Trial Outcomes & Findings for Cilengitide in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) (NCT NCT00705016)
NCT ID: NCT00705016
Last Updated: 2014-04-30
Results Overview
The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors \[RECIST\] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
184 participants
Primary outcome timeframe
Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)
Results posted on
2014-04-30
Participant Flow
Participant milestones
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
60
|
62
|
|
Overall Study
COMPLETED
|
2
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
60
|
58
|
58
|
Reasons for withdrawal
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
11
|
10
|
|
Overall Study
Death
|
5
|
7
|
5
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
2
|
|
Overall Study
Progressive Disease
|
33
|
29
|
33
|
|
Overall Study
Symptomatic Deterioration
|
3
|
1
|
1
|
|
Overall Study
Other
|
9
|
6
|
6
|
Baseline Characteristics
Cilengitide in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Baseline characteristics by cohort
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
n=62 Participants
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
n=60 Participants
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
n=62 Participants
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 7.4 • n=99 Participants
|
56.8 years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
58.6 years
STANDARD_DEVIATION 8.1 • n=206 Participants
|
58.2 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
|
Age, Customized
Less than (<) 65 years
|
47 participants
n=99 Participants
|
48 participants
n=107 Participants
|
46 participants
n=206 Participants
|
141 participants
n=7 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 years
|
15 participants
n=99 Participants
|
12 participants
n=107 Participants
|
15 participants
n=206 Participants
|
42 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
159 Participants
n=7 Participants
|
|
Karnofsky Performance Status
< 80 (Karnofsky Score)
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
5 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Karnofsky Performance Status
>= 80 (Karnofsky Score)
|
55 participants
n=99 Participants
|
54 participants
n=107 Participants
|
57 participants
n=206 Participants
|
166 participants
n=7 Participants
|
|
Extent of disease at study entry
Recurrence
|
30 participants
n=99 Participants
|
32 participants
n=107 Participants
|
31 participants
n=206 Participants
|
93 participants
n=7 Participants
|
|
Extent of disease at study entry
Distant Metastasis
|
32 participants
n=99 Participants
|
28 participants
n=107 Participants
|
31 participants
n=206 Participants
|
91 participants
n=7 Participants
|
|
Tumor Grade
Well or moderately differentiated
|
46 participants
n=99 Participants
|
39 participants
n=107 Participants
|
35 participants
n=206 Participants
|
120 participants
n=7 Participants
|
|
Tumor Grade
Poorly differentiated
|
11 participants
n=99 Participants
|
19 participants
n=107 Participants
|
22 participants
n=206 Participants
|
52 participants
n=7 Participants
|
|
Site of origin of tumor
Oropharynx
|
25 participants
n=99 Participants
|
23 participants
n=107 Participants
|
21 participants
n=206 Participants
|
69 participants
n=7 Participants
|
|
Site of origin of tumor
Hypopharynx
|
10 participants
n=99 Participants
|
14 participants
n=107 Participants
|
14 participants
n=206 Participants
|
38 participants
n=7 Participants
|
|
Site of origin of tumor
Larynx
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
13 participants
n=206 Participants
|
42 participants
n=7 Participants
|
|
Site of origin of tumor
Oral cavity
|
11 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
28 participants
n=7 Participants
|
|
Site of origin of tumor
Other, including non-classifiable
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
7 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)Population: Intention-to-treat (ITT) population included all participants who were randomized to trial treatment.
The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors \[RECIST\] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site.
Outcome measures
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
n=62 Participants
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
n=60 Participants
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
n=62 Participants
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Progression-free Survival (PFS) Time: Investigator Read
|
6.4 months
Interval 5.4 to 8.7
|
5.6 months
Interval 4.0 to 6.1
|
5.7 months
Interval 4.2 to 9.5
|
SECONDARY outcome
Timeframe: Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)Population: ITT population included all participants who were randomized to trial treatment.
The OS time is defined as the time from randomization to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.
Outcome measures
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
n=62 Participants
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
n=60 Participants
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
n=62 Participants
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Overall Survival (OS) Time
|
12.4 months
Interval 9.4 to 14.5
|
10.6 months
Interval 9.0 to 14.8
|
11.6 months
Interval 7.1 to 16.4
|
SECONDARY outcome
Timeframe: Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)Population: ITT population included all participants who were randomized to trial treatment.
The BOR rate is defined as the percentage of the participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response according to radiological assessments (based on RECIST Version 1.0).
Outcome measures
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
n=62 Participants
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
n=60 Participants
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
n=62 Participants
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Best Overall Response (BOR) Rate
|
46.8 percentage of participants
Interval 34.0 to 59.9
|
26.7 percentage of participants
Interval 16.1 to 39.7
|
35.5 percentage of participants
Interval 23.7 to 48.7
|
SECONDARY outcome
Timeframe: Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)Population: ITT population included all participants who were randomized to trial treatment.
The disease control rate is defined as the percentage of participants having achieved confirmed CR, PR or stable disease (SD) as best overall response according to radiological assessments (based on RECIST Version 1.0).
Outcome measures
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
n=62 Participants
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
n=60 Participants
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
n=62 Participants
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Disease Control Rate
|
85.5 percentage of participants
Interval 74.2 to 93.1
|
73.3 percentage of participants
Interval 60.3 to 83.9
|
80.6 percentage of participants
Interval 68.6 to 89.6
|
SECONDARY outcome
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)Population: ITT population included all participants who were randomized to trial treatment.
TTF is defined as the time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 84 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment.
Outcome measures
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
n=62 Participants
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
n=60 Participants
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
n=62 Participants
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Time to Treatment Failure (TTF)
|
5.6 months
Interval 4.2 to 6.9
|
4.5 months
Interval 2.9 to 5.6
|
4.3 months
Interval 3.8 to 7.3
|
SECONDARY outcome
Timeframe: Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)Population: ITT population included all participants who were randomized to trial treatment.
Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of progressive disease (PD), or until the date of death.
Outcome measures
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
n=62 Participants
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
n=60 Participants
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
n=62 Participants
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Duration of Response
|
5.8 months
Interval 4.5 to 7.5
|
4.1 months
Interval 3.1 to 4.4
|
6.4 months
Interval 4.2 to 9.7
|
SECONDARY outcome
Timeframe: Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)Population: Safety population included all participants who were administered any dose of the trial medication, that is, cilengitide, cisplatin, 5-FU, or cetuximab.
Please refer to Adverse Events section for details of individual serious adverse events and other adverse events
Outcome measures
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
n=61 Participants
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
n=59 Participants
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
n=62 Participants
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Safety - Number of Participants Experiencing Any Adverse Event
|
61 participants
|
59 participants
|
61 participants
|
Adverse Events
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
Serious events: 41 serious events
Other events: 61 other events
Deaths: 0 deaths
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
Serious events: 45 serious events
Other events: 57 other events
Deaths: 0 deaths
Cetuximab+5-FU+Cisplatin
Serious events: 44 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
n=61 participants at risk
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
n=59 participants at risk
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
n=62 participants at risk
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.6%
1/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Ear and labyrinth disorders
Deafness
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Ear and labyrinth disorders
Ototoxicity
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic Syndrome
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected Neoplasm
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Eye disorders
Retinal Artery Occlusion
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Eye disorders
Retinal Artery Thrombosis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Eye disorders
Visual Acuity Reduced
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.3%
2/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Duodenal Perforation
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Neutropenic Colitis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Oesophageal Perforation
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Tongue Necrosis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Pneumonia
|
8.2%
5/61 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.5%
5/59 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Sepsis
|
4.9%
3/61 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Device Related Infection
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Pulmonary Sepsis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Catheter Site Infection
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Dermatitis Infected
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Infection
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Parotitis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Postoperative Wound Infection
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Skin Infection
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Wound Infection
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
General Physical Health Deterioration
|
4.9%
3/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Pyrexia
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Fatigue
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
4.8%
3/62 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Device Dislocation
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Asthenia
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Death
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Face Oedema
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Pain
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Thrombosis In Device
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Catheter Site Inflammation
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Device Leakage
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Hyperpyrexia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Oedema Peripheral
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Performance Status Decreased
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Sudden Death
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.9%
3/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
10.2%
6/59 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
9.7%
6/62 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
3/61 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
14.5%
9/62 • Number of events 9 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
10.2%
6/59 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
6.6%
4/61 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
2/61 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Artery Thrombosis
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Organising Pneumonia
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Hypotension
|
4.9%
3/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Thrombosis
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Axillary Vein Thrombosis
|
1.6%
1/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Arterial Rupture
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Arteriosclerosis
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Arteriosclerosis Obliterans
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Jugular Vein Thrombosis
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Phlebitis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Syncope
|
4.9%
3/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Dizziness
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Cardiac disorders
Myocardial Infarction
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
Blood Amylase Increased
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
Blood Creatine Increased
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
Weight Decreased
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Immune system disorders
Drug Hypersensitivity
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Immune system disorders
Hypersensitivity
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Injury, poisoning and procedural complications
Gastrostomy Failure
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Hepatobiliary disorders
Acute Hepatic Failure
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
Other adverse events
| Measure |
Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin
n=61 participants at risk
Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m\^2) intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin
n=59 participants at risk
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
Cetuximab+5-FU+Cisplatin
n=62 participants at risk
Cetuximab 250 mg/m\^2 intravenous infusion (initial starting dose of 400 mg/m\^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m\^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m\^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m\^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
59.0%
36/61 • Number of events 98 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
52.5%
31/59 • Number of events 78 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
64.5%
40/62 • Number of events 137 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Stomatitis
|
44.3%
27/61 • Number of events 85 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
47.5%
28/59 • Number of events 77 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
48.4%
30/62 • Number of events 83 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Vomiting
|
45.9%
28/61 • Number of events 66 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
40.7%
24/59 • Number of events 55 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
45.2%
28/62 • Number of events 96 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Diarrhoea
|
37.7%
23/61 • Number of events 45 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
45.8%
27/59 • Number of events 60 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
38.7%
24/62 • Number of events 65 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Constipation
|
37.7%
23/61 • Number of events 43 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
37.3%
22/59 • Number of events 37 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
38.7%
24/62 • Number of events 36 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Dysphagia
|
8.2%
5/61 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
11.9%
7/59 • Number of events 10 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
12.9%
8/62 • Number of events 12 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
6/61 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
17.7%
11/62 • Number of events 16 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
9.8%
6/61 • Number of events 9 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.5%
5/59 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.5%
7/61 • Number of events 9 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
11.9%
7/59 • Number of events 9 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Dry Mouth
|
4.9%
3/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Odynophagia
|
4.9%
3/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Rash
|
36.1%
22/61 • Number of events 54 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
37.3%
22/59 • Number of events 99 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
43.5%
27/62 • Number of events 91 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
24.6%
15/61 • Number of events 35 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
22.0%
13/59 • Number of events 19 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
17.7%
11/62 • Number of events 18 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
18.0%
11/61 • Number of events 29 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
18.6%
11/59 • Number of events 30 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
17.7%
11/62 • Number of events 34 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.7%
12/61 • Number of events 19 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
15.3%
9/59 • Number of events 13 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
17.7%
11/62 • Number of events 12 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
16.4%
10/61 • Number of events 32 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
15.3%
9/59 • Number of events 19 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
19.4%
12/62 • Number of events 22 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.8%
9/61 • Number of events 22 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.8%
6/61 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.1%
8/61 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
4.8%
3/62 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
4.9%
3/61 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
11.9%
7/59 • Number of events 13 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
8.2%
5/61 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Skin and subcutaneous tissue disorders
Exfoliative Rash
|
6.6%
4/61 • Number of events 27 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Fatigue
|
32.8%
20/61 • Number of events 47 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
40.7%
24/59 • Number of events 62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
38.7%
24/62 • Number of events 65 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Asthenia
|
34.4%
21/61 • Number of events 80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
11.9%
7/59 • Number of events 28 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
27.4%
17/62 • Number of events 61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Pyrexia
|
23.0%
14/61 • Number of events 23 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
22.0%
13/59 • Number of events 17 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
29.0%
18/62 • Number of events 39 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Oedema Peripheral
|
8.2%
5/61 • Number of events 13 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
18.6%
11/59 • Number of events 26 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
16.1%
10/62 • Number of events 17 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
General disorders
Face Oedema
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Neutropenia
|
45.9%
28/61 • Number of events 63 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
40.7%
24/59 • Number of events 108 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
46.8%
29/62 • Number of events 80 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Anaemia
|
36.1%
22/61 • Number of events 57 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
27.1%
16/59 • Number of events 45 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
35.5%
22/62 • Number of events 65 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Leukopenia
|
26.2%
16/61 • Number of events 38 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
25.4%
15/59 • Number of events 52 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
19.4%
12/62 • Number of events 39 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.8%
9/61 • Number of events 24 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
25.4%
15/59 • Number of events 33 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
22.6%
14/62 • Number of events 30 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.2%
5/61 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
4.8%
3/62 • Number of events 13 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Blood and lymphatic system disorders
Normochromic Normocytic Anaemia
|
1.6%
1/61 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
32.8%
20/61 • Number of events 37 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
25.4%
15/59 • Number of events 42 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
29.0%
18/62 • Number of events 45 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
31.1%
19/61 • Number of events 41 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
25.4%
15/59 • Number of events 50 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
24.2%
15/62 • Number of events 37 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
27.9%
17/61 • Number of events 36 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
22.0%
13/59 • Number of events 55 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
22.6%
14/62 • Number of events 38 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.8%
6/61 • Number of events 13 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
13.6%
8/59 • Number of events 25 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
14.5%
9/62 • Number of events 32 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.5%
7/61 • Number of events 19 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
11.9%
7/59 • Number of events 21 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.8%
6/61 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
2/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Paronychia
|
11.5%
7/61 • Number of events 10 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 10 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
9.7%
6/62 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Folliculitis
|
9.8%
6/61 • Number of events 10 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
10.2%
6/59 • Number of events 16 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Pneumonia
|
6.6%
4/61 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.5%
5/59 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Device Related Infection
|
8.2%
5/61 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Oral Candidiasis
|
6.6%
4/61 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Infection
|
3.3%
2/61 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
4.8%
3/62 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
4.8%
3/62 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
Weight Decreased
|
19.7%
12/61 • Number of events 22 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
16.9%
10/59 • Number of events 12 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
19.4%
12/62 • Number of events 15 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
Haemoglobin Decreased
|
13.1%
8/61 • Number of events 39 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
15.3%
9/59 • Number of events 35 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
11.3%
7/62 • Number of events 22 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
Blood Creatinine Increased
|
9.8%
6/61 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
13.6%
8/59 • Number of events 18 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
11.3%
7/62 • Number of events 13 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
Platelet Count Decreased
|
6.6%
4/61 • Number of events 14 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.5%
5/59 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
9.7%
6/62 • Number of events 19 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
Neutrophil Count Decreased
|
11.5%
7/61 • Number of events 26 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Investigations
White Blood Cell Count Decreased
|
11.5%
7/61 • Number of events 32 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 18 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 19 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Dizziness
|
13.1%
8/61 • Number of events 18 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
15.3%
9/59 • Number of events 20 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
9.7%
6/62 • Number of events 14 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Headache
|
13.1%
8/61 • Number of events 13 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Paraesthesia
|
9.8%
6/61 • Number of events 17 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
6.6%
4/61 • Number of events 10 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
11.9%
7/59 • Number of events 15 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
4.8%
3/62 • Number of events 12 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Dysgeusia
|
6.6%
4/61 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Neuropathy Peripheral
|
9.8%
6/61 • Number of events 14 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Polyneuropathy
|
8.2%
5/61 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Nervous system disorders
Syncope
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
4.8%
3/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.1%
8/61 • Number of events 17 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
15.3%
9/59 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
16.1%
10/62 • Number of events 12 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.1%
8/61 • Number of events 14 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
20.3%
12/59 • Number of events 17 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
9.7%
6/62 • Number of events 10 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.8%
6/61 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
15.3%
9/59 • Number of events 13 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 10 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.9%
3/61 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.5%
5/59 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
9.7%
6/62 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.3%
2/61 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.6%
4/61 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
11.9%
7/59 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
4.8%
3/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
10.2%
6/59 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
6.6%
4/61 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.2%
2/62 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.5%
5/59 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/62 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Hypertension
|
11.5%
7/61 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
10.2%
6/59 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
12.9%
8/62 • Number of events 14 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Hypotension
|
9.8%
6/61 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
13.6%
8/59 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Vascular disorders
Phlebitis
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
4.8%
3/62 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Ear and labyrinth disorders
Tinnitus
|
4.9%
3/61 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.5%
5/59 • Number of events 9 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Ear and labyrinth disorders
Deafness
|
8.2%
5/61 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Ear and labyrinth disorders
Vertigo
|
4.9%
3/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.5%
5/59 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
4.8%
3/62 • Number of events 9 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/61 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.8%
4/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Eye disorders
Conjunctivitis
|
13.1%
8/61 • Number of events 9 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
16.1%
10/62 • Number of events 13 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Psychiatric disorders
Insomnia
|
6.6%
4/61 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
11.9%
7/59 • Number of events 8 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
9.7%
6/62 • Number of events 6 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Psychiatric disorders
Anxiety
|
4.9%
3/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.7%
1/59 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Cardiac disorders
Palpitations
|
1.6%
1/61 • Number of events 1 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
0.00%
0/59 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
6.5%
4/62 • Number of events 7 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Renal and urinary disorders
Dysuria
|
3.3%
2/61 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
5.1%
3/59 • Number of events 4 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
1.6%
1/62 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
4.9%
3/61 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
10.2%
6/59 • Number of events 13 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
9.7%
6/62 • Number of events 11 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
|
Immune system disorders
Drug Hypersensitivity
|
4.9%
3/61 • Number of events 3 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
3.4%
2/59 • Number of events 2 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
8.1%
5/62 • Number of events 5 • Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
|
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: LTE60