Trial Outcomes & Findings for A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease (NCT NCT05970640)
NCT ID: NCT05970640
Last Updated: 2025-12-05
Results Overview
Number of subjects with drug-related adverse events (AEs) occurring between first administration of trial medication (BI 3006337 or placebo) and end of study (EOS) is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
From drug administration of BI 3006337 until end of the treatment, up to 99 days
Results posted on
2025-12-05
Participant Flow
This study was single-blind and randomised trial with placebo matching the dose of BI 3006337 as comparator. Treatment allocation was performed within each dose group in a 5:2 ratio (BI 3006337 to placebo). Participants were included in the trial once they had signed the informed consent. The trial consisted of a screening period of up to 6 weeks to assess participant eligibility, a treatment period of 12 weeks and a follow-up period of 3 weeks.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Of 64 enrolled, 63 began treatment; one participant in the BI 3006337 150 mg group withdrew consent before Day -1 and underwent no procedures.
Participant milestones
| Measure |
BI 3006337 50 mg
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
|
BI 3006337 100 mg
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
|
BI 3006337 150 mg
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
|
Placebo
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
23
|
19
|
|
Overall Study
COMPLETED
|
10
|
7
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
3
|
2
|
Reasons for withdrawal
| Measure |
BI 3006337 50 mg
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
|
BI 3006337 100 mg
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
|
BI 3006337 150 mg
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
|
Placebo
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
|
Overall Study
Sponsor decision
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease
Baseline characteristics by cohort
| Measure |
BI 3006337 50 mg
n=11 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
|
BI 3006337 100 mg
n=10 Participants
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
|
BI 3006337 150 mg
n=23 Participants
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
|
Placebo
n=19 Participants
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 9.3 • n=9 Participants
|
45.5 years
STANDARD_DEVIATION 16.1 • n=6 Participants
|
54.4 years
STANDARD_DEVIATION 11.9 • n=9 Participants
|
51.5 years
STANDARD_DEVIATION 14.0 • n=205 Participants
|
50.0 years
STANDARD_DEVIATION 13.4 • n=16 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
10 Participants
n=205 Participants
|
26 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
14 Participants
n=9 Participants
|
9 Participants
n=205 Participants
|
37 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
15 Participants
n=205 Participants
|
52 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=205 Participants
|
11 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
23 Participants
n=9 Participants
|
17 Participants
n=205 Participants
|
59 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: From drug administration of BI 3006337 until end of the treatment, up to 99 daysPopulation: Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
Number of subjects with drug-related adverse events (AEs) occurring between first administration of trial medication (BI 3006337 or placebo) and end of study (EOS) is reported.
Outcome measures
| Measure |
BI 3006337 100 mg
n=10 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
|
BI 3006337 150 mg
n=23 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
|
BI 3006337 50 mg
n=11 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
|
Placebo
n=19 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
|
|---|---|---|---|---|
|
Number of Subjects With Drug-related Adverse Events (AEs)
|
8 Participants
|
14 Participants
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 and 504 hours after drug administration in week 12Population: Pharmacokinetic parameter analysis set (PKS): This set includes all trial participants in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One subject from the 50 mg arm was excluded from the analysis due to a missing sample, which precluded characterization of the elimination phase.
Area under the concentration-time curve of BI 3006337 in serum over the dosing interval tau at steady state (AUCτ,ss) after the last dose in Week 12 is reported.
Outcome measures
| Measure |
BI 3006337 100 mg
n=7 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
|
BI 3006337 150 mg
n=19 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
|
BI 3006337 50 mg
n=9 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
|
Placebo
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Dosing Interval Tau at Steady State (AUCτ,ss) After the Last Dose in Week 12
|
38800 Hour*Microgram/Liter
Geometric Coefficient of Variation 81.1
|
67100 Hour*Microgram/Liter
Geometric Coefficient of Variation 50.4
|
21000 Hour*Microgram/Liter
Geometric Coefficient of Variation 57.3
|
—
|
SECONDARY outcome
Timeframe: 0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 hours after drug administration in week 12Population: Pharmacokinetic parameter analysis set (PKS): This set includes all trial participants in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 3006337 in serum at steady state (Cmax,ss) after the last dose in Week 12 is reported.
Outcome measures
| Measure |
BI 3006337 100 mg
n=7 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
|
BI 3006337 150 mg
n=19 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
|
BI 3006337 50 mg
n=10 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
|
Placebo
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Cmax,ss) After the Last Dose in Week 12
|
761 Microgram/Liter
Geometric Coefficient of Variation 64.9
|
1060 Microgram/Liter
Geometric Coefficient of Variation 64.2
|
312 Microgram/Liter
Geometric Coefficient of Variation 87.7
|
—
|
SECONDARY outcome
Timeframe: 0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 hours after drug administration in week 12Population: Pharmacokinetic parameter analysis set (PKS): This set includes all trial participants in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Time from dosing to the maximum measured concentration of BI 3006337 in serum at steady state (tmax,ss) after the last dose in Week 12 is reported.
Outcome measures
| Measure |
BI 3006337 100 mg
n=7 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
|
BI 3006337 150 mg
n=19 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
|
BI 3006337 50 mg
n=10 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
|
Placebo
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
|
|---|---|---|---|---|
|
Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Tmax,ss) After the Last Dose in Week 12
|
15 Hour
Interval 3.0 to 35.0
|
27 Hour
Interval 7.0 to 47.0
|
13 Hour
Interval 11.0 to 47.0
|
—
|
SECONDARY outcome
Timeframe: Baseline (-48 to -4): the last observed measurement prior to drug administration, Day 85Population: Treated set (TS): The TS includes all subjects from the randomised set who are treated with at least one dose of study medication. The treatment assignment will be determined based on the first treatment the trial subjects received. The TS is the basis for safety analyses. The main efficacy analysis was conducted using the Treated Set and excluded all participants who discontinued due to Coronavirus disease 2019 (COVID-19). Only subjects with available data at baseline and week 12 were included.
Relative percentage change in liver steatosis from baseline after 12 weeks of treatment is reported. Liver steatosis is measured by Magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Outcome measures
| Measure |
BI 3006337 100 mg
n=10 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
|
BI 3006337 150 mg
n=22 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
|
BI 3006337 50 mg
n=10 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
|
Placebo
n=18 Participants
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
|
|---|---|---|---|---|
|
Relative Percentage Change in Liver Steatosis From Baseline After 12 Weeks of Treatment
|
-16.59 Percent change
Standard Deviation 40.28
|
-39.21 Percent change
Standard Deviation 14.73
|
-13.01 Percent change
Standard Deviation 21.92
|
6.13 Percent change
Standard Deviation 35.24
|
Adverse Events
BI 3006337 50 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
BI 3006337 100 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 3006337 150 mg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 3006337 50 mg
n=11 participants at risk
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
|
BI 3006337 100 mg
n=10 participants at risk
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
|
BI 3006337 150 mg
n=23 participants at risk
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
|
Placebo
n=19 participants at risk
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
|
|---|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
4.3%
1/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
Other adverse events
| Measure |
BI 3006337 50 mg
n=11 participants at risk
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
|
BI 3006337 100 mg
n=10 participants at risk
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
|
BI 3006337 150 mg
n=23 participants at risk
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
|
Placebo
n=19 participants at risk
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
20.0%
2/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
18.2%
2/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
20.0%
2/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
4.3%
1/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
4.3%
1/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal wall pain
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
20.0%
2/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
4.3%
1/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
3/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
30.0%
3/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
8.7%
2/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.5%
2/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
17.4%
4/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
4.3%
1/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
40.0%
4/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
8.7%
2/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
20.0%
2/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
4.3%
1/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
General disorders
Chest discomfort
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
General disorders
Chills
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
General disorders
Fatigue
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
General disorders
Injection site erythema
|
27.3%
3/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
30.0%
3/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
8.7%
2/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
General disorders
Injection site pain
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
General disorders
Injection site pruritus
|
18.2%
2/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
8.7%
2/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
General disorders
Injection site reaction
|
27.3%
3/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
50.0%
5/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
26.1%
6/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.5%
2/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Immune system disorders
Sunscreen sensitivity
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Infections and infestations
COVID-19
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
4.3%
1/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
15.8%
3/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.5%
2/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Infections and infestations
Viral infection
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
8.7%
2/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Investigations
Lipase increased
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
20.0%
2/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
17.4%
4/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
17.4%
4/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperphagia
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Increased appetite
|
36.4%
4/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
8.7%
2/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
4.3%
1/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.5%
2/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
8.7%
2/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
20.0%
2/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
21.7%
5/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
21.1%
4/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
18.2%
2/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Renal and urinary disorders
Crystalluria
|
9.1%
1/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
13.0%
3/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
10.0%
1/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
8.7%
2/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/10 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
0.00%
0/23 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
5.3%
1/19 • From drug administration of BI 3006337 until end of the treatment, up to 99 days
Treated set (TS): TS includes all subjects from the randomised set who are treated with at least one dose of study medication.
|
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