Trial Outcomes & Findings for Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate (NCT NCT01688830)
NCT ID: NCT01688830
Last Updated: 2016-06-23
Results Overview
Frequency of subjects with related adverse events (AE) by treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
157 participants
Primary outcome timeframe
AEs occurring until end of follow-up (Up to 3 months after last drug administration)
Results posted on
2016-06-23
Participant Flow
The study is conducted in two parts: Parts 1 and 2 had a single rising dose design; subjects in Part 3 received 2 single doses 1 h apart. Part 1: 8 subjects per dose group Part 2: 12 subjects per dose group Part 3: 12 subjects per dose group
Participant milestones
| Measure |
Placebo 1 h
One single intravenous long infusion (1 h) of Idarucizumab Placebo
This is administered during Part 1 of the study
|
20 mg Idarucizumab 1h
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
Placebo 5min
One single intravenous short infusion (5 min) of Idarucizumab Placebo
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ Placebo 5min
One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 1 g Idarucizumab 5min
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
6
|
6
|
6
|
5
|
6
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
9
|
9
|
9
|
8
|
3
|
9
|
|
Overall Study
COMPLETED
|
21
|
6
|
6
|
6
|
5
|
6
|
12
|
6
|
6
|
6
|
5
|
6
|
6
|
6
|
6
|
9
|
9
|
9
|
8
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo 1 h
One single intravenous long infusion (1 h) of Idarucizumab Placebo
This is administered during Part 1 of the study
|
20 mg Idarucizumab 1h
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
Placebo 5min
One single intravenous short infusion (5 min) of Idarucizumab Placebo
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ Placebo 5min
One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 1 g Idarucizumab 5min
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate
Baseline characteristics by cohort
| Measure |
Placebo 1 h
n=21 Participants
One single intravenous long infusion (1 h) of Idarucizumab Placebo
This is administered during Part 1 of the study
|
20 mg Idarucizumab 1h
n=6 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=6 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
n=6 Participants
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
n=5 Participants
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
n=6 Participants
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
n=12 Participants
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
n=6 Participants
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
n=6 Participants
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
n=6 Participants
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
n=6 Participants
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
Placebo 5min
n=6 Participants
One single intravenous short infusion (5 min) of Idarucizumab Placebo
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
n=6 Participants
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
n=6 Participants
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
n=6 Participants
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ Placebo 5min
n=9 Participants
One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 1 g Idarucizumab 5min
n=9 Participants
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
n=9 Participants
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
n=8 Participants
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
n=3 Participants
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
n=9 Participants
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
36.2 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
36.6 years
STANDARD_DEVIATION 4.5 • n=21 Participants
|
32.0 years
STANDARD_DEVIATION 8.9 • n=8 Participants
|
30.3 years
STANDARD_DEVIATION 8.5 • n=8 Participants
|
32.7 years
STANDARD_DEVIATION 4.2 • n=24 Participants
|
35.3 years
STANDARD_DEVIATION 9.5 • n=42 Participants
|
34.5 years
STANDARD_DEVIATION 8.8 • n=42 Participants
|
35.2 years
STANDARD_DEVIATION 9.1 • n=42 Participants
|
34.5 years
STANDARD_DEVIATION 11.2 • n=42 Participants
|
34.7 years
STANDARD_DEVIATION 8.5 • n=36 Participants
|
31.8 years
STANDARD_DEVIATION 5.4 • n=36 Participants
|
36.0 years
STANDARD_DEVIATION 8.3 • n=24 Participants
|
30.9 years
STANDARD_DEVIATION 8.9 • n=135 Participants
|
31.3 years
STANDARD_DEVIATION 7.0 • n=136 Participants
|
31.1 years
STANDARD_DEVIATION 8.3 • n=44 Participants
|
31.9 years
STANDARD_DEVIATION 9.1 • n=667 Participants
|
30.0 years
STANDARD_DEVIATION 2.6 • n=12 Participants
|
29.9 years
STANDARD_DEVIATION 9.0 • n=12 Participants
|
32.4 years
STANDARD_DEVIATION 7.9 • n=12 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
9 Participants
n=135 Participants
|
9 Participants
n=136 Participants
|
9 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
3 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
157 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: AEs occurring until end of follow-up (Up to 3 months after last drug administration)Population: Treated set
Frequency of subjects with related adverse events (AE) by treatment
Outcome measures
| Measure |
20 mg Idarucizumab 1h
n=21 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=6 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
n=6 Participants
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
n=6 Participants
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
n=5 Participants
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
n=6 Participants
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
n=12 Participants
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
n=6 Participants
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
n=6 Participants
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
n=6 Participants
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
n=6 Participants
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
n=6 Participants
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
n=6 Participants
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ 1 g Idarucizumab 5min
n=6 Participants
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
n=6 Participants
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
n=9 Participants
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
n=9 Participants
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
n=9 Participants
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
n=8 Participants
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
n=3 Participants
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
n=9 Participants
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Drug Related Adverse Events (AE)
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72hPopulation: Pharmacokinetic set (PKS) comprises of all subjects (with evaluable observations) in the TS who provided at least 1 PK endpoint and had no important protocol violations relevant to the evaluation of PK and additionally for Part 2 and 3 had no emesis with onset at or before twice the median tmax of dabigatran.
Cmax (maximum measured concentration) for idarucizumab
Outcome measures
| Measure |
20 mg Idarucizumab 1h
n=6 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=6 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
n=6 Participants
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
n=5 Participants
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
n=6 Participants
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
n=12 Participants
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
n=6 Participants
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
n=6 Participants
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
n=6 Participants
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
n=5 Participants
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
n=6 Participants
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
n=6 Participants
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
n=6 Participants
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ 1 g Idarucizumab 5min
n=9 Participants
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
n=9 Participants
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
n=8 Participants
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
n=9 Participants
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax (Maximum Measured Concentration) for Idarucizumab
|
79.9 nmol/L
Geometric Coefficient of Variation 15.1
|
257 nmol/L
Geometric Coefficient of Variation 11.1
|
809 nmol/L
Geometric Coefficient of Variation 13.9
|
2440 nmol/L
Geometric Coefficient of Variation 13.1
|
4520 nmol/L
Geometric Coefficient of Variation 9.72
|
7420 nmol/L
Geometric Coefficient of Variation 15.1
|
11700 nmol/L
Geometric Coefficient of Variation 10.4
|
15700 nmol/L
Geometric Coefficient of Variation 15.6
|
22100 nmol/L
Geometric Coefficient of Variation 12.0
|
33900 nmol/L
Geometric Coefficient of Variation 13.2
|
6360 nmol/L
Geometric Coefficient of Variation 16.7
|
13600 nmol/L
Geometric Coefficient of Variation 23.4
|
21400 nmol/L
Geometric Coefficient of Variation 13.1
|
5410 nmol/L
Geometric Coefficient of Variation 13.5
|
12500 nmol/L
Geometric Coefficient of Variation 21.5
|
25800 nmol/L
Geometric Coefficient of Variation 25.1
|
35300 nmol/L
Geometric Coefficient of Variation 24.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72hPopulation: PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)
tmax (time from dosing to maximum measured concentration) for idarucizumab
Outcome measures
| Measure |
20 mg Idarucizumab 1h
n=6 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=6 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
n=6 Participants
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
n=5 Participants
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
n=6 Participants
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
n=12 Participants
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
n=6 Participants
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
n=6 Participants
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
n=6 Participants
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
n=5 Participants
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
n=6 Participants
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
n=6 Participants
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
n=6 Participants
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ 1 g Idarucizumab 5min
n=9 Participants
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
n=9 Participants
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
n=8 Participants
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
n=9 Participants
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab
|
1.00 hours
Interval 0.967 to 1.17
|
1.03 hours
Interval 0.967 to 1.17
|
1.03 hours
Interval 0.967 to 1.08
|
1.10 hours
Interval 1.03 to 1.18
|
0.967 hours
Interval 0.967 to 1.08
|
0.984 hours
Interval 0.967 to 1.17
|
1.00 hours
Interval 0.967 to 1.05
|
1.06 hours
Interval 0.967 to 1.17
|
1.03 hours
Interval 0.967 to 1.08
|
1.08 hours
Interval 0.967 to 1.17
|
0.117 hours
Interval 0.083 to 0.167
|
0.142 hours
Interval 0.117 to 0.25
|
0.167 hours
Interval 0.117 to 0.25
|
0.117 hours
Interval 0.083 to 0.167
|
0.200 hours
Interval 0.167 to 0.333
|
0.117 hours
Interval 0.083 to 0.167
|
0.117 hours
Interval 0.083 to 1.12
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72hPopulation: PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)
AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab
Outcome measures
| Measure |
20 mg Idarucizumab 1h
n=6 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=6 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
n=6 Participants
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
n=5 Participants
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
n=6 Participants
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
n=12 Participants
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
n=6 Participants
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
n=6 Participants
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
n=6 Participants
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
n=5 Participants
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
n=6 Participants
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
n=6 Participants
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
n=6 Participants
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ 1 g Idarucizumab 5min
n=9 Participants
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
n=9 Participants
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
n=8 Participants
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
n=9 Participants
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab
|
146 nmol*h/L
Geometric Coefficient of Variation 19.8
|
426 nmol*h/L
Geometric Coefficient of Variation 11.6
|
1950 nmol*h/L
Geometric Coefficient of Variation 129
|
6970 nmol*h/L
Geometric Coefficient of Variation 75.4
|
8780 nmol*h/L
Geometric Coefficient of Variation 4.92
|
14500 nmol*h/L
Geometric Coefficient of Variation 15.9
|
22600 nmol*h/L
Geometric Coefficient of Variation 17.6
|
31000 nmol*h/L
Geometric Coefficient of Variation 12.9
|
41200 nmol*h/L
Geometric Coefficient of Variation 11.8
|
63800 nmol*h/L
Geometric Coefficient of Variation 15.6
|
7790 nmol*h/L
Geometric Coefficient of Variation 13.1
|
16400 nmol*h/L
Geometric Coefficient of Variation 16.8
|
25800 nmol*h/L
Geometric Coefficient of Variation 22.1
|
6480 nmol*h/L
Geometric Coefficient of Variation 17.1
|
16600 nmol*h/L
Geometric Coefficient of Variation 10.7
|
30900 nmol*h/L
Geometric Coefficient of Variation 14.1
|
62300 nmol*h/L
Geometric Coefficient of Variation 8.43
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7 hoursPopulation: PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)
Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2) Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion.
Outcome measures
| Measure |
20 mg Idarucizumab 1h
n=6 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=6 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
n=6 Participants
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
n=5 Participants
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
n=6 Participants
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
n=12 Participants
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
n=6 Participants
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
n=6 Participants
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
n=6 Participants
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
n=5 Participants
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
n=6 Participants
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
n=6 Participants
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
n=6 Participants
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ 1 g Idarucizumab 5min
n=9 Participants
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
n=9 Participants
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
n=8 Participants
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
n=9 Participants
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)
|
NA μmol
Geometric Coefficient of Variation NA
Missing values (denoted with 'NA') were not measured for the respective dose groups.
|
NA μmol
Geometric Coefficient of Variation NA
Missing values (denoted with 'NA') were not measured for the respective dose groups.
|
NA μmol
Geometric Coefficient of Variation NA
Missing values (denoted with 'NA') were not measured for the respective dose groups.
|
NA μmol
Geometric Coefficient of Variation NA
Missing values (denoted with 'NA') were not measured for the respective dose groups.
|
NA μmol
Geometric Coefficient of Variation NA
Missing values (denoted with 'NA') were not measured for the respective dose groups.
|
NA μmol
Geometric Coefficient of Variation NA
Missing values (denoted with 'NA') were not measured for the respective dose groups.
|
NA μmol
Geometric Coefficient of Variation NA
Missing values (denoted with 'NA') were not measured for the respective dose groups.
|
NA μmol
Geometric Coefficient of Variation NA
Missing values (denoted with 'NA') were not measured for the respective dose groups.
|
36.1 μmol
Geometric Coefficient of Variation 50.1
|
39.5 μmol
Geometric Coefficient of Variation 395
|
2.23 μmol
Geometric Coefficient of Variation 76.3
|
8.00 μmol
Geometric Coefficient of Variation 73.1
|
32.6 μmol
Geometric Coefficient of Variation 23.6
|
1.71 μmol
Geometric Coefficient of Variation 90.6
|
11.0 μmol
Geometric Coefficient of Variation 23.4
|
33.6 μmol
Geometric Coefficient of Variation 30.5
|
73.5 μmol
Geometric Coefficient of Variation 24.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Intervals 0-2, 2-6, 6-10, 10-12 hours on Day 3 post dabigatran treatment and -2 to -0:05, -0:05 to 4, 4-8, 8-10, 10-12, 12-24, 24-48, 48-72 on Day 4 post Idarucizumab treatmentPopulation: PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)
Aet1-t2,ss (amount of dabigatran etexilate eliminated in urine from time point t1 to time point t2, at steady state) on Day 3 and Day 4 Ae(0-12h,ss) of sum dabigatran
Outcome measures
| Measure |
20 mg Idarucizumab 1h
n=34 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=9 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
n=9 Participants
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
n=9 Participants
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
n=8 Participants
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
n=12 Participants
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
n=2 Participants
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
n=8 Participants
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ 1 g Idarucizumab 5min
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran
|
6600 μg
Geometric Coefficient of Variation 54.4
|
6870 μg
Geometric Coefficient of Variation 37.8
|
5160 μg
Geometric Coefficient of Variation 57.1
|
3820 μg
Geometric Coefficient of Variation 86.9
|
3860 μg
Geometric Coefficient of Variation 39.1
|
6420 μg
Geometric Coefficient of Variation 38.7
|
5060 μg
Geometric Coefficient of Variation 55.1
|
4290 μg
Geometric Coefficient of Variation 35.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1.92 hours (h), 2 h, 2.5 h, 6 h and 12 h on Day 4Population: Pharmadynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and 1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD.
Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented. The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). "BLQ" values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable.
Outcome measures
| Measure |
20 mg Idarucizumab 1h
n=9 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=9 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
n=9 Participants
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
n=8 Participants
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
n=2 Participants
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
n=8 Participants
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ 1 g Idarucizumab 5min
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)
C1.92,ss (N= 9, 9, 9, 8, 2, 8)
|
119 ng/mL
Geometric Coefficient of Variation 38.0
|
136 ng/mL
Geometric Coefficient of Variation 51.8
|
96.2 ng/mL
Geometric Coefficient of Variation 33.3
|
135 ng/mL
Geometric Coefficient of Variation 47.6
|
101 ng/mL
Geometric Coefficient of Variation 97.8
|
112 ng/mL
Geometric Coefficient of Variation 34.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)
C2,ss (N= 9, 6, NA, NA, 2, NA)
|
123 ng/mL
Geometric Coefficient of Variation 40.8
|
1.59 ng/mL
Geometric Coefficient of Variation 10.7
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
95.6 ng/mL
Geometric Coefficient of Variation 109
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)
C2.5,ss (N= 9, NA, NA, NA, 2, NA )
|
130 ng/mL
Geometric Coefficient of Variation 47.9
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
92.9 ng/mL
Geometric Coefficient of Variation 99.4
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)
C6,ss (N= 9, 9, NA, NA, 2, NA)
|
79.2 ng/mL
Geometric Coefficient of Variation 44.6
|
15.3 ng/mL
Geometric Coefficient of Variation 296
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
54.8 ng/mL
Geometric Coefficient of Variation 93.2
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)
C12,ss (N= 9, 9, NA, NA, 2, NA)
|
38.5 ng/mL
Geometric Coefficient of Variation 40.3
|
18.2 ng/mL
Geometric Coefficient of Variation 71.1
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
28.9 ng/mL
Geometric Coefficient of Variation 90.6
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12hPopulation: PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)
AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4
Outcome measures
| Measure |
20 mg Idarucizumab 1h
n=35 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=9 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
n=9 Participants
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
n=9 Participants
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
n=8 Participants
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
n=12 Participants
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
n=2 Participants
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
n=8 Participants
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ 1 g Idarucizumab 5min
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4
|
805 ng*h/mL
Geometric Coefficient of Variation 57.4
|
754 ng*h/mL
Geometric Coefficient of Variation 45.6
|
161 ng*h/mL
Geometric Coefficient of Variation 148
|
20.9 ng*h/mL
Geometric Coefficient of Variation 199
|
11.9 ng*h/mL
Geometric Coefficient of Variation 44.3
|
786 ng*h/mL
Geometric Coefficient of Variation 40.1
|
542 ng*h/mL
Geometric Coefficient of Variation 98.9
|
10.0 ng*h/mL
Geometric Coefficient of Variation 0.344
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2hours-12 hoursPopulation: Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and 1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD.
AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value). Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented. This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)
Outcome measures
| Measure |
20 mg Idarucizumab 1h
n=9 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=9 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
n=9 Participants
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
n=8 Participants
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ 1 g Idarucizumab 5min
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study
aPTT
|
1.28 ratio
Standard Deviation 0.399
|
0.46 ratio
Standard Deviation 0.342
|
0.14 ratio
Standard Deviation 0.135
|
0.07 ratio
Standard Deviation 0.103
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study
dTT
|
1.01 ratio
Standard Deviation 0.484
|
0.26 ratio
Standard Deviation 0.245
|
0.06 ratio
Standard Deviation 0.094
|
0.02 ratio
Standard Deviation 0.016
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study
TT
|
1.08 ratio
Standard Deviation 0.361
|
0.32 ratio
Standard Deviation 0.280
|
0.06 ratio
Standard Deviation 0.124
|
0.00 ratio
Standard Deviation 0.007
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study
ECT
|
1.04 ratio
Standard Deviation 0.493
|
0.28 ratio
Standard Deviation 0.231
|
0.07 ratio
Standard Deviation 0.080
|
0.03 ratio
Standard Deviation 0.013
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2hours-12 hoursPopulation: Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and 1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD.
AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value). Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented. This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)
Outcome measures
| Measure |
20 mg Idarucizumab 1h
n=3 Participants
Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
This is administered during Part 1 of the study
|
60 mg Idarucizumab 1h
n=9 Participants
Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
This is administered during Part 1 of the study
|
200 mg Idarucizumab 1h
Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
This is administered during Part 1 of the study
|
600 mg Idarucizumab 1h
Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
This is administered during Part 1 of the study
|
1.2 g Idarucizumab 1h
Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 1h
Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
3 g Idarucizumab 1h
Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 1h
Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
6 g Idarucizumab 1h
Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
This is administered during Part 1 of the study
|
8 g Idarucizumab 1h
Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
This is administered during Part 1 of the study
|
1 g Idarucizumab 5min
Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
This is administered during Part 1 of the study
|
2 g Idarucizumab 5min
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
This is administered during Part 1 of the study
|
4 g Idarucizumab 5min
Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
This is administered during Part 1 of the study
|
DE+ 1 g Idarucizumab 5min
Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 2 of the study.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
This is administered during Part 3 of the study
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study
aPTT
|
1.68 ratio
Standard Deviation 0.534
|
0.03 ratio
Standard Deviation 0.045
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study
dTT
|
1.02 ratio
Standard Deviation 1.036
|
0.01 ratio
Standard Deviation 0.029
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo 1 h
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
20 mg Idarucizumab 1h
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
60 mg Idarucizumab 1h
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
200 mg Idarucizumab 1h
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
600 mg Idarucizumab 1h
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1.2 g Idarucizumab 1h
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2 g Idarucizumab 1h
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
3 g Idarucizumab 1h
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
4 g Idarucizumab 1h
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6 g Idarucizumab 1h
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
8 g Idarucizumab 1h
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo 5min
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1 g Idarucizumab 5min
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
2 g Idarucizumab 5min
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
4 g Idarucizumab 5min
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DE (Dose Groups 14-16)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
DE+ Placebo 5min
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DE+ 1 g Idarucizumab 5min
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DE+ 4 g Idarucizumab 5min
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DE+ 2 g Idarucizumab 5min
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DE (Dose Groups 17)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DE+ Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DE+ Placebo+ Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DE+ 5 g
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DE+ 5 g + 2.5 g Idarucizumab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo 1 h
n=21 participants at risk
One single intravenous long infusion (1 h) of Idarucizumab Placebo
|
20 mg Idarucizumab 1h
n=6 participants at risk
One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
|
60 mg Idarucizumab 1h
n=6 participants at risk
One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
|
200 mg Idarucizumab 1h
n=6 participants at risk
One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
|
600 mg Idarucizumab 1h
n=5 participants at risk
One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
|
1.2 g Idarucizumab 1h
n=6 participants at risk
One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
|
2 g Idarucizumab 1h
n=12 participants at risk
One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
|
3 g Idarucizumab 1h
n=6 participants at risk
One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
|
4 g Idarucizumab 1h
n=6 participants at risk
One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
|
6 g Idarucizumab 1h
n=6 participants at risk
One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
|
8 g Idarucizumab 1h
n=6 participants at risk
One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
|
Placebo 5min
n=6 participants at risk
One single intravenous short infusion (5 min) of Idarucizumab Placebo
|
1 g Idarucizumab 5min
n=6 participants at risk
One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
|
2 g Idarucizumab 5min
n=6 participants at risk
Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
|
4 g Idarucizumab 5min
n=6 participants at risk
One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
|
DE (Dose Groups 14-16)
n=35 participants at risk
Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose groups 14-16
|
DE+ Placebo 5min
n=9 participants at risk
One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 1 g Idarucizumab 5min
n=9 participants at risk
One single intravenous short infusion (5 min) of 1g of Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 4 g Idarucizumab 5min
n=8 participants at risk
One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 2 g Idarucizumab 5min
n=9 participants at risk
One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE (Dose Groups 17)
n=12 participants at risk
Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose group 17
|
DE+ Placebo
n=3 participants at risk
One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ Placebo+ Placebo
n=3 participants at risk
Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g
n=9 participants at risk
One single intravenous short infusion (5 min) of 5 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
DE+ 5 g + 2.5 g Idarucizumab
n=9 participants at risk
Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.
DE is administered orally :
Day 1 to 3: twice daily; Day 4: once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
20.0%
1/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
14.3%
5/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
33.3%
2/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
2/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
33.3%
2/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
8.6%
3/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
8.3%
1/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
5.7%
2/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
12.5%
1/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Nervous system disorders
Migraine
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
8.3%
1/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
8.3%
1/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
22.2%
2/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
8.3%
1/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
9.5%
2/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
12.5%
1/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
22.2%
2/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
8.3%
1/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
20.0%
1/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
33.3%
2/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
12.5%
1/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
8.3%
1/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
8.6%
3/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
General disorders
Asthenia
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
12.5%
1/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
General disorders
Catheter site pain
|
4.8%
1/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
8.3%
1/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
General disorders
Fatigue
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
General disorders
Feeling hot
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
General disorders
Influenza like illness
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
General disorders
Infusion site swelling
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
General disorders
Injection site erythema
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
11.1%
1/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
General disorders
Injection site haematoma
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
16.7%
1/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
33.3%
1/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
|
General disorders
Application site irritation
|
0.00%
0/21 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/5 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
8.3%
1/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/6 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
2.9%
1/35 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/8 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/12 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/3 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
0.00%
0/9 • AEs occurring until end of follow-up (Up to 3 months after last drug administration)
AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under "DE + 5g"), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.
|
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