Trial Outcomes & Findings for A Study to Test How Well Men Tolerate Different Doses of BI 3006337 (NCT NCT05076422)
NCT ID: NCT05076422
Last Updated: 2026-01-08
Results Overview
Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
From 1 day pre-dose till end of trial, up to 40 days
Results posted on
2026-01-08
Participant Flow
This was a single-blind, partially randomized within dose groups, placebo-controlled, single rising dose, parallel (sequential) group study in healthy male participants.
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.
Participant milestones
| Measure |
Placebo
This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.2 mg
Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.5 mg
Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 1 mg
Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 2 mg
Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 4 mg
Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 8 mg
Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 15 mg
Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 30 mg
Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 50 mg
Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 100 mg
Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 150 mg
Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
5
|
6
|
5
|
6
|
5
|
4
|
5
|
4
|
6
|
6
|
9
|
|
Overall Study
COMPLETED
|
19
|
5
|
6
|
5
|
6
|
5
|
4
|
5
|
4
|
6
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Test How Well Men Tolerate Different Doses of BI 3006337
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.2 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.5 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 1 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 2 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 4 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 8 mg
n=4 Participants
Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 15 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 30 mg
n=4 Participants
Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 50 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 100 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 150 mg
n=9 Participants
Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 9.7 • n=18 Participants
|
43.0 years
STANDARD_DEVIATION 5.4 • n=17 Participants
|
42.7 years
STANDARD_DEVIATION 6.2 • n=35 Participants
|
44.8 years
STANDARD_DEVIATION 6.9 • n=42 Participants
|
46.3 years
STANDARD_DEVIATION 6.5 • n=217 Participants
|
41.6 years
STANDARD_DEVIATION 8.8 • n=1518 Participants
|
44.8 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 5.3 • n=4 Participants
|
33.0 years
STANDARD_DEVIATION 14.2 • n=48 Participants
|
41.2 years
STANDARD_DEVIATION 9.0 • n=10 Participants
|
39.5 years
STANDARD_DEVIATION 13.9 • n=119 Participants
|
37.2 years
STANDARD_DEVIATION 12.1 • n=301 Participants
|
41.0 years
STANDARD_DEVIATION 9.6 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
6 Participants
n=35 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=217 Participants
|
5 Participants
n=1518 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=48 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=119 Participants
|
9 Participants
n=301 Participants
|
80 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
6 Participants
n=35 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=217 Participants
|
5 Participants
n=1518 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=48 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=119 Participants
|
9 Participants
n=301 Participants
|
78 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
5 Participants
n=35 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=217 Participants
|
5 Participants
n=1518 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=48 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=119 Participants
|
9 Participants
n=301 Participants
|
74 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From 1 day pre-dose till end of trial, up to 40 daysPopulation: Treated set (TS): The treated set included all subjects who were entered and treated with any dose of the trial drug or placebo.
Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
Outcome measures
| Measure |
Placebo
n=19 Participants
This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.2 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.5 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 1 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 2 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 4 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 8 mg
n=4 Participants
Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 15 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 30 mg
n=4 Participants
Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 50 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 100 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 150 mg
n=9 Participants
Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value.
Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity is reported (AUC0-∞).
Outcome measures
| Measure |
Placebo
n=5 Participants
This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.2 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.5 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 1 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 2 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 4 mg
n=4 Participants
Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 8 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 15 mg
n=4 Participants
Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 30 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 50 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 100 mg
n=9 Participants
Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 150 mg
Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
NA hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation NA
PK parameter could not be determined as too many samples had below limit of quantification concentrations.
|
NA hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation NA
PK parameter could not be determined as too many samples had below limit of quantification concentrations.
|
534 hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation 20.7
|
1200 hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation 52.8
|
2870 hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation 32.5
|
3190 hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation 44.9
|
7920 hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation 26.5
|
15100 hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation 38.4
|
40100 hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation 44.2
|
71300 hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation 37.9
|
80600 hour*nanogram per milliliter (h‧ng/mL)
Geometric Coefficient of Variation 34.6
|
—
|
SECONDARY outcome
Timeframe: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value to the statistical assessment.
Maximum measured concentration of BI 3006337 in serum (Cmax) is reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.2 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.5 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 1 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 2 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 4 mg
n=4 Participants
Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 8 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 15 mg
n=4 Participants
Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 30 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 50 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 100 mg
n=9 Participants
Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 150 mg
Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 3006337 in Serum (Cmax)
|
1.78 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 43.5
|
4.38 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 75.1
|
4.70 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 34.2
|
14.5 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 63.7
|
37.3 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 79.3
|
50.8 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 18.7
|
127 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 42.2
|
220 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 37.5
|
642 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 49.6
|
788 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 63.0
|
1290 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 54.6
|
—
|
SECONDARY outcome
Timeframe: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value to the statistical assessment.
Time from dosing to the maximum measured concentration of BI 3006337 in serum (tmax) is reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.2 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 0.5 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 1 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 2 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 4 mg
n=4 Participants
Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 8 mg
n=5 Participants
Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 15 mg
n=4 Participants
Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 30 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 50 mg
n=6 Participants
Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 100 mg
n=9 Participants
Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 3006337 150 mg
Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax)
|
7.0 hour (h)
Interval 7.0 to 27.1
|
15.0 hour (h)
Interval 7.0 to 23.1
|
11.0 hour (h)
Interval 7.0 to 72.0
|
15.0 hour (h)
Interval 7.0 to 35.0
|
11.0 hour (h)
Interval 11.0 to 15.1
|
13.0 hour (h)
Interval 11.0 to 23.2
|
11.0 hour (h)
Interval 7.0 to 11.1
|
13.0 hour (h)
Interval 11.0 to 31.0
|
11.0 hour (h)
Interval 11.0 to 27.0
|
61.5 hour (h)
Interval 11.1 to 96.4
|
11.0 hour (h)
Interval 7.0 to 35.0
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 0.2mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 0.5mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 2mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 4mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 8mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 15mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 30mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 50mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 100mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 150mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=19 participants at risk
This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 0.2mg
n=5 participants at risk
Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 0.5mg
n=6 participants at risk
Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 1mg
n=5 participants at risk
Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 2mg
n=6 participants at risk
Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 4mg
n=5 participants at risk
Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 8mg
n=4 participants at risk
Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 15mg
n=5 participants at risk
Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 30mg
n=4 participants at risk
Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 50mg
n=6 participants at risk
Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 100mg
n=6 participants at risk
Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
BI 150mg
n=9 participants at risk
Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
20.0%
1/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
20.0%
1/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
11.1%
1/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
General disorders
Catheter site induration
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
11.1%
1/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
General disorders
Inflammation
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
General disorders
Injection site bruising
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
11.1%
1/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
General disorders
Injection site reaction
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
General disorders
Medical device site irritation
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
20.0%
1/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
General disorders
Medical device site pruritus
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
20.0%
1/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
11.1%
1/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Infections and infestations
COVID-19
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
11.1%
1/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
20.0%
1/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
20.0%
1/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
22.2%
2/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Infections and infestations
Wound infection
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Investigations
Amylase increased
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
11.1%
1/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Investigations
Electrocardiogram QRS complex abnormal
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
11.1%
1/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
20.0%
1/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Investigations
Lipase increased
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
40.0%
2/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
General disorders
Asthenia
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
20.0%
1/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
20.0%
1/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
11.1%
1/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
16.7%
1/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Eye disorders
Dry eye
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Gastrointestinal disorders
Toothache
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Infections and infestations
Furuncle
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Infections and infestations
Gingivitis
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Infections and infestations
Pustule
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
5.3%
1/19 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/5 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/4 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/6 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
0.00%
0/9 • From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
|
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