Trial Outcomes & Findings for A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma (NCT NCT00943826)
NCT ID: NCT00943826
Last Updated: 2017-09-25
Results Overview
PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization \[WHO\] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging \[MRI\] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(\>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
921 participants
Primary outcome timeframe
Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)
Results posted on
2017-09-25
Participant Flow
The primary completion date for co-primary outcome of Progression-Free Survival (PFS) was 31 Mar 2012, whereas, the primary completion date for co-primary outcome of Overall Survival (OS) was 28 Feb 2013. Data for PFS and OS are reported according to these cut-off dates.
Participant milestones
| Measure |
Bevacizumab + RT + Temozolomide
In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (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 (Avastin) 10 milligrams per kilogram (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.
|
Placebo + RT + Temozolomide
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week 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.
|
|---|---|---|
|
Concurrent Phase
STARTED
|
458
|
463
|
|
Concurrent Phase
Treated
|
452
|
459
|
|
Concurrent Phase
COMPLETED
|
397
|
421
|
|
Concurrent Phase
NOT COMPLETED
|
61
|
42
|
|
Maintenance Phase
STARTED
|
396
|
370
|
|
Maintenance Phase
COMPLETED
|
353
|
331
|
|
Maintenance Phase
NOT COMPLETED
|
43
|
39
|
|
Monotherapy Phase
STARTED
|
269
|
159
|
|
Monotherapy Phase
COMPLETED
|
204
|
143
|
|
Monotherapy Phase
NOT COMPLETED
|
65
|
16
|
|
After Primary Overall Survival Analysis
STARTED
|
27
|
20
|
|
After Primary Overall Survival Analysis
COMPLETED
|
0
|
0
|
|
After Primary Overall Survival Analysis
NOT COMPLETED
|
27
|
20
|
Reasons for withdrawal
| Measure |
Bevacizumab + RT + Temozolomide
In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (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 (Avastin) 10 milligrams per kilogram (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.
|
Placebo + RT + Temozolomide
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week 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.
|
|---|---|---|
|
Concurrent Phase
Adverse Event
|
50
|
27
|
|
Concurrent Phase
Withdrew consent
|
3
|
7
|
|
Concurrent Phase
Refused treatment/Did not cooperate
|
5
|
7
|
|
Concurrent Phase
Administrative reasons
|
2
|
1
|
|
Concurrent Phase
Protocol Violation
|
1
|
0
|
|
Maintenance Phase
Adverse Event
|
31
|
30
|
|
Maintenance Phase
Withdrew consent
|
2
|
4
|
|
Maintenance Phase
Refused treatment/Did not cooperate
|
6
|
3
|
|
Maintenance Phase
Administrative reasons
|
4
|
1
|
|
Maintenance Phase
Failure to return
|
0
|
1
|
|
Monotherapy Phase
Adverse Event
|
42
|
5
|
|
Monotherapy Phase
Administrative reasons
|
11
|
5
|
|
Monotherapy Phase
Refused treatment/ Did not cooperate
|
8
|
2
|
|
Monotherapy Phase
Withdrew Consent
|
2
|
3
|
|
Monotherapy Phase
Failure to return
|
2
|
1
|
|
After Primary Overall Survival Analysis
Adverse Event
|
11
|
0
|
|
After Primary Overall Survival Analysis
Administrative reasons
|
10
|
16
|
|
After Primary Overall Survival Analysis
Progression of Disease
|
2
|
4
|
|
After Primary Overall Survival Analysis
Withdrew Consent
|
4
|
0
|
Baseline Characteristics
A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
Baseline characteristics by cohort
| Measure |
Bevacizumab + RT + Temozolomide
n=458 Participants
In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (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 (Avastin) 10 milligrams per kilogram (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.
|
Placebo + RT +Temozolomide
n=463 Participants
In the Concurrent Phase participants received RT 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.
|
Total
n=921 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
n=5 Participants
|
55.9 years
n=7 Participants
|
55.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
282 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
580 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)Population: Intent to treat population.
PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization \[WHO\] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging \[MRI\] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(\>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.
Outcome measures
| Measure |
Bevacizumab + RT + Temozolomide
n=458 Participants
In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (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 (Avastin) 10 milligrams per kilogram (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.
|
Placebo + RT + Temozolomide
n=463 Participants
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week 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.
|
|---|---|---|
|
Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator
|
10.6 Months
Interval 10.0 to 11.4
|
6.2 Months
Interval 6.0 to 7.5
|
PRIMARY outcome
Timeframe: Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months])Population: Intent to treat population.
Overall Survival was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Bevacizumab + RT + Temozolomide
n=458 Participants
In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (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 (Avastin) 10 milligrams per kilogram (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.
|
Placebo + RT + Temozolomide
n=463 Participants
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week 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.
|
|---|---|---|
|
Co-Primary: Overall Survival (OS)
|
16.8 Months
Interval 15.5 to 18.5
|
16.7 Months
Interval 15.4 to 18.4
|
SECONDARY outcome
Timeframe: Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months])Population: Intent to treat population.
An Independent Review Facility reviewed the MRI scans used by investigator to evaluate radiological tumor response. PFS is defined as time from randomization to PD or death. PD was assessed using adapted Macdonald response (modified WHO) criteria based on 3 components: radiological tumor assessments using MRI scans, neurological assessment and changes in corticosteroid use. PD is assessed as \>=25% increase in sum of products of the longest diameters of all index lesions (enhancing, measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing, non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.
Outcome measures
| Measure |
Bevacizumab + RT + Temozolomide
n=458 Participants
In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (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 (Avastin) 10 milligrams per kilogram (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.
|
Placebo + RT + Temozolomide
n=463 Participants
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week 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.
|
|---|---|---|
|
PFS as Assessed by an Independent Review Facility
|
8.4 Months
Interval 7.9 to 9.7
|
4.3 Months
Interval 4.1 to 5.1
|
SECONDARY outcome
Timeframe: Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])Population: Intent to treat population.
KM estimate of one year overall survival (probability to survive for at least 1 year) was reported. Corresponding 95% confidence interval (CI) was calculated using Greenwood's formula.
Outcome measures
| Measure |
Bevacizumab + RT + Temozolomide
n=458 Participants
In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (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 (Avastin) 10 milligrams per kilogram (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.
|
Placebo + RT + Temozolomide
n=463 Participants
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week 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.
|
|---|---|---|
|
Kaplan-Meier (KM) Estimate of One Year Overall Survival
|
0.72 probability of being alive
Interval 0.68 to 0.77
|
0.66 probability of being alive
Interval 0.62 to 0.71
|
SECONDARY outcome
Timeframe: Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])Population: Intent to treat population.
KM estimate of two year overall survival was reported (probability to survive for at least 2 years). Corresponding 95% CI was calculated using Greenwood's formula.
Outcome measures
| Measure |
Bevacizumab + RT + Temozolomide
n=458 Participants
In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (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 (Avastin) 10 milligrams per kilogram (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.
|
Placebo + RT + Temozolomide
n=463 Participants
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week 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.
|
|---|---|---|
|
Kaplan-Meier (KM) Estimate of Two Year Overall Survival
|
0.34 probability of being alive
Interval 0.29 to 0.38
|
0.30 probability of being alive
Interval 0.26 to 0.34
|
SECONDARY outcome
Timeframe: Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)Population: Intent to treat population. Number of Participants Analyzed = overall participants evaluable for this outcome measure; n = participants evaluable for specified category.
EORTC QLQ-C30: 30 items; 5 functional scales; 9 symptom scales; \& global health status. Most questions used 4-point scale (1:Not at all, 4:Very much), 2 questions used 7-point scale (1:very poor, 7:Excellent). EORTC QLQ-BN20: 20 items rated on a 4 point scale (1:not at all, 4:very much). EORTC QLQ-C30 and BN20 scores were transformed to a 0-100 scale, higher score=better functioning/global health (C30) or more severe symptoms (BN20). Stable HRQoL: change from baseline (BL) within 10 points. Improved HRQoL: an increase from BL \>/=10 points for functioning/global health status, \& decrease of \>/=10 points for symptoms. PFS is reported for participants with Stable/Improved global health; physical, social functioning (C30); motor dysfunction \& communication deficit (BN20). PFS: randomization to PD or death. PD: \>=25% increase in sum of products of longest diameters of index lesions; or progression of existing non-index lesions; or appearance of new lesions; or neurological worsening.
Outcome measures
| Measure |
Bevacizumab + RT + Temozolomide
n=458 Participants
In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (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 (Avastin) 10 milligrams per kilogram (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.
|
Placebo + RT + Temozolomide
n=463 Participants
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week 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.
|
|---|---|---|
|
PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)
Global health status (n=354, 309)
|
8 Months
Interval 0.0 to 26.0
|
4 Months
Interval 1.0 to 29.0
|
|
PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)
Physical functioning (n=353, 318)
|
7 Months
Interval 0.0 to 27.0
|
5 Months
Interval 1.0 to 29.0
|
|
PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)
Social functioning (n=352, 327)
|
8 Months
Interval 0.0 to 26.0
|
4 Months
Interval 0.0 to 27.0
|
|
PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)
Motor dysfunction (n=361, 314)
|
7 Months
Interval 1.0 to 27.0
|
4 Months
Interval 0.0 to 26.0
|
|
PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)
Communication deficit (n=365, 329)
|
8 Months
Interval 0.0 to 27.0
|
4 Months
Interval 1.0 to 24.0
|
SECONDARY outcome
Timeframe: Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])Population: Safety Population included all randomized participants who received study treatment during the treatment period (10 participants did not receive at least one dose of study treatment and were therefore excluded, 4 in Placebo and 6 in Bevacizumab.
An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as AE.A serious adverse event (SAE) is any experience that suggests a significant hazard,contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Non-serious adverse events (Non-SAEs) included all AEs except SAEs (non-SAEs = all AEs - SAEs). Nine 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.
Outcome measures
| Measure |
Bevacizumab + RT + Temozolomide
n=461 Participants
In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (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 (Avastin) 10 milligrams per kilogram (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.
|
Placebo + RT + Temozolomide
n=450 Participants
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week 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.
|
|---|---|---|
|
Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death
Non-SAEs
|
437 Participants
|
412 Participants
|
|
Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death
SAEs
|
179 Participants
|
115 Participants
|
|
Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death
Death
|
335 Participants
|
337 Participants
|
Adverse Events
Bevacizumab + RT+Temozolomide
Serious events: 179 serious events
Other events: 437 other events
Deaths: 0 deaths
Placebo + RT+Temozolomide
Serious events: 115 serious events
Other events: 412 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + RT+Temozolomide
n=461 participants at risk
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.
|
Placebo + RT+Temozolomide
n=450 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.2%
10/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
1.1%
5/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Sepsis
|
1.3%
6/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Urinary tract infection
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.67%
3/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Brain abscess
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.67%
3/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.67%
3/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Postoperative wound infection
|
0.65%
3/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Respiratory tract infection
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Septic shock
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Infection
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Meningitis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Wound infection
|
0.65%
3/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Abscess
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Anal abscess
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Bacteraemia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Cellulitis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Cytomegalovirus infection
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Encephalitis herpes
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Erysipelas
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Gastroenteritis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Gastroenteritis viral
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Graft infection
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Helicobacter infection
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Hepatitis B
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Herpes zoster
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Infectious pleural effusion
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Lobar pneumonia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Lung infection
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Neutropenic sepsis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Oesophageal candidiasis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Oral fungal infection
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Parotitis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Sinusitis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Streptococcal sepsis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Urosepsis
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Viral infection
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Wound infection staphylococcal
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Convulsion
|
1.1%
5/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
1.3%
6/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
8/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Brain oedema
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.89%
4/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Headache
|
0.87%
4/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.65%
3/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Epilepsy
|
0.65%
3/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Ischaemic stroke
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Somnolence
|
0.65%
3/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Hemiparesis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Hydrocephalus
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Intracranial pressure increased
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Neurological decompensation
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Basal ganglia stroke
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Encephalitis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Encephalopathy
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Leukoencephalopathy
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Paraesthesia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Partial seizures
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Speech disorder
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Syncope
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
17/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
1.8%
8/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.87%
4/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
5/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
3/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.8%
13/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
2.7%
12/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
5/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
1.1%
5/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.87%
4/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Anal prolapse
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Colitis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Faecaloma
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Haematemesis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Rectal perforation
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Stomatitis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Vascular disorders
Deep vein thrombosis
|
2.4%
11/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
1.3%
6/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Vascular disorders
Hypertension
|
0.87%
4/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Vascular disorders
Embolism
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Vascular disorders
Embolism venous
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Vascular disorders
Thrombophlebitis
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Vascular disorders
Thrombosis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
General disorders
Pyrexia
|
1.7%
8/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.67%
3/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
General disorders
General physical health deterioration
|
0.65%
3/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
General disorders
Fatigue
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
General disorders
Cyst
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
General disorders
Death
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
General disorders
Impaired healing
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.44%
2/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Fall
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
1.1%
5/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.67%
3/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.67%
3/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Myocardial infarction
|
0.65%
3/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Angina pectoris
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Atrial fibrillation
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Cardiac arrest
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Cardiovascular disorder
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.65%
3/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.65%
3/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.43%
2/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Hepatobiliary disorders
Cholangitis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Psychiatric disorders
Acute psychosis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Psychiatric disorders
Anxiety
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Psychiatric disorders
Delirium
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Psychiatric disorders
Delirium tremens
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Psychiatric disorders
Mania
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Renal and urinary disorders
Proteinuria
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Renal and urinary disorders
Renal failure acute
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Renal and urinary disorders
Urinary retention
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Ear and labyrinth disorders
Vertigo
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Investigations
Troponin increased
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Reproductive system and breast disorders
Scrotal cyst
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Pyelonephritis
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Staphylococcal Infection
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis to liver
|
0.00%
0/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.22%
1/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Eye disorders
Optic Neuropathy
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Extradural Abscess
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Vascular disorders
Hypotension
|
0.22%
1/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
0.00%
0/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
Other adverse events
| Measure |
Bevacizumab + RT+Temozolomide
n=461 participants at risk
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.
|
Placebo + RT+Temozolomide
n=450 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
31/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
3.6%
16/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Nausea
|
48.4%
223/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
42.4%
191/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Constipation
|
38.6%
178/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
30.4%
137/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Vomiting
|
31.5%
145/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
22.2%
100/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Diarrhoea
|
20.6%
95/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
15.3%
69/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Abdominal pain
|
7.2%
33/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
3.8%
17/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.6%
35/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
2.7%
12/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Gastrointestinal disorders
Gingival bleeding
|
7.8%
36/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
1.3%
6/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
General disorders
Fatigue
|
41.4%
191/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
39.6%
178/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
General disorders
Asthenia
|
18.7%
86/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
14.0%
63/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
General disorders
Oedema peripheral
|
7.8%
36/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
7.6%
34/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
General disorders
Pyrexia
|
8.5%
39/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
5.8%
26/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
39.0%
180/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
36.0%
162/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.5%
76/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
13.3%
60/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.7%
54/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
8.2%
37/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.4%
34/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
5.3%
24/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Headache
|
37.3%
172/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
28.9%
130/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Dizziness
|
10.0%
46/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
11.8%
53/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Dysgeusia
|
8.5%
39/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
7.3%
33/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Nervous system disorders
Convulsion
|
7.8%
36/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
8.7%
39/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
32.1%
148/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
26.7%
120/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
66/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
11.8%
53/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.1%
56/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
8.9%
40/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.4%
34/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
8.7%
39/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
27/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
7.6%
34/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
71/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
6.7%
30/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.4%
48/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
4.9%
22/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
37/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
6.4%
29/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.3%
29/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
7.3%
33/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.5%
39/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
2.7%
12/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
28/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
2.7%
12/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.3%
98/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
4.9%
22/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.9%
55/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
10.2%
46/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
9.1%
42/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
1.6%
7/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
26/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
4.0%
18/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.3%
29/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
2.7%
12/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Vascular disorders
Hypertension
|
38.0%
175/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
11.3%
51/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.2%
116/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
16.4%
74/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Psychiatric disorders
Insomnia
|
11.5%
53/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
9.3%
42/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Psychiatric disorders
Depression
|
9.3%
43/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
6.7%
30/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Psychiatric disorders
Anxiety
|
6.3%
29/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
5.6%
25/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Nasopharyngitis
|
13.7%
63/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
5.8%
26/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Urinary tract infection
|
10.6%
49/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
6.0%
27/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
31/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
2.9%
13/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Investigations
Weight decreased
|
7.8%
36/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
4.0%
18/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
22/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
5.6%
25/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Renal and urinary disorders
Proteinuria
|
15.6%
72/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
4.2%
19/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
8.2%
38/461 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
9.3%
42/450 • Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER