Trial Outcomes & Findings for Cilengitide and Cetuximab in Combination With Platinum-based Chemotherapy as First-line Treatment for Subjects With Advanced Non Small Cell Lung Cancer (NSCLC) (NCT NCT00842712)
NCT ID: NCT00842712
Last Updated: 2017-01-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
232 participants
Primary outcome timeframe
Up to Week 3
Results posted on
2017-01-13
Participant Flow
First/last participant (informed consent): Feb 2009/Jun 2012. Clinical data cut-off: 26 Jun 2013, Study completion date: July 2013.
In safety run-in part of study, a total of 12 participants were enrolled and treated. In randomized part of study, 220 participants were enrolled and out of these 220 participants, 215 were treated.
Participant milestones
| Measure |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m\^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy
Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Randomized Part: Cetuximab + Chemotherapy
Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
|---|---|---|---|---|---|---|---|
|
Safety Run-in Part
STARTED
|
3
|
3
|
3
|
3
|
0
|
0
|
0
|
|
Safety Run-in Part
COMPLETED
|
0
|
1
|
3
|
2
|
0
|
0
|
0
|
|
Safety Run-in Part
NOT COMPLETED
|
3
|
2
|
0
|
1
|
0
|
0
|
0
|
|
Randomized Part
STARTED
|
0
|
0
|
0
|
0
|
85
|
51
|
84
|
|
Randomized Part
Treated
|
0
|
0
|
0
|
0
|
85
|
50
|
80
|
|
Randomized Part
COMPLETED
|
0
|
0
|
0
|
0
|
85
|
50
|
78
|
|
Randomized Part
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
6
|
Reasons for withdrawal
| Measure |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m\^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy
Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Randomized Part: Cetuximab + Chemotherapy
Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
|---|---|---|---|---|---|---|---|
|
Safety Run-in Part
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Safety Run-in Part
Progressive disease
|
3
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Randomized Part
Randomized but not treated
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
|
Randomized Part
Ongoing at cut-off date
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Cilengitide and Cetuximab in Combination With Platinum-based Chemotherapy as First-line Treatment for Subjects With Advanced Non Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
n=3 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
n=3 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
n=3 Participants
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
n=3 Participants
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy
n=85 Participants
Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy
n=51 Participants
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Randomized Part: Cetuximab + Chemotherapy
n=84 Participants
Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Less than 65 years
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
68 participants
n=21 Participants
|
37 participants
n=8 Participants
|
66 participants
n=8 Participants
|
182 participants
n=24 Participants
|
|
Age, Customized
Greater than or equal to 65 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
17 participants
n=21 Participants
|
14 participants
n=8 Participants
|
18 participants
n=8 Participants
|
50 participants
n=24 Participants
|
|
Gender
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
85 Participants
n=24 Participants
|
|
Gender
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
57 Participants
n=8 Participants
|
147 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to Week 3Population: DLT population included all participants who completed first 3 weeks of treatment (first chemotherapy cycle) or who discontinued treatment due to any DLT during the first 3 weeks of treatment in the safety-run-in part.
Outcome measures
| Measure |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
n=3 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
n=3 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
n=3 Participants
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
n=3 Participants
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
|---|---|---|---|---|
|
Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)Population: Intent-to-treat (ITT) population included all participants who were randomized to trial 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. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).
Outcome measures
| Measure |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
n=85 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
n=51 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
n=84 Participants
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
|---|---|---|---|---|
|
Randomized Part: Progression Free Survival (PFS) Time - Independent Read
|
6.2 months
Interval 5.6 to 7.4
|
5.6 months
Interval 4.0 to 7.5
|
5.0 months
Interval 4.2 to 5.6
|
—
|
SECONDARY outcome
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)Population: ITT population included all participants who were randomized to trial 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.
Outcome measures
| Measure |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
n=85 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
n=51 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
n=84 Participants
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
|---|---|---|---|---|
|
Randomized Part: Progression Free Survival (PFS) Time - Investigator Read
|
5.6 months
Interval 5.4 to 6.7
|
5.6 months
Interval 4.2 to 7.0
|
5.3 months
Interval 4.2 to 5.7
|
—
|
SECONDARY outcome
Timeframe: Time from randomization until death or last day known to be alive, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)Population: ITT population included all participants who were randomized to trial 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 |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
n=85 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
n=51 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
n=84 Participants
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
|---|---|---|---|---|
|
Randomized Part: Overall Survival (OS) Time
|
13.6 months
Interval 9.5 to 18.6
|
13.6 months
Interval 8.7 to 16.7
|
9.7 months
Interval 7.9 to 13.4
|
—
|
SECONDARY outcome
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)Population: ITT population included all participants who were randomized to trial treatment.
The BOR rate is defined as the percentage of participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors \[RECIST\]) as assessed by Independent Review Committee (IRC): CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
n=85 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
n=51 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
n=84 Participants
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
|---|---|---|---|---|
|
Randomized Part: Best Overall Response (BOR) Rate
|
37.6 percentage of participants
Interval 27.4 to 48.8
|
27.5 percentage of participants
Interval 15.9 to 41.7
|
29.8 percentage of participants
Interval 20.3 to 40.7
|
—
|
SECONDARY outcome
Timeframe: Time from randomization until treatment failure or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)Population: ITT population included all participants who were randomized to trial treatment.
Time to treatment failure was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: Progressive Disease (PD) assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment. Time to treatment failure was assessed according to modified World Health Organization (WHO) criteria by Independent Review Committee (IRC).
Outcome measures
| Measure |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
n=85 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
n=51 Participants
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
n=84 Participants
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
|---|---|---|---|---|
|
Randomized Part: Time to Treatment Failure
|
4.4 months
Interval 3.5 to 5.6
|
2.8 months
Interval 1.4 to 4.2
|
4.2 months
Interval 2.8 to 5.3
|
—
|
Adverse Events
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy
Serious events: 42 serious events
Other events: 84 other events
Deaths: 0 deaths
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy
Serious events: 29 serious events
Other events: 48 other events
Deaths: 0 deaths
Randomized Part: Cetuximab + Chemotherapy
Serious events: 45 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
n=3 participants at risk
Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m\^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
n=3 participants at risk
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
n=3 participants at risk
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
n=3 participants at risk
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy
n=85 participants at risk
Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy
n=50 participants at risk
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Randomized Part: Cetuximab + Chemotherapy
n=80 participants at risk
Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
3.8%
3/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
8/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY THROMBOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
3.8%
3/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
PYREXIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
ASTHENIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
FATIGUE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
MALAISE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
CHEST PAIN
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
IMPAIRED HEALING
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
MEDICAL DEVICE COMPLICATION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
NAIL BED INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
PROTEUS INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
PROCTITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
AORTIC THROMBOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
ARTERIAL DISORDER
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
ARTERIAL THROMBOSIS LIMB
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
AXILLARY VEIN THROMBOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
PERIPHERAL EMBOLISM
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
SHOCK
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
SUBCLAVIAN VEIN THROMBOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
SUPERIOR VENA CAVA SYNDROME
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
VENA CAVA THROMBOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM LESION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
COMA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
STATUS EPILEPTICUS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Injury, poisoning and procedural complications
FAILURE TO ANASTOMOSE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Injury, poisoning and procedural complications
SPLENIC RUPTURE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Cardiac disorders
ARRHYTHMIA SUPRAVENTRICULAR
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Cardiac disorders
STRESS CARDIOMYOPATHY
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO MENINGES
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR EMBOLISM
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Eye disorders
PERIORBITAL OEDEMA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
Other adverse events
| Measure |
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem
n=3 participants at risk
Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m\^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin
n=3 participants at risk
Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem
n=3 participants at risk
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin
n=3 participants at risk
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks.
|
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy
n=85 participants at risk
Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy
n=50 participants at risk
Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
Randomized Part: Cetuximab + Chemotherapy
n=80 participants at risk
Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
3.8%
3/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
RASH
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
41.2%
35/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
34.0%
17/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
36.2%
29/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
22.0%
11/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
21.2%
17/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
14.0%
7/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
20.0%
16/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
15.3%
13/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
14.0%
7/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
11.2%
9/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
15.3%
13/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
11.2%
9/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
SKIN TOXICITY
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
16.0%
8/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.8%
7/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
12.0%
6/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
3.8%
3/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
7.5%
6/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
NAIL TOXICITY
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
NAUSEA
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
57.6%
49/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
52.0%
26/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
52.5%
42/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
DIARRHOEA
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
26.0%
13/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
27.5%
22/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
26.0%
13/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
27.5%
22/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
CONSTIPATION
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
28.0%
14/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
23.8%
19/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
STOMATITIS
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
17.6%
15/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
20.0%
10/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
13.8%
11/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
7.5%
6/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
7.5%
6/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.0%
4/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
FATIGUE
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
34.1%
29/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
26.0%
13/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
23.8%
19/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
ASTHENIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
23.5%
20/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
28.0%
14/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
27.5%
22/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
PYREXIA
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
26.0%
13/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
17.5%
14/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
OEDEMA PERIPHERAL
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
CHEST PAIN
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
CHILLS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
General disorders
XEROSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
49.4%
42/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
42.0%
21/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
42.5%
34/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
38.8%
33/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
42.0%
21/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
27.5%
22/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
32.9%
28/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
32.0%
16/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
26.2%
21/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
23.5%
20/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
14.0%
7/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
11.2%
9/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
THROMBOCYTOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.0%
4/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
26.0%
13/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
26.2%
21/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
18.0%
9/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.8%
7/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.8%
7/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
7.5%
6/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
15.3%
13/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
22.0%
11/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
15.0%
12/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
18.0%
9/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
16.2%
13/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
20.0%
10/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.8%
7/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
12.0%
6/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.8%
7/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
18.8%
15/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
14.0%
7/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.8%
7/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
3.8%
3/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
HEADACHE
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
12.0%
6/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
7.5%
6/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
DYSGEUSIA
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.0%
4/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
DIZZINESS
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.0%
4/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
8/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
15.3%
13/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
16.0%
8/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.8%
7/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
7.5%
6/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.0%
4/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
PARONYCHIA
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
16.5%
14/85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
8/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.8%
7/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
5/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.0%
4/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
10.0%
8/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Psychiatric disorders
INSOMNIA
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
11.2%
9/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
12.0%
6/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.0%
4/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
5.0%
4/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
14.0%
7/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.2%
5/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
8.0%
4/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
7.5%
6/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
6.0%
3/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
HIRSUTISM
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
INTERTRIGO
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
ERUCTATION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEALPAIN
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
100.0%
3/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Metabolism and nutrition disorders
IRON OVERLOAD
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Vascular disorders
THROMBOPHLEBITIS
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
NAIL INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
3.8%
3/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
3.8%
3/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
BLOOD CREATINE INCREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
BLOOD SODIUM DECREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.5%
2/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Eye disorders
BLEPHARITIS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Eye disorders
EYE IRRITATION
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
66.7%
2/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
3.8%
3/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Renal and urinary disorders
LEUKOCYTURIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Renal and urinary disorders
POLYURIA
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Reproductive system and breast disorders
DYSPAREUNIA
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
2.0%
1/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
1.2%
1/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
33.3%
1/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
4.0%
2/50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
0.00%
0/80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
|
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
- Publication restrictions are in place
Restriction type: GT60