Trial Outcomes & Findings for BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment (NCT NCT00632749)
NCT ID: NCT00632749
Last Updated: 2015-09-14
Results Overview
The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only. It was determined using a standard "3 + 3 design with de-escalation".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
up to 28 days of treatment
Results posted on
2015-09-14
Participant Flow
68 participants were entered, and 64 were treated with the study treatment
Participant milestones
| Measure |
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
3
|
4
|
7
|
8
|
5
|
4
|
5
|
3
|
7
|
4
|
3
|
6
|
|
Overall Study
Treated
|
4
|
3
|
3
|
4
|
7
|
7
|
4
|
4
|
5
|
3
|
7
|
4
|
3
|
6
|
|
Overall Study
Not Treated
|
0
|
2
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
3
|
4
|
7
|
8
|
5
|
4
|
5
|
3
|
7
|
4
|
3
|
6
|
Reasons for withdrawal
| Measure |
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
3
|
2
|
2
|
2
|
4
|
4
|
3
|
2
|
3
|
2
|
4
|
3
|
2
|
4
|
|
Overall Study
Other Adverse event
|
1
|
1
|
1
|
1
|
2
|
4
|
1
|
2
|
2
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Refuse to continue medication
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason other than those specified above
|
0
|
2
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
2
|
1
|
0
|
2
|
Baseline Characteristics
BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment
Baseline characteristics by cohort
| Measure |
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
76.0 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
71.3 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
79.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
77.5 years
STANDARD_DEVIATION 4.0 • n=4 Participants
|
67.4 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
72.3 years
STANDARD_DEVIATION 5.1 • n=8 Participants
|
74.3 years
STANDARD_DEVIATION 4.1 • n=8 Participants
|
73.5 years
STANDARD_DEVIATION 6.6 • n=24 Participants
|
79.0 years
STANDARD_DEVIATION 4.4 • n=42 Participants
|
78.3 years
STANDARD_DEVIATION 4.0 • n=42 Participants
|
72.3 years
STANDARD_DEVIATION 4.4 • n=42 Participants
|
69.5 years
STANDARD_DEVIATION 11.8 • n=42 Participants
|
63.3 years
STANDARD_DEVIATION 5.1 • n=36 Participants
|
63.3 years
STANDARD_DEVIATION 5.6 • n=36 Participants
|
72.2 years
STANDARD_DEVIATION 7.6 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
30 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
34 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: up to 28 days of treatmentPopulation: Treated set (TS): All patients who received at least one single dose of trial medication (BI 811283 or cytarabine) were considered.
The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only. It was determined using a standard "3 + 3 design with de-escalation".
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=28 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=36 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine.
|
—
|
100 mg
|
NA mg
Due to the early termination of the study for strategic reasons, the MTD was not reached in Schedule B
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collected up to cut-off date 20Oct2011, Up to 1239 daysPopulation: Treated set
Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria: The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment. * Complete remission (CR): morphologically leukaemia free state (i.e. bone marrow with \< 5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥ 1,000/μL and platelets \> 100,000/μL. * Complete remission with incomplete blood count recovery ("incomplete" CR, CRi).All of the above criteria for CR had to be met, except that neutrophils \< 1,000/μL or platelets \< 100,000/μL in the blood.
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi])
CR
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi])
CRi
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 daysPopulation: Treated set
The severity and timing of AEs indicates how well the treatment regimen was tolerated. Toxicities were evaluated using the common terminology criteria for adverse events (CTCAE) grading scheme.
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)
CTCAE Grade 1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)
CTCAE Grade 2
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)
CTCAE Grade 3
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)
CTCAE Grade 4
|
2 participants
|
0 participants
|
2 participants
|
2 participants
|
2 participants
|
4 participants
|
3 participants
|
1 participants
|
2 participants
|
3 participants
|
1 participants
|
3 participants
|
1 participants
|
2 participants
|
|
Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)
CTCAE Grade 5
|
4 participants
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
4 participants
|
2 participants
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: up to 28 days of treatmentPopulation: Treated set
Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD)
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Dose Limiting Toxicity (DLT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Data collected up to cut-off date 20 Oct 2011, Up to 1239 daysPopulation: Treated set
Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria; The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment. Partial remission (PR). All of the criteria for CR had to be met, except that the bone marrow had to contain ≥ 5% but less than 25% blasts (or ≤ 50% of initial blast count), or \< 5% blasts in the presence of Auer rods or abnormal morphology.
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Partial Remission
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Data collected up to cut-off date 20 Oct 2011, Up to 1239 daysPopulation: Treated set
EFS was defined as the duration of time from randomisation to time of treatment failure (i.e. PD), relapse from CR, or death from any cause, whichever came first.
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Event Free Survival (EFS)
|
30.0 days
Standard Deviation 7.3
|
35.0 days
Standard Deviation 15.6
|
122.3 days
Standard Deviation 120.0
|
32.0 days
Standard Deviation 1.0
|
117.5 days
Standard Deviation 102.4
|
60.4 days
Standard Deviation 52.6
|
62.0 days
Standard Deviation 54.1
|
209.0 days
Standard Deviation 315.8
|
65.0 days
Standard Deviation 41.5
|
168.8 days
Standard Deviation 219.3
|
62.7 days
Standard Deviation 53.9
|
138.7 days
Standard Deviation 183.2
|
48.5 days
Standard Deviation 36.9
|
174.0 days
Standard Deviation 67.2
|
SECONDARY outcome
Timeframe: Data collected up to cut-off date 20 Oct 2011, Up to 1239 daysPopulation: Treated set (Only patients with observed cases (OC) values were analysed)
Relapse-free survival was defined only for patients who achieved CR/CRi and was measured from the date of attaining CR/CRi until the date of recurrence or death from any cause, whichever occurred first. Number of patients having relapse free survival are presented.
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=1 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=1 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=1 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=1 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=1 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=1 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=2 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Relapse Free Survival
|
—
|
—
|
—
|
—
|
1 participants
|
—
|
1 participants
|
1 participants
|
—
|
1 participants
|
1 participants
|
1 participants
|
—
|
2 participants
|
SECONDARY outcome
Timeframe: Data collected up to cut-off date 20 Oct 2011, Up to 1239 daysPopulation: Treated set (Only patients with observed cases (OC) values were analysed)
Remission duration analysis was defined only for patients who achieved CR, and was measured from the date of attaining CR until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of the cause.
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=1 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=1 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=1 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=1 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=1 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=1 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Remission Duration
|
—
|
—
|
—
|
—
|
263.0 days
Standard Deviation NA
As only one participant is analyzed, SD is not calculable
|
—
|
28.0 days
Standard Deviation NA
As only one participant is analyzed, SD is not calculable
|
337.0 days
Standard Deviation NA
As only one participant is analyzed, SD is not calculable
|
—
|
455.0 days
Standard Deviation NA
As only one participant is analyzed, SD is not calculable
|
—
|
128.0 days
Standard Deviation NA
As only one participant is analyzed, SD is not calculable
|
—
|
15.0 days
Standard Deviation NA
As only one participant is analyzed, SD is not calculable
|
SECONDARY outcome
Timeframe: Data collected up to cut-off date 20 Oct 2011, Up to 1239 daysPopulation: Treated set
OS was defined for all patients that entered the trial, and measured from the date of randomization until death from any cause.
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
48.7 days
Standard Deviation 17.9
|
122.8 days
Standard Deviation 166.2
|
212.0 days
Standard Deviation 55.1
|
71.3 days
Standard Deviation 40.5
|
236.8 days
Standard Deviation 225.5
|
148.7 days
Standard Deviation 125.5
|
86.6 days
Standard Deviation 58.1
|
236.8 days
Standard Deviation 322.9
|
137.3 days
Standard Deviation 121.7
|
198.2 days
Standard Deviation 260.1
|
339.7 days
Standard Deviation 364.8
|
175.7 days
Standard Deviation 175.4
|
73.0 days
Standard Deviation 31.3
|
294.7 days
Standard Deviation 101.5
|
SECONDARY outcome
Timeframe: -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283Population: Treated Set (Only patients with observed cases (OC) values were analysed)
Cmax (maximum measured concentration of BI 811283 in plasma) during Cycle 1
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax (Maximum Measured Concentration of BI 811283 in Plasma)
|
1130.00 nmol/L
Geometric Coefficient of Variation 53.3
|
8.03 nmol/L
Geometric Coefficient of Variation 32.3
|
64.10 nmol/L
Geometric Coefficient of Variation 686.0
|
104.00 nmol/L
Geometric Coefficient of Variation 321.0
|
153.00 nmol/L
Geometric Coefficient of Variation 108.0
|
214.00 nmol/L
Geometric Coefficient of Variation 38.8
|
272.00 nmol/L
Geometric Coefficient of Variation 30.0
|
7.06 nmol/L
Geometric Coefficient of Variation 10.0
|
66.10 nmol/L
Geometric Coefficient of Variation 85.3
|
139.00 nmol/L
Geometric Coefficient of Variation 33.8
|
499.00 nmol/L
Geometric Coefficient of Variation 101.0
|
445.00 nmol/L
Geometric Coefficient of Variation 71.0
|
631.00 nmol/L
Geometric Coefficient of Variation 31.0
|
528.00 nmol/L
Geometric Coefficient of Variation 40.5
|
SECONDARY outcome
Timeframe: -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283Population: Treated set (Only patients with observed cases (OC) values were analysed)
AUC(0-inf) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) during Cycle 1
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=2 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=6 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-inf) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
|
23200 nmol·h/L
Geometric Coefficient of Variation 57.9
|
177 nmol·h/L
Geometric Coefficient of Variation 28.2
|
985 nmol·h/L
Geometric Coefficient of Variation 311.0
|
1000 nmol·h/L
Geometric Coefficient of Variation 40.7
|
2790 nmol·h/L
Geometric Coefficient of Variation 130
|
4400 nmol·h/L
Geometric Coefficient of Variation 62.9
|
5620 nmol·h/L
Geometric Coefficient of Variation 27.9
|
192 nmol·h/L
Geometric Coefficient of Variation 47.7
|
1490 nmol·h/L
Geometric Coefficient of Variation 98.1
|
2840 nmol·h/L
Geometric Coefficient of Variation 29.6
|
8870 nmol·h/L
Geometric Coefficient of Variation 59.9
|
9770 nmol·h/L
Geometric Coefficient of Variation 63.0
|
14100 nmol·h/L
Geometric Coefficient of Variation 32.6
|
12800 nmol·h/L
Geometric Coefficient of Variation 64.3
|
SECONDARY outcome
Timeframe: -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283Population: Treated Set (Only patients with observed cases (OC) values were analysed)
AUC0-tz (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) during Cycle 1
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-tz (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
|
21700 nmol·h/L
Geometric Coefficient of Variation 55.2
|
169 nmol·h/L
Geometric Coefficient of Variation 30.5
|
939 nmol·h/L
Geometric Coefficient of Variation 328
|
2010 nmol·h/L
Geometric Coefficient of Variation 207
|
2350 nmol·h/L
Geometric Coefficient of Variation 105
|
2810 nmol·h/L
Geometric Coefficient of Variation 135
|
5340 nmol·h/L
Geometric Coefficient of Variation 27.2
|
156 nmol·h/L
Geometric Coefficient of Variation 17.5
|
1450 nmol·h/L
Geometric Coefficient of Variation 97.3
|
2730 nmol·h/L
Geometric Coefficient of Variation 29.1
|
8680 nmol·h/L
Geometric Coefficient of Variation 60.4
|
9260 nmol·h/L
Geometric Coefficient of Variation 63.6
|
13700 nmol·h/L
Geometric Coefficient of Variation 31.7
|
12100 nmol·h/L
Geometric Coefficient of Variation 63.1
|
SECONDARY outcome
Timeframe: -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283Population: Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.
Cmax (maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax,ss (Maximum Measured Concentration of BI 811283 in Plasma at Steady State)
|
—
|
8.02 nmol/L
Geometric Coefficient of Variation 4.59
|
24.7 nmol/L
Geometric Coefficient of Variation 18.5
|
43.3 nmol/L
Geometric Coefficient of Variation 5.58
|
141 nmol/L
Geometric Coefficient of Variation 52.2
|
213 nmol/L
Geometric Coefficient of Variation 96.1
|
229 nmol/L
Geometric Coefficient of Variation 67.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283Population: Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.
AUC (0-inf, ss)(area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) at steady state during Cycle 1
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=1 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=6 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-inf, ss)(Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) at Steady State
|
—
|
188 nmol·h/L
Geometric Coefficient of Variation 12.7
|
615 nmol·h/L
Geometric Coefficient of Variation 15.3
|
NA nmol·h/L
Geometric Coefficient of Variation NA
Not calculated as estimates of summary statistical values are not considered reliable if data from fewer than 2/3 of tested subjects are available, according to Boehringer-Ingelheim Clinical PK SOP
|
4460 nmol·h/L
Geometric Coefficient of Variation 41.8
|
5140 nmol·h/L
Geometric Coefficient of Variation 105.0
|
4750 nmol·h/L
Geometric Coefficient of Variation 58.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283Population: Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.
AUC (0-tz,ss) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) at steady state during Cycle 1
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-tz,ss) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) at Steady State
|
—
|
183 nmol·h/L
Geometric Coefficient of Variation 14.3
|
597 nmol·h/L
Geometric Coefficient of Variation 15.0
|
1620 nmol·h/L
Geometric Coefficient of Variation 58.2
|
4330 nmol·h/L
Geometric Coefficient of Variation 40.5
|
4340 nmol·h/L
Geometric Coefficient of Variation 83.6
|
4820 nmol·h/L
Geometric Coefficient of Variation 55.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283Population: Treated Set (Only patients with observed cases (OC) values were analysed)
tmax (time from dosing to maximum measured concentration of BI 811283 in plasma) during Cycle 1
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma)
|
14.8 hours
Interval 3.9 to 26.1
|
24.0 hours
Interval 6.0 to 24.1
|
26.0 hours
Interval 6.0 to 48.0
|
25.0 hours
Interval 24.0 to 32.0
|
22.7 hours
Interval 6.0 to 24.1
|
6.0 hours
Interval 4.1 to 24.3
|
23.6 hours
Interval 5.9 to 24.5
|
23.9 hours
Interval 4.0 to 24.2
|
6.0 hours
Interval 6.0 to 6.0
|
24.1 hours
Interval 6.0 to 26.8
|
24.9 hours
Interval 23.6 to 32.0
|
6.0 hours
Interval 6.0 to 25.0
|
23.9 hours
Interval 23.9 to 24.1
|
5.9 hours
Interval 4.8 to 6.0
|
SECONDARY outcome
Timeframe: -0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283Population: Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.
tmax,ss (time from dosing to maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax,ss (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma at Steady State)
|
—
|
23.9 hours
Interval 4.1 to 23.9
|
24.0 hours
Interval 4.0 to 24.0
|
6.0 hours
Interval 4.0 to 24.0
|
6.0 hours
Interval 4.1 to 24.0
|
6.0 hours
Interval 5.9 to 23.5
|
6.0 hours
Interval 4.0 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of CytarabinePopulation: Treated Set (Only patients with observed cases (OC) values were analysed)
Cmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=6 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax (Maximum Measured Concentration of Cytarabine in Plasma)
|
68.7 ng/mL
Geometric Coefficient of Variation 33.1
|
53.2 ng/mL
Geometric Coefficient of Variation 65.4
|
72.6 ng/mL
Geometric Coefficient of Variation 31.0
|
49.0 ng/mL
Geometric Coefficient of Variation 80.6
|
64.9 ng/mL
Geometric Coefficient of Variation 49.5
|
61.9 ng/mL
Geometric Coefficient of Variation 57.3
|
46.0 ng/mL
Geometric Coefficient of Variation 54.1
|
46.3 ng/mL
Geometric Coefficient of Variation 31.8
|
49.8 ng/mL
Geometric Coefficient of Variation 58.1
|
55.0 ng/mL
Geometric Coefficient of Variation 16.5
|
65.1 ng/mL
Geometric Coefficient of Variation 44.5
|
49.4 ng/mL
Geometric Coefficient of Variation 58.9
|
48.6 ng/mL
Geometric Coefficient of Variation 88.4
|
49.0 ng/mL
Geometric Coefficient of Variation 77.0
|
SECONDARY outcome
Timeframe: -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of CytarabinePopulation: Treated Set (Only patients with observed cases (OC) values were analysed)
Tmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=6 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax (Time From Dosing to Maximum Measured Concentration of Cytarabine in Plasma)
|
0.49 hours
Interval 0.48 to 0.57
|
0.50 hours
Interval 0.5 to 1.0
|
0.50 hours
Interval 0.5 to 1.0
|
0.92 hours
Interval 0.5 to 1.0
|
0.83 hours
Interval 0.5 to 1.4
|
0.48 hours
Interval 0.42 to 0.53
|
0.55 hours
Interval 0.5 to 1.5
|
0.50 hours
Interval 0.4 to 0.7
|
0.50 hours
Interval 0.5 to 0.5
|
0.58 hours
Interval 0.47 to 1.0
|
0.50 hours
Interval 0.43 to 0.67
|
0.50 hours
Interval 0.45 to 1.0
|
0.50 hours
Interval 0.47 to 0.5
|
0.48 hours
Interval 0.48 to 1.0
|
SECONDARY outcome
Timeframe: -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of CytarabinePopulation: Treated set (Only patients with observed cases (OC) values were analysed)
AUC (0-inf) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=2 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=5 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=2 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=2 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-inf) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
|
76.8 ng·h/mL
Geometric Coefficient of Variation 42.6
|
104 ng·h/mL
Geometric Coefficient of Variation 31.4
|
122 ng·h/mL
Geometric Coefficient of Variation 6.89
|
102 ng·h/mL
Geometric Coefficient of Variation 31.5
|
85.4 ng·h/mL
Geometric Coefficient of Variation 35.3
|
65.9 ng·h/mL
Geometric Coefficient of Variation 42.5
|
68.1 ng·h/mL
Geometric Coefficient of Variation 41.4
|
62.0 ng·h/mL
Geometric Coefficient of Variation 24.1
|
NA ng·h/mL
Geometric Coefficient of Variation NA
Not calculated as estimates of summary statistical values are not considered reliable if data from fewer than 2/3 of tested subjects are available, according to Boehringer-Ingelheim Clinical PK SOP
|
NA ng·h/mL
Geometric Coefficient of Variation NA
Not calculated as estimates of summary statistical values are not considered reliable if data from fewer than 2/3 of tested subjects are available, according to Boehringer-Ingelheim Clinical PK SOP
|
71.2 ng·h/mL
Geometric Coefficient of Variation 20.7
|
72.7 ng·h/mL
Geometric Coefficient of Variation 23.6
|
75.5 ng·h/mL
Geometric Coefficient of Variation 27.2
|
76.9 ng·h/mL
Geometric Coefficient of Variation 19.5
|
SECONDARY outcome
Timeframe: -0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of CytarabinePopulation: Treated Set (Only patients with observed cases (OC) values were analysed)
AUC (0-tz) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
Outcome measures
| Measure |
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 Participants
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 Participants
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 Participants
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=6 Participants
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 Participants
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 Participants
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 Participants
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 Participants
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 Participants
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-tz) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
|
51.6 ng·h/L
Geometric Coefficient of Variation 38.1
|
45.0 ng·h/L
Geometric Coefficient of Variation 156.0
|
66.9 ng·h/L
Geometric Coefficient of Variation 73.8
|
66.8 ng·h/L
Geometric Coefficient of Variation 57.6
|
71.8 ng·h/L
Geometric Coefficient of Variation 26.4
|
46.6 ng·h/L
Geometric Coefficient of Variation 51.2
|
42.3 ng·h/L
Geometric Coefficient of Variation 64.3
|
45.9 ng·h/L
Geometric Coefficient of Variation 20.0
|
33.9 ng·h/L
Geometric Coefficient of Variation 245.0
|
57.0 ng·h/L
Geometric Coefficient of Variation 18.2
|
60.2 ng·h/L
Geometric Coefficient of Variation 30.4
|
52.5 ng·h/L
Geometric Coefficient of Variation 38.8
|
52.1 ng·h/L
Geometric Coefficient of Variation 42.1
|
41.3 ng·h/L
Geometric Coefficient of Variation 87.2
|
SECONDARY outcome
Timeframe: On Day 5, i.e. 72 hours after the end of the first BI 811283 infusion, and on Day 28 in the first cycle onlyPopulation: Treated set
Pharmacodynamic monitoring: drug effect on leukaemia cells (e.g. polyploidy, histone H3 phosphorylation, morphologic changes). An evaluation of this secondary endpoint is not possible due to missing samples / samples of poor quality of the provided material.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: -0.05, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hoursPopulation: Treated set
The study protocol originally included a phase II part with a treatment arm in which Cytarabine was given alone, however the sponsor discontinued the clinical development of BI 811283, therefore the protocol was amended and the reference therapy arm was removed from the study protocol" -\> (Protocol Amendment 5, version 19 -May-2010, approved 28-Jun-2010). Since there was never a treatment arm in which Cytarabine was given alone; hence pharmacokinetics are not calculated.
Outcome measures
Outcome data not reported
Adverse Events
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
Serious events: 7 serious events
Other events: 6 other events
Deaths: 0 deaths
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 participants at risk
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 participants at risk
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 participants at risk
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 participants at risk
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 participants at risk
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 participants at risk
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 participants at risk
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 participants at risk
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 participants at risk
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 participants at risk
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 participants at risk
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 participants at risk
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 participants at risk
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 participants at risk
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
75.0%
3/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Cardiac fibrillation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Congenital, familial and genetic disorders
Aplasia
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Eye disorders
Blindness
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Asthenia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Death
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Multi-organ failure
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Abscess
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Endocarditis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Gingivitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Groin abscess
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Pneumonia
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood uric acid increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Convulsion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Renal failure
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
Other adverse events
| Measure |
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 participants at risk
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 participants at risk
15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=3 participants at risk
30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=4 participants at risk
60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 participants at risk
100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A
n=7 participants at risk
120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 participants at risk
5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 participants at risk
40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=5 participants at risk
80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 participants at risk
160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=7 participants at risk
240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=4 participants at risk
300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=3 participants at risk
360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B
n=6 participants at risk
420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);
Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);
BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Chest pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
71.4%
5/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
71.4%
5/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
100.0%
3/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
100.0%
3/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
3/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
71.4%
5/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
100.0%
3/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Lymph node pain
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
100.0%
3/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
75.0%
3/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
60.0%
3/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Eye disorders
Cataract
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Eye disorders
Eyelid bleeding
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Eye disorders
Photopsia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
75.0%
3/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Anal haemorrhage
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
75.0%
3/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Gingival bleeding
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
60.0%
3/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
75.0%
3/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
100.0%
3/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Palatal disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Adverse drug reaction
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Asthenia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Catheter site erythema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Catheter site inflammation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Chills
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
75.0%
3/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Discomfort
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Facial pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Fatigue
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
100.0%
3/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Feeling cold
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
General physical health deterioration
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
3/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Inflammation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Injection site inflammation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Injection site pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Local swelling
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Localised oedema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Mass
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Mucosal inflammation
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Oedema
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Pain
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
75.0%
3/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
60.0%
3/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Hepatobiliary disorders
Hepatic vein occlusion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Erysipelas
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Infection
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Infectious disease carrier
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Localised infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Periodontitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Puncture site infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Skin candida
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
100.0%
3/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Activated partial thromboplastin time
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Alanine aminotransferase decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Antithrombin III decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Aspartate aminotransferase decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Basophil count increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood calcium decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood calcium increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood chloride decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood chloride increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood cholinesterase decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood glucose increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
3/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
71.4%
5/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
100.0%
3/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood sodium decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood uric acid increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Blood urine present
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Eosinophil count increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Heart rate increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Mean cell haemoglobin concentration increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Protein total decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Protein total increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Prothrombin time prolonged
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
Weight increased
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Investigations
pH urine decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteoma
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Ageusia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Convulsion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Dementia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Disturbance in attention
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
60.0%
3/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Spinal haematoma
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Catatonia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Illusion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Mood altered
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
57.1%
4/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
100.0%
3/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
71.4%
5/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
42.9%
3/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
3/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
2/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
66.7%
2/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Social circumstances
Bedridden
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Surgical and medical procedures
Catheterisation venous
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
75.0%
3/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
28.6%
2/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
50.0%
2/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
40.0%
2/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Thrombophlebitis
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
14.3%
1/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
25.0%
1/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
16.7%
1/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Thrombosis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
33.3%
1/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
|
Vascular disorders
Vasculitis
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
20.0%
1/5 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/7 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/4 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/3 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
0.00%
0/6 • Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER