NCT00943826 · ADVERSE EVENTS

Adverse events

A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma · Source last updated 2017-09-25

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: Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
Other-event reporting threshold: 5%

Safety Population.10 participants did not receive at least 1 dose of drug and were excluded, 4 in Placebo and 6 in Bevacizumab.9 participants randomized to the Placebo+RT+Temozolomide arm incorrectly received at least 1 dose of bevacizumab and were added to the Bevacizumab+RT+Temozolomide arm for safety.Other AEs are non-SAEs (AEs excluding SAEs).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bevacizumab + RT+Temozolomide In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.	179 / 461	437 / 461	Not reported / Not reported
Placebo + RT+Temozolomide In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.	115 / 450	412 / 450	Not reported / Not reported

Group identifiers: EG000: Bevacizumab + RT+Temozolomide · EG001: Placebo + RT+Temozolomide

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
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
461
group Id
EG001
num Affected
5
num At Risk
450
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
6
num At Risk
461
group Id
EG001
num Affected
1
num At Risk
450
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
3
num At Risk
450
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
3
num At Risk
450
term
Brain abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
461
group Id
EG001
num Affected
3
num At Risk
450
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
2
num At Risk
450
term
Pneumocystis jiroveci pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
3
num At Risk
461
group Id
EG001
num Affected
0
num At Risk
450
term
Postoperative wound infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
2
num At Risk
450
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
461
group Id
EG001
num Affected
1
num At Risk
450
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
461
group Id
EG001
num Affected
0
num At Risk
450
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
1
num At Risk
450
term
Meningitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
1
num At Risk
450
term
Upper respiratory tract infection

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 (16.0)
stats
group Id
EG000
num Affected
223
num At Risk
461
group Id
EG001
num Affected
191
num At Risk
450
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
178
num At Risk
461
group Id
EG001
num Affected
137
num At Risk
450
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
145
num At Risk
461
group Id
EG001
num Affected
100
num At Risk
450
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
95
num At Risk
461
group Id
EG001
num Affected
69
num At Risk
450
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
33
num At Risk
461
group Id
EG001
num Affected
17
num At Risk
450
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
31
num At Risk
461
group Id
EG001
num Affected
16
num At Risk
450
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
35
num At Risk
461
group Id
EG001
num Affected
12
num At Risk
450
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
36
num At Risk
461
group Id
EG001
num Affected
6
num At Risk
450
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
191
num At Risk
461
group Id
EG001
num Affected
178
num At Risk
450
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
86
num At Risk
461
group Id
EG001
num Affected
63
num At Risk
450
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
36
num At Risk
461
group Id
EG001
num Affected
34
num At Risk
450
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
39
num At Risk
461
group Id
EG001
num Affected
26
num At Risk
450
term
Pyrexia

Complete source fields

description

event Groups

description
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
id
EG000
other Num Affected
437
other Num At Risk
461
serious Num Affected
179
serious Num At Risk
461
title
Bevacizumab + RT+Temozolomide
description
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
id
EG001
other Num Affected
412
other Num At Risk
450
serious Num Affected
115
serious Num At Risk
450
title
Placebo + RT+Temozolomide

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
223
num At Risk
461
group Id
EG001
num Affected
191
num At Risk
450
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
178
num At Risk
461
group Id
EG001
num Affected
137
num At Risk
450
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
145
num At Risk
461
group Id
EG001
num Affected
100
num At Risk
450
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
95
num At Risk
461
group Id
EG001
num Affected
69
num At Risk
450
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
33
num At Risk
461
group Id
EG001
num Affected
17
num At Risk
450
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
31
num At Risk
461
group Id
EG001
num Affected
16
num At Risk
450
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
35
num At Risk
461
group Id
EG001
num Affected
12
num At Risk
450
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
36
num At Risk
461
group Id
EG001
num Affected
6
num At Risk
450
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
191
num At Risk
461
group Id
EG001
num Affected
178
num At Risk
450
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
86
num At Risk
461
group Id
EG001
num Affected
63
num At Risk
450
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
36
num At Risk
461
group Id
EG001
num Affected
34
num At Risk
450
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
39
num At Risk
461
group Id
EG001
num Affected
26
num At Risk
450
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
461
group Id
EG001
num Affected
5
num At Risk
450
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
6
num At Risk
461
group Id
EG001
num Affected
1
num At Risk
450
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
3
num At Risk
450
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
3
num At Risk
450
term
Brain abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
461
group Id
EG001
num Affected
3
num At Risk
450
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
2
num At Risk
450
term
Pneumocystis jiroveci pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
3
num At Risk
461
group Id
EG001
num Affected
0
num At Risk
450
term
Postoperative wound infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
2
num At Risk
450
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
461
group Id
EG001
num Affected
1
num At Risk
450
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
461
group Id
EG001
num Affected
0
num At Risk
450
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
1
num At Risk
450
term
Meningitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
461
group Id
EG001
num Affected
1
num At Risk
450
term
Upper respiratory tract infection

time Frame

Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])

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

Preserved source evidence · Not medical advice