Gastroenteritis salmonella
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
0
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Hepatitis C
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
1
num At Risk
337
group Id
EG001
num Affected
0
num At Risk
304
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
0
num At Risk
337
group Id
EG001
num Affected
1
num At Risk
304
term
Labyrinthitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
1
num At Risk
337
group Id
EG001
num Affected
0
num At Risk
304
term
Localised infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 11.1
stats
group Id
EG000
num Affected
1
num At Risk
337
group Id
EG001
num Affected
0
num At Risk
304
term
Postoperative abscess

time Frame

Baseline up to 4.25 years

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Preserved source evidence · Not medical advice