Trial Outcomes & Findings for This Study Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357 (NCT NCT03279978)
NCT ID: NCT03279978
Last Updated: 2024-12-19
Results Overview
Number of subjects with drug-related Adverse Events (AEs) assessed by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
83 participants
Primary outcome timeframe
From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Results posted on
2024-12-19
Participant Flow
Randomised, placebo-controlled, double-blind design investigating multiple rising doses
All subjects were screened for eligibility to participate in trial. Subjects attended specialist site to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.
Participant milestones
| Measure |
Placebo Fast
Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after a fasting period of at least 6 hours.
|
Placebo Fed
Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after the intake of a standard continental breakfast.
|
BI 730357 25 mg Fast
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 50mg/Placebo
Subject was orally administered mixed treatment of BI 730357 50 mg and placebo, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fed
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast.
|
BI 730357 100 mg Fast
Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fast
Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 400 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
9
|
9
|
1
|
8
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
10
|
8
|
8
|
9
|
1
|
8
|
8
|
9
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Fast
Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after a fasting period of at least 6 hours.
|
Placebo Fed
Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after the intake of a standard continental breakfast.
|
BI 730357 25 mg Fast
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 50mg/Placebo
Subject was orally administered mixed treatment of BI 730357 50 mg and placebo, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fed
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast.
|
BI 730357 100 mg Fast
Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fast
Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 400 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other than stated above
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
This Study Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357
Baseline characteristics by cohort
| Measure |
Placebo Fast
n=11 Participants
Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after a fasting period of at least 6 hours.
|
Placebo Fed
n=9 Participants
Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after the intake of a standard continental breakfast.
|
BI 730357 25 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 50mg/Placebo
n=1 Participants
Subject was orally administered mixed treatment of BI 730357 50 mg and placebo, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fed
n=8 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast.
|
BI 730357 100 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fed
n=9 Participants
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 400 mg Fed
n=9 Participants
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.8 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
26.8 Years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
33.3 Years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
32.3 Years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
25.0 Years
STANDARD_DEVIATION NA • n=21 Participants
|
25.4 Years
STANDARD_DEVIATION 3.6 • n=8 Participants
|
27.3 Years
STANDARD_DEVIATION 2.2 • n=8 Participants
|
27.1 Years
STANDARD_DEVIATION 5.9 • n=24 Participants
|
25.6 Years
STANDARD_DEVIATION 4.4 • n=42 Participants
|
30.6 Years
STANDARD_DEVIATION 8.5 • n=42 Participants
|
29.1 Years
STANDARD_DEVIATION 6.6 • n=42 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
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
83 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
82 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
1 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
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
74 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)Population: Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm)
Number of subjects with drug-related Adverse Events (AEs) assessed by the investigator.
Outcome measures
| Measure |
BI 730357 200 mg Fed
n=9 Participants
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 400 mg Fed
n=9 Participants
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 25 mg Fast
n=12 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 25 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=10 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 50 mg Fed
n=8 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast.
|
BI 730357 100 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Drug-related Adverse Events (AEs)
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: -0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h and 23.5h after first dosing on Day1.Population: Pharmacokinetic analysis set (PKS): all subjects from the treated set (TS) who provided at least one evaluable secondary pharmacokinetic endpoint and did not have an important protocol deviation relevant for the evaluation of pharmacokinetics. Arm: BI 730357 50mg/Placebo: This arm comprised 1 subject that was excluded from the PKS due the important protocol deviation of having received a mixed treatment (placebo and investigational drug), therefore was not included in the PK analysis.
Area under the concentration-time curve of the analyte BI 730357 in plasma over a uniform dosing interval tau after administration of the first dose (AUCtau,1). In this study AUCtau,1 = AUC0-24
Outcome measures
| Measure |
BI 730357 200 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 400 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 25 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 25 mg Fast
n=8 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=8 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 50 mg Fed
n=9 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast.
|
BI 730357 100 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte BI 730357 in Plasma Over a Uniform Dosing Interval Tau After Administration of the First Dose (AUCtau,1)
|
—
|
—
|
2150 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 31.2
|
3590 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 34.4
|
4620 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 27.9
|
6650 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 26.4
|
9240 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 32.2
|
11900 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 22.6
|
15600 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 24.5
|
SECONDARY outcome
Timeframe: -0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h and 23.5h after first dosing on Day1.Population: Pharmacokinetic analysis set (PKS): all subjects from the treated set (TS) who provided at least one evaluable secondary pharmacokinetic endpoint and did not have an important protocol deviation relevant for the evaluation of pharmacokinetics. Arm: BI 730357 50mg/Placebo: This arm comprised 1 subject that was excluded from the PKS due the important protocol deviation of having received a mixed treatment (placebo and investigational drug), therefore was not included in the PK analysis.
Maximum measured concentration of the analyte BI 730357 in plasma after administration of the first dose (Cmax)
Outcome measures
| Measure |
BI 730357 200 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 400 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 25 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 25 mg Fast
n=8 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=8 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 50 mg Fed
n=9 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast.
|
BI 730357 100 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the Analyte BI 730357 in Plasma After Administration of the First Dose (Cmax)
|
—
|
—
|
143 Nanomole (nmol)/liter(L)
Geometric Coefficient of Variation 25.4
|
247 Nanomole (nmol)/liter(L)
Geometric Coefficient of Variation 37.6
|
368 Nanomole (nmol)/liter(L)
Geometric Coefficient of Variation 34.8
|
408 Nanomole (nmol)/liter(L)
Geometric Coefficient of Variation 32.5
|
537 Nanomole (nmol)/liter(L)
Geometric Coefficient of Variation 26.8
|
953 Nanomole (nmol)/liter(L)
Geometric Coefficient of Variation 36.5
|
1320 Nanomole (nmol)/liter(L)
Geometric Coefficient of Variation 24.0
|
SECONDARY outcome
Timeframe: Day 14 and Day 28 (Please refer description for the time frame in detail)Population: Pharmacokinetic analysis set (PKS): all subjects from the treated set (TS) who provided at least one evaluable secondary pharmacokinetic endpoint and did not have an important protocol deviation relevant for the evaluation of pharmacokinetics. Arm: BI 730357 50mg/Placebo: This arm comprised 1 subject that was excluded from the PKS due the important protocol deviation of having received a mixed treatment (placebo and investigational drug), therefore was not included in the PK analysis.
Area under the concentration-time curve of BI 730357 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after last dose administration is reported. τ for 25, 50, 100 , 200 and 400 mg dose groups is: 24 hours (h). Time Frame: For 25, 50, and 100 mg dose groups: -0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h, 23.5h, 47.5 and 71.5 h after last dose on Day14. For 200 and 400 mg dose groups: -0.5h before last dose and 1.0h, 2.0h, 3.0h, 4.0h and 24.0h after last dose on Day28.
Outcome measures
| Measure |
BI 730357 200 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 400 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 25 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 25 mg Fast
n=8 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=8 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 50 mg Fed
n=7 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast.
|
BI 730357 100 mg Fast
n=8 Participants
Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 730357 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After Last Dose Administration.
|
—
|
—
|
4200 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 50.0
|
7550 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 30.3
|
9950 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 29.4
|
14100 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 24.5
|
14600 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 45.0
|
29700 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 30.0
|
31400 Nanomole (nmol)·hour (h)/ liter(L)
Geometric Coefficient of Variation 38.2
|
SECONDARY outcome
Timeframe: Day 14 and Day 28 (Please refer description for the time frame in detail)Population: Pharmacokinetic analysis set (PKS): all subjects from the treated set (TS) who provided at least one evaluable secondary pharmacokinetic endpoint and did not have an important protocol deviation relevant for the evaluation of pharmacokinetics. Arm: BI 730357 50mg/Placebo: This arm comprised 1 subject that was excluded from the PKS due the important protocol deviation of having received a mixed treatment (placebo and investigational drug), therefore was not included in the PK analysis.
Maximum measured concentration of BI 730357 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after last dose administration is reported. τ for 25, 50, 100 , 200 and 400 mg dose groups is: 24 hours (h). Time Frame: For 25, 50, and 100 mg dose groups:-0.5h before dosing and 0.25h, 0.5h, 1h, 1.5h, 2 h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 12h, 23.5h, 47.5 and 71.5 h after last dose on Day14. For 200 and 400 mg dose groups: -0.5h before last dose and 1.0h, 2.0h, 3.0h, 4.0h and 24.0h after last dose on Day28.
Outcome measures
| Measure |
BI 730357 200 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 400 mg Fed
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 25 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 25 mg Fast
n=8 Participants
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 50 mg Fast
n=8 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 50 mg Fed
n=9 Participants
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast.
|
BI 730357 100 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours
|
BI 730357 200 mg Fast
n=9 Participants
Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the Analyte BI 730357 in Plasma at Steady State Over a Uniform Dosing Interval τ After the Last Dose (Cmax,ss)
|
—
|
—
|
277 Nanomole (nmol)/ liter(L)
Geometric Coefficient of Variation 37.6
|
474 Nanomole (nmol)/ liter(L)
Geometric Coefficient of Variation 26.7
|
697 Nanomole (nmol)/ liter(L)
Geometric Coefficient of Variation 26.5
|
793 Nanomole (nmol)/ liter(L)
Geometric Coefficient of Variation 29.2
|
948 Nanomole (nmol)/ liter(L)
Geometric Coefficient of Variation 37.5
|
1840 Nanomole (nmol)/ liter(L)
Geometric Coefficient of Variation 27.8
|
2260 Nanomole (nmol)/ liter(L)
Geometric Coefficient of Variation 25.8
|
Adverse Events
Placebo Fast
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Fed
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 730357 25 mg Fast
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 730357 50 mg Fast
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 730357 50 mg Fed
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 730357 100 mg Fast
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 730357 200 mg Fast
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BI 730357 200 mg Fed
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 730357 400 mg Fed
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Fast
n=12 participants at risk
Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after a fasting period of at least 6 hours.
|
Placebo Fed
n=9 participants at risk
Subjects were orally administered matching Placebo to BI 730357, film-coated tablet after the intake of a standard continental breakfast.
|
BI 730357 25 mg Fast
n=9 participants at risk
Subjects were orally administered BI 730357 25 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 50 mg Fast
n=10 participants at risk
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 50 mg Fed
n=8 participants at risk
Subjects were orally administered BI 730357 50 mg, film-coated tablet once daily over 14 days after the intake of a standard continental breakfast.
|
BI 730357 100 mg Fast
n=9 participants at risk
Subjects were orally administered BI 730357 100 mg, film-coated tablet once daily over 14 days after a fasting period of at least 6 hours.
|
BI 730357 200 mg Fast
n=9 participants at risk
Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after a fasting period of at least 6 hours.
|
BI 730357 200 mg Fed
n=9 participants at risk
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 200 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
BI 730357 400 mg Fed
n=9 participants at risk
Subjects were orally administered a microdose of midazolam 75 microgram (75 μg) solution for injection, orally on Day -1, and prior receiving BI 730357 on Days 3, and 14. Subjects were orally administered BI 730357 400 mg, film-coated tablet once daily over 28 days after the intake of a standard continental breakfast.
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Nervous system disorders
Headache
|
33.3%
4/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
33.3%
3/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
22.2%
2/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
30.0%
3/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
12.5%
1/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
22.2%
2/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
44.4%
4/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
22.2%
2/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
22.2%
2/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Nervous system disorders
Ageusia
|
8.3%
1/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
10.0%
1/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
25.0%
2/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
22.2%
2/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
22.2%
2/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
12.5%
1/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
12.5%
1/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
10.0%
1/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
22.2%
2/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
10.0%
1/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
25.0%
2/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Infections and infestations
Hordeolum
|
8.3%
1/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
22.2%
2/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
10.0%
1/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
12.5%
1/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
10.0%
1/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
10.0%
1/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
1/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
22.2%
2/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
10.0%
1/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.3%
1/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
12.5%
1/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
12.5%
1/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
General disorders
Chills
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
General disorders
Fatigue
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
10.0%
1/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
General disorders
Malaise
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
12.5%
1/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
General disorders
Pyrexia
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
12.5%
1/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
11.1%
1/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
|
Immune system disorders
Seasonal allergy
|
8.3%
1/12 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/10 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/8 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
0.00%
0/9 • From first drug administration until 7 days after last dose, up to 21 days (for 25, 50 and 100 mg dose groups) and up to 35 days (for 200 and 400 mg dose groups)
Treated Set: This subject set included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. (One subject was orally administered mixed treatment of BI 730357 50 mg fast and placebo fast, thus evaluated twice in each respective treatment arm).
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
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