Trial Outcomes & Findings for Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status (NCT NCT00813943)
NCT ID: NCT00813943
Last Updated: 2017-01-30
Results Overview
The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
265 participants
Primary outcome timeframe
Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)
Results posted on
2017-01-30
Participant Flow
First/last participant (informed consent): Mar 2009/Sep 2011. Clinical data cut-off: 07 Feb 2013, Study completion date: Aug 2013.
Enrolled: 294 screened for eligibility; 29 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria), 265 participants randomized.
Participant milestones
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Overall Study
STARTED
|
88
|
88
|
89
|
|
Overall Study
COMPLETED
|
83
|
83
|
86
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
3
|
Reasons for withdrawal
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Overall Study
Ongoing at cut-off date
|
5
|
5
|
3
|
Baseline Characteristics
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status
Baseline characteristics by cohort
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=88 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
n=88 Participants
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
n=89 Participants
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 10.44 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 11.64 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 10.57 • n=4 Participants
|
|
Gender
Female
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Gender
Male
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)Population: ITT population included all the participants who were randomized to study treatment.
The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=88 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
n=88 Participants
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
n=89 Participants
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Overall Survival (OS) Time
|
16.3 Months
Interval 13.2 to 18.1
|
14.5 Months
Interval 12.6 to 16.5
|
13.4 Months
Interval 12.2 to 14.3
|
SECONDARY outcome
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)Population: ITT population included all the participants who were randomized to study treatment.
The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=88 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
n=88 Participants
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
n=89 Participants
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Progression Free Survival (PFS) Time - Investigator and Independent Read
PFS Time: Independent read
|
5.6 Months
Interval 3.6 to 5.9
|
5.9 Months
Interval 4.2 to 7.6
|
4.1 Months
Interval 3.7 to 4.7
|
|
Progression Free Survival (PFS) Time - Investigator and Independent Read
PFS Time: Investigator read
|
6.4 Months
Interval 4.2 to 7.9
|
7.5 Months
Interval 5.9 to 8.2
|
6.0 Months
Interval 4.1 to 7.7
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Week 1Population: Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=11 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Day 1 (Single dose)
|
108527 nanogram per milliliter (ng/mL)
Standard Deviation 27197
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax)
Day 5 (Repeated doses)
|
150873 nanogram per milliliter (ng/mL)
Standard Deviation 97220
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Week 1Population: Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
The Tmax and t1/2 for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=11 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2)
Tmax: Day 1 (Single dose)
|
0.97 hours
Standard Deviation 0.34
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2)
Tmax: Day 5 (Repeated doses)
|
1.17 hours
Standard Deviation 0.34
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2)
t1/2: Day 1 (Single dose)
|
2.38 hours
Standard Deviation 0.8
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2)
t1/2: Day 5 (Repeated doses)
|
2.44 hours
Standard Deviation 0.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Week 1Population: Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
The AUC (0-infinity) and AUC (0-24) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=11 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) and Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24])
AUC (0-infinity): Day 1 (Single dose)
|
280944 hour*ng/mL
Standard Deviation 75720
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) and Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24])
AUC (0-infinity): Day 5 (Repeated Doses)
|
335263 hour*ng/mL
Standard Deviation 105435
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) and Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24])
AUC (0-24): Day 1 (Single dose)
|
269941 hour*ng/mL
Standard Deviation 82850
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) and Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24])
AUC (0-24): Day 5 (Repeated doses)
|
316137 hour*ng/mL
Standard Deviation 110425
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Week 1Population: Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. One participant had implausible pre-dose concentration.
The Cpre and CT for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=11 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT)
Cpre: Day 1 (Single dose)
|
6372.7 ng/mL
Standard Deviation 21135.95
|
—
|
—
|
|
Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT)
Cpre: Day 5 (Repeated doses)
|
286.0 ng/mL
Standard Deviation 319.05
|
—
|
—
|
|
Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT)
CT: Day 1 (Single dose)
|
108045.5 ng/mL
Standard Deviation 27981.04
|
—
|
—
|
|
Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT)
CT: Day 5 (Repeated doses)
|
157470.0 ng/mL
Standard Deviation 99849.26
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Week 1Population: Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
The apparent terminal rate constant for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=11 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Apparent Terminal Rate Constant
Day 1 (Single dose)
|
0.32 per hour
Standard Deviation 0.11
|
—
|
—
|
|
Apparent Terminal Rate Constant
Day 5 (Repeated doses)
|
0.32 per hour
Standard Deviation 0.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Week 1Population: Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
The MRT (0-infinity) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=11 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Mean Residence Time From Time 0 to Infinity (MRT [0-infinity])
Day 1 (Single dose)
|
2.8 hour
Standard Deviation 0.71
|
—
|
—
|
|
Mean Residence Time From Time 0 to Infinity (MRT [0-infinity])
Day 5 (Repeated doses)
|
2.9 hour
Standard Deviation 0.97
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Week 1Population: Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
The CL for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=11 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Plasma Clearance (CL)
Day 1 (Single dose)
|
125.7 milliliter per minute
Standard Deviation 29.93
|
—
|
—
|
|
Plasma Clearance (CL)
Day 5 (Repeated doses)
|
109.3 milliliter per minute
Standard Deviation 36.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 of Week 1Population: Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
The Vz (after single dose) and Vss (after repeated doses) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=11 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase (Vz) and Apparent Volume of Distribution at Steady State (Vss)
Vz
|
24.7 liter
Standard Deviation 6.29
|
—
|
—
|
|
Apparent Volume of Distribution During the Terminal Phase (Vz) and Apparent Volume of Distribution at Steady State (Vss)
Vss
|
19.2 liter
Standard Deviation 8.54
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)Population: Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.
An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (Version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=89 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
n=81 Participants
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
n=85 Participants
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4
AEs
|
88 Participants
|
80 Participants
|
82 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4
Serious AEs
|
47 Participants
|
36 Participants
|
30 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4
Treatment-related AEs
|
70 Participants
|
64 Participants
|
56 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4
Treatment-related serious AEs
|
13 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4
AEs leading to death
|
8 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4
Treatment-related AEs leading to death
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4
AEs of Grade 3 or 4
|
57 Participants
|
47 Participants
|
45 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4
Treatment-related AEs of Grade 3 or 4
|
25 Participants
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)Population: Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.
Thromboembolic events (standardized MedDRA query \[SMQ\]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.
Outcome measures
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=89 Participants
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
n=81 Participants
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
n=85 Participants
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI-CTC Toxicity Grade 3 or 4
SMQ: Thromboembolic events
|
17 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI-CTC Toxicity Grade 3 or 4
SMQ:Hemorrhage
|
3 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)Population: Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section
Outcome measures
Outcome data not reported
Adverse Events
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
Serious events: 47 serious events
Other events: 83 other events
Deaths: 0 deaths
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
Serious events: 36 serious events
Other events: 79 other events
Deaths: 0 deaths
Temozolomide + Radiotherapy
Serious events: 30 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=89 participants at risk
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
n=81 participants at risk
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
n=85 participants at risk
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
Nervous system disorders
CONVULSION
|
5.6%
5/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
8.6%
7/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
HEMIPARESIS
|
4.5%
4/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.7%
3/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
5.9%
5/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
EPILEPSY
|
4.5%
4/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.5%
2/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
HEADACHE
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
BRAIN OEDEMA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
CEREBRAL CYST
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.7%
3/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
NEUROLOGICAL DECOMPENSATION
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.7%
3/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
APHASIA
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.5%
2/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
PARTIAL SEIZURES
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
SOMNOLENCE
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
CEREBRAL VENTRICLE DILATATION
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
DYSARTHRIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
DYSKINESIA
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
HEMIANOPIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
MOTOR DYSFUNCTION
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
PYRAMIDAL TRACT SYNDROME
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
RADICULAR PAIN
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
UNRESPONSIVE TO STIMULI
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
DISEASE PROGRESSION
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.5%
2/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
PYREXIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
FATIGUE
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
ASTHENIA
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
CONDITION AGGRAVATED
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
DEVICE MALFUNCTION
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
GENERALISED OEDEMA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
TERMINAL STATE
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
10.1%
9/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.5%
2/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Respiratory, thoracic and mediastinal disorders
MEDIASTINAL HAEMORRHAGE
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
4.5%
4/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Vascular disorders
VENOUS THROMBOSIS
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Vascular disorders
HYPOTENSION
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Vascular disorders
HAEMATOMA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Vascular disorders
HYPERTENSION
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
PNEUMONIA
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
BRONCHITIS
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
HERPES ZOSTER
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
MENINGITIS
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
NASOPHARYNGITIS
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECI PNEUMONIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM RECURRENCE
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.5%
2/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM MALIGNANT
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN STEM GLIOMA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEAVY CHAIN DISEASE
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM PROGRESSION
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
NAUSEA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
VOMITING
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Investigations
LIPASE INCREASED
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Investigations
AMYLASE INCREASED
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Investigations
FIBRIN D DIMER INCREASED
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Investigations
HEPATIC ENZYME INCREASED
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Cardiac disorders
BRADYCARDIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK RIGHT
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Cardiac disorders
PULSELESS ELECTRICAL ACTIVITY
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Renal and urinary disorders
OLIGURIA
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Eye disorders
RETINAL ARTERY EMBOLISM
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Social circumstances
SOCIAL STAY HOSPITALISATION
|
1.1%
1/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
Other adverse events
| Measure |
Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy
n=89 participants at risk
Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy
n=81 participants at risk
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m\^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
|
Temozolomide + Radiotherapy
n=85 participants at risk
TMZ 75 mg/m\^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
|
|---|---|---|---|
|
General disorders
FATIGUE
|
30.3%
27/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
25.9%
21/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
22.4%
19/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
ASTHENIA
|
24.7%
22/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
29.6%
24/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
12.9%
11/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
PYREXIA
|
18.0%
16/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
17.3%
14/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
9.4%
8/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
OEDEMA PERIPHERAL
|
10.1%
9/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
9.4%
8/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
General disorders
GAIT DISTURBANCE
|
3.4%
3/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
8.6%
7/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
11.8%
10/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
NAUSEA
|
36.0%
32/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
37.0%
30/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
35.3%
30/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
CONSTIPATION
|
29.2%
26/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
33.3%
27/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
31.8%
27/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
VOMITING
|
19.1%
17/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
22.2%
18/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
24.7%
21/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
DIARRHOEA
|
9.0%
8/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
7.4%
6/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.6%
5/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Gastrointestinal disorders
STOMATITIS
|
5.6%
5/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
HEADACHE
|
42.7%
38/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
39.5%
32/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
29.4%
25/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
CONVULSION
|
9.0%
8/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
8.6%
7/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
10.6%
9/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
7.9%
7/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
9.9%
8/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
8.2%
7/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
DIZZINESS
|
6.7%
6/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
5.9%
5/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
APHASIA
|
7.9%
7/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.7%
3/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
7.1%
6/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
TREMOR
|
6.7%
6/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
DYSGEUSIA
|
6.7%
6/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
4.9%
4/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Nervous system disorders
PARAESTHESIA
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
7.4%
6/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
10.1%
9/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
17.3%
14/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
20.0%
17/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
12.4%
11/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
11.1%
9/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
9.4%
8/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
10.1%
9/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
8.6%
7/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
8.2%
7/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
5.6%
5/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
7.4%
6/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
8.2%
7/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.6%
5/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
11.1%
9/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
15.7%
14/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
22.2%
18/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
12.9%
11/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.1%
9/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
13.6%
11/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
5.9%
5/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Skin and subcutaneous tissue disorders
RASH
|
12.4%
11/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
9.9%
8/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
4.5%
4/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
8.6%
7/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
10.1%
9/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
23.5%
19/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
4.7%
4/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
10.1%
9/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.7%
3/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
7.1%
6/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
7.9%
7/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.7%
3/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.5%
4/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.9%
7/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.7%
3/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
0.00%
0/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
6.7%
6/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.5%
2/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Psychiatric disorders
INSOMNIA
|
13.5%
12/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
18.5%
15/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
12.9%
11/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Psychiatric disorders
DEPRESSION
|
13.5%
12/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
11.1%
9/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Psychiatric disorders
ANXIETY
|
6.7%
6/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
8.6%
7/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
7.1%
6/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.7%
6/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
12.3%
10/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
7.1%
6/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.7%
6/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
12.3%
10/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
5.9%
5/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
ORAL CANDIDIASIS
|
6.7%
6/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
7.4%
6/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.1%
9/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
22.5%
20/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
22.2%
18/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
21.2%
18/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
6.7%
6/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
10.1%
9/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
8.6%
7/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.6%
5/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
4.9%
4/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Injury, poisoning and procedural complications
RADIATION SKIN INJURY
|
12.4%
11/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.7%
3/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Injury, poisoning and procedural complications
FALL
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Vascular disorders
HYPERTENSION
|
5.6%
5/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
7.4%
6/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
2.2%
2/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
3.5%
3/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Eye disorders
VISION BLURRED
|
6.7%
6/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.5%
2/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
1.2%
1/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/89 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
6.2%
5/81 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
2.4%
2/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All manuscripts and materials relating to Study shall be submitted to Sponsor at least 60 days prior to submitting/presenting and allow Sponsor 60 days for review. If Sponsor requests, any confidential information shall be removed. In multi-center study, any publication shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within 1 year from database lock, then Site may publish individually in accordance with this provision.
- Publication restrictions are in place
Restriction type: OTHER